Glenmark launches Winlevi for acne vulgaris across European markets
Launch follows European Commission authorisation and expands availability of clascoterone cream for adults and adolescents in Europe
Glenmark Specialty S.A. (GSSA), a wholly-owned subsidiary of Glenmark Pharmaceuticals, has announced the launch of Winlevi (clascoterone 10 mg/g cream) across key markets in Europe.
The launch follows the grant of marketing authorisation by the European Commission to Cassiopea S.p.A., a subsidiary of Cosmo N.V., in October 2025 for the treatment of acne vulgaris in adults and adolescents aged 12 to less than 18 years, with use in adolescents limited to facial application.
Glenmark has initiated direct launches in several European markets, including the Nordics, Central and Eastern Europe, and Spain. In Portugal, the company has launched the product through a strategic partner. Glenmark is also advancing additional launches through strategic partnerships across other European markets.
The product is authorised in the European Union for the treatment of acne vulgaris in adults and adolescents. It was developed by Cassiopea, which holds rights across Europe and collaborates with regional partners for commercialisation.
According to the company, acne vulgaris is one of the most common dermatological conditions globally. More than 95 per cent of males and 85 per cent of females experience acne during adolescence, while 50 per cent continue to experience it in adulthood.
Winlevi is a topical acne therapy with a mechanism of action based on clascoterone. The active ingredient is a topical androgen-receptor inhibitor that acts locally in the sebaceous glands to reduce sebum production and inflammation without systemic anti-androgen effects. The product is intended for use in both males and females and provides an additional treatment option for healthcare professionals and patients in Europe.
The company stated that the launch forms part of its dermatology growth strategy and its focus on expanding access to therapies across global markets. It also supports Glenmark’s approach to multi-market launches in Europe through a combination of direct presence and strategic partnerships.
Giovanni Di Napoli, Chief Executive Officer of Cosmo, commented, “The European launch of Winlevi represents an important milestone for Cosmo and reflects the strength of our collaboration with Glenmark. This achievement supports our strategy of expanding the global reach of our innovative dermatology portfolio through trusted partnerships and disciplined execution. We are pleased to see Winlevi becoming available to patients across Europe and look forward to continuing to build on the momentum of our long-term partnership with Glenmark.”
Jiri Havranek, Group Vice President and Business Head – Europe, Glenmark Pharmaceuticals, commented, “This launch is an important step in strengthening Glenmark’s dermatology portfolio and advancing our 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. We remain committed to expanding access to therapies that address unmet needs and support better outcomes for patients.”