Glenmark Pharmaceuticals has announced the launch of its innovative acne treatment, Winlevi® (clascoterone 10 mg/g cream), in key European markets. This marks Glenmark’s first launch of a New Chemical Entity (NCE) in Europe. The product, authorized for acne vulgaris in adults and adolescents aged 12+, offers a first-in-class topical androgen-receptor inhibitor mechanism, addressing a significant unmet need in dermatology. The launch strengthens Glenmark’s global dermatology portfolio.
Glenmark Pharmaceuticals Expands Dermatology Portfolio in Europe
Glenmark Specialty S.A (GSSA), a wholly-owned subsidiary of Glenmark Pharmaceuticals Ltd., has officially launched Winlevi® (clascoterone 10 mg/g cream) across key European markets. This significant development follows the European Commission’s grant of marketing authorization in October 2025 to Cassiopea S.p.A., a subsidiary of Cosmo N.V., for the treatment of acne vulgaris in both adults and adolescents aged 12 to <18 years. Usage in adolescents is limited to facial application.
First NCE Launch in Europe
The launch of Winlevi® signifies Glenmark’s first introduction of a New Chemical Entity (NCE) in the European market. This strategic move aims to strengthen the company’s dermatology portfolio and advance its branded business in the region. Glenmark has initiated direct launches in markets including the Nordics, Central and Eastern Europe, and Spain. Additionally, the product has been launched in Portugal through a strategic partner, with further launches planned via similar partnerships across other European territories.
Addressing a Common Dermatological Condition
Acne vulgaris is identified as one of the most common dermatological conditions globally, affecting a significant portion of the population. The announcement highlights that over 95% of males and 85% of females experience acne during adolescence, with approximately 50% continuing to experience it in adulthood. Winlevi® is presented as the first topical acne therapy in over 40 years with a novel mechanism of action. Its active ingredient, clascoterone, is a topical androgen-receptor inhibitor that works locally in the sebaceous glands to reduce sebum production and inflammation. This targeted action supports safe use in both males and females by avoiding systemic anti-androgen effects.
Strategic Partnerships and Future Outlook
Giovanni Di Napoli, Chief Executive Officer of Cosmo, expressed enthusiasm for the European launch, calling it an important milestone for Cosmo and a testament to the strong collaboration with Glenmark. He emphasized that this achievement aligns with their strategy of expanding the global reach of their innovative dermatology portfolio through trusted partnerships and disciplined execution. Jiri Havranek, Group Vice President & Business Head Europe at Glenmark Pharmaceuticals, also commented on the launch, stating it is a crucial step in fortifying Glenmark’s dermatology offerings and branded business in Europe. He reiterated the company’s commitment to making differentiated treatment options accessible to patients who need them.
About Glenmark Pharmaceuticals Limited
Glenmark Pharmaceuticals Ltd. is a global, research-led pharmaceutical company focused on innovation and accessibility. The company pioneers transformative therapies and aims to expand access to high-quality, affordable medicines worldwide. With a global presence spanning over 80 countries, 11 manufacturing facilities across four continents, and six R&D centers, Glenmark offers a diverse portfolio in areas like respiratory, dermatology, and oncology. It was recognized among the Top 100 biopharmaceutical companies globally by pharmaceutical sales for 2024.
About Cosmo
Cosmo is a life sciences company specializing in MedTech AI, dermatology, and gastrointestinal diseases, alongside contract development and manufacturing (CDMO). The company designs, develops, and manufactures advanced solutions to meet critical medical needs. Cosmo’s technologies are utilized by leading pharmaceutical and MedTech firms globally. Founded in 1997, Cosmo is headquartered in Dublin, Ireland, with additional offices in San Diego (USA), and several Italian cities.
Contact Information
For more information, please contact:
Glenmark Pharmaceuticals Ltd.
Akhila Natarajan
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+91 22 4018 9999
Tanvi Pathak, Adfactors PR
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+91 95356 35461
Cosmo N.V.
Investor Relations
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