Glenmark Launches Winlevi® in Key European Markets for Acne Vulgaris Treatment

Glenmark Launches Winlevi® in Key European Markets for Acne Vulgaris Treatment​

Glenmark Specialty S.A (GSSA), a wholly-owned subsidiary of Glenmark Pharmaceuticals Ltd., has announced the launch of Winlevi® (clascoterone 10 mg/g cream) across key markets in Europe. This expansion follows the granting of marketing authorization for the product by the European Commission in October 2025.

The treatment, developed by Cassiopea S.p.A., a subsidiary of Cosmo N.V. (SIX: COPN), is authorized for the treatment of acne vulgaris in both adults and adolescents aged 12 to <18 years. Usage in adolescents is specifically limited to facial application.

Glenmark has commenced direct launches in several European markets, including Central and Eastern Europe, the Nordics, and Spain. In Portugal, the Company initiated the launch through a strategic partner, and additional launches are being advanced through other strategic partnerships across various European countries.

Product Differentiation and Market Need​

Winlevi® holds significance as it is reportedly the first topical acne therapy in over 40 years to utilize a first-in-class mechanism of action. Its active ingredient, clascoterone, is noted as the first commercially available topical androgenreceptor inhibitor that acts locally within sebaceous glands. This targeted action aims to reduce sebum production and inflammation without requiring systemic anti-androgen effects, supporting its safe application for both males and females.

Acne vulgaris is a common dermatological condition globally; approximately 95% of males and 85% of females are expected to experience acne during adolescence, with fifty percent continuing the condition into adulthood. Winlevi® offers an additional treatment option for healthcare professionals and patients in Europe.

The launch represents an important milestone in Glenmark's dermatology growth strategy, reinforcing the company's ability to execute multi-market launches across Europe through a combination of direct market presence and strategic partnerships.

Industry Perspective​

Giovanni Di Napoli, Chief Executive Officer of Cosmo, commented that the European launch of Winlevi® is a significant achievement for Cosmo, reflecting the strength of its collaboration with Glenmark. He added that this success supports their strategy to expand 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, stated that the launch is an important step in advancing Glenmark's branded business and strengthening its dermatology portfolio in the region. As Glenmark's first NCE (New Chemical Entity) launch in Europe, it underscores their focus on bringing differentiated treatment options to patients through disciplined execution and meaningful partnerships.

GLENMARK Stock Price Movement​

Shares of Glenmark Pharmaceuticals Limited are edging higher to ₹2158.8 as of 10:29 AM today, gaining 0.67% in live trading. The equity shows strong interest with 94,564 shares traded during the current session.