Winlevi Approved in Europe for Acne Treatment

New Delhi, Nov 18 (PTI) Glenmark Pharmaceuticals Ltd and Ireland's Cosmo Pharmaceuticals N.V. on Tuesday announced that the European Commission (EC) has granted marketing authorisation for Winlevi (clascoterone 10 mg/g cream) used in treatment of acne vulgaris in 15 countries in Europe.

The marketing authorisation by EC follows the positive opinion issued by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on August 25, 2025, Glenmark Pharmaceuticals Ltd said in a regulatory filing.

"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," Glenmark Pharmaceuticals President & Business Head, Europe and Emerging Markets, Christoph Stoller said.


Winlevi is authorised in the EU for the treatment of acne vulgaris in both adults and adolescents aged 12 to 18 years, with usage in adolescents limited to facial application, the filing said.

"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," Cosmo CEO Giovanni Di Napoli said.

With receipt of this approval, Glenmark will initiate commercialising Winlevi across 15 countries in EU -- Bulgaria, Czech Republic, Denmark, Finland, France, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, and Sweden, the company said.