Ogsiveo (nirogacestat)
OrphanAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- nirogacestat
- Company
- Merck Europe B.V.
- Status
- Authorised
- Therapeutic area
- Desmoid Tumors
- CHMP opinion
- Thu 19 Jun 2025
- EU approval
- Thu 14 Aug 2025
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/006071
- ATC
- L01XX81
- Official record
- www.ema.europa.eu
Indication
Ogsiveo as monotherapy is indicated for the treatment of adult patients with progressing desmoid tumours who require systemic treatment.
Regulatory milestones
No milestones recorded in the last year.
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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.