Cosmo and Glenmark's Winlevi®: A Game-Changer in UK Acne Treatment

Cosmo Pharmaceuticals N.V. and Glenmark Pharmaceuticals Limited have made waves in the dermatology world with the UK MHRA approval of Winlevi®, a novel topical treatment for acne vulgaris in patients aged 12 and older. This breakthrough therapy, featuring clascoterone as its active ingredient, is the first topical acne treatment in nearly 40 years with a first-in-class mechanism of action, targeting androgen receptors in sebaceous glands without systemic anti-androgen effects. This approach makes it safe for both males and females, addressing a significant unmet need in the market.

Winlevi®'s unique mechanism of action sets it apart from existing treatments like isotretinoin and oral antibiotics. While isotretinoin is a retinoid that reduces sebum production and oral antibiotics help to reduce inflammation and bacterial growth, both treatments can have significant side effects. Winlevi®, on the other hand, offers a topical, non-systemic approach with minimal side effects, making it an attractive alternative for patients and healthcare providers.

Two identical phase III studies demonstrated that clascoterone cream 1%, applied topically twice daily for 12 weeks, was more effective than the application of vehicle cream in achieving the Investigator’s Global Assessment (IGA) of success, reducing non-inflammatory lesion count (NILC) and inflammatory lesion count (ILC) in patients with facial acne vulgaris. clascoterone cream 1%, was generally well tolerated, further cementing its potential as a game-changer in the UK acne treatment market.

As part of the agreement signed in September 2023, Glenmark has in-licensed the product from Cosmo Pharmaceuticals for distribution in Europe and South Africa. This collaboration underscores Cosmo’s and Glenmark’s dedication to expanding its dermatology portfolio and addressing the unmet needs of patients with acne vulgaris, a condition that affects millions of individuals worldwide and can cause both physical discomfort and psychological distress.

Giovanni Di Napoli, Chief Executive Officer of Cosmo, commented: “We are thrilled that Winlevi® has been approved for the UK market, bringing an innovative approach to acne treatment. This milestone underscores our commitment, alongside Glenmark, to providing patients with breakthrough solutions that address not just the physical symptoms of acne, but also its emotional impact. We take great pride in expanding access to this game-changing therapy and making a real difference in patients’ lives.”

“We are excited to receive the approval and bring Winlevi® to the UK market, offering patients a new and efficacious treatment for acne,” said Christoph Stoller, President & Business Head – Europe and Emerging Markets, Glenmark Pharmaceuticals. “This approval by the MHRA represents a significant step forward in our mission to enhance dermatology care. Our partnership with Cosmo Pharmaceuticals plays an important role in enabling us to expand our dermatology portfolio, and we are proud to offer this new treatment to market that can improve the quality of life for those living with acne.”

The approval of Winlevi® for the UK market marks a crucial milestone in Glenmark’s ongoing efforts to evolve dermatology treatments. With acne vulgaris affecting more than 90% of the world’s population at some point in their lives, the potential market for Winlevi® is vast. Its unique mechanism of action, positive clinical data, and strong potential for market penetration indicate that it could capture a significant market share in the UK acne treatment market, potentially challenging the dominance of existing treatments like isotretinoin and oral antibiotics.



In conclusion, Cosmo and Glenmark's Winlevi® represents a significant advancement in the UK acne treatment market, offering a novel, topical, and well-tolerated treatment option for patients and healthcare providers. With its unique mechanism of action and positive clinical data, Winlevi® has the potential to capture a significant market share and improve the quality of life for those living with acne vulgaris. As the global acne treatment market continues to grow, Winlevi®'s innovative approach could contribute to this market growth and address the unmet needs of patients with this common and often debilitating condition.