Winlevi (clascoterone cream 1%) / Cosmo Pharma, Glenmark, Sun Pharma - LARVOL DELTA

Efficacy and Safety of Hormonal Therapies for Acne: A Narrative Review. (PubMed, Clin Cosmet Investig Dermatol) - "Eligible articles included randomized controlled trials, cohort studies, systematic reviews, and meta-analyses evaluating hormonal therapies such as combined oral contraceptives (COCs), spironolactone, cyproterone acetate, and topical antiandrogens (eg, clascoterone)...Hormonal therapies are effective and well-tolerated options for acne, particularly in women with hormonal patterns or refractory disease. By specifically targeting androgen-driven pathways, hormonal agents offer sustained improvement and should be incorporated into personalized acne management."

Journal • Review • Acne Vulgaris • Dermatology • Inflammation

Cosmo and Glenmark Announce Market Authorisation of Winlevi (clascoterone) 10 mg/g cream for Treatment of Acne in 17 countries in Europe (PRNewswire) - "With receipt of this approval, Glenmark will initiate commercializing Winlevi across 17 countries in EU namely Belgium, Bulgaria, the Czech Republic, Denmark, Finland, France, Greece, Hungary, Iceland, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, and Sweden."

EMA approval • Launch Europe • Acne Vulgaris

Glenmark Pharmaceuticals Ltd and Ireland's Cosmo Pharmaceuticals N.V. on Tuesday announced that the European Commission (EC) has granted marketing authorisation for Winlevi (clascoterone 10 mg/g cream) used in treatment of acne vulgaris in 15 countries in Europe. (The Economic Times) - "Winlevi is authorised in the EU for the treatment of acne vulgaris in both adults and adolescents aged 12 to 18 years, with usage in adolescents limited to facial application, the filing said."

EMA approval • Acne Vulgaris

Cosmo Pharmaceuticals N.V…announced that the Brazilian Health Regulatory Agency (ANVISA) has approved Winlevi (clascoterone) cream 1% for the treatment of acne vulgaris in patients aged twelve years and older. (Yahoo Finance) - "In Brazil, Cosmo’s long-standing partner Sun Pharmaceutical Industries Limited...will launch the product."

Approval • Acne Vulgaris

Cosmo Pharmaceuticals N.V…announced that the European Commission has granted regulatory approval in the EU for Winlevi (clascoterone 1% cream) for the treatment of acne vulgaris in both adults and adolescents aged 12 to <18 years, with usage in adolescents limited to facial application. (Cosmo Press Release) - "This formal approval came following on the positive recommendation for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on 25th of August 2025."

EMA approval • Acne Vulgaris

Hyundai Pharm announced on Thursday that it has received marketing approval from the Ministry of Food and Drug Safety (MFDS) for its new acne treatment drug Winlevi Cream (clascoterone). (Korea Biomedical Review) - "In two phase 3 clinical trials involving over 1,400 acne patients, twice-daily topical application for 12 weeks demonstrated significant therapeutic efficacy compared to placebo, along with good tolerability and safety. Furthermore, results from a 12-month long-term extension study confirmed that Winlevi's efficacy increases over time."

Korea approval • Acne Vulgaris

Clascoterone Stability When Combined with Topical Acne Medications In Vitro. (PubMed, Dermatol Ther (Heidelb)) - "Clascoterone demonstrated consistent and reproducible stability in the presence of other topical acne medications."

Journal • Preclinical • Acne Vulgaris • Dermatology

The Clinical-Stage Topical Anti-Androgen Breezula® enhances Dermal Papilla Inductivity and reduces IL-6 Secretion in MPHL affected Skin Samples Ex Vivo (EADV 2025) - "These preliminary findings indicate that Breezula® is able to promote both DP inductivity and hair matrix keratinocyte proliferation, exhibiting effects comparable to those of Minoxidil. The additional reduction in IL-6 secretion suggests that Breezula® may hold superior therapeutic potential for treating MPHL. Overall, this study highlights the promise of Breezula® as a novel treatment option for managing MPHL."

Preclinical • Alopecia • IL6 • VCAN

Cosmo Pharmaceuticals…announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending European approval of Winlevi (clascoterone 1% cream) for the treatment of facial acne vulgaris in both adults and adolescents aged 12 to <18 years. (Yahoo Finance) - "The decision follows a successful re-examination of the initial negative CHMP opinion issued in April....The CHMP has now concluded that the benefit-risk profile of Winlevi is favourable for both adults and adolescents, recommending for the approval in both age groups, with usage in adolescents limited to facial application."

CHMP • Acne Vulgaris

Reduction in Facial Sebum Production Following Treatment with Clascoterone Cream 1% in Patients with Acne Vulgaris: 12-Week Interim Analysis. (PubMed, Dermatol Ther (Heidelb)) - P4 | "Clascoterone cream 1% led to significant reductions in sebum measurements with improvements in acne severity and was well tolerated."

Journal • Acne Vulgaris • Dermatology

Update to acne vulgaris treatment for Canadian practice. (PubMed, Can Fam Physician) - "The 2024 AAD guidelines provide a valuable framework for Canadian management of AV. Mild cases are managed with topical treatments, while moderate to severe cases often require oral medication. Antibiotic monotherapy is discouraged; combination with benzoyl peroxide may mitigate antibiotic resistance. Treatments using multiple modalities and mechanisms of action are recommended."

Journal • Review • Acne Vulgaris • CNS Disorders • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Mental Retardation • Psychiatry

Efficacy of oral isotretinoin monotherapy compared to combination isotretinoin and topical clascoterone for severe acne vulgaris: a multi-center retrospective study. (PubMed, J Dermatolog Treat) - "Clascoterone 1% cream may enhance isotretinoin efficacy without worsening adverse effects, offering a promising approach for severe/nodular acne. Further studies are needed to confirm long-term benefits."

Clinical • Journal • Monotherapy • Retrospective data • Acne Vulgaris • CNS Disorders • Dermatology

Efficacy and Safety of Clascoterone Cream 1% in Facial Acne Vulgaris (clinicaltrials.gov) - P3 | N=692 | Recruiting | Sponsor: Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. | Trial completion date: Feb 2025 ➔ Oct 2026 | Trial primary completion date: Feb 2025 ➔ Oct 2026

Trial completion date • Trial primary completion date • Acne Vulgaris • Dermatology

Pharmacokinetics, Safety, and Skin Irritation and Sensitization Potential of Clascoterone Cream in Early-Phase Clinical Study Participants. (PubMed, Clin Pharmacol Drug Dev) - "Skin irritation and sensitization with clascoterone treatment were minimal. Phase 1 study findings supported low systemic absorption of clascoterone and a favorable safety profile after topical application of clascoterone cream 1%, with no evidence of irritation or sensitization."

Journal • PK/PD data • Acne Vulgaris • Dermatology

Efficacy Of Oral Isotretinoin Combined With Topical Clascoterone Compared To Isotretinoin Monotherapy For Severe Acne Vulgaris: A Multi-Center Study (CDA 2025) - "Our study suggests that the addition of clascoterone 1% cream may enhance the efficacy of oral isotretinoin therapy without exacerbating adverse effects, offering a promising approach for managing severe/nodular acne. Further studies are needed to confirm these results and evaluate long-term effects."

Clinical • Monotherapy • Acne Vulgaris • CNS Disorders • Dermatology

Breezula, a clinical stage topical anti-androgen, promotes dermal papilla inductivity and reduces IL-6 secretion in balding skin samples ex vivo (SID 2025) - "Additionally, Breezula® reduced the secretion of the hair growth inhibitor IL-6, reported to be up-regulated in balding DP cells, after 5 days of culture, whereas Minoxidil did not exert a clear effect. Our data suggest that Breezula® restores DP inductivity and promotes HM keratinocyte proliferation to a similar extent as Minoxidil while its effect in reducing IL-6 secretion may indicate a greater potency for promoting hair growth, warranting further investigation."

Preclinical • Alopecia • IL6 • VCAN

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 May 2025 (European Medicines Agency) - "The European Medicines Agency has recommended the refusal of the marketing authorisation for Winlevi, a medicine intended for treating acne vulgaris. The Agency issued its opinion on 25 April 2025. The company that applied for authorisation, Cassiopea S.p.A, may ask for re-examination of the opinion within 15 days of receiving the opinion."

European regulatory • Acne Vulgaris

A Study Evaluating the Efficacy and Safety of Clascoterone Cream 1% in Skin of Color Patients With Acne (clinicaltrials.gov) - P4 | N=10 | Completed | Sponsor: Sun Pharmaceutical Industries Limited | Active, not recruiting ➔ Completed

Trial completion • Acne Vulgaris • Dermatology

Efficacy and Safety of Topical Clascoterone (WINLEVI) Cream 1% in Patients With Facial Acneiform Rosacea (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Narrows Institute for Biomedical Research

New P2 trial • Dermatology • Rosacea

Cosmo Receives Negative CHMP Opinion on Winlevi (clascoterone Cream 1%) in Europe and Will Appeal the Decision (Newsfile) - "Cosmo Pharmaceuticals...announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a negative opinion on the marketing authorization application (MAA) for Winlevi (clascoterone cream 1%) for the treatment of acne vulgaris. The opinion is principally based on the CHMP’s negative benefit-risk assessment on the therapeutic use of Winlevi in adolescents (12 to 17 years of age), despite the fact that such an assessment is demonstrably positive in adults (18 years of age and older)."

CHMP • Acne Vulgaris

A Study to Evaluate the Reduction in Sebum (Skin Oil) Induced by Clascoterone Cream 1% in Acne Patients (clinicaltrials.gov) - P4 | N=40 | Completed | Sponsor: Sun Pharmaceutical Industries Limited | Active, not recruiting ➔ Completed

Trial completion • Acne Vulgaris • Dermatology

Improvement in Skin Moisturization and Lack of Barrier Damage Following Treatment With Clascoterone Cream 1. (PubMed, J Drugs Dermatol) - "Twice-daily treatment with clascoterone cream 1% for 2 weeks was associated with increased moisturization and maintenance of skin barrier function as assessed by corneometry and TEWL and was otherwise well tolerated. J Drugs Dermatol. 2025;24(4):397-402. doi:10.36849/JDD.8774."

Journal • Acne Vulgaris • Dermatology

A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Adapalene 0.3% for the Treatment of Acne (clinicaltrials.gov) - P4 | N=20 | Completed | Sponsor: Sun Pharmaceutical Industries Limited | Active, not recruiting ➔ Completed

Trial completion • Acne Vulgaris • Dermatology

Four years of study by an expert group on truncal acne: where are we now? (PubMed, Eur J Dermatol) - "Truncal acne has significantly gained interest over recent years, and novel assessment tools and treatments are available to manage this condition efficiently. However, international treatment guidelines require updating, considering the importance of truncal acne."

Journal • Review • Acne Vulgaris

Clascoterone stability when combined with topical acne medications (AAD 2025) - " Tretinoin cream 0.025%, adapalene gel 0.3%, dapsone gel 7.5%, azelaic acid 15%, BP 5%/clindamycin 1%, BP 2.5%/adapalene 0.1%, and encapsulated BP 5% (0.5 mL each) were placed on individual microscope slides with 0.5 mL of clascoterone cream 1% and incubated for 8 hours at 37°C. Clascoterone demonstrated consistent and reproducible stability in the presence of other topical acne medications."

Acne Vulgaris • Dermatology