Rezurock (belumosudil)
- Region
- 🇪🇺 EU
- Active substance
- belumosudil
- Company
- Sanofi Winthrop Industrie
- Status
- Authorised
- Therapeutic area
- Graft vs Host Disease
- CHMP opinion
- Thu 29 Jan 2026
- EU approval
- Tue 24 Mar 2026
- Designations
- Orphan, Conditional, Additional monitoring
- Application
- EMEA/H/C/006421
- ATC
- L04AA48
- Official record
- www.ema.europa.eu
Indication
Rezurock is indicated for the treatment of adults and paediatric patients (12 years and older with a body weight of at least 40 kg) with chronic graft-versus-host disease (cGVHD) when other treatment options provide limited clinical benefit, are not suitable, or have been exhausted.
Regulatory milestones
Rezurock (belumosudil) approved in the EU
Marketing authorisation to Sanofi Winthrop Industrie; Orphan, Conditional, Additional monitoring · source
Rezurock (belumosudil): CHMP positive opinion
Sanofi Winthrop Industrie; Orphan, Conditional, Additional monitoring · source
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.