Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate the bioavailability, drug-drug interactions, and therapeutic efficacy of Belumosudil (KD025) across autoimmune and fibrotic conditions, including chronic graft-versus-host disease, diffuse cutaneous systemic sclerosis, psoriasis vulgaris, and lung transplant rejection. Sponsored by pharmaceutical developers like Kadmon (a Sanofi company) alongside academic research institutions such as the Fred Hutchinson Cancer Center and Northside Hospital, this trial portfolio encompasses diverse recruitment statuses ranging from completed foundational studies and actively recruiting Phase 2 and 3 trials to terminated or withdrawn protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07794514 RECRUITING
Hematopoietic Stem Cell Transplantation (HSCT); cGVHD; Hepatic cGVHD; Belumosudil; Ruxolitinib
First Affiliated Hospital of Zhejiang University
 2026-10-01
NCT07771439 NOT_YET_RECRUITING
Chronic Graft Versus Host Disease
Sanofi
 2026-09-07 PHASE3
NCT07643025 NOT_YET_RECRUITING
cGVHD
Dennis Kim
 2026-07 PHASE2
NCT07006506 RECRUITING
Graft Versus Host Disease; Graft Vs Host Disease; Hematologic Malignancy
Memorial Sloan Kettering Cancer Center
 2025-05-21 PHASE2
NCT06082037 RECRUITING
Lung Transplant Rejection
Sanofi
 2023-10-10 PHASE3
NCT06143891 ACTIVE_NOT_RECRUITING
Chronic Graft Versus Host Disease
Sanofi
 2024-01-23 PHASE3
NCT07116031 RECRUITING
Chronic Graft Versus Host Disease
Sanofi
 2025-12-02 PHASE2
NCT05806749 ACTIVE_NOT_RECRUITING
End Stage Kidney Disease; Immunological Tolerance; Kidney Transplant Failure and Rejection; Chronic Kidney Diseases
University of California, Los Angeles
 2023-07-07 PHASE1
NCT07484113 NOT_YET_RECRUITING
cGVHD
Stanford University
 2026-09 PHASE1
NCT05996627 RECRUITING
Chronic Graft Versus Host Disease
Fred Hutchinson Cancer Center
 2023-12-06 PHASE2
NCT07127926 RECRUITING
Chronic Graft Versus Host Disease
M.D. Anderson Cancer Center
 2026-02-09 PHASE1
NCT06751602 ENROLLING_BY_INVITATION
Rejection Chronic Renal
The Methodist Hospital Research Institute
 2025-09-11 PHASE2
NCT04643002 RECRUITING
Plasma Cell Myeloma Refractory
Sanofi
 2021-01-25 PHASE1; PHASE2
NCT06105554 RECRUITING
Multiple Myeloma
M.D. Anderson Cancer Center
 2024-01-30 PHASE1; PHASE2
NCT07135973 NOT_YET_RECRUITING
Chronic Graft Versus Host Disease
Sanofi
 2026-08-10 PHASE4
NCT05922761 RECRUITING
Bronchiolitis Obliterans Syndrome; Bronchiolitis Obliterans; Lung Diseases; Chronic Graft Versus Host Disease
Dana-Farber Cancer Institute
 2024-05-31 PHASE2
NCT06476132 RECRUITING
Lung Transplant
National Institute of Allergy and Infectious Diseases (NIAID)
 2025-03-12 PHASE2
NCT06046248 RECRUITING
Chronic Graft Versus Host Disease
Northside Hospital, Inc.
 2024-01-29 PHASE2
NCT07726914 NOT_YET_RECRUITING
Chronic Graft Versus Host Disease
Sanofi
 2026-08-06 PHASE1
NCT05567406 WITHDRAWN
Chronic Graft Versus Host Disease
Kadmon, a Sanofi Company
 2025-06-16 PHASE2
NCT06616415 COMPLETED
Chronic Graft Versus Host Disease
Sanofi
 2024-12-04 PHASE4
NCT06509490 UNKNOWN
Safety Issues
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
 2024-07-17
NCT05305989 COMPLETED
Chronic Graft-versus-host-disease
Kadmon, a Sanofi Company
 2022-02-23 PHASE2
NCT05382377 UNKNOWN
CRC; Solid Tumor
jianming xu
 2022-05-17 EARLY_PHASE1
NCT03640481 TERMINATED
Chronic Graft-versus-host-disease
Kadmon, a Sanofi Company
 2018-10-11 PHASE2
NCT05806567 COMPLETED
Immune System Disorder; Healthy Volunteers
Kadmon, a Sanofi Company
 2022-07-27 PHASE1
NCT04550663 UNKNOWN
Solid Tumor; Hepatocellular Carcinoma; Colorectal Cancer; Glioma
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
 2020-09-25 PHASE1
NCT03919799 TERMINATED
System; Sclerosis; Diffuse Cutaneous Systemic Sclerosis
Kadmon, a Sanofi Company
 2019-06-26 PHASE2
NCT04166942 COMPLETED
Hepatic Impairment
Kadmon, a Sanofi Company
 2019-12-11 PHASE1
NCT02841995 COMPLETED
Graft vs Host Disease
Kadmon, a Sanofi Company
 2016-09-15 PHASE2
NCT04680975 TERMINATED
Diffuse Cutaneous Systemic Sclerosis
Kadmon, a Sanofi Company
 2021-03-03 PHASE2
NCT04735822 COMPLETED
Healthy Volunteers
Kadmon Corporation, LLC
 2020-10-26 EARLY_PHASE1
NCT02688647 COMPLETED
Idiopathic Pulmonary Fibrosis
Kadmon Corporation, LLC
 2016-05-26 PHASE2
NCT03919799 Terminated
System; Sclerosis|Diffuse Cutaneous Systemic Sclerosis
Kadmon a Sanofi Company|Sanofi
 2019-06-26 Phase 2
NCT03907540 COMPLETED
Autoimmune Diseases; Fibrosis
Kadmon Corporation, LLC
 2019-04-05 PHASE1
NCT02852967 COMPLETED
Chronic Plaque Psoriasis
Kadmon Corporation, LLC
 2016-09-14 PHASE2
NCT03530995 COMPLETED
Drug-drug Interaction; Autoimmune Diseases; Fibrotic Disease
Kadmon Corporation, LLC
 2018-04-09 PHASE1
NCT02841995 Completed
Graft vs Host Disease
Kadmon a Sanofi Company|Sanofi
 2016-09-15 Phase 2
NCT02317627 COMPLETED
Psoriasis Vulgaris
Kadmon Corporation, LLC
 2014-12 PHASE2
NCT02557139 COMPLETED
Bioavailability
Kadmon Corporation, LLC
 2015-09 PHASE1
NCT02557139 Completed
Bioavailability
Kadmon Corporation LLC|Quotient Clinical
 2015-09 Phase 1
NCT02317627 Completed
Psoriasis Vulgaris
Kadmon Corporation LLC
 2014-12 Phase 2
NCT02106195 COMPLETED
Psoriasis Vulgaris
Kadmon Corporation, LLC
 2014-04 PHASE2
NCT05918614 COMPLETED
Immune System Disorder (Healthy Volunteer)
Kadmon, a Sanofi Company
 2014-03-28 PHASE1
NCT05918588 COMPLETED
Immune System Disorder (Healthy Volunteer)
Kadmon, a Sanofi Company
 2013-11-21 PHASE1
NCT05918627 COMPLETED
Immune System Disorder (Healthy Volunteer)
Kadmon, a Sanofi Company
 2009-09-21 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-31)

Check the KD025 (Belumosudil) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Belumosudil (KD025) selectively inhibits Rho-associated coiled-coil kinase 2 (ROCK2) with nanomolar affinity, thereby suppressing pro-inflammatory Th17 cell differentiation and reducing aberrant pro-fibrotic signaling cascades driven by STAT3 activation. This dual regulation of immune balance and tissue remodeling underlies its therapeutic efficacy in downregulating pathological fibrosis and hyperactive immune responses in clinical conditions such as chronic graft-versus-host disease and systemic sclerosis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.