Cosmo Pharmaceuticals Receives Regulatory Approval by the European Commission for Winlevi(R) in the EU, Following on the Positive CHMP Opinion
Cosmo Pharmaceuticals (CMOPF) announced that the European Commission approved Winlevi (clascoterone 1% cream) for treatment of acne vulgaris in adults and adolescents aged 12 to <18 years (adolescent use limited to facial application) on 21 October 2025, following a positive CHMP opinion on 25 August 2025.
Cosmo said it is preparing commercial launches across 20 European markets with its partners. Winlevi is described as a first-in-class topical androgen-receptor inhibitor that acts locally in sebaceous glands and has prior approvals in the United States, United Kingdom, Canada, Australia and several other countries.
Cosmo Pharmaceuticals (CMOPF) ha annunciato che la Commissione Europea ha approvato Winlevi (crema al clascoteroone 1%) per il trattamento dell'acne vulgaris in adulti e in adolescenti di età compresa tra 12 e <18 anni (l'uso negli adolescenti è limitato all'applicazione sul viso) il 21 ottobre 2025, a seguito di un'opinione positiva del CHMP il 25 agosto 2025.
Cosmo ha detto che sta preparando lanci commerciali in 20 mercati europei con i propri partner. Winlevi è descritto come un inibitore del recettore degli androgeni topico di prima classe che agisce localmente nelle ghiandole sebacee e ha precedenti approvazioni negli Stati Uniti, Regno Unito, Canada, Australia e in diversi altri paesi.
Cosmo Pharmaceuticals (CMOPF) anunció que la Comisión Europea aprobó Winlevi (crema de clascoterona 1%) para el tratamiento del acné vulgar en adultos y adolescentes de 12 a menos de 18 años (el uso en adolescentes se limita a la aplicación facial) el 21 de octubre de 2025, tras una opinión favorable del CHMP el 25 de agosto de 2025.
Cosmo dijo que está preparando lanzamientos comerciales en 20 mercados europeos con sus socios. Winlevi se describe como un inhibidor del receptor de andrógenos tópico de primera clase que actúa localmente en las glándulas sebáceas y ya cuenta con aprobaciones previas en Estados Unidos, Reino Unido, Canadá, Australia y varios otros países.
Cosmo Pharmaceuticals (CMOPF)는 유럽연합 집행위원회가 Winlevi(클라스토테론 1% 크림)을 성인 및 12세에서 18세 미만의 청소년(청소년의 피부분야 적용에 한정) 여드름 치료제로 승인했다고 2025년 10월 21일에 발표했다. 이는 2025년 8월 25일의 CHMP 의견에 따른 것이다.
Cosmo는 파트너와 함께 유럽 20개 시장에서 상용화 출시를 준비 중이라고 말했다. Winlevi는 모낭선상 피지선에 국소적으로 작용하는 1류의 턴온-안드로겐 수용체 억제제로 미국, 영국, 캐나다, 호주 및 여러 다른 나라에서 이미 승인받은 바 있다.
Cosmo Pharmaceuticals (CMOPF) a annoncé que la Commission européenne a approuvé Winlevi (crème à la clascoterone 1%) pour le traitement de l'acné vulgaris chez l'adulte et les adolescents âgés de 12 à moins de 18 ans (utilisation chez l'adolescent limitée à l'application faciale) le 21 octobre 2025, suite à une opinion positive du CHMP le 25 août 2025.
Cosmo a déclaré qu'il prépare des lancements commerciaux dans 20 marchés européens avec ses partenaires. Winlevi est décrit comme un inhibiteur topique du récepteur des androgènes de première classe qui agit localement sur les glandes sébacées et a obtenu des autorisations préalables aux États‑Unis, au Royaume‑Uni, au Canada, en Australie et dans plusieurs autres pays.
Cosmo Pharmaceuticals (CMOPF) gab bekannt, dass die Europäische Kommission Winlevi (Clascoteron 1% Creme) zur Behandlung von Akne vulgaris bei Erwachsenen und Jugendlichen im Alter von 12 bis unter 18 Jahren (Jugendliche dürfen nur im Gesicht angewendet werden) am 21. Oktober 2025 genehmigt hat, nach einer positiven CHMP-Meinung am 25. August 2025.
Cosmo sagte, es bereite kommerzielle Markteinführungen in 20 europäischen Märkten mit seinen Partnern vor. Winlevi wird als erster-in-class topischer Androgenrezeptor-Inhibitor beschrieben, der lokal in den Talgdrüsen wirkt und bereits in den USA, dem Vereinigten Königreich, Kanada, Australien und mehreren anderen Ländern zugelassen ist.
Cosmo Pharmaceuticals (CMOPF) أعلنت أن المفوضية الأوروبية أقرت Winlevi (كريم clascoterone 1%) لعلاج حب الشباب vulgaris لدى البالغين والمراهقين من عمر 12 إلى أقل من 18 عامًا (الاستخدام للمراهقين يقتصر على التطبيق على الوجه) في 21 أكتوبر 2025، عقب رأي CHMP الإيجابي في 25 أغسطس 2025.
قالتCosmo إنها تجهز إطلاقات تجارية عبر 20 سوقًا أوروبية مع شركائها. يوصف Winlevi بأنه مثبط مستقبلات الأندروجين الموضعي من فئة أولى يعمل محليًا في غدد دهنية وله موافقات سابقة في الولايات المتحدة والمملكة المتحدة وكندا وأستراليا وعدة دول أخرى.
Cosmo Pharmaceuticals (CMOPF) 宣布 欧盟委员会已批准 Winlevi（克拉斯托洛酮 1% 面霜）用于治疗成人和12岁至<18岁之间的青少年（青少年使用限于面部涂抹）的痤疮，日期为2025年10月21日，这是在2025年8月25日CHMP意见为积极之后。
Cosmo表示正与合作伙伴在20个欧洲市场推进商业上市。Winlevi被描述为一款同类第一的局部睾酮受体抑制剂，主要在皮脂腺局部作用，已在美国、英国、加拿大、澳大利亚等多个国家获得批准。
- EU approval for Winlevi on 21 Oct 2025
- Indicated for adults and adolescents 12 to <18 years
- Preparing launches across 20 European markets
- First-in-class topical androgen-receptor inhibitor
- Prior approvals in US, UK, Canada, Australia and others
- Adolescent use is limited to facial application
Dublin, Ireland--(Newsfile Corp. - October 21, 2025) - Cosmo Pharmaceuticals N.V. (SIX: COPN), a global leader in AI-powered healthcare and specialty pharma, today announced that the European Commission has granted regulatory approval in the EU for Winlevi® (clascoterone
Acne vulgaris is among the most common skin conditions worldwide, affecting over 90 percent of people at some point in their lives and often leading to both physical and emotional consequences, including reduced self-esteem and quality of life. Conventional topical therapies can cause irritation or limited tolerability, and few options directly target the hormonal component of acne.
Winlevi® is the first topical acne therapy in more than 40 years with a first-in-class mechanism of action. Its active ingredient, clascoterone, is the first commercially available topical androgen-receptor inhibitor acting locally in the sebaceous glands to reduce sebum production and inflammation without systemic anti-androgen effects, supporting safe use in both males and females.
Giovanni Di Napoli, CEO of Cosmo, commented: “The regulatory approval of Winlevi® by the European Commission is another major corporate milestone for us in 2025. We expect it to contribute significantly to our Company's mid- and long-term growth. We are also delighted that we can now offer our compound to adolescents in Europe, who previously had no access to a topical anti-androgen solution for treating acne.”
Prof. Brigitte Dréno, founder member of the European Association of Dermato-Oncology, past president of the French Society of Dermatology, and member of the American Academy of Dermatology, said: “It’s exciting to see Winlevi® finally completed all regulatory milestones and is now ready for commercialisation. The dermatology community has been eager for a genuine breakthrough in acne therapy, a topical anti-androgen that’s both effective and well tolerated, including in adolescents. This is a meaningful advancement and a welcome new option for our patients.”
Winlevi® has already been approved in the United States, Canada, Australia, the United Kingdom, New Zealand, Jordan, Singapore, Malaysia, Mexico, South Korea, Kuwait and Egypt. Additional registrations are progressing as Cosmo and its partners continue to expand commercial access to this innovative acne therapy globally.
A full summary of the product characteristics for Winlevi® are available from the EMA website at www.ema.europa.eu. Winlevi®, Cosmo and Cosmo logo are trademarks of Cosmo Pharmaceuticals N.V. or its related companies.
About Cosmo
Cosmo is a life sciences company focused on MedTech AI, dermatology, gastrointestinal diseases, and contract development and manufacturing (CDMO). We design, develop, and manufacture advanced solutions that address critical medical needs and raise the standard of care. Our technologies are trusted by leading global pharmaceutical and MedTech companies and reach patients and healthcare providers around the world. Guided by our purpose - Building Health Confidence - our mission is to empower patients, healthcare professionals, and partners by innovating at the intersection of science and technology. Founded in 1997, Cosmo is headquartered in Dublin, Ireland, with offices in San Diego (USA), and in Lainate, Rome, and Catania (Italy). For more information, visit www.cosmohealthconfidence.com.
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