Glenmark Pharmaceuticals, through its wholly-owned subsidiary Glenmark Specialty S.A. (GSSA), has launched Winlevi® (clascoterone 10 mg/g cream) in several key European markets for the treatment of acne vulgaris in adults and adolescents.
The launch follows the European Commission's approval of the product in October 2025. Glenmark has commenced direct commercialization in regions including the Nordics, Central and Eastern Europe, and Spain, while introducing the product in Portugal through a strategic partner. Additional launches across Europe are also being pursued through partnership arrangements.
Winlevi® is regarded as the first topical acne treatment in more than four decades with a novel mechanism of action. Its active ingredient, clascoterone, works locally by targeting androgen receptors in the sebaceous glands, helping reduce excess oil production and inflammation without causing systemic anti-androgen effects.
Acne vulgaris remains one of the most prevalent skin conditions worldwide, affecting the majority of adolescents and a significant proportion of adults. The introduction of Winlevi® provides healthcare professionals and patients with an innovative treatment option aimed at addressing this widespread dermatological condition.
The launch represents a significant milestone in Glenmark’s dermatology business and marks the company's first New Chemical Entity (NCE) launch in Europe. The move aligns with Glenmark’s strategy of expanding access to differentiated therapies through a mix of direct market presence and strategic collaborations across international markets.
The product was developed by Cassiopea, a subsidiary of Cosmo, which holds the commercialization rights in Europe and works with regional partners, including Glenmark, to expand patient access across the continent.