Maruishi Pharma Trials - LARVOL Sigma

Trial + Data / Events

Status

Region

Interventions

Sponsor

Conditions

Primary compl

Study compl

grapiprant (RQ-00000007) / AskAt, Ikena Oncology, Maruishi Pharma

NCT05265052: 3D1002 in Combination With Oxycodone Hydrochloride Sustained-release Tablets in Patients With Moderate to Severe Cancer Pain

Not yet recruiting

177

3D1002 (50 mg)(Phase IIa), 3D1002 (100 mg)(Phase IIa), 3D1002 (150 mg)(Phase IIa), 3D1002 monotherapy (Phase IIb), OxyContin monotherapy (Phase IIb), 3D1002 + OxyContin (Phase IIb)

3D Medicines

Cancer Pain

12/25

NCT05041101: Grapiprant and Eribulin for the Treatment of Metastatic Inflammatory Breast Cancer

Terminated

1/2

Eribulin Mesylate, B1939 Mesylate, E7389, ER-086526, Halaven, Halichondrin B Analog, Grapiprant, AAT-007, AT-001, CJ 023,423, CJ-023,423, CJ023,423, RQ-00000007, RQ-07

M.D. Anderson Cancer Center

Breast Inflammatory Carcinoma, Recurrent Breast Inflammatory Carcinoma, Stage IV Breast Inflammatory Carcinoma

09/24

KEYNOTE-878, NCT03658772: Grapiprant and Pembrolizumab in Patients With Advanced or Progressive MSS Colorectal Cancer

Completed

grapiprant, ARYS-007, IK-007, grapiprant and pembrolizumab, ARYS-007, MK3475, KEYNOTE-878

Arrys Therapeutics, Merck Sharp & Dohme LLC

Microsatellite Stable Colorectal Cancer

03/23

ChiCTR1800015060: phase I clinical study evaluated the safety, tolerability, and pharmacokinetic characteristics of RMX1002 in healthy Chinese adult subjects

Recruiting

placebo

Zhongshan Hospital Affiliated to Fudan University; Zhongshan Hospital Affiliated to Fudan University, Fully self-raised

Arthritis, pain, familial adenomatous polyposis

ChiCTR1900026031: A Single Arm, Open-label, Dose Escalation and Expansion Study for RMX1002 in the Treatment of Advanced Solid Tumor Patients

Recruiting

Divide into 7 groups and treat respectively ;Two appropriate dose

Beijing Cancer Hospital; Beijing Cancer Hospital, Ningbo NewBay Medical Technology Ltd., Co.

Advanced solid tumor

Korsuva IV (difelikefalin IV) / Maruishi Pharma, CSL Behring

NCT04711603: A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.

Completed

178

Japan

MR13A9, Placebo

Kissei Pharmaceutical Co., Ltd.

Uremic Pruritus

01/22

09/22

NCT05885737: Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus

Completed

184

RoW

Difelikefalin Injection, Placebo Injection

Vifor Fresenius Medical Care Renal Pharma, Tigermed Consulting Co., Ltd

Uremic Pruritus

09/24

2021-000894-94: Single dose study to evaluate how intravenous administered difelikefalin is absorbed by and cleared from Adolescents on Haemodialysis Studio a dose singola per valutare come difelikefalin somministrato per via endovenosa viene assorbito ed eliminato dagli adolescenti in emodialisi

Ongoing

Europe

Difelikefalin, [CR845], Solution for infusion

Vifor Fresenius Medical Care Renal Pharma Ltd., Vifor Fresenius Medical Care Renal Pharma Ltd.

Renal disease in the final stage Nefropatia allo stadio terminale, Renal disease in the final stage Malattia renale allo stadio terminale, Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

KOR-PED-202, NCT06593392: Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus

Recruiting

Europe

Difelikefalin

Vifor Fresenius Medical Care Renal Pharma

Pruritus, Chronic Kidney Diseases

08/29

NCT05885763: Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis

Completed

RoW

Difelikefalin Injection

Vifor Fresenius Medical Care Renal Pharma, Tigermed Consulting Co., Ltd

End Stage Renal Disease on Hemodialysis

10/23

Korsuva oral (difelikefalin oral) / CSL Behring

2022-000149-34: A Placebo-controlled 12-Week Study to Evaluate the Safety and Efficacy of Oral Difelikefalin in Advanced Chronic Kidney Disease Subjects with Moderate-to-Severe Pruritus with an up to 52-Week Long-term Extension

Not yet recruiting

400

Europe, RoW

Difelikefalin, CR845, Tablet

Cara Therapeutics, Inc., Cara Therapeutics, Inc,, Cara Therapeutics, Inc.

Chronic Kidney Disease, Chronic Kidney Disease, Diseases [C] - Nutritional and Metabolic Diseases [C18]

NCT05342623: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus

	Trial initiation in non-hemodialysis CKD-aP patients
	Apr 2022 - Apr 2022: Trial initiation in non-hemodialysis CKD-aP patients

Terminated

286

Difelikefalin 1 mg Oral Tablet, CR845, Placebo Oral Tablet

Cara Therapeutics, Inc.

Chronic Kidney Diseases, Pruritus

02/24

NCT05356403 / 2022-000149-34: CR845-310302: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus

Terminated

105

Europe, US, RoW

Difelikefalin 1 mg Oral Tablet, CR845, Placebo Oral Tablet

Cara Therapeutics, Inc., Cara Therapeutics, Inc.

Chronic Kidney Diseases, Pruritus

02/24

KIND-1, NCT05387707: Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis

Terminated

287

difelikefalin 0.25 mg, CR845, difelikefalin 0.5 mg, TCS Cream, Placebo, Vehicle Cream

Cara Therapeutics, Inc.

Pruritus, Atopic Dermatitis

02/24

NCT05978063: Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica

Terminated

2/3

214

Europe, Canada, US

difelikefalin 2.0 mg tablets, CR845, difelikefalin 1.0 mg tablets, difelikefalin 0.25 mg tablets, Placebo tablets

Cara Therapeutics, Inc.

Pruritus, Notalgia Paresthetica

04/24

05/24

Traumakine (IFN beta-1a) / Faron Pharma, Maruishi Pharma

Faron Pharma_COVID_T: Faron Pharmaceuticals drug accepted to global pneumonia programme

Not yet recruiting

Asia-Pacific, Europe and North America

Traumakine

Faron Pharma, Maruishi Pharma

Coronavirus (COVID-19)

Faron Pharma_COVID_Traumakine: Faron Pharmaceuticals drug accepted to global pneumonia programme

Recruiting

Asia-Pacific, Europe and North America

Traumakine

Faron Pharma, Maruishi Pharma

Coronavirus (COVID-19)

NCT05936229: Interferon-Beta-1a (FP-1201) to Prevent Toxicities After CD19-Directed CAR T-Cell Therapy

Withdrawn

1/2

Interferon Beta-1A, 145258-61-3, Avonex, BG9418, Rebif, Recombinant interferon beta-1a, X-Ray Imaging, Conventional X-Ray, Diagnostic Radiology, Medical Imaging, Plain film radiographs, Radiographic Imaging, Radiographic imaging procedure (procedure), Radiography, RG, Static X-Ray, Echocardiography, EC, Multigated Acquisition Scan, Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide ventriculography, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning, Computed Tomography, CAT Scan, Computed Axial Tomography, Computerized axial tomography (procedure), Positron Emission Tomography, Pet Scan, Positron emission tomography (procedure), Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, Lumbar Puncture, LP, spinal tap, Bone Marrow Aspiration, Bone Marrow Biopsy, Biospecimen Collection, Biological Sample Collection, Biopsy, BIOPSY_TYPE, Bx

Fred Hutchinson Cancer Center, Faron Pharmaceuticals Ltd

Recurrent B Acute Lymphoblastic Leukemia, Recurrent B-Cell Non-Hodgkin Lymphoma, Refractory B Acute Lymphoblastic Leukemia, Refractory B-Cell Non-Hodgkin Lymphoma, Recurrent Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma

10/27

Trial + Data / Events

Status

Region

Interventions

Sponsor

Conditions

Primary compl

Study compl

grapiprant (RQ-00000007) / AskAt, Ikena Oncology, Maruishi Pharma

NCT05265052: 3D1002 in Combination With Oxycodone Hydrochloride Sustained-release Tablets in Patients With Moderate to Severe Cancer Pain

Not yet recruiting

177

3D1002 (50 mg)(Phase IIa), 3D1002 (100 mg)(Phase IIa), 3D1002 (150 mg)(Phase IIa), 3D1002 monotherapy (Phase IIb), OxyContin monotherapy (Phase IIb), 3D1002 + OxyContin (Phase IIb)

3D Medicines

Cancer Pain

12/25

NCT05041101: Grapiprant and Eribulin for the Treatment of Metastatic Inflammatory Breast Cancer

Terminated

1/2

Eribulin Mesylate, B1939 Mesylate, E7389, ER-086526, Halaven, Halichondrin B Analog, Grapiprant, AAT-007, AT-001, CJ 023,423, CJ-023,423, CJ023,423, RQ-00000007, RQ-07

M.D. Anderson Cancer Center

Breast Inflammatory Carcinoma, Recurrent Breast Inflammatory Carcinoma, Stage IV Breast Inflammatory Carcinoma

09/24

KEYNOTE-878, NCT03658772: Grapiprant and Pembrolizumab in Patients With Advanced or Progressive MSS Colorectal Cancer

Completed

grapiprant, ARYS-007, IK-007, grapiprant and pembrolizumab, ARYS-007, MK3475, KEYNOTE-878

Arrys Therapeutics, Merck Sharp & Dohme LLC

Microsatellite Stable Colorectal Cancer

03/23

ChiCTR1800015060: phase I clinical study evaluated the safety, tolerability, and pharmacokinetic characteristics of RMX1002 in healthy Chinese adult subjects

Recruiting

placebo

Zhongshan Hospital Affiliated to Fudan University; Zhongshan Hospital Affiliated to Fudan University, Fully self-raised

Arthritis, pain, familial adenomatous polyposis

ChiCTR1900026031: A Single Arm, Open-label, Dose Escalation and Expansion Study for RMX1002 in the Treatment of Advanced Solid Tumor Patients

Recruiting

Divide into 7 groups and treat respectively ;Two appropriate dose

Beijing Cancer Hospital; Beijing Cancer Hospital, Ningbo NewBay Medical Technology Ltd., Co.

Advanced solid tumor

Korsuva IV (difelikefalin IV) / Maruishi Pharma, CSL Behring

NCT04711603: A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.

Completed

178

Japan

MR13A9, Placebo

Kissei Pharmaceutical Co., Ltd.

Uremic Pruritus

01/22

09/22

NCT05885737: Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus

Completed

184

RoW

Difelikefalin Injection, Placebo Injection

Vifor Fresenius Medical Care Renal Pharma, Tigermed Consulting Co., Ltd

Uremic Pruritus

09/24

Ongoing

Europe

Difelikefalin, [CR845], Solution for infusion

Vifor Fresenius Medical Care Renal Pharma Ltd., Vifor Fresenius Medical Care Renal Pharma Ltd.

KOR-PED-202, NCT06593392: Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus

Recruiting

Europe

Difelikefalin

Vifor Fresenius Medical Care Renal Pharma

Pruritus, Chronic Kidney Diseases

08/29

NCT05885763: Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis

Completed

RoW

Difelikefalin Injection

Vifor Fresenius Medical Care Renal Pharma, Tigermed Consulting Co., Ltd

End Stage Renal Disease on Hemodialysis

10/23

Korsuva oral (difelikefalin oral) / CSL Behring

Not yet recruiting

400

Europe, RoW

Difelikefalin, CR845, Tablet

Cara Therapeutics, Inc., Cara Therapeutics, Inc,, Cara Therapeutics, Inc.

Chronic Kidney Disease, Chronic Kidney Disease, Diseases [C] - Nutritional and Metabolic Diseases [C18]

NCT05342623: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus

	Trial initiation in non-hemodialysis CKD-aP patients
	Apr 2022 - Apr 2022: Trial initiation in non-hemodialysis CKD-aP patients

Terminated

286

Difelikefalin 1 mg Oral Tablet, CR845, Placebo Oral Tablet

Cara Therapeutics, Inc.

Chronic Kidney Diseases, Pruritus

02/24

NCT05356403 / 2022-000149-34: CR845-310302: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus

Terminated

105

Europe, US, RoW

Difelikefalin 1 mg Oral Tablet, CR845, Placebo Oral Tablet

Cara Therapeutics, Inc., Cara Therapeutics, Inc.

Chronic Kidney Diseases, Pruritus

02/24

KIND-1, NCT05387707: Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis

Terminated

287

difelikefalin 0.25 mg, CR845, difelikefalin 0.5 mg, TCS Cream, Placebo, Vehicle Cream

Cara Therapeutics, Inc.

Pruritus, Atopic Dermatitis

02/24

NCT05978063: Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica

Terminated

2/3

214

Europe, Canada, US

difelikefalin 2.0 mg tablets, CR845, difelikefalin 1.0 mg tablets, difelikefalin 0.25 mg tablets, Placebo tablets

Cara Therapeutics, Inc.

Pruritus, Notalgia Paresthetica

04/24

05/24

Traumakine (IFN beta-1a) / Faron Pharma, Maruishi Pharma

Faron Pharma_COVID_T: Faron Pharmaceuticals drug accepted to global pneumonia programme

Not yet recruiting

Asia-Pacific, Europe and North America

Traumakine

Faron Pharma, Maruishi Pharma

Coronavirus (COVID-19)

Faron Pharma_COVID_Traumakine: Faron Pharmaceuticals drug accepted to global pneumonia programme

Recruiting

Asia-Pacific, Europe and North America

Traumakine

Faron Pharma, Maruishi Pharma

Coronavirus (COVID-19)

NCT05936229: Interferon-Beta-1a (FP-1201) to Prevent Toxicities After CD19-Directed CAR T-Cell Therapy

Withdrawn

1/2

Fred Hutchinson Cancer Center, Faron Pharmaceuticals Ltd

10/27



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