Dublin's Cosmo Pharmaceuticals Secures Korean Approval for Acne Drug

Irish Pharmaceutical Innovation Expands Global Reach

Dublin-based Cosmo Pharmaceuticals, contributing to Ireland's robust corporate sector, has achieved a significant milestone with the South Korean approval of its groundbreaking acne treatment, Winlevi®.

The Ministry of Food and Drug Safety (MFDS) of South Korea has authorized the use of Winlevi® (clascoterone) cream 1% for treating acne vulgaris in patients aged twelve and above, marking a pivotal moment in Dublin's growing influence in global healthcare innovation.

Revolutionary Treatment Approach

Winlevi® represents the first significant advancement in topical acne therapy in over four decades, employing a novel mechanism of action. The treatment works locally in sebaceous glands to reduce sebum production and inflammation, offering a safe solution for both male and female patients.

Strategic Partnership and Market Impact

Through a strategic partnership with Hyundai Pharm Co., Ltd., established in June 2023, the Irish company continues to strengthen its international business relationships while maintaining manufacturing control. This collaboration exemplifies Ireland's growing role in global pharmaceutical innovation.

Global Expansion

The Korean approval adds to Winlevi®'s impressive global presence, now approved in ten countries including the United States, Canada, and Australia. This expansion reinforces Dublin's position as a hub for pharmaceutical innovation and development.

"Approval of Winlevi® in South Korea is a meaningful milestone in our dermatology global expansion," stated Giovanni Di Napoli, Chief Executive Officer of Cosmo Pharmaceuticals.