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

Reduction in facial sebum production following treatment with clascoterone cream 1% for 52 weeks in patients with acne vulgaris (AAD 2026) - "Results from this exploratory study show that there were significant reductions in sebum measurements with improvements in acne severity and no new tolerability or safety concerns following treatment with clascoterone cream 1% for 52 weeks."

Clinical • Acne Vulgaris • Dermatology

Efficacy and safety of combination treatment with clascoterone cream 1% and clindamycin 1.2%/benzoyl peroxide 5% gel for 16 weeks in patients with acne (AAD 2026) - "Combination treatment with clascoterone cream 1% and CP 1.2%/BP 5% gel for 16 weeks was effective and well tolerated in patients with moderate-to-severe acne."

Clinical • Acne Vulgaris

Efficacy and safety of combination treatment with clascoterone cream 1% and adapalene gel 0.3% for 16 weeks in patients with acne (AAD 2026) - "Sixteen-week topical combination treatment with clascoterone cream 1% and adapalene gel 0.3% decreased acne severity, improved QoL, and was well tolerated in patients with moderate-to-severe acne."

Clinical • Acne Vulgaris

SCALP1: A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (clinicaltrials.gov) - P3 | N=703 | Active, not recruiting | Sponsor: Cassiopea SpA | Trial completion date: Dec 2025 ➔ Jun 2026

Trial completion date • Alopecia • Dermatology • Immunology

Update of the EuroGuiDerm evidence-based guideline for the treatment of acne-Short version. (PubMed, J Eur Acad Dermatol Venereol) - "For which types of acne and patient groups should new topical treatments, including trifarotene and clascoterone, be recommended and with what strength of recommendation? Additionally, the updated guideline provides revised recommendations regarding: safety of benzoyl peroxide (BPO), selection of systemic antibiotic therapy, treatment considerations during pregnancy, isotretinoin dosing strategies, and the use of hormonal antiandrogenic contraceptives or other combined hormonal contraceptives, as well as spironolactone. All other aspects remain unchanged from the 2016 guideline."

Journal • Acne Vulgaris • Dermatology

1% Clascoterone Cream for the Treatment Acne Vulgaris (clinicaltrials.gov) - P3 | N=692 | Not yet recruiting | Sponsor: Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.

New P3 trial • Acne Vulgaris • Dermatology

Overview of the Efficacy and Safety of Topical Hormonal Therapies for the Treatment of Acne Vulgaris: A Narrative Review. (PubMed, J Clin Aesthet Dermatol) - "Available evidence supports the use of clascoterone cream 1% and suggests potential benefits and limitations of topical spironolactone in patients with AV; however, for topical spironolactone, pharmacokinetic studies and large-scale RCTs are needed to better characterize both efficacy and safety profiles."

Journal • Review • Acne Vulgaris • Dermatology

Efficacy and Safety of Clascoterone Cream 1% for Acne Are Independent of Age and Sex. (PubMed, J Drugs Dermatol) - P3 | "These results further support the efficacy and tolerability of clascoterone cream 1% across the spectrum of patients ≥12 years of age with acne vulgaris. &nbsp."

Clinical • Journal • 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: Nov 2025 ➔ Mar 2026 | Trial primary completion date: Nov 2025 ➔ Mar 2026

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

Perioral dermatitis secondary to topical clascoterone 1. (PubMed, JAAD Case Rep) - No abstract available

Journal • Acne Vulgaris • Dermatitis • Dermatology • Immunology

Clascoterone 1% in the treatment of acne: a review of its efficacy, safety, and therapeutic positioning". (PubMed, Actas Dermosifiliogr) - "treatment guidelines conditionally recommend it for acne management due to its high cost. The strength of recommendation is lower than that of topical retinoids and benzoyl peroxide."

Clinical • Journal • Review • Acne Vulgaris

Analysis of Reddit Reveals Clascoterone Questions Among People with Acne. (PubMed, J Clin Aesthet Dermatol) - "This Reddit analysis of clascoterone therapy reveals key themes in questions and gaps in knowledge among people with acne that may not be readily apparent in clinical settings. This information can guide physicians to better address patient needs and improve patient outcomes."

Journal • Acne Vulgaris • CNS Disorders • Psychiatry

SCALP1: A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (clinicaltrials.gov) - P3 | N=703 | Active, not recruiting | Sponsor: Cassiopea SpA | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2025 ➔ Dec 2025 | Trial primary completion date: Oct 2024 ➔ Dec 2025

Enrollment closed • Trial completion date • Trial primary completion date • Alopecia • Dermatology • Immunology

A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (SCALP2) (clinicaltrials.gov) - P3 | N=762 | Completed | Sponsor: Cassiopea SpA | Recruiting ➔ Completed | Trial completion date: Mar 2025 ➔ Jul 2025 | Trial primary completion date: Aug 2024 ➔ Jul 2025

Trial completion • Trial completion date • Trial primary completion date • Alopecia • Dermatology • Immunology

Efficient synthesis of clascoterone via lipase-catalyzed solvent-free alcoholysis. (PubMed, Biodes Res) - "In this study, we developed a regioselective solvent-free alcoholysis method with the commercially available immobilized lipase Novozyme 435 as a catalyst and isopropanol (IPA) as an alcohol donor, achieving a conversion rate of over 98.0 ​% with 20 ​g/L substrate. Furthermore, we implemented a continuous flow microreactor process that increased the conversion rate to 100 ​% with 4 ​g/L substrate, demonstrating scalability for industrial manufacturing."

Journal • Acne Vulgaris

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