#Ireland #Dublin #Glenmark #Cosmo #Winlevi®

Winlevi® Approved for Acne Treatment in 17 European Countries

Cosmo Pharmaceuticals N.V. and Glenmark Pharmaceuticals Limited have achieved a notable milestone in dermatologic care with the European Commission's recent approval of Winlevi® (clascoterone 10 mg/g cream). This innovative cream is specifically designed for the treatment of acne vulgaris, addressing the needs of both adults and adolescents aged 12 to under 18 years, limited to facial use. The announcement was made on December 1, 2025.

A Collaborative Achievement

The approval marks a significant collaborative effort between Cosmo and Glenmark, following a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) received on August 25, 2025. Giovanni Di Napoli, the CEO of Cosmo, expressed that this approval underscores the strength of their partnership and a joint commitment to enhancing dermatologic solutions. "Winlevi represents a groundbreaking topical innovation that is set to change the landscape of acne treatment," he said.

Launch Across Europe

With the authorization in place, Glenmark is poised to initiate the commercialization of Winlevi across 17 European markets, including Belgium, Bulgaria, the Czech Republic, Denmark, Finland, France, Greece, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, and Sweden. Christoph Stoller, President and Business Head for Europe and Emerging Markets at Glenmark, highlighted the approval as a pivotal moment in their mission to be a research-led, global pharmaceutical company. He stated, "Winlevi is our first New Chemical Entity (NCE) launch in Europe, and it is essential for expanding our presence in the dermatology sector in this region."

Significance of Winlevi®

Winlevi® brings a new approach to acne treatment with its unique formula. Acne vulgaris affects millions of individuals, and effective treatment options are crucial for improving quality of life. The cream, now accessible to patients across multiple countries, promises to deliver results that adhere to the highest regulatory standards. Both Cosmo and Glenmark have emphasized their dedication to execute timely and precise launches, ensuring patients have access to this new treatment at the earliest opportunity.

About Glenmark Pharmaceuticals

Glenmark Pharmaceuticals is a globally recognized healthcare organization focused on pharmaceuticals across various therapeutic areas including dermatology. The company has a robust presence in 80 countries and operates 11 advanced manufacturing facilities distributed over four continents. With a strong commitment to sustainability, Glenmark’s Green House Gas emission reduction targets have been recognized by the Science Based Target initiative, making it a leader in environmentally responsible practices in the pharmaceutical sector.

About Cosmo Pharmaceuticals

Cosmo is a life sciences company that specializes in medical technologies and solutions for dermatology and other critical health challenges. Established in 1997, Cosmo operates globally, developing advanced therapeutic options and manufacturing capabilities to meet significant medical needs. Headquartered in Dublin, Ireland, with operations extending to the USA and Italy, the organization emphasizes its core mission: to build health confidence through innovation at the intersection of science and technology.

With Winlevi® now available, both companies are set to make a notable impact on the dermatological treatment landscape throughout Europe, providing hope and effective solutions for those suffering from acne. The collaboration between Cosmo and Glenmark signifies a promising future in the dermatologic field, reflecting the importance of research and innovative solutions in addressing common yet challenging medical conditions.