13 completed, 8 recruiting, 5 not yet recruiting, 3 terminated. 20 Phase 2, 10 Phase 1, 3 Phase 3, 2 Phase 4.
Follow belumosudil: new trials by email Literature Review of belumosudil trials Research Report on belumosudil
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Belumosudil With Ruxolitnib as Third Line Therapy for Chronic Graft Versus Host Disease (cGvHD) Belumosudil, Ruxolitinib - cGVHD | Phase 2 | Not yet recruiting | Dennis Kim | 53 | 2026-11-01 | 2026-10-02 |
| A Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD) Belumosudil - Chronic Graft Versus Host Disease | Phase 4 | Not yet recruiting | Sanofi | 26 | 2026-10-30 | 2026-10-23 |
| A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease Belumosudil, Best available therapy (BAT) - Chronic Graft Versus Host Disease | Phase 3 | Not yet recruiting | Sanofi | 356 | 2026-09-07 | 2026-09-15 |
| IL6-receptor Inhibitor Iwith Belumosudil for the Treatment of Belumosudil-refractory cGVHD Belumosudil, Sarilumab - cGVHD | Phase 1 | Not yet recruiting | Stanford University | 10 | 2026-09-01 | 2026-08-12 |
| Study to Compare the Plasma Concentration of Belumosudil Given as an Oral Suspension and as a Tablet to Healthy Adult Male Participants Belumosudil - Chronic Graft Versus Host Disease | Phase 1 | Not yet recruiting | Sanofi | 58 | 2026-08-06 | 2026-07-24 |
| Evaluation of Belumosudil Whole Tablets vs. Crushed Tablets Pharmacokinetics in Patients Suffering From Chronic GvHD Belumosudil - Chronic Graft Versus Host Disease | Phase 1 | Recruiting | M.D. Anderson Cancer Center | 8 | 2026-02-09 | 2026-08-27 |
| A Study of Belumosudil in Children With Chronic Graft Versus Host Disease (schoolROCK) Belumosudil - Chronic Graft Versus Host Disease | Phase 2 | Recruiting | Sanofi | 37 | 2025-12-02 | 2026-09-22 |
| Belumosudil for Abrogation of Interstitial Fibrosis and Tubular Atrophy Following Kidney Transplantation Belumosudil 200 mg QD, Placebo - Rejection Chronic Renal | Phase 2 | Enrolling by invitation | The Methodist Hospital Research Institute | 40 | 2025-09-11 | 2025-11-12 |
| Safety and Efficacy of Oral Belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander Male and Female Participants Aged 12 Years and Above With Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy Belumosudil - Chronic Graft Versus Host Disease | Phase 2 | Withdrawn | Kadmon, a Sanofi Company | 2025-06-16 | 2026-02-12 | |
| A Study of Belumosudil in People at Risk of Developing Graft-Versus-Host Disease After a Stem Cell Transplant Belumosudil - Graft Versus Host Disease, Graft Vs Host Disease | Phase 2 | Recruiting | Memorial Sloan Kettering Cancer Center | 46 | 2025-05-21 | 2026-06-29 |
| Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients Belumosudil, Placebo for Belumosudil - Lung Transplant | Phase 2 | Recruiting | National Institute of Allergy and Infectious Diseases (NIAID) | 234 | 2025-03-12 | 2026-08-10 |
| A Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Belumosudil in Chinese Adolescents With cGVHD Who Have Had an Inadequate Response to Glucocorticoids or Other Systemic Therapies Belumosudil - Chronic Graft Versus Host Disease | Phase 4 | Completed | Sanofi | 6 | 2024-12-04 | 2026-05-27 |
| BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP) Belumosudil, Fluticasone, Azithromycin - Bronchiolitis Obliterans Syndrome, Bronchiolitis Obliterans | Phase 2 | Recruiting | Dana-Farber Cancer Institute | 45 | 2024-05-31 | 2026-06-10 |
| Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease Belumosudil, Rituximab - Chronic Graft Versus Host Disease | Phase 2 | Suspended | Northside Hospital, Inc. | 25 | 2024-01-29 | 2026-10-16 |
| A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease. Belumosudil, Placebo, Prednisone - Chronic Graft Versus Host Disease | Phase 3 | Active not recruiting | Sanofi | 260 | 2024-01-23 | 2026-10-16 |
| Belumosudil for the Pre-emptive Treatment of Patients With Chronic Graft Versus Host Disease Belumosudil, Biospecimen Collection, Electronic Health Record Review - Chronic Graft Versus Host Disease | Phase 2 | Recruiting | Fred Hutchinson Cancer Center | 82 | 2023-12-06 | 2026-09-17 |
| A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction Belumosudil, Azithromycin, Placebo - Lung Transplant Rejection | Phase 3 | Recruiting | Sanofi | 180 | 2023-10-10 | 2026-10-28 |
| Immunological Tolerance in Patients With Mismatched Kidney Transplants Donor CD34+, CD3+. and belumosudil - End Stage Kidney Disease, Immunological Tolerance | Phase 1 | Active not recruiting | University of California, Los Angeles | 16 | 2023-07-07 | 2025-11-26 |
| A Study to Assess the Effect of Oral Belumosudil on Inhibition of Various Proteins in the Fed State in Healthy Male Subjects Belumosudil, UGT1A1 victim drug, P-gp victim drug - Immune System Disorder, Healthy Volunteers | Phase 1 | Completed | Kadmon, a Sanofi Company | 52 | 2022-07-27 | 2025-09-25 |
| Extended Treatment and Follow-up of Subjects Treated With Belumosudil in Study KD025-208 or Study KD025-213 Belumosudil 200 mg QD, Belumosudil 200 mg BID, Belumosudil 400 mg QD - Chronic Graft-versus-host-disease | Phase 2 | Completed | Kadmon, a Sanofi Company | 23 | 2022-02-23 | 2025-05-02 |
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Bronchiolitis Obliterans Syndrome (14) · Autoimmune Diseases (2) · Fibrosis (2) · Graft vs Host Disease (2) · Immune System Diseases (2) · Lung Diseases (2) · Pulmonary Fibrosis (2) · Scleroderma, Diffuse (2) · Skin Diseases (2) · Acute Lung Injury (1) · Bronchiolitis Obliterans (1) · Hematologic Neoplasms (1) · Idiopathic Interstitial Pneumonias (1) · Idiopathic Pulmonary Fibrosis (1) · Kidney Failure, Chronic (1)
Kadmon, a Sanofi Company (8) · Sanofi (8) · Kadmon Corporation, LLC (7) · BioNova Pharmaceuticals (Shanghai) LTD. (1) · Dana-Farber Cancer Institute (1) · Dennis Kim (1) · Fred Hutchinson Cancer Center (1) · M.D. Anderson Cancer Center (1) · Memorial Sloan Kettering Cancer Center (1) · National Institute of Allergy and Infectious Diseases (NIAID) (1) · Northside Hospital, Inc. (1) · Stanford University (1) · The Methodist Hospital Research Institute (1) · University of California, Los Angeles (1)
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Amin Alousi, MD (1) · Corey Cutler, MD, MPH (1) · Depei Wu, Prof (1) · Doris Ponce, MD (1) · Sally Arai, MD (1) · Scott M. Palmer, M.D., M.H.S. (1) · Scott Solomon, MD (1) · Stephanie Lee, MD, MPH (1)
PMID 34265047, PMID 35781099, PMID 10387937, PMID 10845940, PMID 10997973, PMID 11222360, PMID 11509929, PMID 11981005, PMID 12070007, PMID 12931119, PMID 14512314, PMID 15142114, PMID 15251978, PMID 15292060, PMID 15613541, PMID 16046530, PMID 16239908, PMID 16551963, PMID 16788100, PMID 16946302, PMID 17549053, PMID 17671231, PMID 19597425, PMID 22500839, PMID 23861248, PMID 24315843, PMID 24820310, PMID 25385601, PMID 25395505, PMID 25687558, PMID 25985915, PMID 2670000, PMID 26983850, PMID 27436361, PMID 29281578, PMID 3042041, PMID 30518977, PMID 33877856, PMID 38532458, PMID 40088930, PMID 40311075, PMID 40614122, PMID 8485479, PMID 9027268, PMID 9193757
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