Regulatory PathRegulatory requirements compared

Active substance

Clascoterone

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
WINLEVI1%cream · topicalSUN PHARMPrescription26 Aug 2020

EMA European Union — centrally authorised medicines

Winlevi Cassiopea S.p.A. · Authorised · authorised 17 Oct 2025 · ATC D10AX06

Therapeutic indication (EMA)

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.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
WINLEVI025388811 % / W/WCREAM · TOPICALSUN PHARMACEUTICAL INDUSTRIES LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACWINLEVI 1% CREAM$10.00099per GM23 Sep 2026
NHS Drug TariffClascoterone 10mg/g cream£19.4360 gram1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.