Clascoterone
Other Anti-Acne Preparations For Topical Use
Sold as Winlevi
- Drug class
- Other Anti-Acne Preparations For Topical Use
- Availability
- Prescription only
- Routes
- Topical
- Markets covered
- 4
- Products on record
- 4
- FDA reports (12 mo)
- 262
Overview
Clascoterone is an active pharmaceutical ingredient in the Other Anti-Acne Preparations For Topical Use group (D10AX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 1 | January 2, 2025 |
| EU European Union | EMA | 1 | February 10, 2026 |
| CA Canada | Health Canada | 1 | July 15, 2025 |
| GB United Kingdom | MHRA | 1 | April 11, 2025 |
USUnited States· FDA
1 product
Uses
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 )
How to take
EUEuropean Union· EMA
1 product
Uses
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.
How to take
CACanada· Health Canada
1 product
Uses
WINLEVI (clascoterone) is indicated for: • the topical treatment of acne vulgaris in patients 12 years of age and older. 1 Pediatrics Pediatrics (12 to <18 years): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of WINLEVI in pediatric patients aged 12 to <18 years have been established.
3 Pediatrics). 3 Pediatrics). 2 Geriatrics Geriatrics (≥ 65years): The clinical studies did not include participants ≥ 65 years of age. Thus, the clinical studies did not determine whether patients ≥ 65 years of age respond differently from younger patients.
How to take
GBUnited Kingdom· MHRA
1 product
Uses
Winlevi (clascoterone) is indicated for: the topical treatment of acne vulgaris in patients 12 years of age and older.
Paediatrics (<12 years):
The safety and efficacy of Winlevi have not been established in paediatric patients under 12 years of age.
How to take
Sources & citations
- [1]FDA DailyMed · 1673a84b-7f5c-47… · revised January 2, 2025 [PDF]
- [2]European Medicines Agency · EMEA/H/C/006138 · revised February 10, 2026
- [3]Health Canada (DPD) · 02538881 · revised July 15, 2025
- [4]MHRA (UK) · PL252580425 · revised April 11, 2025
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.