Glenmark Specialty S.A. (GSSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd., has announced the launch of Winlevi® (clascoterone 10 mg/g cream) across key markets in Europe.
This follows the grant of marketing authorization of the product for the treatment of acne vulgaris in both adults and adolescents aged 12 to <18 years (with usage in adolescents limited to facial application) by the European Commission to Cassiopea S.p.A., a subsidiary of Cosmo N.V. (SIX: COPN) (“Cosmo”) in October 2025.
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. 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 & 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.”
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 has been developed by Cassiopea, which holds rights across Europe and collaborates with regional partners for commercialization. Acne vulgaris is one of the most common dermatological conditions globally. More than 95% of males and 85% of females will experience acne during adolescence. Fifty percent will continue to experience it in adulthood. Acne can have a significant physical and psychological impact, particularly among adolescents and young adults. Winlevi® is the first topical acne therapy in more than 40 years with a first-in-class mechanism of action. Its active ingredient, clascoterone, is the first commercially available topical androgen receptor inhibitor that acts locally in the sebaceous glands to reduce sebum production and inflammation without systemic anti-androgen effects, supporting safe use in both males and females. The availability of the product represents an additional treatment option for healthcare professionals and patients in Europe.
