Cosmo & Glenmark Unveil Winlevi: The Acne Cream That’s Set to Conquer Europe

Updated: December 01, 2025 23:22

Image Source: eHealth Magazine

Cosmo Pharmaceuticals and Glenmark Pharmaceuticals have secured European Commission marketing authorization for Winlevi (clascoterone 10 mg/g cream), a first-in-class topical acne treatment. The approval enables commercial rollout across 17 European nations, targeting both adults and adolescents aged 12–18.

Cosmo Pharmaceuticals N.V. and Glenmark Pharmaceuticals Limited have announced that the European Commission has granted marketing authorization for Winlevi® (clascoterone 10 mg/g cream), a novel topical therapy for acne vulgaris. This approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in August 2025 and paves the way for the product’s launch in 17 European countries, including Belgium, Bulgaria, the Czech Republic, Denmark, Finland, France, Greece, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, and Sweden.

Winlevi is indicated for the treatment of acne vulgaris in both adults and adolescents aged 12 to under 18 years, with use in adolescents restricted to facial application. This marks Glenmark’s first new chemical entity (NCE) launch in Europe, strengthening its dermatology portfolio and reinforcing its commitment to innovation and patient access.

Notable Updates:

Winlevi is a first-in-class topical innovation, redefining acne treatment standards.
The authorization allows commercialization in 17 European countries.
The product is approved for both adults and adolescents (12–18 years), with pediatric use limited to facial application.
This approval is a major milestone for Glenmark, marking its debut NCE launch in Europe.
The launch is a result of the strategic collaboration between Cosmo and Glenmark, focused on advancing dermatologic care.

Major Takeaways:

Winlevi offers a novel approach to acne management, targeting androgen receptors topically.
The European approval broadens access for millions of acne patients across the region.
Glenmark plans urgent and precise execution of the launch to ensure timely patient access.
The partnership with Cosmo underscores the companies’ commitment to global innovation in dermatology.

Sources: Cosmo Pharmaceuticals, Glenmark Pharmaceuticals, European Medicines Agency, Exchange Corporate Announcements

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