Glenmark Pharmaceuticals Limited, through its wholly-owned subsidiary Glenmark Specialty S.A. launched Winlevi (clascoterone 10 mg/g cream) in key European markets for treating acne vulgaris. The European Commission granted marketing authorization for the product in October 2025 to Cassiopea S.p.A. a subsidiary of Cosmo N.V.
Winlevi is authorized for adults and adolescents aged 12 to less than 18 years, with adolescent use limited to facial application. This is Glenmark's first launch of a New Chemical Entity in Europe.
Glenmark initiated direct product launches in the Nordics, Central and Eastern Europe, and Spain. In Portugal, Glenmark launched the product through a strategic partner. Additional launches across other European markets are being advanced through partnerships.
Acne vulgaris is one of the most common dermatological conditions globally. More than 95% of males and 85% of females experience acne during adolescence. Fifty percent continue to experience it in adulthood. Winlevi is the first topical acne therapy in more than 40 years with a first-in-class mechanism of action. Clascoterone, the active ingredient, is the first commercially available topical androgen-receptor inhibitor that acts locally in sebaceous glands to reduce sebum production and inflammation without systemic anti-androgen effects, supporting safe use in both males and females.
The launch expands Glenmark's dermatology portfolio across Europe. Glenmark's Group Vice President and Business Head for Europe, Jiri Havranek, stated that the launch is an important step in advancing Glenmark's branded business in the region and bringing differentiated treatment options to patients.
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