NDAORALTABLETPriority Review
Approved
Jul 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
17
Data completeness
5/8 — Partial
Priority Review
REZUROCK (belumosudil) by Sanofi. Approved for chronic graft-versus-host disease. First approved in 2021.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
REZUROCK (belumosudil) is an oral small molecule tablet approved by the FDA on July 16, 2021, manufactured by Sanofi. The mechanism of action and specific indications are not documented in the provided data. The product is currently in its peak lifecycle stage, indicating it has achieved market maturity following its initial commercialization.
$0.1BPart D
16.2 years to LOEMechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications (1)
Clinical Trials (17)
A Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)
Started Apr 2026
26 enrolled
Chronic Graft Versus Host Disease
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
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
Started Dec 2024
6 enrolled
Chronic Graft Versus Host Disease
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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.