Glenmark launches Winlevi across key European markets

First-in-class topical androgen receptor inhibitor marks Glenmark’s first New Chemical Entity (NCE) launch in Europe

Glenmark Specialty S.A. (GSSA), a wholly owned subsidiary of Glenmark Pharmaceuticals, has announced the launch of Winlevi (clascoterone 10 mg/g cream) across key European markets for the treatment of acne vulgaris in adults and adolescents aged 12 to under 18 years.

The launch follows the European Commission’s marketing authorization granted in October 2025 to Cassiopea S.p.A., a subsidiary of Cosmo N.V., for the treatment of acne vulgaris in adults and adolescents, with use in adolescents limited to facial application.

Glenmark has commenced direct commercialization of Winlevi® in several European markets, including the Nordics, Central and Eastern Europe, and Spain. In Portugal, the product has been launched through a strategic partner, while additional launches are being pursued through partnerships across other European countries.

Acne vulgaris remains one of the most prevalent dermatological conditions worldwide, affecting more than 95% of males and 85% of females during adolescence. Approximately half of those affected continue to experience acne into adulthood. The condition can have significant physical and psychological consequences, particularly among adolescents and young adults.

Winlevi is the first topical acne treatment introduced in more than four decades with a first-in-class mechanism of action. Its active ingredient, clascoterone, is the first commercially available topical androgen receptor inhibitor that acts locally within sebaceous glands to reduce sebum production and inflammation without systemic anti-androgen effects. This localized mechanism supports its use in both male and female patients.

The company said the launch represents a significant milestone in Glenmark’s dermatology growth strategy and underscores its commitment to expanding access to differentiated therapies across global markets. It also highlights the company's capability to execute multi-country launches in Europe through a combination of direct commercial operations and strategic partnerships.

“The European launch of Winlevi represents an important milestone for Cosmo and reflects the strength of our collaboration with Glenmark,” said Giovanni Di Napoli, Chief Executive Officer of Cosmo added. 

“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,” Napoli

Jiri Havranek, Group Vice President & Business Head – Europe, Glenmark Pharmaceuticals, said, “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,” Havranek added.