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21 Trials

   

Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Igalmi (dexmedetomedine sublingual) / BioXcel
NCT06041646: Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder

Completed
4
23
US
Sublingual film containing Igalmi, Dexmedetomidine, BXCL501
BioXcel Therapeutics Inc, Lotus Clinical Research, LLC
Bipolar Disorder, Schizophrenia, Agitation,Psychomotor, Schizo Affective Disorder, Schizophreniform Disorders
04/24
04/24
NCT06093451: Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder

Recruiting
4
32
US
Dexmedetomidine, Igalmi, Lorazepam 2 MG/ML, Ativan
Temple University, BioXcel Therapeutics Inc
Schizophrenia Agitation, Schizo Affective Disorder, Bipolar Disorder, Dexmedetomidine
07/24
07/24
NCT05974527: Pilot Study 1: Efficacy and Safety of Sublingual Dexmedetomidine (BXCL501) for the Treatment of Agitation in the Emergency Department

Not yet recruiting
4
30
NA
Sublingual film containing dexmedetomidine (BXCL501)
Brigham and Women's Hospital
Agitation, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders, Bipolar Disorder
09/25
06/26
TRANQUILITY II, NCT05271552: Dexmedetomidine in the Treatment of Agitation Associated With Dementia

Completed
3
151
US
BXCL501, Dexmedetomidine, Matching Placebo, Placebo
BioXcel Therapeutics Inc, Cognitive Research Corporation
Agitation, Dementia
04/23
04/23
NCT05665088: Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III)

Terminated
3
13
US
BXCL501, Dexmedetomidine, Matching Placebo, Placebo
BioXcel Therapeutics Inc, Cognitive Research Corporation
Agitation, Dementia
09/23
09/23
NCT05658510: Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)

Active, not recruiting
3
452
US
BXCL501, Dexmedetomidine, Matching Placebo, Placebo
BioXcel Therapeutics Inc, Worldwide Clinical Trials
Agitation,Psychomotor, Bipolar I Disorder, Bipolar II Disorder, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders
09/25
09/25
NCT03708315: BXCL501 for Agitation in Schizophrenia

Recruiting
2
50
US
Dexmedetomidine Hydrochloride, Precedex, Placebos
Yale University
Schizophrenia, Schizoaffective Disorder
12/24
06/25
BASIS, NCT06943404: BXCL501 After Stress to Increase Recovery Success

Not yet recruiting
2
100
US
BXCL501 (dexmedetomidine HCl), BXCL501, Placebo
University of North Carolina, Chapel Hill, United States Department of Defense, Mclean Hospital, Washington University School of Medicine, University of Florida, Rhode Island Hospital, Vanderbilt University School of Medicine, Walter Reed Army Institute of Research (WRAIR)
Acute Stress Reaction, Acute Stress Disorder, Post-traumatic Stress Disorder
09/26
09/26
NCT04470050: Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal

Completed
1b/2
225
US
Dexmedetomidine, BXCL501, Placebo, Placebo comparator
BioXcel Therapeutics Inc, Cognitive Research Corporation
Opioid Withdrawal
02/21
02/21
NCT05712707: Sublingual Dexmedetomidine for Treating Opioid Withdrawal

Recruiting
1/2
160
US
BXCL501 (180 micrograms), BXCL501 (240 micrograms), Placebo, Lofexidine (Positive Control)
New York State Psychiatric Institute, BioXcel Therapeutics Inc, Yale University, Clinilabs, Inc., National Institute on Drug Abuse (NIDA), CenExel HRI
Opioid Use Disorder, Opioid Withdrawal
06/25
07/25
2021-001337-40: STUDY TO DETERMINE EFFICACY AND SAFETY OF BXCL501 IN AGITATION ASSOCIATED WITH PEDIATRIC SCHIZOPHRENIA AND BIPOLAR DISORDER ESTUDIO PARA DETERMINAR LA EFICACIA Y LA SEGURIDAD DE BXCL501 EN LA AGITACIÓN ASOCIADA A ESQUIZOFRENIA Y TRASTORNO BIPOLAR PEDIÁTRICOS

Not yet recruiting
1
120
Europe
BXCL501, Buccal film
BioXcel Therapeutics, Inc., BioXcel Therapeutics, Inc.
Subject that meets DSM-5 criteria for schizophrenia, schizoaffective, or schizophreniform disorder, or other specified/unspecified schizophrenia spectrum and/or other psychotic disorders OR Subject meets DSM-5 criteria for bipolar disorder (bipolar I or II ). Pacientes que cumplan los criterios de DSM-5 para esquizofrenia, trastorno esquizoafectivo o trastorno esquizofreniforme u otro espectro de esquizofrenia especificado/no especificado uy otros trastornos psicóticos O Pacientes que cumplan los criterios de DSM-5 para trastorno bipolar (bipolar I o II)., Schizophrenia and bipolar disorder Esquizofrenia y trastorno bipolar, Psychiatry and Psychology [F] - Mental Disorders [F03]
 
 
NCT04827056: Effect of Sublingual Formulation of Dexmedetomidine HCl (BXCL501) - Alcohol Interaction Study

Completed
1
10
US
Placebo, Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg, BXCL501 40µg, Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg, BXCL501 80µg, Ethanol Infusion, PTSD Reactivity Condition, Alcohol Cue Reactivity
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, United States Department of Defense, Congressionally Directed Medical Research Programs, RTI International, VA Connecticut Healthcare System, BioXcel Therapeutics Inc, Yale University
Alcohol Use Disorder (AUD), Post Traumatic Stress Disorder (PTSD)
05/23
06/23
NCT05025605 / 2021-001337-40: Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder

Recruiting
1
140
US
BXCL501 80 Micrograms, Dexmedetomidine, Placebo Film, Placebo, BXCL501 120 Micrograms, BXCL501 60 Micrograms
BioXcel Therapeutics Inc, Cognitive Research Corporation
Schizophrenia, Schizo-Affective Disorder, Schizophreniform; Schizophrenic, Bipolar Disorder I, Bipolar Disorder II
07/26
12/26
NCT06335407: Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study

Not yet recruiting
1
10
US
Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg, BXCL501 40µg, Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg, BXCL501 80µg
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, United States Department of Defense, Congressionally Directed Medical Research Programs, VA Connecticut Healthcare System, BioXcel Therapeutics Inc, Yale University, RTI International
Alcohol Use Disorder (AUD), Post Traumatic Stress Disorder (PTSD)
09/25
10/25
talabostat (BXCL701) / BioXcel
NCT04171219: Talabostat and Pembrolizumab for the Treatment of Advanced Solid Cancers

Checkmark From Basket trial in combination with BXCL701 for solid tumor
Nov 2020 - Nov 2020: From Basket trial in combination with BXCL701 for solid tumor
Checkmark Efficacy data from Stage 1 of Basket trial in combination with BXCL701 for advanced solid tumors
Nov 2020 - Nov 2020: Efficacy data from Stage 1 of Basket trial in combination with BXCL701 for advanced solid tumors
Terminated
2
31
US
Pembrolizumab, Keytruda, Lambrolizumab, MK-3475, SCH 900475, Talabostat Mesylate, Val-boro-Pro
M.D. Anderson Cancer Center, National Cancer Institute (NCI)
Advanced Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm
03/25
03/25
EXPEL PANC, NCT05558982: BXCL701 and Pembrolizumab in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

Recruiting
2
43
US
BXCL701, Pembrolizumab, Keytruda
Georgetown University, BioXcel Therapeutics Inc, Merck Sharp & Dohme LLC
Metastatic Pancreatic Ductal Adenocarcinoma
11/26
11/27
BXCL701-201, NCT03910660 / 2018-003734-32: A Trial of BXCL701 and Pembrolizumab in Patients With mCRPC Either Small Cell Neuroendocrine Prostate Cancer or Adenocarcinoma Phenotype.

Checkmark Initial interim data from trial in combination with BXCL701 for treatment-emergent neuroendocrine prostate cancer
Oct 2020 - Oct 2020: Initial interim data from trial in combination with BXCL701 for treatment-emergent neuroendocrine prostate cancer
Checkmark Data from P1b part of P1b/2 trial in combination with BXCL701 for Neuroendocrine prostate cancer
Apr 2020 - Apr 2020: Data from P1b part of P1b/2 trial in combination with BXCL701 for Neuroendocrine prostate cancer
Active, not recruiting
1b/2
98
Europe, US
BXCL701 plus Pembrolizumab, BXCL701 plus Pembro, BXCL701 monotherapy, BXCL701
BioXcel Therapeutics Inc, BioXcel Therapeutics, Inc
Prostate Cancer, Neuroendocrine Tumors, Small Cell Carcinoma
10/23
12/25
2018-003734-32: A Phase 1b/2 Study of BXCL701, Administered in Combination with Pembrolizumab (PEMBRO; Keytruda®) in Patients with Small Cell Neuroendocrine Prostate Cancer (SCNC; NEPC)

Not yet recruiting
1/2
68
Europe
Talabostat, pembrolizumab, BXCL701, Tablet, Powder for infusion, KEYTRUDA
BioXcel Therapeutics, Inc, BioXcel Therapeutics, Inc
Small Cell Neuroendocrine Prostate Cancer, Prostate cancer, Diseases [C] - Cancer [C04]
 
 
NCT05703542: BXCL701 Phase 1 R/R Acute Myeloid Leukemia or Myelodysplastic Syndrome

Recruiting
1
24
US
BXCL701, Talabostat
Eric Stephen Winer, MD
Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blasts-2
02/25
07/25
Dimebon (latrepirdine) / BioXcel
2008-006352-22: CONNECTION PLUS: An Open-Label Extension of the CONNECTION Protocol (DIM14) Evaluating Oral Dimebon in Patients with Alzheimer’s Disease

 
3
48
Europe
Dimebon, Dimebon,
Medivation, Inc.
Alzheimer\'s Disease
 
05/10
NCT06292351: DMB-I in the Treatment of Alzheimer Type Dementia

Completed
2
133
RoW
DMB-I (Dimebon), Placebo
Bigespas LTD
Alzheimer Disease, Dementia of Alzheimer Type
01/25
01/25
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Igalmi (dexmedetomedine sublingual) / BioXcel
NCT06041646: Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder

Completed
4
23
US
Sublingual film containing Igalmi, Dexmedetomidine, BXCL501
BioXcel Therapeutics Inc, Lotus Clinical Research, LLC
Bipolar Disorder, Schizophrenia, Agitation,Psychomotor, Schizo Affective Disorder, Schizophreniform Disorders
04/24
04/24
NCT06093451: Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder

Recruiting
4
32
US
Dexmedetomidine, Igalmi, Lorazepam 2 MG/ML, Ativan
Temple University, BioXcel Therapeutics Inc
Schizophrenia Agitation, Schizo Affective Disorder, Bipolar Disorder, Dexmedetomidine
07/24
07/24
NCT05974527: Pilot Study 1: Efficacy and Safety of Sublingual Dexmedetomidine (BXCL501) for the Treatment of Agitation in the Emergency Department

Not yet recruiting
4
30
NA
Sublingual film containing dexmedetomidine (BXCL501)
Brigham and Women's Hospital
Agitation, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders, Bipolar Disorder
09/25
06/26
TRANQUILITY II, NCT05271552: Dexmedetomidine in the Treatment of Agitation Associated With Dementia

Completed
3
151
US
BXCL501, Dexmedetomidine, Matching Placebo, Placebo
BioXcel Therapeutics Inc, Cognitive Research Corporation
Agitation, Dementia
04/23
04/23
NCT05665088: Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III)

Terminated
3
13
US
BXCL501, Dexmedetomidine, Matching Placebo, Placebo
BioXcel Therapeutics Inc, Cognitive Research Corporation
Agitation, Dementia
09/23
09/23
NCT05658510: Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)

Active, not recruiting
3
452
US
BXCL501, Dexmedetomidine, Matching Placebo, Placebo
BioXcel Therapeutics Inc, Worldwide Clinical Trials
Agitation,Psychomotor, Bipolar I Disorder, Bipolar II Disorder, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders
09/25
09/25
NCT03708315: BXCL501 for Agitation in Schizophrenia

Recruiting
2
50
US
Dexmedetomidine Hydrochloride, Precedex, Placebos
Yale University
Schizophrenia, Schizoaffective Disorder
12/24
06/25
BASIS, NCT06943404: BXCL501 After Stress to Increase Recovery Success

Not yet recruiting
2
100
US
BXCL501 (dexmedetomidine HCl), BXCL501, Placebo
University of North Carolina, Chapel Hill, United States Department of Defense, Mclean Hospital, Washington University School of Medicine, University of Florida, Rhode Island Hospital, Vanderbilt University School of Medicine, Walter Reed Army Institute of Research (WRAIR)
Acute Stress Reaction, Acute Stress Disorder, Post-traumatic Stress Disorder
09/26
09/26
NCT04470050: Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal

Completed
1b/2
225
US
Dexmedetomidine, BXCL501, Placebo, Placebo comparator
BioXcel Therapeutics Inc, Cognitive Research Corporation
Opioid Withdrawal
02/21
02/21
NCT05712707: Sublingual Dexmedetomidine for Treating Opioid Withdrawal

Recruiting
1/2
160
US
BXCL501 (180 micrograms), BXCL501 (240 micrograms), Placebo, Lofexidine (Positive Control)
New York State Psychiatric Institute, BioXcel Therapeutics Inc, Yale University, Clinilabs, Inc., National Institute on Drug Abuse (NIDA), CenExel HRI
Opioid Use Disorder, Opioid Withdrawal
06/25
07/25
2021-001337-40: STUDY TO DETERMINE EFFICACY AND SAFETY OF BXCL501 IN AGITATION ASSOCIATED WITH PEDIATRIC SCHIZOPHRENIA AND BIPOLAR DISORDER ESTUDIO PARA DETERMINAR LA EFICACIA Y LA SEGURIDAD DE BXCL501 EN LA AGITACIÓN ASOCIADA A ESQUIZOFRENIA Y TRASTORNO BIPOLAR PEDIÁTRICOS

Not yet recruiting
1
120
Europe
BXCL501, Buccal film
BioXcel Therapeutics, Inc., BioXcel Therapeutics, Inc.
Subject that meets DSM-5 criteria for schizophrenia, schizoaffective, or schizophreniform disorder, or other specified/unspecified schizophrenia spectrum and/or other psychotic disorders OR Subject meets DSM-5 criteria for bipolar disorder (bipolar I or II ). Pacientes que cumplan los criterios de DSM-5 para esquizofrenia, trastorno esquizoafectivo o trastorno esquizofreniforme u otro espectro de esquizofrenia especificado/no especificado uy otros trastornos psicóticos O Pacientes que cumplan los criterios de DSM-5 para trastorno bipolar (bipolar I o II)., Schizophrenia and bipolar disorder Esquizofrenia y trastorno bipolar, Psychiatry and Psychology [F] - Mental Disorders [F03]
 
 
NCT04827056: Effect of Sublingual Formulation of Dexmedetomidine HCl (BXCL501) - Alcohol Interaction Study

Completed
1
10
US
Placebo, Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg, BXCL501 40µg, Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg, BXCL501 80µg, Ethanol Infusion, PTSD Reactivity Condition, Alcohol Cue Reactivity
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, United States Department of Defense, Congressionally Directed Medical Research Programs, RTI International, VA Connecticut Healthcare System, BioXcel Therapeutics Inc, Yale University
Alcohol Use Disorder (AUD), Post Traumatic Stress Disorder (PTSD)
05/23
06/23
NCT05025605 / 2021-001337-40: Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder

Recruiting
1
140
US
BXCL501 80 Micrograms, Dexmedetomidine, Placebo Film, Placebo, BXCL501 120 Micrograms, BXCL501 60 Micrograms
BioXcel Therapeutics Inc, Cognitive Research Corporation
Schizophrenia, Schizo-Affective Disorder, Schizophreniform; Schizophrenic, Bipolar Disorder I, Bipolar Disorder II
07/26
12/26
NCT06335407: Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study

Not yet recruiting
1
10
US
Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg, BXCL501 40µg, Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg, BXCL501 80µg
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, United States Department of Defense, Congressionally Directed Medical Research Programs, VA Connecticut Healthcare System, BioXcel Therapeutics Inc, Yale University, RTI International
Alcohol Use Disorder (AUD), Post Traumatic Stress Disorder (PTSD)
09/25
10/25
talabostat (BXCL701) / BioXcel
NCT04171219: Talabostat and Pembrolizumab for the Treatment of Advanced Solid Cancers

Checkmark From Basket trial in combination with BXCL701 for solid tumor
Nov 2020 - Nov 2020: From Basket trial in combination with BXCL701 for solid tumor
Checkmark Efficacy data from Stage 1 of Basket trial in combination with BXCL701 for advanced solid tumors
Nov 2020 - Nov 2020: Efficacy data from Stage 1 of Basket trial in combination with BXCL701 for advanced solid tumors
Terminated
2
31
US
Pembrolizumab, Keytruda, Lambrolizumab, MK-3475, SCH 900475, Talabostat Mesylate, Val-boro-Pro
M.D. Anderson Cancer Center, National Cancer Institute (NCI)
Advanced Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm
03/25
03/25
EXPEL PANC, NCT05558982: BXCL701 and Pembrolizumab in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

Recruiting
2
43
US
BXCL701, Pembrolizumab, Keytruda
Georgetown University, BioXcel Therapeutics Inc, Merck Sharp & Dohme LLC
Metastatic Pancreatic Ductal Adenocarcinoma
11/26
11/27
BXCL701-201, NCT03910660 / 2018-003734-32: A Trial of BXCL701 and Pembrolizumab in Patients With mCRPC Either Small Cell Neuroendocrine Prostate Cancer or Adenocarcinoma Phenotype.

Checkmark Initial interim data from trial in combination with BXCL701 for treatment-emergent neuroendocrine prostate cancer
Oct 2020 - Oct 2020: Initial interim data from trial in combination with BXCL701 for treatment-emergent neuroendocrine prostate cancer
Checkmark Data from P1b part of P1b/2 trial in combination with BXCL701 for Neuroendocrine prostate cancer
Apr 2020 - Apr 2020: Data from P1b part of P1b/2 trial in combination with BXCL701 for Neuroendocrine prostate cancer
Active, not recruiting
1b/2
98
Europe, US
BXCL701 plus Pembrolizumab, BXCL701 plus Pembro, BXCL701 monotherapy, BXCL701
BioXcel Therapeutics Inc, BioXcel Therapeutics, Inc
Prostate Cancer, Neuroendocrine Tumors, Small Cell Carcinoma
10/23
12/25
2018-003734-32: A Phase 1b/2 Study of BXCL701, Administered in Combination with Pembrolizumab (PEMBRO; Keytruda®) in Patients with Small Cell Neuroendocrine Prostate Cancer (SCNC; NEPC)

Not yet recruiting
1/2
68
Europe
Talabostat, pembrolizumab, BXCL701, Tablet, Powder for infusion, KEYTRUDA
BioXcel Therapeutics, Inc, BioXcel Therapeutics, Inc
Small Cell Neuroendocrine Prostate Cancer, Prostate cancer, Diseases [C] - Cancer [C04]
 
 
NCT05703542: BXCL701 Phase 1 R/R Acute Myeloid Leukemia or Myelodysplastic Syndrome

Recruiting
1
24
US
BXCL701, Talabostat
Eric Stephen Winer, MD
Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blasts-2
02/25
07/25
Dimebon (latrepirdine) / BioXcel
2008-006352-22: CONNECTION PLUS: An Open-Label Extension of the CONNECTION Protocol (DIM14) Evaluating Oral Dimebon in Patients with Alzheimer’s Disease

 
3
48
Europe
Dimebon, Dimebon,
Medivation, Inc.
Alzheimer\'s Disease
 
05/10
NCT06292351: DMB-I in the Treatment of Alzheimer Type Dementia

Completed
2
133
RoW
DMB-I (Dimebon), Placebo
Bigespas LTD
Alzheimer Disease, Dementia of Alzheimer Type
01/25
01/25

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