NDAORALTABLETPriority Review
Approved
Jul 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
Drug data last refreshed 11h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
REZUROCK (belumosudil) is an oral small-molecule RHO kinase inhibitor approved in 2021 for chronic graft-versus-host disease (cGVHD). It works by inhibiting RHO kinase signaling, reducing T-cell and fibroblast activation that drives GVHD pathology. This represents a novel mechanism targeting a serious complication of hematopoietic stem cell transplantation.
$146MPart D
PeakGrowing
15.8 years to LOEProduct is at peak lifecycle with established market presence; commercial team focused on specialty pharmacy penetration and hematology/oncology channel optimization.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Belumosudil Versus Ruxolitinib for Steroid-Refractory or Breakthrough Hepatic cGVHD
Started Oct 2026
170 enrolled
Hematopoietic Stem Cell Transplantation (HSCT)cGVHDHepatic cGVHD+2 more
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
Started Sep 2026
356 enrolled
Chronic Graft Versus Host Disease
A Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)
Started Aug 2026
26 enrolled
Chronic Graft Versus Host Disease
Study to Compare the Plasma Concentration of Belumosudil Given as an Oral Suspension and as a Tablet to Healthy Adult Male Participants
Started Aug 2026
58 enrolled
Chronic Graft Versus Host Disease
Belumosudil With Ruxolitnib as Second Line Therapy for Chronic Graft Versus Host Disease (cGvHD) After Steroid Failure
Started Jul 2026
63 enrolled
cGVHD
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.