Glenmark Pharmaceuticals has launched Winlevi (clascoterone 10 mg/g cream) across key European markets, marking a major expansion of its dermatology portfolio and its first New Chemical Entity (NCE) launch in Europe.
The company introduced the treatment through its wholly owned subsidiary, Glenmark Speciality S.A. (GSSA), targeting patients suffering from acne vulgaris. With this launch, the company strengthens its European dermatology presence and expands access to a novel first-in-class acne therapy.
Novel mechanism of action for acne treatment
Winlevi contains clascoterone, a topical androgen receptor inhibitor that works directly on androgen receptors in the sebaceous glands. By targeting hormonal pathways responsible for excess sebum production and inflammation, the cream helps reduce acne symptoms at their source. Unlike systemic hormonal treatments, Winlevi acts locally on the skin, allowing both male and female patients to use it safely without significant systemic anti-androgen effects.
Regulatory approval and market authorization
The European Commission granted marketing authorisation for Winlevi in October 2025 following regulatory review. The approval covers the treatment of acne vulgaris in adults and adolescents aged 12 to under 18 years, with adolescent use restricted to facial application. This authorisation enabled Glenmark and its partner Cosmo Pharmaceuticals to move forward with commercial launches across multiple European markets.
Strategic significance for Glenmark’s growth
Company executives emphasised that the launch represents a strategic milestone in Glenmark’s dermatology growth journey. They also highlighted that Winlevi strengthens the company’s branded portfolio in Europe and demonstrates its ability to execute complex, multi-country launches in regulated markets. Glenmark also positioned the product as part of its broader effort to expand access to differentiated therapies that address unmet needs in dermatology care.
Partnership with Cosmo Pharmaceuticals
Cosmo Pharmaceuticals, Glenmark’s development partner, also underscored the importance of the launch, noting that Winlevi’s rollout reflects the strength of their long-term collaboration. The partners continue to work together to expand the global reach of innovative dermatology treatments and improve patient access across international markets.
Outlook for dermatology-led growth
Winlevi’s introduction adds momentum to Glenmark’s speciality and innovation-focused strategy. The company continues to prioritise differentiated products in regulated markets as it expands its global footprint.
With this rollout, Glenmark advances European dermatology expansion and reinforces its commitment to developing novel acne treatments.