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65 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Idhifa (enasidenib) / BMS, Servier
IDHENTIFY, NCT02577406 / 2015-000344-42: An Efficacy and Safety Study of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation

Checkmark From IDHENTIFY trial in combination with best supportive care vs. conventional care regimens in r/r AML
Aug 2020 - Aug 2020: From IDHENTIFY trial in combination with best supportive care vs. conventional care regimens in r/r AML
Checkmark Study initiation in relapsed AML patients with an IDH2 mutation
Oct 2015 - Oct 2015: Study initiation in relapsed AML patients with an IDH2 mutation
Completed
3
319
Europe, Canada, US, RoW
AG-221, BSC, Azacitidine, Low-dose cytarabine (LDAC), Intermediate-dose cytarabine (IDAC)
Celgene
Leukemia, Myeloid, Isocitrate Dehydrogenase
03/20
03/24
HOVON150AML, NCT03839771 / 2018-000451-41: A Study of Ivosidenib or Enasidenib in Combination With Induction Therapy and Consolidation Therapy, Followed by Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myedysplastic Syndrome EB2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy

Checkmark Initiation of P3 HOVON 150 AML/AMLSG 29-18 trial in frontline AML patients with IDH1/IDH2 mutation
Jul 2019 - Jul 2019: Initiation of P3 HOVON 150 AML/AMLSG 29-18 trial in frontline AML patients with IDH1/IDH2 mutation
Active, not recruiting
3
968
Europe, RoW
AG-120, Ivosidenib, Placebo for AG-120, AG-221, Enasidenib, Placebo for AG-221
Stichting Hemato-Oncologie voor Volwassenen Nederland, Deutsch-Österreichische Studiengruppe Akute Myeloische Leukämie (AMLSG)
Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blasts-2
04/27
09/34
ACTRN12619001031156: A placebo controlled study to compare ivosidenib or enasidenib in patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome.

Active, not recruiting
3
968
 
HOVON (the Haemato Oncology Foundation for Adults in the Netherlands), HOVON (the Haemato Oncology Foundation for Adults in the Netherlands), Leukemia Foundation
Acute myeloid leukaemia, Myelodysplastic syndrome
 
 
2018-001693-25: study of the efficacy of treatment with AG-221 in patients with myelodysplastic syndrome and mutation IDH2

Not yet recruiting
2
68
Europe
Enasidenib, Film-coated tablet
Groupe Francophone des Myelodysplasies, celgene
Myelodysplastic syndromes, mutation IDH-2, inhibitor IDH-2, Myelodysplastic syndromes, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
2019-001416-30: Trial evaluating the safety and efficacy of Enasidenib for the treatment of recurrence or prophylactic treatment of certain forms of leukemia following blood stem cell transplantation. Studie zur Bewertung der Sicherheit und Wirksamkeit von Enasidenib zur Behandlung von Rückfällen oder zur vorbeugenden Behandlung bestimmter Formen von Leukämie nach einer Blutstammzelltransplantation.

Not yet recruiting
2
50
Europe
Enasidenib, Film-coated tablet
Heinrich-Heine-University Düsseldorf represented by the Coordinating Investigator, Celgene International II Sàrl
Patients with myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML) or acute myelogenous leukemia (AML) after allogeneic stem cell transplantation (allo-SCT) and with an IDH2 mutation (IDH2 R172 or R140 mutation) Patienten mit myelodysplastischem Syndrom (MDS), chronischer myelomonozytärer Leukämie (CMML) oder akuter myeloischer Leukämie (AML) nach allogener Stammzelltransplantation (allo-SCT) und einer IDH2-Mutation (IDH2 R172 oder R140-Mutation), Patients with certain forms of leukemia after stem cell transplantation Patienten mit bestimmten Formen von Leukämie nach Stammzelltransplantation, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
IDEAL Study, NCT03744390: IDH2 (AG 221) Inhibitor in Patients With IDH2 Mutated Myelodysplastic Syndrome

Active, not recruiting
2
68
Europe
AG-221, Enasidenib
Groupe Francophone des Myelodysplasies
Myelodysplastic Syndromes, Leukemia Acute Myeloid
02/23
03/26
NCT03728335: Enasidenib (AG-221) Maintenance Post Allogeneic HCT in Patients With IDH2 Mutation

Recruiting
2
35
US
Enasidenib Mesylate, 2-Methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol Methanesulfonate, 2-Propanol, 2-Methyl-1-((4-(6-(trifluoromethyl)-2-pyridinyl)-6-((2-(trifluoromethyl)-4-pyridinyl)amino)-1,3,5-triazin-2-yl)amino)-, Methanesulfonate (1:1), AG-221 Mesylate, CC-90007, Enasidenib Methanesulfonate, Idhifa
City of Hope Medical Center, National Cancer Institute (NCI)
Acute Myeloid Leukemia
01/27
01/27
NCT06176989: Enasidenib in IDH2-Mutated Malignant Sinonasal and Skull Base Tumors

Recruiting
2
40
US
Enasidenib
National Cancer Institute (NCI)
Metastatic Chondrosarcoma, Locally Advanced Chondrosarcoma, Metastatic Sinonasal Adenocarcinoma, Locally Advanced Sinonasal Adenocarcinoma, Metastatic Large-cell Neuroendocrine Carcinoma, Locally Advanced Large-cell Neuroendocrine Carcinoma, Metastatic Olfactory Neuroblastoma, Locally Advanced Olfactory Neuroblastoma, Metastatic Sinonasal Undifferentiated Carcinoma, Locally Advanced Sinonasal Undifferentiated Carcinoma
12/27
12/30
MPN-RC 119, NCT04281498: Combined Ruxolitinib and Enasidenib in Patients With Accelerated/Blast-phase Myeloproliferative Neoplasm or Chronic-phase Myelofibrosis With an IDH2 Mutation

Completed
2
6
Canada, US
Ruxolitinib, Enasidenib
John Mascarenhas, Celgene Corporation, Incyte Corporation, Myeloproliferative Neoplasms Research Consortium, National Institutes of Health (NIH), National Cancer Institute (NCI)
Accelerated/Blast-phase Myeloproliferative Neoplasm, Chronic-phase Myelofibrosis, IDH2 Mutation
05/23
05/23
NCT04522895: IDH2-Post-Allo-Trial for Patients with IDH2-mut Myeloid Neoplasms After Allo-SCT

Completed
2
50
Europe
Enasidenib
Heinrich-Heine University, Duesseldorf, Celgene Corporation, Koordinierungszentrum für Klinische Studien Düsseldorf
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, IDH2 Gene Mutation, IDH2 R172, IDH2 R140
07/24
07/24
NCI-2018-02998, NCT03825796: CPX-351 Plus Enasidenib for Relapsed AML

Active, not recruiting
2
2
US
Enasidenib Mesylate, 2-Methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol Methanesulfonate, 2-Propanol, 2-Methyl-1-((4-(6-(trifluoromethyl)-2-pyridinyl)-6-((2-(trifluoromethyl)-4-pyridinyl)amino)-1,3,5-triazin-2-yl)amino)-, Methanesulfonate (1:1), AG-221 Mesylate, CC-90007, Enasidenib Methanesulfonate, Idhifa, Liposome-encapsulated Daunorubicin-Cytarabine, CPX-351, Cytarabine-Daunorubicin Liposome for Injection, Liposomal AraC-Daunorubicin CPX-351, Liposomal Cytarabine-Daunorubicin, Liposome-encapsulated Combination of Daunorubicin and Cytarabine, Vyxeos
Jonsson Comprehensive Cancer Center, Jazz Pharmaceuticals
Recurrent Acute Myeloid Leukemia
09/24
09/24
NCT06240754: Enasidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH2A Decentralized Trial

Recruiting
2
15
US
Enasidenib
Washington University School of Medicine, Bristol-Myers Squibb, Damon Runyon Cancer Research Foundation
Clonal Cytopenia of Undetermined Significance, CCUS Clonal Cytopenia of Undetermined Significance
09/26
10/26
NCT06756308: A Study of Enasidenib in People With T-Cell Lymphoma

Recruiting
2
25
US
Enasidenib, Rituximab
Memorial Sloan Kettering Cancer Center, Bristol-Myers Squibb, The Leukemia and Lymphoma Society
T-cell Lymphoma
12/27
12/27
P30CA016672, NCT03383575: Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome

Recruiting
2
63
US
Azacitidine, 5 AZC, 5-AC, 5-Azacytidine, 5-AZC, Azacytidine, Azacytidine, 5-, Ladakamycin, Mylosar, U-18496, Vidaza, Enasidenib, AG-221, CC-90007, Quality-of-Life Assessment, Quality of Life Assessment
M.D. Anderson Cancer Center, National Cancer Institute (NCI), Celgene
Acute Myeloid Leukemia, Blasts 20-30 Percent of Bone Marrow Nucleated Cells, Chronic Myelomonocytic Leukemia, IDH2 Gene Mutation, Myelodysplastic Syndrome With Excess Blasts, Recurrent High Risk Myelodysplastic Syndrome, Refractory High Risk Myelodysplastic Syndrome
02/27
02/27
NCT06672146: Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial)

Recruiting
2
93
US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Biopsy of Bone Marrow, Biopsy, Bone Marrow, Decitabine and Cedazuridine, ASTX 727, ASTX-727, ASTX727, C-DEC, CDA Inhibitor E7727/Decitabine Combination Agent ASTX727, Cedazuridine/Decitabine Combination Agent ASTX727, Cedazuridine/Decitabine Tablet, DEC-C, Inaqovi, Inqovi, Enasidenib, AG 221, AG-221, AG221, CC-90007 Free Base, Venetoclax, ABT 199, ABT-0199, ABT-199, ABT199, GDC 0199, GDC-0199, GDC0199, RG7601, Venclexta, Venclyxto
National Cancer Institute (NCI)
Acute Myeloid Leukemia
03/27
03/27
MyeloMATCH, NCT06577441: Testing the Addition of an IDH2 Inhibitor, Enasidenib, to Usual Treatment (Cedazuridine-Decitabine) for Higher-Risk Myelodysplastic Syndrome (MDS) With IDH2 Mutation (A Treatment Trial)

Recruiting
2
54
US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Biopsy of Bone Marrow, Biopsy, Bone Marrow, Decitabine and Cedazuridine, ASTX 727, ASTX-727, ASTX727, C-DEC, CDA Inhibitor E7727/Decitabine Combination Agent ASTX727, Cedazuridine/Decitabine Combination Agent ASTX727, Cedazuridine/Decitabine Tablet, DEC-C, Inaqovi, Inqovi, Enasidenib, AG 221, AG-221, AG221, CC-90007 Free Base
National Cancer Institute (NCI)
Myelodysplastic Syndrome
03/27
03/27
NCI-2018-01919, NCT03683433: Enasidenib and Azacitidine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia and IDH2 Gene Mutation

Recruiting
2
50
US
Azacitidine, 5 AZC, 5-AC, 5-Azacytidine, 5-AZC, Azacytidine, Azacytidine, 5-, Ladakamycin, Mylosar, U-18496, Vidaza, Enasidenib Mesylate, 2-Methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol Methanesulfonate, 2-Propanol, 2-Methyl-1-((4-(6-(trifluoromethyl)-2-pyridinyl)-6-((2-(trifluoromethyl)-4-pyridinyl)amino)-1,3,5-triazin-2-yl)amino)-, Methanesulfonate (1:1), AG-221 Mesylate, CC-90007, Enasidenib Methanesulfonate, Idhifa
M.D. Anderson Cancer Center, National Cancer Institute (NCI)
Acute Bilineal Leukemia, Acute Biphenotypic Leukemia, Chronic Myelomonocytic Leukemia, IDH2 Gene Mutation, Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
09/25
09/25
I-DATA, NCT05401097: IDH Targeted/Non- Targeted vs Non-targeted/IDH-targeted Approaches in the Treatment of Newly Diagnosed IDH Mutated AML Patients Not Candidates for Intensive Induction Therapy (I- DATA Study)

Recruiting
2
125
US
Azacitidine, 5 AZC, 5-AC, 5-Azacytidine, 5-AZC, Azacytidine, Azacytidine, 5-, Ladakamycin, Mylosar, Onureg, U-18496, Vidaza, Biopsy, BIOPSY_TYPE, Bx, Enasidenib, AG-221, CC-90007 Free Base, Ivosidenib, AG-120, Tibsovo, Venetoclax, ABT-0199, ABT-199, ABT199, GDC-0199, RG7601, Venclexta, Venclyxto
Alice Mims, National Cancer Institute (NCI)
Acute Myeloid Leukemia
09/27
06/29
NCT04203316: Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With an IDH2 Mutation

Active, not recruiting
2
10
Canada, US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Biopsy of Bone Marrow, Biopsy, Bone Marrow, Enasidenib, AG 221, AG-221, AG221, CC-90007 Free Base, Enasidenib Mesylate, 2-Methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol Methanesulfonate, 2-Propanol, 2-Methyl-1-((4-(6-(trifluoromethyl)-2-pyridinyl)-6-((2-(trifluoromethyl)-4-pyridinyl)amino)-1,3,5-triazin-2-yl)amino)-, Methanesulfonate (1:1), AG-221 Mesylate, CC 90007, CC-90007, CC90007, Enasidenib Methanesulfonate, Idhifa
Children's Oncology Group, National Cancer Institute (NCI)
Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
06/25
06/25
MyeloMATCH, NCT05564390: MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH ( Screening Trial)

Recruiting
2
2000
Canada, US
Allogeneic Hematopoietic Stem Cell Transplantation, Allogeneic, Allogeneic Hematopoietic Cell Transplantation, Allogeneic Stem Cell Transplantation, HSC, HSCT, Stem Cell Transplantation, Allogeneic, Azacitidine, 5 AZC, 5-AC, 5-Azacitidine, 5-Azacytidine, 5-AZC, Azacytidine, Azacytidine, 5-, Ladakamycin, Mylosar, U-18496, Vidaza, Best Practice, standard of care, standard therapy, Biopsy Procedure, Biopsy, BIOPSY_TYPE, Bx, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Biopsy of Bone Marrow, Biopsy, Bone Marrow, Busulfan, 1, 4-Bis[methanesulfonoxy]butane, BUS, Busilvex, Bussulfam, Busulfanum, Busulfex, Busulphan, CB 2041, CB-2041, Glyzophrol, GT 41, GT-41, Joacamine, Methanesulfonic Acid Tetramethylene Ester, Methanesulfonic acid, tetramethylene ester, Mielucin, Misulban, Misulfan, Mitosan, Myeleukon, Myeloleukon, Myelosan, Mylecytan, Myleran, Sulfabutin, Tetramethylene Bis(methanesulfonate), Tetramethylene bis[methanesulfonate], WR-19508, Chest Radiography, Chest X-ray, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Cytarabine, .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-Cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453, Daunorubicin Hydrochloride, Cerubidin, Cerubidine, Cloridrato de Daunorubicina, Daunoblastin, Daunoblastina, Daunoblastine, Daunomycin Hydrochloride, Daunomycin, hydrochloride, Daunorubicin.HCl, Daunorubicini Hydrochloridum, FI-6339, Ondena, RP-13057, Rubidomycin Hydrochloride, Rubilem, Decitabine and Cedazuridine, ASTX 727, ASTX-727, ASTX727, C-DEC, CDA Inhibitor E7727/Decitabine Combination Agent ASTX727, Cedazuridine/Decitabine Combination Agent ASTX727, Cedazuridine/Decitabine Tablet, DEC-C, Inaqovi, Inqovi, Echocardiography Test, EC, Echocardiography, Enasidenib, AG 221, AG-221, AG221, CC-90007 Free Base, Fludarabine, Fluradosa, Gemtuzumab Ozogamicin, Calicheamicin-Conjugated Humanized Anti-CD33 Monoclonal Antibody, CDP-771, CMA-676, gemtuzumab, hP67.6-Calicheamicin, Mylotarg, WAY-CMA-676, Gilteritinib, ASP 2215, ASP-2215, ASP2215, Liposome-encapsulated Daunorubicin-Cytarabine, CPX 351, CPX-351, CPX351, Cytarabine and Daunorubicin Liposomal, Cytarabine-Daunorubicin Liposome for Injection, Daunorubicin and Cytarabine (Liposomal), Liposomal AraC-Daunorubicin CPX-351, Liposomal Cytarabine-Daunorubicin, Liposome-encapsulated Combination of Daunorubicin and Cytarabine, Vyxeos, Melphalan, Alanine Nitrogen Mustard, CB-3025, L-PAM, L-Phenylalanine Mustard, L-Sarcolysin, L-Sarcolysin Phenylalanine mustard, L-Sarcolysine, Melphalan for Injection-Hepatic Delivery System, Melphalanum, Phenylalanine Mustard, Phenylalanine Nitrogen Mustard, Sarcoclorin, Sarkolysin, WR-19813, Multigated Acquisition Scan, Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide Ventriculography, RNV Scan, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning, Mutation Carrier Screening, Placebo Administration, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT, Total-Body Irradiation, SCT_TBI, TBI, Total Body Irradiation, Whole Body, Whole Body Irradiation, Whole-Body Irradiation, Venetoclax, ABT 199, ABT-0199, ABT-199, ABT199, GDC 0199, GDC-0199, GDC0199, RG7601, Venclexta, Venclyxto
National Cancer Institute (NCI)
Acute Myeloid Leukemia, Myelodysplastic Syndrome
05/29
05/29
AG-221-AML-005, NCT02677922 / 2015-003951-23: A Study to Assess the Safety and Efficacy of Two Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Harboring IDH Mutations Who Are Not Candidates to Receive Intensive Induction Chemotherapy

Checkmark In combination with azacitidine for IDH1 mutant AML
Dec 2019 - Dec 2019: In combination with azacitidine for IDH1 mutant AML
Checkmark Mutation clearance and measurable residual disease data from P1b trial at ASH 2019
Dec 2019 - Dec 2019: Mutation clearance and measurable residual disease data from P1b trial at ASH 2019
Checkmark P1b data from P1b/2 trial in combination with azacitidine for newly diagnosed AML at ASCO 2019 [screenshot]
More
Active, not recruiting
1/2
130
Europe, Canada, US, RoW
AG-120, Azacitidine, AG-221
Celgene
Leukemia, Myeloid, Acute
08/18
09/25
AG-221-C-001, NCT01915498: Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation

Checkmark From trial for advanced HM at ASH 2017 [screenshot]
Dec 2017 - Dec 2017: From trial for advanced HM at ASH 2017 [screenshot]
Checkmark R/R AML
Aug 2017 - Aug 2017: R/R AML
Checkmark Data presentation for r/r AML at EHA 2017
More
Completed
1/2
345
Europe, US
Enasidenib, AG-221, IDHIFA
Celgene, Agios Pharmaceuticals, Inc.
Hematologic Neoplasms
07/19
10/23
MyDRUG, NCT03732703: Myeloma-Developing Regimens Using Genomics

Checkmark Data from MyDRUG study for MM at ASH 2022
Dec 2022 - Dec 2022: Data from MyDRUG study for MM at ASH 2022
Completed
1/2
103
US
Abemaciclib, dexamethasone, ixazomib, pomalidomide, abemaciclib: Verzenio, LY2835219, ixazomib: Ninlaro, MLN2238, pomalidomide: Pomalyst, Enasidenib, dexamethasone, ixazomib, pomalidomide, enasidenib: AG221, IDHIFA, Cobimetinib, dexamethasone, ixazomib, pomalidomide, cobimetinib: Cotellic, GDC-0973, RG7420, Erdafitinib, dexamethasone, ixazomib, pomalidomide, erdafitinib: G-024, JNJ-42756493, JNJ-493, Venetoclax, dexamethasone, ixazomib, pomalidomide, venetoclax: Venclexta: ABT-199, Daratumumab, dexamethasone, ixazomib, pomalidomide, daratumumab: Darzalex, Belantamab mafodotin, dexamethasone, ixazomib, pomalidomide, Belantamab mafodotin: BLENREP, GSK2857916, Selinexor, dexamethasone, ixazomib, pomalidomide, Selinexor: XPOVIO
Multiple Myeloma Research Consortium, AbbVie, Celgene Corporation, Eli Lilly and Company, Genentech, Inc., Janssen, LP, Takeda, GlaxoSmithKline, Karyopharm Therapeutics Inc
Relapsed Refractory Multiple Myeloma
12/24
12/24
ENAVEN-AML, NCT04092179: Study of Enasidenib and Venetoclax in IDH2-Mutated Blood Cancers

Terminated
1/2
27
Canada
Enasidenib, IDHIFA, Venetoclax, VENCLEXTA
University Health Network, Toronto, Celgene, AbbVie
Acute Myeloid Leukemia, Relapsed Cancer, Refractory Cancer, IDH2 Gene Mutation
10/23
10/23
Beat AML, NCT03013998: Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

Hourglass Jan 2023 - Mar 2023 : Data from Beat AML trial for acute myeloid leukemia
Recruiting
1/2
2000
US
Samalizumab (BAML-16-001-S1), BI 836858 (BAML-16-001-S2), Laboratory Biomarker Analysis, Daunorubicin (BAML-16-001-S1), Cytarabine (BAML-16-001-S1), Azacitidine (BAML-16-001-S2), AG-221 (BAML-16-001-S3), Enasidenib, Azacitidine (BAML-16-001-S3), Entospletinib (BAML-16-001-S4), GS-9973, ENTO, Azacitidine (BAML-16-001-S4), Entospletinib (BAML-16-001-S5), Decitabine (BAML-16-001-S5), Entospletinib (BAML-16-001-S6), Daunorubicin (BAML-16-001-S6), Cytarabine (BAML-16-001-S6), Pevonedistat (BAML-16-001-S9), TAK-924, MLN4924, Azacitidine (BAML-16-001-S9), AG-120 (BAML-16-001-S16), Azacitidine (BAML-16-001-S16), Gilteritinib (BAML-16-001-S8 Group 1), Decitabine (BAML-16-001-S8 Group 1), AZD5153 (BAML-16-001-S10), Venetoclax (BAML-16-001-S10), TP-0903 (BAML-16-001-S14), Decitabine (BAML-16-001-S14), Decitabine (BAML-16-001-S8 Group 2), Venetoclax (BAML-16-001-S8 Group 2), AZD5991 (BAML-16-001-S18), Azacitidine (BAML-16-001-S18), SNDX-5613 (BAML-16-001-S17), Azacitidine (BAML-16-001-S17), Venetoclax (BAML-16-001-S17), Gilteritinib (BAML-16-001-S8 Group 2), Venetoclax (BAML-16-001-S12 Arm A), Azacitidine (BAML-16-001-S12 Arm A), Venetoclax (BAML-16-001-S12 Arm B), Azacitidine (BAML-16-001-S12 Arm B), ZE46-0134 (BAML-16-001-S21)
Beat AML, LLC
Previously Untreated Relapsed Refractory Acute Myeloid Leukemia
12/26
12/26
NCI-2022-02837, NCT05282459: Enasidenib in MDS &Non-proliferative Chronic Myelomonocytic Leukemia w/o IDH2 Mutation

Completed
1/2
17
US
Enasidenib mesylat dose escalation, (Idhifa, AG 221)
Stanford University, Celgene Corporation
Leukemia, Leukemia, Myeloid, Monocytic Leukemia
12/24
03/25
NCI-2021-00893, NCT04774393: Decitabine/Cedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Recruiting
1/2
84
US
Decitabine and Cedazuridine, ASTX727, CDA Inhibitor E7727/Decitabine Combination Agent ASTX727, Cedazuridine/Decitabine Combination Agent ASTX727, Cedazuridine/Decitabine Tablet, Inqovi, Enasidenib, AG-221, CC-90007 Free Base, Ivosidenib, AG-120, Tibsovo, Venetoclax, ABT-0199, ABT-199, ABT199, GDC-0199, RG7601, Venclexta, Venclyxto
M.D. Anderson Cancer Center
Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
11/25
11/25
ESMART, NCT02813135 / 2016-000133-40: European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors

Recruiting
1/2
455
Europe
Ribociclib, Kisqali, LEE011, Topotecan, Hycamtin, Temozolomide, Temodar, Everolimus, Afinitor, votubia, Adavosertib, AZD1775, Carboplatin, Paraplatin, Olaparib, Lynparza, Irinotecan, Camptosar, CPT-11, Vistusertib, AZD2014, Nivolumab, Opdivo, Cyclophosphamide, Cytoxan, Selumetinib, Koselugo, Enasidenib, Idhifa, Lirilumab, BMS-986015, Fadraciclib, CYC065, Cytarabine, Arabinosylcytosine, Cytosar-U, Dexamethasone, Decadron, Dexasone, Diodex, Hexadrol, Maxidex, Ceralasertib, AZD6738, Futibatinib, Tas-120, Capmatinib, Tabrecta, INC280, Avelumab, BAVENCIO, Peposertib
Gustave Roussy, Cancer Campus, Grand Paris, National Cancer Institute, France
Pediatric Cancer
02/31
02/31
V-FAST master, NCT04075747: A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid Leukemia

Completed
1b
57
US
CPX-351, Vyxeos, JZP351, Venetoclax, Venclexta, Midostaurin, Rydapt, Enasidenib, Idhifa
Jazz Pharmaceuticals
Acute Myeloid Leukemia
02/22
09/23
AG120-221-C-001, NCT02632708: Safety Study of AG-120 or AG-221 in Combination With Induction and Consolidation Therapy in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) With an IDH1 and/or IDH2 Mutation

Checkmark Updated data from P1 trial in combination with chemotherapy in IDH1/2m newly diagnosed AML at ASH 2018 [screenshot]
Dec 2018 - Dec 2018: Updated data from P1 trial in combination with chemotherapy in IDH1/2m newly diagnosed AML at ASH 2018 [screenshot]
Checkmark First data in combination trial of enasidenib or ivosidenib with standard of care intensive chemotherapy at ASH 2017 [screenshot]
Dec 2017 - Dec 2017: First data in combination trial of enasidenib or ivosidenib with standard of care intensive chemotherapy at ASH 2017 [screenshot]
Checkmark Initiation of P1b combination trials for frontline AML
More
Active, not recruiting
1
153
Europe, US
AG-120, AG-221, cytarabine, daunorubicin, idarubicin, mitoxantrone, etoposide
Institut de Recherches Internationales Servier, Celgene Corporation
Newly Diagnosed Acute Myeloid Leukemia (AML), Untreated AML, AML Arising From Myelodysplastic Syndrome (MDS), AML Arising From Antecedent Hematologic Disorder (AHD), AML Arising After Exposure to Genotoxic Injury
12/18
07/26
NCT03515512: IDH2 Inhibition Using Enasidenib as Maintenance Therapy for IDH2-mutant Myeloid Neoplasms Following Allogeneic Stem Cell Transplantation

Checkmark Safety data from trial for AML at ASH 2020
Dec 2020 - Dec 2020: Safety data from trial for AML at ASH 2020
Completed
1
23
US
Enasidenib, idhifa
Massachusetts General Hospital, Celgene
Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia
12/21
02/23
NCT04573582: Pharmacokinetics of Enasidenib (CC-90007) in Participants With Mild, Moderate and Severe Hepatic Impairment

Completed
1
40
US
Enasidenib, AG-221, AG-221 mesylate, AGI-12910, AGI-12910 mesylate, CC-90007, IDHIFA
Celgene
Hepatic Impairment
03/23
03/23
NCT03720366: A Study of Perpetrator Drug Interactions of Enasidenib in AML Patients

Completed
1
40
RoW
enasidenib, CC-90007, AG-221, Arm 1 probes, Arm 2 Probes, Arm 3 probes
Celgene
Leukemia, Myeloid, Acute
09/23
12/23
NCT05441514: Enasidenib in Combination With Cobimetinib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Suspended
1
3
US
Cobimetinib, Cotellic, GDC-0973, MEK Inhibitor GDC-0973, XL518, Enasidenib Mesylate, 2-Methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol Methanesulfonate, 2-Propanol, 2-Methyl-1-((4-(6-(trifluoromethyl)-2-pyridinyl)-6-((2-(trifluoromethyl)-4-pyridinyl)amino)-1,3,5-triazin-2-yl)amino)-, Methanesulfonate (1:1), AG-221 Mesylate, CC-90007, Enasidenib Methanesulfonate, Idhifa
City of Hope Medical Center, National Cancer Institute (NCI)
Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
05/27
05/27
NCT05756777: A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)

Recruiting
1
36
US
Gilteritinib, Ivosidenib, Enasidenib
Memorial Sloan Kettering Cancer Center, Astellas Pharma US, Inc.
Acute Myeloid Leukemia (AML)
02/26
02/26
SMMART, NCT03878524: Serial Measurements of Molecular and Architectural Responses to Therapy () PRIME Trial

Terminated
1
2
US
Abemaciclib, LY-2835219, LY2835219, Verzenio, Abiraterone, CB 7598, Afatinib, BIBW 2992, BIBW2992, Bevacizumab, ABP 215, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin, Bevacizumab awwb, Bevacizumab Biosimilar ABP 215, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar CT-P16, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar GB-222, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar Mvasi, Bevacizumab Biosimilar MYL-1402O, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar RPH-001, Bevacizumab Biosimilar SCT501, Bevacizumab Biosimilar Zirabev, Bevacizumab-awwb, Bevacizumab-bvzr, BP102, BP102 Biosimilar, HD204, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Mvasi, MYL-1402O, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501, Zirabev, Anti-VEGF Monoclonal Antibody SIBP04, SIBP 04, SIBP-04, SIBP04, Bicalutamide, Casodex, Cosudex, ICI 176,334, ICI 176334, Biospecimen Collection, Biological Sample Collection, Specimen Collection, Bortezomib, [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid, LDP 341, MLN341, PS-341, PS341, Velcade, Cabazitaxel, Jevtana, RPR-116258A, Taxoid XRP6258, XRP-6258, Cabozantinib, Capecitabine, Ro 09-1978/000, Xeloda, Carboplatin, Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo, Celecoxib, Benzenesulfonamide, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-, Celebrex, SC-58635, YM 177, Cobimetinib, Cotellic, GDC-0973, MEK Inhibitor GDC-0973, XL518, 934660-93-2, Copanlisib, BAY 80-6946, PI3K Inhibitor BAY 80-6946, Dabrafenib, BRAF Inhibitor GSK2118436, GSK-2118436, GSK-2118436A, GSK2118436, Dacomitinib, EGFR Inhibitor PF-00299804, PF-00299804, PF-00299804-03, PF-299804, Vizimpro, Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Nubeqa, ODM 201, ODM-201, 1297538-32-9, Dasatinib, BMS-354825, Dasatinib Hydrate, Dasatinib Monohydrate, Sprycel, Doxorubicin, Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin, Durvalumab, Imfinzi, Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI-4736, MEDI4736, 1428935-60-7, Enasidenib, AG-221, CC-90007 Free Base, Entrectinib, Rozlytrek, RXDX 101, RXDX-101, RXDX101, Enzalutamide, ASP9785, MDV3100, Xtandi, Erlotinib, Everolimus, 42-O-(2-Hydroxy)ethyl Rapamycin, Afinitor, Certican, RAD 001, RAD001, Votubia, Zortress, Fluorouracil, 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-Fu, 5FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757, Idelalisib, CAL-101, GS 1101, GS-1101, Phosphoinositide-3 Kinase Delta Inhibitor CAL-101, Zydelig, Imatinib, Ipilimumab, Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, Ipilimumab Biosimilar CS1002, MDX-010, MDX-CTLA4, Yervoy, Lenvatinib, E7080, ER-203492-00, Multi-Kinase Inhibitor E7080, Leucovorin, Folinic acid, Lorlatinib, 2H-4,8-Methenopyrazolo(4,3-H)(2,5,11)benzoxadiazacyclotetradecine-3-carbonitrile, 7-amino-12-fluoro-10,15,16,17-tetrahydro-2,10,16-trimethyl-15-oxo-, (10R)-, Lorbrena, PF-06463922, Losartan, Nab-paclitaxel, ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, Paclitaxel Albumin, paclitaxel albumin-stabilized nanoparticle formulation, Protein-bound Paclitaxel, Neratinib, (2E)-N-(4-((3-chloro-4-((pyridin-2-yl)methoxy)phenyl)amino)-3-cyano-7-ethoxyquinolin-6-yl)-4-(dimethylamino)but-2-enamide, HKI 272, HKI-272, PB 272, PB-272, Nivolumab, BMS-936558, CMAB819, MDX-1106, NIVO, Nivolumab Biosimilar CMAB819, ONO-4538, Opdivo, Olaparib, AZD 2281, AZD-2281, AZD2281, KU-0059436, Lynparza, PARP Inhibitor AZD2281, Oxaliplatin, 1-OHP, Ai Heng, Aiheng, Dacotin, Dacplat, Diaminocyclohexane Oxalatoplatinum, Eloxatin, Eloxatine, JM-83, Oxalatoplatin, Oxalatoplatinum, RP 54780, RP-54780, SR-96669, Palbociclib, 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one, Ibrance, PD 0332991, PD 332991, PD 991, PD-0332991, Panobinostat, Faridak, LBH589, Pembrolizumab, Keytruda, Lambrolizumab, MK-3475, SCH 900475, Pertuzumab, 2C4, 2C4 Antibody, HS627, MoAb 2C4, Monoclonal Antibody 2C4, Omnitarg, Perjeta, Pertuzumab Biosimilar HS627, rhuMAb2C4, RO4368451, HLX11, Ponatinib, AP-24534, AP24534, Quality-of-Life Assessment, Quality of Life Assessment, Regorafenib, BAY 73-4506, REGORAFENIB ANHYDROUS, Stivarga, Ruxolitinib, INCB-18424, INCB18424, Jakafi, Oral JAK Inhibitor INCB18424, Sirolimus, AY 22989, RAPA, Rapamune, Rapamycin, SILA 9268A, WY-090217, Sorafenib, BA4 43 9006, BAY 43-9006, Bay-439006, Sunitinib, Trametinib, GSK1120212, JTP-74057, MEK Inhibitor GSK1120212, Trastuzumab Emtansine, Ado Trastuzumab Emtansine, ADO-Trastuzumab Emtansine, Kadcyla, PRO132365, RO5304020, T-DM1, Trastuzumab-DM1, Trastuzumab-MCC-DM1, Trastuzumab-MCC-DM1 Antibody-Drug Conjugate, Trastuzumab-MCC-DM1 Immunoconjugate, Tretinoin, 2,4,6,8-Nonatetraenoic acid, 3, 7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-, (all-E)-, Aberel, Airol, Aknoten, all trans-Retinoic acid, All-trans Retinoic Acid, All-trans Vitamin A Acid, all-trans-Retinoic acid, all-trans-Vitamin A acid, ATRA, Avita, beta-Retinoic Acid, Cordes Vas, Dermairol, Epi-Aberel, Eudyna, Renova, Retin-A, Retin-A MICRO, Retin-A-Micro, Retinoic Acid, Retisol-A, Ro 5488, Stieva-A, Stieva-A Forte, Trans Retinoic Acid, Trans Vitamin A Acid, trans-Retinoic Acid, Tretinoinum, Vesanoid, Vitamin A Acid, Vitamin A acid, all-trans-, Vitinoin, Vemurafenib, BRAF (V600E) kinase inhibitor RO5185426, BRAF(V600E) Kinase Inhibitor RO5185426, PLX-4032, PLX4032, RG 7204, RG7204, RO 5185426, Zelboraf, Venetoclax, ABT-0199, ABT-199, ABT199, GDC-0199, RG7601, Venclexta, Venclyxto, Vismodegib, Erivedge, GDC-0449, Hedgehog Antagonist GDC-0449, Vorinostat, L-001079038, MSK-390, SAHA, Suberanilohydroxamic Acid, Suberoylanilide Hydroxamic Acid, Zolinza
OHSU Knight Cancer Institute, Oregon Health and Science University
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Anatomic Stage IV Breast Cancer AJCC v8, Anemia, Ann Arbor Stage III Hodgkin Lymphoma, Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma, Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Castration-Resistant Prostate Carcinoma, Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Hematopoietic and Lymphoid System Neoplasm, Locally Advanced Pancreatic Adenocarcinoma, Metastatic Breast Carcinoma, Metastatic Malignant Solid Neoplasm, Metastatic Pancreatic Adenocarcinoma, Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Primary Myelofibrosis, Recurrent Acute Lymphoblastic Leukemia, Recurrent Acute Myeloid Leukemia, Recurrent Chronic Lymphocytic Leukemia, Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Recurrent Hematologic Malignancy, Recurrent Hodgkin Lymphoma, Recurrent Myelodysplastic Syndrome, Recurrent Myelodysplastic/Myeloproliferative Neoplasm, Recurrent Myeloproliferative Neoplasm, Recurrent Non-Hodgkin Lymphoma, Recurrent Plasma Cell Myeloma, Recurrent Small Lymphocytic Lymphoma, Refractory Acute Lymphoblastic Leukemia, Refractory Acute Myeloid Leukemia, Refractory Chronic Lymphocytic Leukemia, Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Refractory Chronic Myelomonocytic Leukemia, Refractory Hematologic Malignancy, Refractory Hodgkin Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Myelodysplastic Syndrome, Refractory Myelodysplastic/Myeloproliferative Neoplasm, Refractory Non-Hodgkin Lymphoma, Refractory Plasma Cell Myeloma, Refractory Primary Myelofibrosis, Refractory Small Lymphocytic Lymphoma, Stage II Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8, Unresectable Pancreatic Adenocarcinoma
12/20
12/20
NCT04955938: A Study of Fedratinib With IDH Inhibition in Advanced-Phase, IDH-Mutated Ph-Negative Myeloproliferative Neoplasms

Withdrawn
1
50
US
Ivosidenib, Tibsovo, Enasidenib, IDHIFA, Fedratinib, INREBIC
University of Chicago
IDH Mutation, IDH1 Mutation, IDH2 Gene Mutation, Blood Cancer, Myeloproliferative Neoplasm
06/23
06/23
NCT05102370: A Study of Enasidenib in People With Clonal Cytopenia of Undetermined Significance

Active, not recruiting
1
4
US
Enasidenib
Memorial Sloan Kettering Cancer Center
Clonal Cytopenia of Undetermined Significance, CCUS Clonal Cytopenia of Undetermined Significance
10/25
10/25
NCI-2021-08496, NCT05010772: Decitabine Alone or in Combination With Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib as Maintenance Therapy for the Treatment of Acute Myeloid Leukemia in Remission

Recruiting
1
125
US
Decitabine and Cedazuridine, ASTX727, C-DEC, CDA Inhibitor E7727/Decitabine Combination Agent ASTX727, Cedazuridine/Decitabine Combination Agent ASTX727, Cedazuridine/Decitabine Tablet, DEC-C, Inqovi, Enasidenib, AG-221, CC-90007 Free Base, Gilteritinib, ASP-2215, ASP2215, Ivosidenib, AG-120, Tibsovo, Venetoclax, ABT-0199, ABT-199, ABT199, GDC-0199, RG7601, Venclexta, Venclyxto
M.D. Anderson Cancer Center, National Cancer Institute (NCI)
Acute Myeloid Leukemia
12/26
12/26
NCT03723057: Expanded Access for AG-221

No Longer Available
N/A
US
AG-221, CC-90007; Enasidenib; Idhifa
Celgene
Acute Myeloid Leukemia
 
 
Pyrukynd (mitapivat) / Agios Pharma
NCT05777993: A Study to Provide Continued Access to Mitapivat for Participants Who Previously Completed an Agios-Sponsored Mitapivat Study

Enrolling by invitation
4
6
Canada, Japan
Mitapivat, AG-348, Mitapivat sulfate, PYRUKYND®
Agios Pharmaceuticals, Inc.
Pyruvate Kinase Deficiency, Anemia, Hemolytic
08/29
08/29
2021-000212-34: A study to Evaluate the Efficacy and Safety of Mitapivat in Subjects With Transfusion-Dependent Alpha- or Beta-Thalassemia (ENERGIZE-T) Estudio para evaluar la eficacia y seguridad de mitapivat en sujetos con Alfa- o Beta- talasemia dependiente de transfusiones (ENERGIZE-T)

Not yet recruiting
3
240
Europe, RoW
Mitapivat, Mitapivat sulfate, AG-348, Tablet
Agios Pharmaceuticals, Inc., AGIOS PHARMACEUTICALS, INC., Agios Pharmaceuticals, Inc.
Transfusion-Dependent Alpha- or Beta-Thalassemia α- o β-talasemia dependiente de transfusiones, Thalassemia-genetic blood disorder where not enough hemoglobin isproduced.2Types-α &βTransfusion-dependent thalassemias-Patients who do require lifelong regular transfusions. Talasemia-Trastorno genético sanguíneo donde no se produce suficiente hemoglobina.2Tipos-α&β dependientes de transfusión-Pacientes que requieren transfusiones regulares de por vida., Diseases [C] - Blood and lymphatic diseases [C15]
 
 
2021-000211-23: A study to Evaluate the Efficacy and Safety of Mitapivat in Subjects With Non Transfusion-Dependent Alpha- or Beta-Thalassemia (ENERGIZE) Estudio para evaluar la eficacia y seguridad de mitapivat en sujetos con Alfa- o Beta-talasemia no dependiente de transfusiones (ENERGIZE)

Not yet recruiting
3
171
Europe, RoW
Mitapivat, Mitapivat sulfate, AG-348, Tablet
Agios Pharmaceuticals, Inc., AGIOS PHARMACEUTICALS, INC., Agios Pharmaceuticals, Inc.
Non–Transfusion-Dependent Alpha- or Beta-Thalassemia α- o β-talasemia no dependiente de transfusiones, Thalassemia-genetic blood disorder where not enough hemoglobin is produced.2Types-α &βNon-transfusion-dependent thalassemias-Patients who do not require lifelong regular transfusions Talasemia-Trastorno genético sanguíneo donde no se produce suficiente hemoglobina.2Tipos-α&β no dependientes de transfusión-Pacientes que no requieren transfusiones regulares de por vida, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
2021-003333-11: Study to Evaluate how effective and safe the investigationall product, Mitapivat, is when administred to Pediatric Subjects With Pyruvate Kinase Deficiency, who are not receiving regular blood transfusions, followed by a 5-Year Open-label Extension Period, where subjects will be given the option to receive mitapivat for an additional 5 years. Estudio para evaluar la eficacia y seguridad del producto en investigación, Mitapivat, cuando se administra a sujetos pediátricos con deficiencia de piruvato cinasa, que no estén recibiendo transfusiones de sangre regulares, seguidas de un periodo de extensión abierto de 5-Year, en el que se dará a los sujetos la opción de recibir mitapivat durante 5 años más.

Ongoing
3
45
Europe
AG-348 sulfate hydrate granules, AG-348 sulfate hydrate, AG-348, Granules, Tablet
Agios Pharmaceuticals, Inc., AGIOS PHARMACEUTICALS, INC., Agios Pharmaceuticals, Inc.
Pyruvate Kinase Deficiency Deficiencia de piruvato cinasa, Lack of Pyruvate Kinase enzyme Ausencia de enzima piruvato cinasa, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
ENERGIZE, NCT04770753 / 2021-000211-23: A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)

Active, not recruiting
3
194
Europe, Canada, US, RoW
Placebo Matching Mitapivat, Mitapivat, AG-348, AG-348 sulfate hydrate, Mitapivat sulfate
Agios Pharmaceuticals, Inc., Agios Pharmaceuticals, Inc.
Non-Transfusion-dependent Alpha-Thalassemia, Non-Transfusion-dependent Beta-Thalassemia
11/23
12/28
ENERGIZE-T, NCT04770779 / 2021-000212-34: A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-TDT)

Active, not recruiting
3
258
Europe, Canada, US, RoW
Placebo Matching Mitapivat, Mitapivat, AG-348, AG-348 sulfate hydrate, Mitapivat sulfate
Agios Pharmaceuticals, Inc., Agios Pharmaceuticals, Inc.
Transfusion-dependent Alpha-Thalassemia, Transfusion-dependent Beta-Thalassemia
04/24
06/29
NCT03853798 / 2018-003459-39: Extension Study of AG-348 in Adult Participants With Pyruvate Kinase Deficiency Previously Enrolled in AG-348-006 or AG348-C-007

Completed
3
90
Europe, Canada, Japan, US, RoW
AG-348
Agios Pharmaceuticals, Inc.
Pyruvate Kinase Deficiency
07/24
07/24
ACTIVATE-Kids, NCT05175105 / 2021-003333-11: A Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Participants With Pyruvate Kinase Deficiency (PKD) Who Are Not Regularly Transfused, Followed by a 5-Year Extension Period

Active, not recruiting
3
30
Europe, Canada, US
Mitapivat, AG-348, AG-348 sulfate hydrate, Mitapivat sulfate, Mitapivat-matching placebo
Agios Pharmaceuticals, Inc., Agios Pharmaceuticals, Inc.
Pediatric Pyruvate Kinase Deficiency, Pediatric Hemolytic Anemia
12/24
01/30
ACTIVATE-KidsT, NCT05144256 / 2021-003265-36: A Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Participants With Pyruvate Kinase Deficiency (PKD) Who Are Regularly Transfused, Followed by a 5-Year Extension Period

Active, not recruiting
3
49
Europe, Canada, US, RoW
Mitapivat, AG-348, AG-348 sulfate hydrate, Mitapivat sulfate, Mitapivat-matching placebo
Agios Pharmaceuticals, Inc.
Pediatric Pyruvate Kinase Deficiency, Pediatric Hemolytic Anemia
05/24
06/29
RISE UP, NCT05031780 / 2021-001674-34: A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease

Active, not recruiting
2/3
286
Europe, Canada, US, RoW
Mitapivat, AG-348, Mitapivat Sulfate, Mitapivat-matching placebo
Agios Pharmaceuticals, Inc.
Sickle Cell Disease
10/25
02/30
DRIVE-PK, NCT02476916 / 2015-000484-13: A Study of AG-348 in Adult Participants With Pyruvate Kinase (PK) Deficiency

Completed
2
52
Europe, Canada, US
AG-348, Mitapivat
Agios Pharmaceuticals, Inc.
Pyruvate Kinase Deficiency
05/17
04/25
2018-002217-35: A Phase 2, Open-Label, Multicenter Study to Determine the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of AG-348 in Adult Subjects With Non-Transfusion-Dependent Thalassemia

Not yet recruiting
2
17
Europe
AG-348 sulfate hydrate, AG-348, Tablet
Agios Pharmaceuticals, Inc., Agios Pharmaceuticals, Inc.
Non-Transfusion-Dependent Thalassemia, Thalassemia (genetic blood disorder where not enough hemoglobin is produced), not requiring lifelong regular transfusion for survival, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
2019-003438-18: A study of mitapivat in sickle cell disease Een studie naar mitapivat in sikkelcelziekte

Not yet recruiting
2
10
Europe
AG-348 sulfate hydrate, AG-348, Tablet
Julius Clinical, Agios Pharmaceuticals
Sickle cell disease, Sickling of red blood cells, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
NCT03692052 / 2018-002217-35: A Study to Determine the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of AG-348 in Adult Participants With Non-transfusion-dependent Thalassemia

Active, not recruiting
2
20
Europe, Canada, US
AG-348, Mitapivat
Agios Pharmaceuticals, Inc., Agios Pharmaceuticals, Inc.
Thalassemia
08/20
09/30
SATISFY, NCT05935202: Safety and Efficacy of Mitapivat Sulfate in Adult Patients With Erythrocyte Membranopathies

Not yet recruiting
2
25
Europe
Mitapivat sulfate, AG-348
EuroBloodNet Association
Hereditary Red Blood Cell Disorder (Disorder)
07/25
12/26
AG348-C-026, NCT06286046: A Study of Mitapivat in Participants With Sickle Cell Disease and Nephropathy

Not yet recruiting
2
40
NA
Mitapivat, AG-348, Mitapivat sulfate, AG-348 sulfate hydrate
Agios Pharmaceuticals, Inc.
Sickle Cell Disease, Nephropathy
05/27
12/28
NCT04610866: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat

Active, not recruiting
1/2
15
US
Mitapivat
National Heart, Lung, and Blood Institute (NHLBI)
Sickle Cell Disease, Hemolytic Anemia
02/28
02/28
NCT05610657: A Pharmacokinetic Study of Mitapivat in Participants With Moderate Hepatic Impairment Compared to Matched Healthy Control Participants With Normal Hepatic Function

Completed
1
20
US
Mitapivat, AG-348, AG-348 sulfate hydrate, Mitapivat sulfate
Agios Pharmaceuticals, Inc.
Moderate Hepatic Impairment
07/23
07/23
NCT06648824: Study of How Mitapivat Affects Midazolam Blood Levels in Healthy Participants

Completed
1
20
US
Mitapivat, AG-348, PYRUKYND®, AG-348 sulfate hydrate, Mitapivat sulfate, Midazolam
Agios Pharmaceuticals, Inc.
Healthy Participants
12/24
12/24
NCT04995315: Pyruvate Kinase Deficiency Global Longitudinal Registry Substudy of Protocol AG348-C-008

Completed
N/A
13
Europe, US
Agios Pharmaceuticals, Inc.
Pyruvate Kinase Deficiency
09/23
09/23
NCT05675436: Investigating the Mechanistic Effects of Mitapivat in Subjects With Sickle Cell Disease

Active, not recruiting
N/A
6
US
National Heart, Lung, and Blood Institute (NHLBI)
Sickle Cell Anemia, Sickle Cell Thalassemia, Sickle Cell Pain, Hbss, Hbsc, Sickle Beta Thalassemia, Sickle Beta Zero Thalassemia, Sickle Cell Syndrome Variant
10/27
10/27
tebapivat (AG-946) / Agios Pharma
NCT06924970: A Dose-Finding Study of Tebapivat to Assess Efficacy, and Safety in Participants With Sickle Cell Disease (SCD)

Recruiting
2
56
US
Tebapivat, AG-946, Tebapivat Matched Placebo
Agios Pharmaceuticals, Inc.
Sickle Cell Disease
05/26
05/27
NCT05490446: A Study of Tebapivat (AG-946) in Participants With Anemia Due to Lower-Risk Myelodysplastic Syndromes (LR-MDS)

Recruiting
2
82
Europe, US, RoW
Tebapivat, AG-946
Agios Pharmaceuticals, Inc.
Myelodysplastic Syndromes
11/25
11/28
NCT04536792: A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-946 in Healthy Volunteers and in Participants With Sickle Cell Disease

Completed
1
122
Europe, US
AG-946, AG-946 Matched Placebo
Agios Pharmaceuticals, Inc.
Healthy Volunteers, Anemia, Sickle Cell
12/23
12/23
AG946-C-004, NCT06745271: A Study to Determine How Tebapivat is Absorbed, Broken Down, and Removed From the Body and the Extent to Which Tebapivat is Made Available in the Body in Healthy Participants

Completed
1
8
US
[14C]-tebapivat, [13C2,15N3]-tebapivat
Agios Pharmaceuticals, Inc.
Healthy Participants
02/25
02/25
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Idhifa (enasidenib) / BMS, Servier
IDHENTIFY, NCT02577406 / 2015-000344-42: An Efficacy and Safety Study of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation

Checkmark From IDHENTIFY trial in combination with best supportive care vs. conventional care regimens in r/r AML
Aug 2020 - Aug 2020: From IDHENTIFY trial in combination with best supportive care vs. conventional care regimens in r/r AML
Checkmark Study initiation in relapsed AML patients with an IDH2 mutation
Oct 2015 - Oct 2015: Study initiation in relapsed AML patients with an IDH2 mutation
Completed
3
319
Europe, Canada, US, RoW
AG-221, BSC, Azacitidine, Low-dose cytarabine (LDAC), Intermediate-dose cytarabine (IDAC)
Celgene
Leukemia, Myeloid, Isocitrate Dehydrogenase
03/20
03/24
HOVON150AML, NCT03839771 / 2018-000451-41: A Study of Ivosidenib or Enasidenib in Combination With Induction Therapy and Consolidation Therapy, Followed by Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myedysplastic Syndrome EB2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy

Checkmark Initiation of P3 HOVON 150 AML/AMLSG 29-18 trial in frontline AML patients with IDH1/IDH2 mutation
Jul 2019 - Jul 2019: Initiation of P3 HOVON 150 AML/AMLSG 29-18 trial in frontline AML patients with IDH1/IDH2 mutation
Active, not recruiting
3
968
Europe, RoW
AG-120, Ivosidenib, Placebo for AG-120, AG-221, Enasidenib, Placebo for AG-221
Stichting Hemato-Oncologie voor Volwassenen Nederland, Deutsch-Österreichische Studiengruppe Akute Myeloische Leukämie (AMLSG)
Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blasts-2
04/27
09/34
ACTRN12619001031156: A placebo controlled study to compare ivosidenib or enasidenib in patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome.

Active, not recruiting
3
968
 
HOVON (the Haemato Oncology Foundation for Adults in the Netherlands), HOVON (the Haemato Oncology Foundation for Adults in the Netherlands), Leukemia Foundation
Acute myeloid leukaemia, Myelodysplastic syndrome
 
 
2018-001693-25: study of the efficacy of treatment with AG-221 in patients with myelodysplastic syndrome and mutation IDH2

Not yet recruiting
2
68
Europe
Enasidenib, Film-coated tablet
Groupe Francophone des Myelodysplasies, celgene
Myelodysplastic syndromes, mutation IDH-2, inhibitor IDH-2, Myelodysplastic syndromes, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
2019-001416-30: Trial evaluating the safety and efficacy of Enasidenib for the treatment of recurrence or prophylactic treatment of certain forms of leukemia following blood stem cell transplantation. Studie zur Bewertung der Sicherheit und Wirksamkeit von Enasidenib zur Behandlung von Rückfällen oder zur vorbeugenden Behandlung bestimmter Formen von Leukämie nach einer Blutstammzelltransplantation.

Not yet recruiting
2
50
Europe
Enasidenib, Film-coated tablet
Heinrich-Heine-University Düsseldorf represented by the Coordinating Investigator, Celgene International II Sàrl
Patients with myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML) or acute myelogenous leukemia (AML) after allogeneic stem cell transplantation (allo-SCT) and with an IDH2 mutation (IDH2 R172 or R140 mutation) Patienten mit myelodysplastischem Syndrom (MDS), chronischer myelomonozytärer Leukämie (CMML) oder akuter myeloischer Leukämie (AML) nach allogener Stammzelltransplantation (allo-SCT) und einer IDH2-Mutation (IDH2 R172 oder R140-Mutation), Patients with certain forms of leukemia after stem cell transplantation Patienten mit bestimmten Formen von Leukämie nach Stammzelltransplantation, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
IDEAL Study, NCT03744390: IDH2 (AG 221) Inhibitor in Patients With IDH2 Mutated Myelodysplastic Syndrome

Active, not recruiting
2
68
Europe
AG-221, Enasidenib
Groupe Francophone des Myelodysplasies
Myelodysplastic Syndromes, Leukemia Acute Myeloid
02/23
03/26
NCT03728335: Enasidenib (AG-221) Maintenance Post Allogeneic HCT in Patients With IDH2 Mutation

Recruiting
2
35
US
Enasidenib Mesylate, 2-Methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol Methanesulfonate, 2-Propanol, 2-Methyl-1-((4-(6-(trifluoromethyl)-2-pyridinyl)-6-((2-(trifluoromethyl)-4-pyridinyl)amino)-1,3,5-triazin-2-yl)amino)-, Methanesulfonate (1:1), AG-221 Mesylate, CC-90007, Enasidenib Methanesulfonate, Idhifa
City of Hope Medical Center, National Cancer Institute (NCI)
Acute Myeloid Leukemia
01/27
01/27
NCT06176989: Enasidenib in IDH2-Mutated Malignant Sinonasal and Skull Base Tumors

Recruiting
2
40
US
Enasidenib
National Cancer Institute (NCI)
Metastatic Chondrosarcoma, Locally Advanced Chondrosarcoma, Metastatic Sinonasal Adenocarcinoma, Locally Advanced Sinonasal Adenocarcinoma, Metastatic Large-cell Neuroendocrine Carcinoma, Locally Advanced Large-cell Neuroendocrine Carcinoma, Metastatic Olfactory Neuroblastoma, Locally Advanced Olfactory Neuroblastoma, Metastatic Sinonasal Undifferentiated Carcinoma, Locally Advanced Sinonasal Undifferentiated Carcinoma
12/27
12/30
MPN-RC 119, NCT04281498: Combined Ruxolitinib and Enasidenib in Patients With Accelerated/Blast-phase Myeloproliferative Neoplasm or Chronic-phase Myelofibrosis With an IDH2 Mutation

Completed
2
6
Canada, US
Ruxolitinib, Enasidenib
John Mascarenhas, Celgene Corporation, Incyte Corporation, Myeloproliferative Neoplasms Research Consortium, National Institutes of Health (NIH), National Cancer Institute (NCI)
Accelerated/Blast-phase Myeloproliferative Neoplasm, Chronic-phase Myelofibrosis, IDH2 Mutation
05/23
05/23
NCT04522895: IDH2-Post-Allo-Trial for Patients with IDH2-mut Myeloid Neoplasms After Allo-SCT

Completed
2
50
Europe
Enasidenib
Heinrich-Heine University, Duesseldorf, Celgene Corporation, Koordinierungszentrum für Klinische Studien Düsseldorf
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, IDH2 Gene Mutation, IDH2 R172, IDH2 R140
07/24
07/24
NCI-2018-02998, NCT03825796: CPX-351 Plus Enasidenib for Relapsed AML

Active, not recruiting
2
2
US
Enasidenib Mesylate, 2-Methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol Methanesulfonate, 2-Propanol, 2-Methyl-1-((4-(6-(trifluoromethyl)-2-pyridinyl)-6-((2-(trifluoromethyl)-4-pyridinyl)amino)-1,3,5-triazin-2-yl)amino)-, Methanesulfonate (1:1), AG-221 Mesylate, CC-90007, Enasidenib Methanesulfonate, Idhifa, Liposome-encapsulated Daunorubicin-Cytarabine, CPX-351, Cytarabine-Daunorubicin Liposome for Injection, Liposomal AraC-Daunorubicin CPX-351, Liposomal Cytarabine-Daunorubicin, Liposome-encapsulated Combination of Daunorubicin and Cytarabine, Vyxeos
Jonsson Comprehensive Cancer Center, Jazz Pharmaceuticals
Recurrent Acute Myeloid Leukemia
09/24
09/24
NCT06240754: Enasidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH2A Decentralized Trial

Recruiting
2
15
US
Enasidenib
Washington University School of Medicine, Bristol-Myers Squibb, Damon Runyon Cancer Research Foundation
Clonal Cytopenia of Undetermined Significance, CCUS Clonal Cytopenia of Undetermined Significance
09/26
10/26
NCT06756308: A Study of Enasidenib in People With T-Cell Lymphoma

Recruiting
2
25
US
Enasidenib, Rituximab
Memorial Sloan Kettering Cancer Center, Bristol-Myers Squibb, The Leukemia and Lymphoma Society
T-cell Lymphoma
12/27
12/27
P30CA016672, NCT03383575: Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome

Recruiting
2
63
US
Azacitidine, 5 AZC, 5-AC, 5-Azacytidine, 5-AZC, Azacytidine, Azacytidine, 5-, Ladakamycin, Mylosar, U-18496, Vidaza, Enasidenib, AG-221, CC-90007, Quality-of-Life Assessment, Quality of Life Assessment
M.D. Anderson Cancer Center, National Cancer Institute (NCI), Celgene
Acute Myeloid Leukemia, Blasts 20-30 Percent of Bone Marrow Nucleated Cells, Chronic Myelomonocytic Leukemia, IDH2 Gene Mutation, Myelodysplastic Syndrome With Excess Blasts, Recurrent High Risk Myelodysplastic Syndrome, Refractory High Risk Myelodysplastic Syndrome
02/27
02/27
NCT06672146: Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial)

Recruiting
2
93
US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Biopsy of Bone Marrow, Biopsy, Bone Marrow, Decitabine and Cedazuridine, ASTX 727, ASTX-727, ASTX727, C-DEC, CDA Inhibitor E7727/Decitabine Combination Agent ASTX727, Cedazuridine/Decitabine Combination Agent ASTX727, Cedazuridine/Decitabine Tablet, DEC-C, Inaqovi, Inqovi, Enasidenib, AG 221, AG-221, AG221, CC-90007 Free Base, Venetoclax, ABT 199, ABT-0199, ABT-199, ABT199, GDC 0199, GDC-0199, GDC0199, RG7601, Venclexta, Venclyxto
National Cancer Institute (NCI)
Acute Myeloid Leukemia
03/27
03/27
MyeloMATCH, NCT06577441: Testing the Addition of an IDH2 Inhibitor, Enasidenib, to Usual Treatment (Cedazuridine-Decitabine) for Higher-Risk Myelodysplastic Syndrome (MDS) With IDH2 Mutation (A Treatment Trial)

Recruiting
2
54
US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Biopsy of Bone Marrow, Biopsy, Bone Marrow, Decitabine and Cedazuridine, ASTX 727, ASTX-727, ASTX727, C-DEC, CDA Inhibitor E7727/Decitabine Combination Agent ASTX727, Cedazuridine/Decitabine Combination Agent ASTX727, Cedazuridine/Decitabine Tablet, DEC-C, Inaqovi, Inqovi, Enasidenib, AG 221, AG-221, AG221, CC-90007 Free Base
National Cancer Institute (NCI)
Myelodysplastic Syndrome
03/27
03/27
NCI-2018-01919, NCT03683433: Enasidenib and Azacitidine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia and IDH2 Gene Mutation

Recruiting
2
50
US
Azacitidine, 5 AZC, 5-AC, 5-Azacytidine, 5-AZC, Azacytidine, Azacytidine, 5-, Ladakamycin, Mylosar, U-18496, Vidaza, Enasidenib Mesylate, 2-Methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol Methanesulfonate, 2-Propanol, 2-Methyl-1-((4-(6-(trifluoromethyl)-2-pyridinyl)-6-((2-(trifluoromethyl)-4-pyridinyl)amino)-1,3,5-triazin-2-yl)amino)-, Methanesulfonate (1:1), AG-221 Mesylate, CC-90007, Enasidenib Methanesulfonate, Idhifa
M.D. Anderson Cancer Center, National Cancer Institute (NCI)
Acute Bilineal Leukemia, Acute Biphenotypic Leukemia, Chronic Myelomonocytic Leukemia, IDH2 Gene Mutation, Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
09/25
09/25
I-DATA, NCT05401097: IDH Targeted/Non- Targeted vs Non-targeted/IDH-targeted Approaches in the Treatment of Newly Diagnosed IDH Mutated AML Patients Not Candidates for Intensive Induction Therapy (I- DATA Study)

Recruiting
2
125
US
Azacitidine, 5 AZC, 5-AC, 5-Azacytidine, 5-AZC, Azacytidine, Azacytidine, 5-, Ladakamycin, Mylosar, Onureg, U-18496, Vidaza, Biopsy, BIOPSY_TYPE, Bx, Enasidenib, AG-221, CC-90007 Free Base, Ivosidenib, AG-120, Tibsovo, Venetoclax, ABT-0199, ABT-199, ABT199, GDC-0199, RG7601, Venclexta, Venclyxto
Alice Mims, National Cancer Institute (NCI)
Acute Myeloid Leukemia
09/27
06/29
NCT04203316: Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With an IDH2 Mutation

Active, not recruiting
2
10
Canada, US
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Biopsy of Bone Marrow, Biopsy, Bone Marrow, Enasidenib, AG 221, AG-221, AG221, CC-90007 Free Base, Enasidenib Mesylate, 2-Methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol Methanesulfonate, 2-Propanol, 2-Methyl-1-((4-(6-(trifluoromethyl)-2-pyridinyl)-6-((2-(trifluoromethyl)-4-pyridinyl)amino)-1,3,5-triazin-2-yl)amino)-, Methanesulfonate (1:1), AG-221 Mesylate, CC 90007, CC-90007, CC90007, Enasidenib Methanesulfonate, Idhifa
Children's Oncology Group, National Cancer Institute (NCI)
Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
06/25
06/25
MyeloMATCH, NCT05564390: MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH ( Screening Trial)

Recruiting
2
2000
Canada, US
Allogeneic Hematopoietic Stem Cell Transplantation, Allogeneic, Allogeneic Hematopoietic Cell Transplantation, Allogeneic Stem Cell Transplantation, HSC, HSCT, Stem Cell Transplantation, Allogeneic, Azacitidine, 5 AZC, 5-AC, 5-Azacitidine, 5-Azacytidine, 5-AZC, Azacytidine, Azacytidine, 5-, Ladakamycin, Mylosar, U-18496, Vidaza, Best Practice, standard of care, standard therapy, Biopsy Procedure, Biopsy, BIOPSY_TYPE, Bx, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Biopsy of Bone Marrow, Biopsy, Bone Marrow, Busulfan, 1, 4-Bis[methanesulfonoxy]butane, BUS, Busilvex, Bussulfam, Busulfanum, Busulfex, Busulphan, CB 2041, CB-2041, Glyzophrol, GT 41, GT-41, Joacamine, Methanesulfonic Acid Tetramethylene Ester, Methanesulfonic acid, tetramethylene ester, Mielucin, Misulban, Misulfan, Mitosan, Myeleukon, Myeloleukon, Myelosan, Mylecytan, Myleran, Sulfabutin, Tetramethylene Bis(methanesulfonate), Tetramethylene bis[methanesulfonate], WR-19508, Chest Radiography, Chest X-ray, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Cytarabine, .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-Cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453, Daunorubicin Hydrochloride, Cerubidin, Cerubidine, Cloridrato de Daunorubicina, Daunoblastin, Daunoblastina, Daunoblastine, Daunomycin Hydrochloride, Daunomycin, hydrochloride, Daunorubicin.HCl, Daunorubicini Hydrochloridum, FI-6339, Ondena, RP-13057, Rubidomycin Hydrochloride, Rubilem, Decitabine and Cedazuridine, ASTX 727, ASTX-727, ASTX727, C-DEC, CDA Inhibitor E7727/Decitabine Combination Agent ASTX727, Cedazuridine/Decitabine Combination Agent ASTX727, Cedazuridine/Decitabine Tablet, DEC-C, Inaqovi, Inqovi, Echocardiography Test, EC, Echocardiography, Enasidenib, AG 221, AG-221, AG221, CC-90007 Free Base, Fludarabine, Fluradosa, Gemtuzumab Ozogamicin, Calicheamicin-Conjugated Humanized Anti-CD33 Monoclonal Antibody, CDP-771, CMA-676, gemtuzumab, hP67.6-Calicheamicin, Mylotarg, WAY-CMA-676, Gilteritinib, ASP 2215, ASP-2215, ASP2215, Liposome-encapsulated Daunorubicin-Cytarabine, CPX 351, CPX-351, CPX351, Cytarabine and Daunorubicin Liposomal, Cytarabine-Daunorubicin Liposome for Injection, Daunorubicin and Cytarabine (Liposomal), Liposomal AraC-Daunorubicin CPX-351, Liposomal Cytarabine-Daunorubicin, Liposome-encapsulated Combination of Daunorubicin and Cytarabine, Vyxeos, Melphalan, Alanine Nitrogen Mustard, CB-3025, L-PAM, L-Phenylalanine Mustard, L-Sarcolysin, L-Sarcolysin Phenylalanine mustard, L-Sarcolysine, Melphalan for Injection-Hepatic Delivery System, Melphalanum, Phenylalanine Mustard, Phenylalanine Nitrogen Mustard, Sarcoclorin, Sarkolysin, WR-19813, Multigated Acquisition Scan, Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide Ventriculography, RNV Scan, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning, Mutation Carrier Screening, Placebo Administration, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT, Total-Body Irradiation, SCT_TBI, TBI, Total Body Irradiation, Whole Body, Whole Body Irradiation, Whole-Body Irradiation, Venetoclax, ABT 199, ABT-0199, ABT-199, ABT199, GDC 0199, GDC-0199, GDC0199, RG7601, Venclexta, Venclyxto
National Cancer Institute (NCI)
Acute Myeloid Leukemia, Myelodysplastic Syndrome
05/29
05/29
AG-221-AML-005, NCT02677922 / 2015-003951-23: A Study to Assess the Safety and Efficacy of Two Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Harboring IDH Mutations Who Are Not Candidates to Receive Intensive Induction Chemotherapy

Checkmark In combination with azacitidine for IDH1 mutant AML
Dec 2019 - Dec 2019: In combination with azacitidine for IDH1 mutant AML
Checkmark Mutation clearance and measurable residual disease data from P1b trial at ASH 2019
Dec 2019 - Dec 2019: Mutation clearance and measurable residual disease data from P1b trial at ASH 2019
Checkmark P1b data from P1b/2 trial in combination with azacitidine for newly diagnosed AML at ASCO 2019 [screenshot]
More
Active, not recruiting
1/2
130
Europe, Canada, US, RoW
AG-120, Azacitidine, AG-221
Celgene
Leukemia, Myeloid, Acute
08/18
09/25
AG-221-C-001, NCT01915498: Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation

Checkmark From trial for advanced HM at ASH 2017 [screenshot]
Dec 2017 - Dec 2017: From trial for advanced HM at ASH 2017 [screenshot]
Checkmark R/R AML
Aug 2017 - Aug 2017: R/R AML
Checkmark Data presentation for r/r AML at EHA 2017
More
Completed
1/2
345
Europe, US
Enasidenib, AG-221, IDHIFA
Celgene, Agios Pharmaceuticals, Inc.
Hematologic Neoplasms
07/19
10/23
MyDRUG, NCT03732703: Myeloma-Developing Regimens Using Genomics

Checkmark Data from MyDRUG study for MM at ASH 2022
Dec 2022 - Dec 2022: Data from MyDRUG study for MM at ASH 2022
Completed
1/2
103
US
Abemaciclib, dexamethasone, ixazomib, pomalidomide, abemaciclib: Verzenio, LY2835219, ixazomib: Ninlaro, MLN2238, pomalidomide: Pomalyst, Enasidenib, dexamethasone, ixazomib, pomalidomide, enasidenib: AG221, IDHIFA, Cobimetinib, dexamethasone, ixazomib, pomalidomide, cobimetinib: Cotellic, GDC-0973, RG7420, Erdafitinib, dexamethasone, ixazomib, pomalidomide, erdafitinib: G-024, JNJ-42756493, JNJ-493, Venetoclax, dexamethasone, ixazomib, pomalidomide, venetoclax: Venclexta: ABT-199, Daratumumab, dexamethasone, ixazomib, pomalidomide, daratumumab: Darzalex, Belantamab mafodotin, dexamethasone, ixazomib, pomalidomide, Belantamab mafodotin: BLENREP, GSK2857916, Selinexor, dexamethasone, ixazomib, pomalidomide, Selinexor: XPOVIO
Multiple Myeloma Research Consortium, AbbVie, Celgene Corporation, Eli Lilly and Company, Genentech, Inc., Janssen, LP, Takeda, GlaxoSmithKline, Karyopharm Therapeutics Inc
Relapsed Refractory Multiple Myeloma
12/24
12/24
ENAVEN-AML, NCT04092179: Study of Enasidenib and Venetoclax in IDH2-Mutated Blood Cancers

Terminated
1/2
27
Canada
Enasidenib, IDHIFA, Venetoclax, VENCLEXTA
University Health Network, Toronto, Celgene, AbbVie
Acute Myeloid Leukemia, Relapsed Cancer, Refractory Cancer, IDH2 Gene Mutation
10/23
10/23
Beat AML, NCT03013998: Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

Hourglass Jan 2023 - Mar 2023 : Data from Beat AML trial for acute myeloid leukemia
Recruiting
1/2
2000
US
Samalizumab (BAML-16-001-S1), BI 836858 (BAML-16-001-S2), Laboratory Biomarker Analysis, Daunorubicin (BAML-16-001-S1), Cytarabine (BAML-16-001-S1), Azacitidine (BAML-16-001-S2), AG-221 (BAML-16-001-S3), Enasidenib, Azacitidine (BAML-16-001-S3), Entospletinib (BAML-16-001-S4), GS-9973, ENTO, Azacitidine (BAML-16-001-S4), Entospletinib (BAML-16-001-S5), Decitabine (BAML-16-001-S5), Entospletinib (BAML-16-001-S6), Daunorubicin (BAML-16-001-S6), Cytarabine (BAML-16-001-S6), Pevonedistat (BAML-16-001-S9), TAK-924, MLN4924, Azacitidine (BAML-16-001-S9), AG-120 (BAML-16-001-S16), Azacitidine (BAML-16-001-S16), Gilteritinib (BAML-16-001-S8 Group 1), Decitabine (BAML-16-001-S8 Group 1), AZD5153 (BAML-16-001-S10), Venetoclax (BAML-16-001-S10), TP-0903 (BAML-16-001-S14), Decitabine (BAML-16-001-S14), Decitabine (BAML-16-001-S8 Group 2), Venetoclax (BAML-16-001-S8 Group 2), AZD5991 (BAML-16-001-S18), Azacitidine (BAML-16-001-S18), SNDX-5613 (BAML-16-001-S17), Azacitidine (BAML-16-001-S17), Venetoclax (BAML-16-001-S17), Gilteritinib (BAML-16-001-S8 Group 2), Venetoclax (BAML-16-001-S12 Arm A), Azacitidine (BAML-16-001-S12 Arm A), Venetoclax (BAML-16-001-S12 Arm B), Azacitidine (BAML-16-001-S12 Arm B), ZE46-0134 (BAML-16-001-S21)
Beat AML, LLC
Previously Untreated Relapsed Refractory Acute Myeloid Leukemia
12/26
12/26
NCI-2022-02837, NCT05282459: Enasidenib in MDS &Non-proliferative Chronic Myelomonocytic Leukemia w/o IDH2 Mutation

Completed
1/2
17
US
Enasidenib mesylat dose escalation, (Idhifa, AG 221)
Stanford University, Celgene Corporation
Leukemia, Leukemia, Myeloid, Monocytic Leukemia
12/24
03/25
NCI-2021-00893, NCT04774393: Decitabine/Cedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Recruiting
1/2
84
US
Decitabine and Cedazuridine, ASTX727, CDA Inhibitor E7727/Decitabine Combination Agent ASTX727, Cedazuridine/Decitabine Combination Agent ASTX727, Cedazuridine/Decitabine Tablet, Inqovi, Enasidenib, AG-221, CC-90007 Free Base, Ivosidenib, AG-120, Tibsovo, Venetoclax, ABT-0199, ABT-199, ABT199, GDC-0199, RG7601, Venclexta, Venclyxto
M.D. Anderson Cancer Center
Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
11/25
11/25
ESMART, NCT02813135 / 2016-000133-40: European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors

Recruiting
1/2
455
Europe
Ribociclib, Kisqali, LEE011, Topotecan, Hycamtin, Temozolomide, Temodar, Everolimus, Afinitor, votubia, Adavosertib, AZD1775, Carboplatin, Paraplatin, Olaparib, Lynparza, Irinotecan, Camptosar, CPT-11, Vistusertib, AZD2014, Nivolumab, Opdivo, Cyclophosphamide, Cytoxan, Selumetinib, Koselugo, Enasidenib, Idhifa, Lirilumab, BMS-986015, Fadraciclib, CYC065, Cytarabine, Arabinosylcytosine, Cytosar-U, Dexamethasone, Decadron, Dexasone, Diodex, Hexadrol, Maxidex, Ceralasertib, AZD6738, Futibatinib, Tas-120, Capmatinib, Tabrecta, INC280, Avelumab, BAVENCIO, Peposertib
Gustave Roussy, Cancer Campus, Grand Paris, National Cancer Institute, France
Pediatric Cancer
02/31
02/31
V-FAST master, NCT04075747: A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid Leukemia

Completed
1b
57
US
CPX-351, Vyxeos, JZP351, Venetoclax, Venclexta, Midostaurin, Rydapt, Enasidenib, Idhifa
Jazz Pharmaceuticals
Acute Myeloid Leukemia
02/22
09/23
AG120-221-C-001, NCT02632708: Safety Study of AG-120 or AG-221 in Combination With Induction and Consolidation Therapy in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) With an IDH1 and/or IDH2 Mutation

Checkmark Updated data from P1 trial in combination with chemotherapy in IDH1/2m newly diagnosed AML at ASH 2018 [screenshot]
Dec 2018 - Dec 2018: Updated data from P1 trial in combination with chemotherapy in IDH1/2m newly diagnosed AML at ASH 2018 [screenshot]
Checkmark First data in combination trial of enasidenib or ivosidenib with standard of care intensive chemotherapy at ASH 2017 [screenshot]
Dec 2017 - Dec 2017: First data in combination trial of enasidenib or ivosidenib with standard of care intensive chemotherapy at ASH 2017 [screenshot]
Checkmark Initiation of P1b combination trials for frontline AML
More
Active, not recruiting
1
153
Europe, US
AG-120, AG-221, cytarabine, daunorubicin, idarubicin, mitoxantrone, etoposide
Institut de Recherches Internationales Servier, Celgene Corporation
Newly Diagnosed Acute Myeloid Leukemia (AML), Untreated AML, AML Arising From Myelodysplastic Syndrome (MDS), AML Arising From Antecedent Hematologic Disorder (AHD), AML Arising After Exposure to Genotoxic Injury
12/18
07/26
NCT03515512: IDH2 Inhibition Using Enasidenib as Maintenance Therapy for IDH2-mutant Myeloid Neoplasms Following Allogeneic Stem Cell Transplantation

Checkmark Safety data from trial for AML at ASH 2020
Dec 2020 - Dec 2020: Safety data from trial for AML at ASH 2020
Completed
1
23
US
Enasidenib, idhifa
Massachusetts General Hospital, Celgene
Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia
12/21
02/23
NCT04573582: Pharmacokinetics of Enasidenib (CC-90007) in Participants With Mild, Moderate and Severe Hepatic Impairment

Completed
1
40
US
Enasidenib, AG-221, AG-221 mesylate, AGI-12910, AGI-12910 mesylate, CC-90007, IDHIFA
Celgene
Hepatic Impairment
03/23
03/23
NCT03720366: A Study of Perpetrator Drug Interactions of Enasidenib in AML Patients

Completed
1
40
RoW
enasidenib, CC-90007, AG-221, Arm 1 probes, Arm 2 Probes, Arm 3 probes
Celgene
Leukemia, Myeloid, Acute
09/23
12/23
NCT05441514: Enasidenib in Combination With Cobimetinib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Suspended
1
3
US
Cobimetinib, Cotellic, GDC-0973, MEK Inhibitor GDC-0973, XL518, Enasidenib Mesylate, 2-Methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol Methanesulfonate, 2-Propanol, 2-Methyl-1-((4-(6-(trifluoromethyl)-2-pyridinyl)-6-((2-(trifluoromethyl)-4-pyridinyl)amino)-1,3,5-triazin-2-yl)amino)-, Methanesulfonate (1:1), AG-221 Mesylate, CC-90007, Enasidenib Methanesulfonate, Idhifa
City of Hope Medical Center, National Cancer Institute (NCI)
Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
05/27
05/27
NCT05756777: A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)

Recruiting
1
36
US
Gilteritinib, Ivosidenib, Enasidenib
Memorial Sloan Kettering Cancer Center, Astellas Pharma US, Inc.
Acute Myeloid Leukemia (AML)
02/26
02/26
SMMART, NCT03878524: Serial Measurements of Molecular and Architectural Responses to Therapy () PRIME Trial

Terminated
1
2
US
Abemaciclib, LY-2835219, LY2835219, Verzenio, Abiraterone, CB 7598, Afatinib, BIBW 2992, BIBW2992, Bevacizumab, ABP 215, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin, Bevacizumab awwb, Bevacizumab Biosimilar ABP 215, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar CT-P16, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar GB-222, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar Mvasi, Bevacizumab Biosimilar MYL-1402O, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar RPH-001, Bevacizumab Biosimilar SCT501, Bevacizumab Biosimilar Zirabev, Bevacizumab-awwb, Bevacizumab-bvzr, BP102, BP102 Biosimilar, HD204, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Mvasi, MYL-1402O, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501, Zirabev, Anti-VEGF Monoclonal Antibody SIBP04, SIBP 04, SIBP-04, SIBP04, Bicalutamide, Casodex, Cosudex, ICI 176,334, ICI 176334, Biospecimen Collection, Biological Sample Collection, Specimen Collection, Bortezomib, [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid, LDP 341, MLN341, PS-341, PS341, Velcade, Cabazitaxel, Jevtana, RPR-116258A, Taxoid XRP6258, XRP-6258, Cabozantinib, Capecitabine, Ro 09-1978/000, Xeloda, Carboplatin, Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo, Celecoxib, Benzenesulfonamide, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-, Celebrex, SC-58635, YM 177, Cobimetinib, Cotellic, GDC-0973, MEK Inhibitor GDC-0973, XL518, 934660-93-2, Copanlisib, BAY 80-6946, PI3K Inhibitor BAY 80-6946, Dabrafenib, BRAF Inhibitor GSK2118436, GSK-2118436, GSK-2118436A, GSK2118436, Dacomitinib, EGFR Inhibitor PF-00299804, PF-00299804, PF-00299804-03, PF-299804, Vizimpro, Darolutamide, Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Nubeqa, ODM 201, ODM-201, 1297538-32-9, Dasatinib, BMS-354825, Dasatinib Hydrate, Dasatinib Monohydrate, Sprycel, Doxorubicin, Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin, Durvalumab, Imfinzi, Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI-4736, MEDI4736, 1428935-60-7, Enasidenib, AG-221, CC-90007 Free Base, Entrectinib, Rozlytrek, RXDX 101, RXDX-101, RXDX101, Enzalutamide, ASP9785, MDV3100, Xtandi, Erlotinib, Everolimus, 42-O-(2-Hydroxy)ethyl Rapamycin, Afinitor, Certican, RAD 001, RAD001, Votubia, Zortress, Fluorouracil, 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-Fu, 5FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757, Idelalisib, CAL-101, GS 1101, GS-1101, Phosphoinositide-3 Kinase Delta Inhibitor CAL-101, Zydelig, Imatinib, Ipilimumab, Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, Ipilimumab Biosimilar CS1002, MDX-010, MDX-CTLA4, Yervoy, Lenvatinib, E7080, ER-203492-00, Multi-Kinase Inhibitor E7080, Leucovorin, Folinic acid, Lorlatinib, 2H-4,8-Methenopyrazolo(4,3-H)(2,5,11)benzoxadiazacyclotetradecine-3-carbonitrile, 7-amino-12-fluoro-10,15,16,17-tetrahydro-2,10,16-trimethyl-15-oxo-, (10R)-, Lorbrena, PF-06463922, Losartan, Nab-paclitaxel, ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, Paclitaxel Albumin, paclitaxel albumin-stabilized nanoparticle formulation, Protein-bound Paclitaxel, Neratinib, (2E)-N-(4-((3-chloro-4-((pyridin-2-yl)methoxy)phenyl)amino)-3-cyano-7-ethoxyquinolin-6-yl)-4-(dimethylamino)but-2-enamide, HKI 272, HKI-272, PB 272, PB-272, Nivolumab, BMS-936558, CMAB819, MDX-1106, NIVO, Nivolumab Biosimilar CMAB819, ONO-4538, Opdivo, Olaparib, AZD 2281, AZD-2281, AZD2281, KU-0059436, Lynparza, PARP Inhibitor AZD2281, Oxaliplatin, 1-OHP, Ai Heng, Aiheng, Dacotin, Dacplat, Diaminocyclohexane Oxalatoplatinum, Eloxatin, Eloxatine, JM-83, Oxalatoplatin, Oxalatoplatinum, RP 54780, RP-54780, SR-96669, Palbociclib, 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one, Ibrance, PD 0332991, PD 332991, PD 991, PD-0332991, Panobinostat, Faridak, LBH589, Pembrolizumab, Keytruda, Lambrolizumab, MK-3475, SCH 900475, Pertuzumab, 2C4, 2C4 Antibody, HS627, MoAb 2C4, Monoclonal Antibody 2C4, Omnitarg, Perjeta, Pertuzumab Biosimilar HS627, rhuMAb2C4, RO4368451, HLX11, Ponatinib, AP-24534, AP24534, Quality-of-Life Assessment, Quality of Life Assessment, Regorafenib, BAY 73-4506, REGORAFENIB ANHYDROUS, Stivarga, Ruxolitinib, INCB-18424, INCB18424, Jakafi, Oral JAK Inhibitor INCB18424, Sirolimus, AY 22989, RAPA, Rapamune, Rapamycin, SILA 9268A, WY-090217, Sorafenib, BA4 43 9006, BAY 43-9006, Bay-439006, Sunitinib, Trametinib, GSK1120212, JTP-74057, MEK Inhibitor GSK1120212, Trastuzumab Emtansine, Ado Trastuzumab Emtansine, ADO-Trastuzumab Emtansine, Kadcyla, PRO132365, RO5304020, T-DM1, Trastuzumab-DM1, Trastuzumab-MCC-DM1, Trastuzumab-MCC-DM1 Antibody-Drug Conjugate, Trastuzumab-MCC-DM1 Immunoconjugate, Tretinoin, 2,4,6,8-Nonatetraenoic acid, 3, 7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-, (all-E)-, Aberel, Airol, Aknoten, all trans-Retinoic acid, All-trans Retinoic Acid, All-trans Vitamin A Acid, all-trans-Retinoic acid, all-trans-Vitamin A acid, ATRA, Avita, beta-Retinoic Acid, Cordes Vas, Dermairol, Epi-Aberel, Eudyna, Renova, Retin-A, Retin-A MICRO, Retin-A-Micro, Retinoic Acid, Retisol-A, Ro 5488, Stieva-A, Stieva-A Forte, Trans Retinoic Acid, Trans Vitamin A Acid, trans-Retinoic Acid, Tretinoinum, Vesanoid, Vitamin A Acid, Vitamin A acid, all-trans-, Vitinoin, Vemurafenib, BRAF (V600E) kinase inhibitor RO5185426, BRAF(V600E) Kinase Inhibitor RO5185426, PLX-4032, PLX4032, RG 7204, RG7204, RO 5185426, Zelboraf, Venetoclax, ABT-0199, ABT-199, ABT199, GDC-0199, RG7601, Venclexta, Venclyxto, Vismodegib, Erivedge, GDC-0449, Hedgehog Antagonist GDC-0449, Vorinostat, L-001079038, MSK-390, SAHA, Suberanilohydroxamic Acid, Suberoylanilide Hydroxamic Acid, Zolinza
OHSU Knight Cancer Institute, Oregon Health and Science University
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Anatomic Stage IV Breast Cancer AJCC v8, Anemia, Ann Arbor Stage III Hodgkin Lymphoma, Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma, Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Castration-Resistant Prostate Carcinoma, Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Hematopoietic and Lymphoid System Neoplasm, Locally Advanced Pancreatic Adenocarcinoma, Metastatic Breast Carcinoma, Metastatic Malignant Solid Neoplasm, Metastatic Pancreatic Adenocarcinoma, Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Primary Myelofibrosis, Recurrent Acute Lymphoblastic Leukemia, Recurrent Acute Myeloid Leukemia, Recurrent Chronic Lymphocytic Leukemia, Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Recurrent Hematologic Malignancy, Recurrent Hodgkin Lymphoma, Recurrent Myelodysplastic Syndrome, Recurrent Myelodysplastic/Myeloproliferative Neoplasm, Recurrent Myeloproliferative Neoplasm, Recurrent Non-Hodgkin Lymphoma, Recurrent Plasma Cell Myeloma, Recurrent Small Lymphocytic Lymphoma, Refractory Acute Lymphoblastic Leukemia, Refractory Acute Myeloid Leukemia, Refractory Chronic Lymphocytic Leukemia, Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Refractory Chronic Myelomonocytic Leukemia, Refractory Hematologic Malignancy, Refractory Hodgkin Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Myelodysplastic Syndrome, Refractory Myelodysplastic/Myeloproliferative Neoplasm, Refractory Non-Hodgkin Lymphoma, Refractory Plasma Cell Myeloma, Refractory Primary Myelofibrosis, Refractory Small Lymphocytic Lymphoma, Stage II Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8, Unresectable Pancreatic Adenocarcinoma
12/20
12/20
NCT04955938: A Study of Fedratinib With IDH Inhibition in Advanced-Phase, IDH-Mutated Ph-Negative Myeloproliferative Neoplasms

Withdrawn
1
50
US
Ivosidenib, Tibsovo, Enasidenib, IDHIFA, Fedratinib, INREBIC
University of Chicago
IDH Mutation, IDH1 Mutation, IDH2 Gene Mutation, Blood Cancer, Myeloproliferative Neoplasm
06/23
06/23
NCT05102370: A Study of Enasidenib in People With Clonal Cytopenia of Undetermined Significance

Active, not recruiting
1
4
US
Enasidenib
Memorial Sloan Kettering Cancer Center
Clonal Cytopenia of Undetermined Significance, CCUS Clonal Cytopenia of Undetermined Significance
10/25
10/25
NCI-2021-08496, NCT05010772: Decitabine Alone or in Combination With Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib as Maintenance Therapy for the Treatment of Acute Myeloid Leukemia in Remission

Recruiting
1
125
US
Decitabine and Cedazuridine, ASTX727, C-DEC, CDA Inhibitor E7727/Decitabine Combination Agent ASTX727, Cedazuridine/Decitabine Combination Agent ASTX727, Cedazuridine/Decitabine Tablet, DEC-C, Inqovi, Enasidenib, AG-221, CC-90007 Free Base, Gilteritinib, ASP-2215, ASP2215, Ivosidenib, AG-120, Tibsovo, Venetoclax, ABT-0199, ABT-199, ABT199, GDC-0199, RG7601, Venclexta, Venclyxto
M.D. Anderson Cancer Center, National Cancer Institute (NCI)
Acute Myeloid Leukemia
12/26
12/26
NCT03723057: Expanded Access for AG-221

No Longer Available
N/A
US
AG-221, CC-90007; Enasidenib; Idhifa
Celgene
Acute Myeloid Leukemia
 
 
Pyrukynd (mitapivat) / Agios Pharma
NCT05777993: A Study to Provide Continued Access to Mitapivat for Participants Who Previously Completed an Agios-Sponsored Mitapivat Study

Enrolling by invitation
4
6
Canada, Japan
Mitapivat, AG-348, Mitapivat sulfate, PYRUKYND®
Agios Pharmaceuticals, Inc.
Pyruvate Kinase Deficiency, Anemia, Hemolytic
08/29
08/29
2021-000212-34: A study to Evaluate the Efficacy and Safety of Mitapivat in Subjects With Transfusion-Dependent Alpha- or Beta-Thalassemia (ENERGIZE-T) Estudio para evaluar la eficacia y seguridad de mitapivat en sujetos con Alfa- o Beta- talasemia dependiente de transfusiones (ENERGIZE-T)

Not yet recruiting
3
240
Europe, RoW
Mitapivat, Mitapivat sulfate, AG-348, Tablet
Agios Pharmaceuticals, Inc., AGIOS PHARMACEUTICALS, INC., Agios Pharmaceuticals, Inc.
Transfusion-Dependent Alpha- or Beta-Thalassemia α- o β-talasemia dependiente de transfusiones, Thalassemia-genetic blood disorder where not enough hemoglobin isproduced.2Types-α &βTransfusion-dependent thalassemias-Patients who do require lifelong regular transfusions. Talasemia-Trastorno genético sanguíneo donde no se produce suficiente hemoglobina.2Tipos-α&β dependientes de transfusión-Pacientes que requieren transfusiones regulares de por vida., Diseases [C] - Blood and lymphatic diseases [C15]
 
 
2021-000211-23: A study to Evaluate the Efficacy and Safety of Mitapivat in Subjects With Non Transfusion-Dependent Alpha- or Beta-Thalassemia (ENERGIZE) Estudio para evaluar la eficacia y seguridad de mitapivat en sujetos con Alfa- o Beta-talasemia no dependiente de transfusiones (ENERGIZE)

Not yet recruiting
3
171
Europe, RoW
Mitapivat, Mitapivat sulfate, AG-348, Tablet
Agios Pharmaceuticals, Inc., AGIOS PHARMACEUTICALS, INC., Agios Pharmaceuticals, Inc.
Non–Transfusion-Dependent Alpha- or Beta-Thalassemia α- o β-talasemia no dependiente de transfusiones, Thalassemia-genetic blood disorder where not enough hemoglobin is produced.2Types-α &βNon-transfusion-dependent thalassemias-Patients who do not require lifelong regular transfusions Talasemia-Trastorno genético sanguíneo donde no se produce suficiente hemoglobina.2Tipos-α&β no dependientes de transfusión-Pacientes que no requieren transfusiones regulares de por vida, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
2021-003333-11: Study to Evaluate how effective and safe the investigationall product, Mitapivat, is when administred to Pediatric Subjects With Pyruvate Kinase Deficiency, who are not receiving regular blood transfusions, followed by a 5-Year Open-label Extension Period, where subjects will be given the option to receive mitapivat for an additional 5 years. Estudio para evaluar la eficacia y seguridad del producto en investigación, Mitapivat, cuando se administra a sujetos pediátricos con deficiencia de piruvato cinasa, que no estén recibiendo transfusiones de sangre regulares, seguidas de un periodo de extensión abierto de 5-Year, en el que se dará a los sujetos la opción de recibir mitapivat durante 5 años más.

Ongoing
3
45
Europe
AG-348 sulfate hydrate granules, AG-348 sulfate hydrate, AG-348, Granules, Tablet
Agios Pharmaceuticals, Inc., AGIOS PHARMACEUTICALS, INC., Agios Pharmaceuticals, Inc.
Pyruvate Kinase Deficiency Deficiencia de piruvato cinasa, Lack of Pyruvate Kinase enzyme Ausencia de enzima piruvato cinasa, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
ENERGIZE, NCT04770753 / 2021-000211-23: A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)

Active, not recruiting
3
194
Europe, Canada, US, RoW
Placebo Matching Mitapivat, Mitapivat, AG-348, AG-348 sulfate hydrate, Mitapivat sulfate
Agios Pharmaceuticals, Inc., Agios Pharmaceuticals, Inc.
Non-Transfusion-dependent Alpha-Thalassemia, Non-Transfusion-dependent Beta-Thalassemia
11/23
12/28
ENERGIZE-T, NCT04770779 / 2021-000212-34: A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-TDT)

Active, not recruiting
3
258
Europe, Canada, US, RoW
Placebo Matching Mitapivat, Mitapivat, AG-348, AG-348 sulfate hydrate, Mitapivat sulfate
Agios Pharmaceuticals, Inc., Agios Pharmaceuticals, Inc.
Transfusion-dependent Alpha-Thalassemia, Transfusion-dependent Beta-Thalassemia
04/24
06/29
NCT03853798 / 2018-003459-39: Extension Study of AG-348 in Adult Participants With Pyruvate Kinase Deficiency Previously Enrolled in AG-348-006 or AG348-C-007

Completed
3
90
Europe, Canada, Japan, US, RoW
AG-348
Agios Pharmaceuticals, Inc.
Pyruvate Kinase Deficiency
07/24
07/24
ACTIVATE-Kids, NCT05175105 / 2021-003333-11: A Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Participants With Pyruvate Kinase Deficiency (PKD) Who Are Not Regularly Transfused, Followed by a 5-Year Extension Period

Active, not recruiting
3
30
Europe, Canada, US
Mitapivat, AG-348, AG-348 sulfate hydrate, Mitapivat sulfate, Mitapivat-matching placebo
Agios Pharmaceuticals, Inc., Agios Pharmaceuticals, Inc.
Pediatric Pyruvate Kinase Deficiency, Pediatric Hemolytic Anemia
12/24
01/30
ACTIVATE-KidsT, NCT05144256 / 2021-003265-36: A Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Participants With Pyruvate Kinase Deficiency (PKD) Who Are Regularly Transfused, Followed by a 5-Year Extension Period

Active, not recruiting
3
49
Europe, Canada, US, RoW
Mitapivat, AG-348, AG-348 sulfate hydrate, Mitapivat sulfate, Mitapivat-matching placebo
Agios Pharmaceuticals, Inc.
Pediatric Pyruvate Kinase Deficiency, Pediatric Hemolytic Anemia
05/24
06/29
RISE UP, NCT05031780 / 2021-001674-34: A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease

Active, not recruiting
2/3
286
Europe, Canada, US, RoW
Mitapivat, AG-348, Mitapivat Sulfate, Mitapivat-matching placebo
Agios Pharmaceuticals, Inc.
Sickle Cell Disease
10/25
02/30
DRIVE-PK, NCT02476916 / 2015-000484-13: A Study of AG-348 in Adult Participants With Pyruvate Kinase (PK) Deficiency

Completed
2
52
Europe, Canada, US
AG-348, Mitapivat
Agios Pharmaceuticals, Inc.
Pyruvate Kinase Deficiency
05/17
04/25
2018-002217-35: A Phase 2, Open-Label, Multicenter Study to Determine the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of AG-348 in Adult Subjects With Non-Transfusion-Dependent Thalassemia

Not yet recruiting
2
17
Europe
AG-348 sulfate hydrate, AG-348, Tablet
Agios Pharmaceuticals, Inc., Agios Pharmaceuticals, Inc.
Non-Transfusion-Dependent Thalassemia, Thalassemia (genetic blood disorder where not enough hemoglobin is produced), not requiring lifelong regular transfusion for survival, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
2019-003438-18: A study of mitapivat in sickle cell disease Een studie naar mitapivat in sikkelcelziekte

Not yet recruiting
2
10
Europe
AG-348 sulfate hydrate, AG-348, Tablet
Julius Clinical, Agios Pharmaceuticals
Sickle cell disease, Sickling of red blood cells, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
NCT03692052 / 2018-002217-35: A Study to Determine the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of AG-348 in Adult Participants With Non-transfusion-dependent Thalassemia

Active, not recruiting
2
20
Europe, Canada, US
AG-348, Mitapivat
Agios Pharmaceuticals, Inc., Agios Pharmaceuticals, Inc.
Thalassemia
08/20
09/30
SATISFY, NCT05935202: Safety and Efficacy of Mitapivat Sulfate in Adult Patients With Erythrocyte Membranopathies

Not yet recruiting
2
25
Europe
Mitapivat sulfate, AG-348
EuroBloodNet Association
Hereditary Red Blood Cell Disorder (Disorder)
07/25
12/26
AG348-C-026, NCT06286046: A Study of Mitapivat in Participants With Sickle Cell Disease and Nephropathy

Not yet recruiting
2
40
NA
Mitapivat, AG-348, Mitapivat sulfate, AG-348 sulfate hydrate
Agios Pharmaceuticals, Inc.
Sickle Cell Disease, Nephropathy
05/27
12/28
NCT04610866: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat

Active, not recruiting
1/2
15
US
Mitapivat
National Heart, Lung, and Blood Institute (NHLBI)
Sickle Cell Disease, Hemolytic Anemia
02/28
02/28
NCT05610657: A Pharmacokinetic Study of Mitapivat in Participants With Moderate Hepatic Impairment Compared to Matched Healthy Control Participants With Normal Hepatic Function

Completed
1
20
US
Mitapivat, AG-348, AG-348 sulfate hydrate, Mitapivat sulfate
Agios Pharmaceuticals, Inc.
Moderate Hepatic Impairment
07/23
07/23
NCT06648824: Study of How Mitapivat Affects Midazolam Blood Levels in Healthy Participants

Completed
1
20
US
Mitapivat, AG-348, PYRUKYND®, AG-348 sulfate hydrate, Mitapivat sulfate, Midazolam
Agios Pharmaceuticals, Inc.
Healthy Participants
12/24
12/24
NCT04995315: Pyruvate Kinase Deficiency Global Longitudinal Registry Substudy of Protocol AG348-C-008

Completed
N/A
13
Europe, US
Agios Pharmaceuticals, Inc.
Pyruvate Kinase Deficiency
09/23
09/23
NCT05675436: Investigating the Mechanistic Effects of Mitapivat in Subjects With Sickle Cell Disease

Active, not recruiting
N/A
6
US
National Heart, Lung, and Blood Institute (NHLBI)
Sickle Cell Anemia, Sickle Cell Thalassemia, Sickle Cell Pain, Hbss, Hbsc, Sickle Beta Thalassemia, Sickle Beta Zero Thalassemia, Sickle Cell Syndrome Variant
10/27
10/27
tebapivat (AG-946) / Agios Pharma
NCT06924970: A Dose-Finding Study of Tebapivat to Assess Efficacy, and Safety in Participants With Sickle Cell Disease (SCD)

Recruiting
2
56
US
Tebapivat, AG-946, Tebapivat Matched Placebo
Agios Pharmaceuticals, Inc.
Sickle Cell Disease
05/26
05/27
NCT05490446: A Study of Tebapivat (AG-946) in Participants With Anemia Due to Lower-Risk Myelodysplastic Syndromes (LR-MDS)

Recruiting
2
82
Europe, US, RoW
Tebapivat, AG-946
Agios Pharmaceuticals, Inc.
Myelodysplastic Syndromes
11/25
11/28
NCT04536792: A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-946 in Healthy Volunteers and in Participants With Sickle Cell Disease

Completed
1
122
Europe, US
AG-946, AG-946 Matched Placebo
Agios Pharmaceuticals, Inc.
Healthy Volunteers, Anemia, Sickle Cell
12/23
12/23
AG946-C-004, NCT06745271: A Study to Determine How Tebapivat is Absorbed, Broken Down, and Removed From the Body and the Extent to Which Tebapivat is Made Available in the Body in Healthy Participants

Completed
1
8
US
[14C]-tebapivat, [13C2,15N3]-tebapivat
Agios Pharmaceuticals, Inc.
Healthy Participants
02/25
02/25

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