Glenmark launches first NCE in Europe with Winlevi
Glenmark Pharmaceuticals Ltd has launched Winlevi (clascoterone 10 mg/g cream) in key European markets for acne vulgaris treatment, marking its first New Chemical Entity (NCE) launch in Europe. The product, authorized for adults and adolescents, is being rolled out through direct entries and strategic partnerships. Winlevi features a first-in-class mechanism acting as a topical androgen-receptor inhibitor.

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Glenmark Pharmaceuticals Ltd has launched Winlevi (clascoterone 10 mg/g cream) across key European markets for the treatment of acne vulgaris. This launch marks the company's first introduction of a New Chemical Entity (NCE) in Europe, strengthening its dermatology portfolio. The product is authorized for adults and adolescents aged 12 to <18 years, with usage in adolescents limited to facial application. Glenmark Specialty S.A (GSSA), a wholly-owned subsidiary, is executing the launch through a mix of direct market entries and strategic partnerships.
Market Entry and Authorization
The European Commission granted marketing authorization to Cassiopea S.p.A., a subsidiary of Cosmo N.V., in October 2025. Glenmark has initiated direct launches in several markets, including the Nordics, Central and Eastern Europe, and Spain. In Portugal, the company has introduced the product through a strategic partner, with additional launches planned via partnerships across other European regions.
Product Details and Mechanism
Winlevi is the first topical acne therapy in more than 40 years with a first-in-class mechanism of action. Its active ingredient, clascoterone, acts as a topical androgen-receptor inhibitor locally in the sebaceous glands. This mechanism reduces sebum production and inflammation without systemic anti-androgen effects, supporting safe use in both males and females.
| Parameter | Details |
|---|---|
| Product Name | Winlevi (clascoterone 10 mg/g cream) |
| Therapeutic Area | Acne Vulgaris |
| Target Group | Adults and adolescents (12 to <18 years) |
| Launch Region | Key European Markets |
| Milestone | First NCE launch in Europe for Glenmark |
Strategic Significance
Jiri Havranek, Group Vice President & Business Head – Europe at Glenmark Pharmaceuticals, stated that the launch reflects the company's focus on bringing differentiated treatment options to patients. Giovanni Di Napoli, Chief Executive Officer of Cosmo, highlighted that the European launch supports the strategy of expanding the global reach of their innovative dermatology portfolio through trusted partnerships. The launch reinforces Glenmark's ability to execute multi-market launches in Europe through a combination of direct presence and strategic collaborations.
Historical Stock Returns for Glenmark Pharmaceuticals
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| +0.00% | -0.91% | -7.27% | +8.62% | +28.12% | +236.51% |
What revenue impact is Glenmark expecting from Winlevi in the first full year of European sales?
Will Glenmark pursue regulatory approval for Winlevi in additional regions beyond Europe?
How will Glenmark differentiate Winlevi from established generic acne treatments in these markets?


































