Glenmark Pharmaceuticals has recently obtained approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to launch Winlevi, a topical acne treatment. This new drug, designed for patients aged 12 and above, represents the first topical acne treatment with a unique mechanism of action in almost four decades.
At 12.21 pm today, Glenmark Pharmaceuticals Limited’s shares were trading at ₹1,529, experiencing a decrease of ₹11.15 or 0.72 per cent on the NSE. Winlevi comprises clascoterone as its active ingredient, making it the initial commercially available topical androgen receptor inhibitor. Notably, this treatment is suitable for both male and female patients as it does not have any systemic anti-androgen effects. Two phase 3 studies have demonstrated the efficacy of clascoterone cream 1 per cent when applied twice daily for a span of 12 weeks.
The approval follows a September 2023 agreement in which Glenmark acquired the product from Cosmo Pharmaceuticals for distribution in Europe and South Africa. The endorsement is significant considering that acne vulgaris impacts over 90 per cent of the global population at some stage in their lives.
Glenmark, listed among the Top 100 Companies by R&D and Pharmaceutical Sales according to In Vivo/Scrip 100, will be responsible for distributing the product in the UK market. The company operates 11 manufacturing facilities across four continents and maintains a presence in over 80 countries.
Published on February 10, 2025.
