NDAORALTABLETPriority Review
Approved
Jul 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
18
Data completeness
5/8 — Partial
Priority Review
Drug data last refreshed 4h 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 by the FDA in July 2021 for chronic graft-versus-host disease (cGVHD). It represents a novel mechanism of action in transplant immunology, targeting a distinct pathway to reduce fibrotic and inflammatory responses. The drug is indicated for adult patients with cGVHD after failure of at least two prior lines of systemic therapy.
$146MPart D
PeakStable
16.1 years to LOEProduct is at peak commercial performance in a rare disease market with stable revenue and limited team expansion anticipated in near term.
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 (18)
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
Belumosudil With Ruxolitnib as Second Line Therapy for Chronic Graft Versus Host Disease (cGvHD) After Steroid Failure
Started Jul 2026
63 enrolled
cGVHD
A Study of Belumosudil in Children With Chronic Graft Versus Host Disease (schoolROCK)
Started Dec 2025
37 enrolled
Chronic Graft Versus Host Disease
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
Started Jun 2025
0Chronic Graft Versus Host Disease
Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients
Started Mar 2025
234 enrolled
Lung Transplant
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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.