Glenmark Specialty S.A. (GSSA), a wholly-owned subsidiary of Glenmark Pharmaceuticals Ltd., has announced the European launch of Winlevi (clascoterone 10 mg/g cream) across several key markets. The launch marks an important step in Glenmark’s strategy to strengthen its dermatology portfolio and expand access to innovative treatments across the region.
The launch comes after the European Commission granted marketing authorization for Winlevi in October 2025 to Cassiopea S.p.A., a subsidiary of Cosmo N.V. The product is approved for the treatment of acne vulgaris in adults and adolescents aged 12 to under 18 years. In adolescents, the treatment is currently limited to facial application.
If you look at acne treatments available today, many of them have been around for decades. Winlevi stands out because it introduces a completely different approach.
The cream contains clascoterone, which is the first commercially available topical androgen-receptor inhibitor. It works directly in the sebaceous glands, helping reduce excess sebum production and inflammation that contribute to acne development. One of the key advantages of this mechanism is that it acts locally on the skin without causing systemic anti-androgen effects. This allows the treatment to be used safely in both male and female patients.
According to the company, Winlevi is the first topical acne treatment with a new mechanism of action introduced in more than 40 years, making it a significant addition to the dermatology treatment landscape.
Launch Rollout Across European Markets
Glenmark has already started launching Winlevi in multiple European countries through a combination of direct operations and partnerships.
The company has initiated direct launches in:
In Portugal, the product has been introduced through a strategic commercial partner. Glenmark is also working on expanding availability through additional partnerships across other European countries. This multi-market strategy allows the company to increase patient access while building a stronger branded business presence throughout the region.
Addressing a Widespread Skin Condition
Acne vulgaris remains one of the most common skin disorders worldwide and affects millions of people every year.
The condition is especially common during adolescence. Industry data shows that more than 95% of males and 85% of females experience acne during their teenage years. For many individuals, the condition does not disappear after adolescence. Around half of all affected patients continue to experience acne symptoms into adulthood. While acne is often viewed as a cosmetic issue, its impact can go much deeper. Persistent acne can affect self-confidence, social interactions, emotional well-being, and overall quality of life. This is particularly true for teenagers and young adults, who are often most affected by the condition.
The availability of new treatment options gives healthcare professionals more flexibility in selecting therapies that match individual patient needs.
A Milestone for Glenmark’s Dermatology Business
The launch of Winlevi represents more than just a product introduction. It also marks Glenmark’s first New Chemical Entity (NCE) launch in Europe. The achievement highlights the company’s growing capabilities in bringing innovative branded products to international markets. It also demonstrates Glenmark’s ability to manage complex launches across multiple countries through a mix of direct commercial operations and strategic partnerships.
As healthcare systems continue to look for differentiated treatment options, products like Winlevi can help strengthen Glenmark’s position in the dermatology segment.
Leadership Perspectives on the Launch
Giovanni Di Napoli, Chief Executive Officer of Cosmo, described the launch as an important milestone for both organizations.
He noted that the European rollout reflects the strength of the collaboration between Cosmo and Glenmark and supports Cosmo’s strategy of expanding the global reach of its dermatology portfolio through trusted partnerships. He also emphasized the company’s commitment to continuing its long-term collaboration with Glenmark as Winlevi becomes available to patients across Europe. Jiri Havranek, Group Vice President and Business Head – Europe at Glenmark Pharmaceuticals, highlighted the significance of the launch for Glenmark’s regional business.
According to him, Winlevi strengthens Glenmark’s dermatology portfolio and supports the company’s branded business growth strategy in Europe. He added that the launch reflects Glenmark’s focus on providing differentiated treatment options through strong execution, effective market access planning, and meaningful partnerships.
Looking Ahead
The European launch of Winlevi marks an important development in acne treatment and represents a major milestone for Glenmark’s dermatology business.
With its first-in-class mechanism of action, the product offers healthcare professionals a new option for managing acne vulgaris in both adults and adolescents. As Glenmark continues to expand distribution across Europe, more patients are expected to gain access to this innovative treatment. The launch also reinforces Glenmark’s broader commitment to bringing differentiated therapies to global markets while addressing unmet needs in dermatology and improving patient outcomes.