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. According to reports from Business Standard, this follows the grant of marketing authorization 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 both adults and adolescents aged 12 to <18 years. As reported by ETPharma, this marks Glenmark's first New Chemical Entity (NCE) launch in Europe, representing a significant milestone for the company's dermatology portfolio.
As reported by Business Standard, 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. According to ETPharma, the launch is expected to expand treatment options available to healthcare professionals and patients across Europe while reinforcing Glenmark's strategy of building a differentiated branded dermatology business in international markets.
According to the announcement, the product is authorized in the European Union for the treatment of acne vulgaris in adults and adolescents. The product has been developed by Cassiopea, which holds rights across Europe and collaborates with regional partners for commercialization. As reported by Business Standard, the treatment is limited to facial application in adolescents aged 12 to <18 years. According to ETPharma, the condition affects more than 95% of males and 85% of females during adolescence, while around half continue to be affected in adulthood, highlighting the significant unmet medical need this treatment addresses.
The product is notable for being the first topical acne therapy in more than 40 years with a first-in-class mechanism of action. As reported by ETPharma, 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. This localized action supports its use in both male and female patients, making it a significant advancement in acne treatment options. Giovanni Di Napoli, Chief Executive Officer of Cosmo, described the launch as an important milestone reflecting the strength of their collaboration with Glenmark.
Jiri Havranek, Group Vice President & Business Head – Europe at Glenmark Pharmaceuticals, emphasized that as Glenmark's first NCE launch in Europe, it reflects their focus on bringing differentiated treatment options to patients through disciplined execution, strong market access alignment and meaningful partnerships. According to ETPharma, the company remains committed to expanding access to therapies that address unmet needs and support better outcomes for patients. Giovanni Di Napoli from Cosmo expressed satisfaction with seeing the product become available to patients across Europe and looks forward to building on the momentum of their long-term partnership with Glenmark.
