belumosudil
belumosudil: developed by 1 company · 15 clinical trials tracked.
belumosudil evidence translation
What we can confirm
15 tracked trials
What it means
What to watch
Prepared research question
How could belumosudil → KDMN affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence6 indications · 1 study sponsors
Related indications
Study sponsors
Development Pipeline (1)
| Company | Phase |
|---|---|
| Kadmon Holdings, Inc. (KDMN) chronic graft-versus-host disease (cGVHD) | BLA Filed |
Clinical Trials (15)showing 10 most recent
A Parallel Group, Phase 3, Randomized, Open-label, 2-arm Study to Demonstrate the Superiority of Belumosudil Versus Best Available Therapy (BAT) in Participants at Least 12 Years of Age With Chronic Graft Versus Host Disease (cGVHD) Refractory to or Recurrent After 2 to 5 Prior Lines of Systemic Therapy
Primary endpoint: Overall response rate
A Multi-center, Single-arm Phase IV Clinical Trial to Evaluate the Safety of Belumosudil in Indian Participants, 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)
Primary endpoint: Drug related Grade ≥ 3 treatment emergent adverse events (TEAE)
An Open-label, Randomized, Phase 1, 2-treatment, 2-period, 2-sequence, Cross-over, Bioequivalence Study Comparing Belumosudil Oral Suspension (Test Formulation) With Belumosudil Tablet (Commercially Available Reference Formulation) in Healthy Adult Male Participants Under Fed Condition
Primary endpoint: AUClast
A Phase 2 Study of Belumosudil Combined With Ruxolitinib as Second Line Therapy to Treat Chronic Graft Versus Host Disease (cGvHD) After Steroid Failure (BELRUX)
Primary endpoint: Efficacy will be assessed using overall response rate (ORR) as per the NIH cGvHD Consensus Response Criteria at 24 weeks of combination treatment. Tolerability and safety will be assessed by the incidence and severity of adverse events (AEs)
An Open-label, Phase 1/2, Multicenter Study of Belumosudil in Children Aged 1 to <18 Years Requiring Systemic Treatment for Active Moderate-to-severe Chronic Graft Versus Host Disease (cGVHD)
Primary endpoint: Phase 1: AUC
A Phase 2, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander Participants With Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy
Primary endpoint: Number of participants with treatment emergent adverse events and serious adverse events
A Multicenter, Open-label, Single-arm, Phase 4 Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Belumosudil Mesylate Tablets in Chinese Adolescents (Aged From 12 to Less Than 18 Years) With Chronic Graft-versus-host Disease (cGVHD) Who Have Had an Inadequate Response to Glucocorticoids or Other Systemic Therapies
Primary endpoint: Plasma concentrations of belumosudil at specified time points
An Open-Label, Phase 2 Study to Evaluate the Activity of Belumosudil in Subjects With New Onset and Incipient Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Cell Transplantation
Primary endpoint: 24-week Overall Response Rate (ORR) [Cohort A]
Phase I/II Open Label Study of Belumosudil Mesylate Alone, and in Combination With Dexamethasone, in Patients With Relapsed/Refractory Multiple Myeloma
Primary endpoint: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Phase II Trial of Belumosudil and Rituximab for the Primary Treatment of Extensive Chronic Graft-versus-host Disease
Primary endpoint: Number of patients who achieve partial and complete responses after treatment
Frequently asked questions
Who is developing belumosudil?
belumosudil is being developed by Kadmon Holdings, Inc..
How many clinical trials involve belumosudil?
BioSniper tracks 15 clinical trials involving belumosudil.