Anpheros Search · Treatment

Clascoterone

Also known as: Winlevi

General information only. Anpheros does not diagnose and does not recommend treatment. Talk to a doctor or pharmacist about your situation. In an emergency, call 112 (or your local emergency number).

Codes

RxNorm
2474340 clascoterone
EMA
EMEA/H/C/006138

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

EMA (EU) Winlevi

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.

Source: European Medicines Agency (EMA), Winlevi — EPAR, 10/02/2026. © European Medicines Agency.

Document date: 10/02/2026 · Official document →

FDA (USA) Winlevi

1 INDICATIONS AND USAGE WINLEVI (clascoterone) cream is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. WINLEVI (clascoterone) cream is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. ( 1 )

Data provided by the U.S. Food and Drug Administration.

Document date: 20250102 · Official document →

Related terms in the cited sources

Has an official indication for

In alphabetical order.

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What people report

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External resources

Questions

What is Clascoterone approved for in the European Union?

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. (Source: European Medicines Agency (EMA), Winlevi — EPAR, 10/02/2026. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • Data provided by the U.S. Food and Drug Administration.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), Winlevi — EPAR, 10/02/2026. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →