Glenmark Specialty S.A (GSSA), a wholly-owned subsidiary of Glenmark Pharmaceuticals Ltd., announced the launch of Winlevi® (clascoterone 10 mg/g cream) across key markets in Europe. This regulatory disclosure was filed with the National Stock Exchange of India Limited and BSE Limited under reference number 22/26-27.
The product launch follows the grant of marketing authorization by the European Commission to Cassiopea S.p.A., a subsidiary of Cosmo N.V. (SIX: COPN), which was received in October 2025. The authorization covers treatment of acne vulgaris in both adults and adolescents aged 12 to <18 years, with usage in adolescents limited to facial application.
Launch Details
Glenmark has initiated direct launches in several European markets including the Nordics, Central and Eastern Europe, and Spain. In Portugal, the company launched the product through a strategic partner. Additional launches are being advanced through strategic partnerships across other European markets.
Product Significance
This launch marks Glenmark's first New Chemical Entity (NCE) launch in Europe and strengthens the company's dermatology portfolio across the region. Winlevi® is described as 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.
Market Context
Acne vulgaris is highlighted as one of the most common dermatological conditions globally, with more than 95% of males and 85% of females experiencing it during adolescence, and 50% continuing to experience it in adulthood.
Executive Commentary
Giovanni Di Napoli, Chief Executive Officer of Cosmo, commented that the European launch represents an important milestone for Cosmo and reflects the strength of their collaboration with Glenmark, supporting their strategy of expanding global reach through trusted partnerships.
Jiri Havranek, Group Vice President & Business Head – Europe, Glenmark Pharmaceuticals, stated that this launch strengthens Glenmark's dermatology portfolio and advances their branded business in the region, reflecting focus on bringing differentiated treatment options through disciplined execution and partnerships.
Corporate Background
The document includes background information on Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK) as a global, research-led pharmaceutical company with 11 manufacturing facilities across four continents, six R&D centres, and commercial footprint in 80+ countries, focusing on respiratory, dermatology, and oncology. The company is positioned among Top 100 biopharmaceutical companies globally by pharmaceutical sales for 2024.
Cosmo is described as a life sciences company focused on MedTech AI, dermatology, gastrointestinal diseases, and contract development and manufacturing (CDMO), headquartered in Dublin, Ireland with offices in San Diego, USA and multiple locations in Italy.