Winlevi (clascoterone)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- clascoterone
- Company
- Cassiopea S.p.A.
- Status
- Authorised
- Therapeutic area
- Acne Vulgaris
- CHMP opinion
- Mon 25 Aug 2025
- EU approval
- Fri 17 Oct 2025
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006138
- ATC
- D10AX06
- Official record
- www.ema.europa.eu
Indication
Adults Winlevi is indicated for the treatment of acne vulgaris. Adolescents (from 12 to < 18 years of age) Winlevi is indicated for the treatment of facial acne vulgaris.
Regulatory milestones
Fri 17 Oct 2025🇪🇺 EU approval (EC decision)
Winlevi (clascoterone) approved in the EU
Marketing authorisation to Cassiopea S.p.A.; 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.