New Delhi – Cosmo Pharmaceuticals N.V. (SIX: COPN) and Glenmark Pharmaceuticals Limited have jointly announced that the European Commission (EC) has granted Marketing Authorization (MA) for Winlevi® (clascoterone 10 mg/g cream), a first-in-class topical treatment for acne vulgaris. This milestone follows the positive opinion issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on 25 August 2025.
Winlevi® is now authorized for use across the European Union in both adults and adolescents aged 12 to under 18 years, with adolescent usage restricted to facial application. The approval paves the way for Glenmark to commence commercialization of the product across 15 European countries: Bulgaria, the Czech Republic, Denmark, Finland, France, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, and Sweden.
Giovanni Di Napoli, CEO of Cosmo Pharmaceuticals, emphasized the significance of the approval, stating, “This approval reflects the strength of our collaboration with Glenmark and our shared commitment to advancing dermatologic care. Winlevi represents a first-in-class topical innovation that redefines how acne is treated, and we are excited to see it become accessible to patients throughout Europe.”
Christoph Stoller, President & Business Head – Europe and Emerging Markets at Glenmark Pharmaceuticals, highlighted the strategic importance of the development: “The approval is a key milestone in executing our mission to become a research-led, global pharmaceutical company. Winlevi is the first NCE (New Chemical Entity) launch of Glenmark in Europe and is key to strengthening our presence in Dermatology in the region. We are committed to executing successful launches with urgency and precision, ensuring timely access for patients in full alignment with regulatory and access frameworks.”
Winlevi® is the first topical androgen receptor inhibitor approved for the treatment of acne, offering a novel mechanism of action that targets the hormonal component of acne pathogenesis. Its approval in Europe marks a significant advancement in dermatologic therapeutics and underscores the growing emphasis on innovation in topical treatments.
With this development, Glenmark reinforces its strategic focus on expanding its dermatology portfolio in Europe, while Cosmo continues to leverage its research capabilities to bring cutting-edge treatments to market. The collaboration between the two companies exemplifies a shared vision of delivering impactful, science-driven solutions to patients worldwide.
