Glenmark Launches Winlevi® (clascoterone) 10 mg/g cream in Key European Markets for the Treatment of Acne Vulgaris
2026-06-11 · Glenmark Pharmaceuticals Ltd. India · original glenmarkpharma.com ↗
Glenmark Launches Winlevi® (clascoterone) 10 mg/g cream in Key European Markets for the Treatment of Acne Vulgaris Marks Glenmark’s first launch of a New Chemical Entity (NCE) in Europe Launch strengthens Glenmark’s dermatology portfolio across the region Dublin, Ireland and Mumbai, India, 11 June 2026 – Glenmark Specialty S.A (GSSA), a wholly -owned subsidiary of Glenmark Pharmaceuticals Ltd. , today 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. 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 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. Acne vulgaris is one of the most common dermatological conditions globall y. 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 acting 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. The launch marks an important milestone in Glenmark’s dermatology growth strategy and reflects the Company’s continued focus on expanding access to differentiated therapies across global markets. It also reinforces Glenmark’s ability to execute 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 t rusted 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 & 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.” About Glenmark Pharmaceuticals Limited: Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK) is a global, research‐ led pharmaceutical company with a unique focus on innovation and accessibility. We pioneer transformative breakthrough therapies that aim to redefine treatment while expanding access to high-quality and affordable medicines for patients around the world. With 11 world -class manufacturing facilities across four continents, supported by six cutting-edge R&D centres, and a commercial footprint in 80+ countries, we deliver a diversified portfolio across branded, innovative, generics, and consumer health products, with a focus on respiratory, dermatology, and oncology. Scrip 100 positions Glenmark among the Top 100 biopharmaceutical companies globally by pharmaceutical sales for 2024. For more information, visit www.glenmarkpharma.com. About Cosmo: Cosmo is a life sciences company focused on MedTech AI, dermatology, gastrointestinal diseases, and contract development and manufacturing (CDMO). We design, develop, and manufacture advanced solutions that address critical medical needs and raise the standard of care. Our technologies are trusted by leading global pharmaceutical and MedTech companies and reach patients and healthcare providers around the world. Guided by our purpose – Building Health Confidence – our mission is to empower patients, healthcare professionals, and partners by innovating at the intersection of science and technology. Founded in 1997, Cosmo is headquartered in Dublin, Ireland, with offices in San Diego (USA), and in Lainate, Rome, and Catania (Italy). For more information, visit www.cosmohealthconfidence.com For more information, please contact Glenmark Pharmaceuticals Ltd. Cosmo N.V. Akhila Natarajan | [email protected] | +91 22 4018 9999 Tanvi Pathak, Adfactors PR | [email protected] | +91 95356 35461 Investor Relations | [email protected] 7th Floor One North Dock 91/94 North Wall Quay Dublin 1, D01 H7V7 Ireland
The release as fetched from its publisher. glenmarkpharma.com ↗