The launch follows the European Commission's marketing authorisation granted to Cassiopea S.p.A., a subsidiary of Cosmo N.V., in October 2025 for use in adults and adolescents aged 12 to under 18 years, with adolescent use limited to facial application.
Glenmark has initiated direct launches in several European markets, including the Nordics, Central and Eastern Europe, and Spain. In Portugal, the product is being introduced through a strategic partner. The company is also advancing additional launches through strategic partnerships across other European markets.
The product is approved in the European Union for the treatment of acne vulgaris in both adults and adolescents. It has been developed by Cassiopea, which holds the rights across Europe and works with regional partners for commercialisation.
Acne vulgaris is one of the most common dermatological conditions globally, with more than 95% of males and 85% of females experiencing it during adolescence. Around 50% of individuals continue to experience acne into adulthood. The condition can have significant physical and psychological effects, particularly among adolescents and young adults.
Winlevi is the first topical acne therapy in over 40 years with a first-in-class 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 without systemic anti-androgen effects, supporting safe use in both males and females.
The availability of the therapy provides an additional treatment option for healthcare professionals and patients across Europe.
The launch marks an important milestone in Glenmark's dermatology growth strategy and reflects its continued focus on expanding access to differentiated therapies across global markets. It also strengthens the company'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 trusted 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.'
Glenmark Pharmaceuticals is engaged in the business of development, manufacturing, and marketing of pharmaceutical products, both formulations and active pharmaceutical ingredients, to regulated and semi-regulated markets. The company reported a 6,381.9% zoom in consolidated net profit to Rs 301.41 crore on a 16.8% increase in revenue from operations to Rs 3,760.28 crore in Q4 FY26 over Q4 FY25.
The counter rose 0.39% to Rs 2,152.50 on the BSE.
Powered by Capital Market - Live News