s has launched its dermatological product Winlevi (clascoterone 10 mg/g cream) in key European markets, through its subsidiary Glenmark Specialty SA, the company said. The launch marks a milestone in Glenmark’s strategy to grow its dermatology portfolio, besides reflecting its focus on expanding access to differentiated therapies across global markets, it added.
The launch follows the marketing authorisation it received for the product, used to treat acne vulgaris in both adults and adolescents aged 12 to 18 years (with usage in adolescents limited to facial application). The European Commission approval was given to Cassiopea SpA, a subsidiary of Cosmo NV in October 2025, and Glenmark is its commercial partner. The product has been developed by Cassiopea, which holds rights across Europe and collaborates with regional partners for commercialisation.
Glenmark has initiated direct launches in several European markets, including the Nordics, Central and Eastern Europe, and Spain. In Portugal, it has launched the product through a strategic partner, it said. Glenmark is also advancing additional launches through strategic partnerships across other European markets, it added.
Giovanni Di Napoli, Chief Executive Officer of Cosmo, said the launch supported its strategy of “expanding the global reach of our innovative dermatology portfolio through trusted partnerships and disciplined execution.” Jiri Havranek, Glenmark Pharma Group Vice President and Business Head – Europe, said, the launch strengthened its dermatology portfolio and advanced its branded business in the region. “As Glenmark’s first NCE launch in Europe, it reflects our focus on bringing differentiated treatment options to patients through disciplined execution, strong market access alignment and meaningful partnerships.”
Acne vulgaris is one of the most common dermatological conditions globally, it said, and more than 95 per cent of males and 85 per cent of females will experience acne during adolescence, it added. 50 per cent will continue to experience it in adulthood, the company said.
Winlevi is the first topical acne therapy in more than 40 years, with a first-in-class mechanism of action, Glenmark said. Its active ingredient, clascoterone, is the first commercially available topical androgen-receptor inhibitor acting locally in the sebaceous glands to reduce sebum production and inflammation without systemic anti-androgen effects, supports safe use in both males and females, it added.