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

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

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

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

Reduction in facial sebum production following treatment with clascoterone cream 1% in patients with acne vulgaris: 12-week interim analysis (AAD 2025) - "Clascoterone cream 1% led to significant reductions in sebum measurements with improvements in acne severity, and there were no tolerability or safety issues."

Clinical • Acne Vulgaris • Dermatology

A Study to Assess Sebaceous Gland Changes and Constituents of Sebum (Skin Oil) Induced by Clascoterone 1% Cream in Acne Patients (clinicaltrials.gov) - P4 | N=10 | Active, not recruiting | Sponsor: Sun Pharmaceutical Industries Limited | Trial completion date: Dec 2024 ➔ Sep 2025 | Trial primary completion date: Dec 2024 ➔ Sep 2025

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

Cosmo and Glenmark Announces UK MHRA Approval of Winlevi for Treatment of Acne (Cosmo Press Release) - "Cosmo Pharmaceuticals N.V...announced that Glenmark had received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to market Winlevi in the United Kingdom. Winlevi is a topical treatment for acne vulgaris in patients aged 12 years and older, marking a significant milestone in the commitment of both companies to providing innovative, patient-focused dermatology solutions....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."

MHRA approval • Acne Vulgaris • Dermatology

Pharmacokinetics, Safety and Tolerability of Clascoterone Cream 1% in Healthy Chinese Adult Subjects (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. | Not yet recruiting ➔ Completed

Trial completion • Acne Vulgaris • Dermatology

Real-World Experience of Clascoterone Cream 1% in Acne Management: Case Series and Canadian Experience. (PubMed, Clin Cosmet Investig Dermatol) - "Moreover, clascoterone also helped to address other concerns in several patients, including hirsutism, hidradenitis suppurativa, retinoid-induced dermatitis, androgenetic alopecia, folliculitis, postinflammatory hyperpigmentation, and laser-induced acne flares. This early real-world clinical experience supports the effectiveness, tolerability, and versatility of clascoterone cream 1% for patients with acne across a variety of clinical and demographic characteristics."

Journal • Real-world evidence • Acne Vulgaris • Alopecia • Dermatitis • Dermatology • Hidradenitis Suppurativa • Immunology

Topical Anti-Androgens in Pilonidal Sinus Disease (clinicaltrials.gov) - P2 | N=75 | Recruiting | Sponsor: University of Pennsylvania | Not yet recruiting ➔ Recruiting | Trial primary completion date: Aug 2027 ➔ Jan 2028

Enrollment open • Trial primary completion date • Otorhinolaryngology

Prospective Pilot Evaluation of the Safety, Tolerability, and Efficacy of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel plus Clascoterone 1% Cream in Adult Patients with Acne. (PubMed, J Clin Aesthet Dermatol) - "This pilot evaluation, albeit small and open-label, demonstrates promising results for the first studied combination of topical agents to target all four aspects of acne pathophysiology. Further large-scale studies are needed to further elucidate the additive efficacy and side effect profile when these two topical medications are used concomitantly."

Journal • Acne Vulgaris • Dermatology • Inflammation

Innovations in Acne. (PubMed, Dermatol Clin) - "The mechanisms of action, pivotal trial data, and potential role in clinical practice are reviewed for emerging therapies such as 1726 nm laser, sarecycline, clascoterone, trifarotene, minocycline foam, and fixed-dose combination topicals. The clinical pipeline is also summarized. In addition, opportunities to improve the patient experience with spironolactone and isotretinoin are discussed."

Journal • Review • Acne Vulgaris • Dermatology

Clascoterone for acne. (PubMed, Aust Prescr) - No abstract available

Journal • Review • Acne Vulgaris • Dermatology