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

Advances in Acne Vulgaris: From Pathogenesis to Innovative Drug Delivery. (PubMed, Recent Adv Inflamm Allergy Drug Discov) - "Acne vulgaris poses a significant clinical and socioeconomic burden. Innovative drug delivery systems offer promising solutions to overcome the limitations of traditional therapies. However, further clinical validation, long-term safety studies, and regulatory alignment are essential for successful translation into routine clinical practice."

Journal • Acne Vulgaris • Dermatology • Inflammation

Clascoterone 5% topical solution, an androgen receptor inhibitor in clinical development for male pattern hair loss, modulates androgen‑driven inflammatory and fibrotic pathways in an ex vivo human affected scalp skin organ culture model (EADV 2026) - No abstract available

Preclinical • Alopecia • Fibrosis

Evaluation of the Efficacy of an Ultra-Concentrated Tri-Acid Complex Serum in Combination with Clascoterone 1% Cream (EADV 2026) - No abstract available

Clinical • Combination therapy • Acne Vulgaris • Dermatology • Dermatopathology • Hidradenitis Suppurativa • Immunology

Real-world experience with topical clascoterone (Winlevi) for acne vulgaris in the United Kingdom: aretrospective case series (EADV 2026) - No abstract available

Real-world • Real-world evidence • Retrospective data • Acne Vulgaris • Dermatology

Clascoterone Cream 1% in Transgender Acne: Real-World Evidence Addressing a Critical Therapeutic Gap (EADV 2026) - No abstract available

Clinical • HEOR • Real-world • Real-world evidence • Acne Vulgaris

Bridging the Evidence Gap in Acne Tarda: Real-World Validation of Clascoterone Cream 1% in a Subgroup Analysis of Acne Tarda patients from a Retrospective Study involving 291 Acne Patients (EADV 2026) - No abstract available

Real-world • Real-world evidence • Retrospective data • Acne Vulgaris

Real-World Evidence of Clascoterone Cream 1% in Acne Management: A Canadian Retrospective Review of 291 Patients (EADV 2026) - No abstract available

HEOR • Real-world • Real-world evidence • Retrospective data • Review • Acne Vulgaris

Real-World Use of Clascoterone cream 1% in Transgender Patients with Acne: A Subgroup Analysis from a Canadian Retrospective Study. (EADV 2026) - No abstract available

Real-world • Real-world evidence • Retrospective data • Acne Vulgaris

Clascoterone in the Treatment of Acne Vulgaris: A Narrative Review. (PubMed, Pharmaceuticals (Basel)) - "Clascoterone cream is the first topical androgen receptor inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of acne vulgaris in patients aged 12 years and older, and the first agent in this class approved for use in both male and female patients...Clascoterone represents a novel addition to the therapeutic armamentarium for acne vulgaris, offering a unique mechanism of action with a favorable safety profile. Further research is warranted to establish its role in combination therapies and in other androgen-dependent dermatoses."

Journal • Review • Acne Vulgaris • Alopecia • Dermatology • Hidradenitis Suppurativa • Immunology

Clascoterone Cream 1% is Safe and Effective for Papulopustular Rosacea: A Phase 2 Clinical Trial. (PubMed, J Drugs Dermatol) - "Clascoterone cream 1% demonstrated favorable tolerability, safety, and efficacy in PPR, with significant improvements in sebaceous gland count and patient-centered outcomes. These findings support the therapeutic potential of clascoterone cream 1% for the treatment of PPR. &nbsp."

Journal • P2 data • Dermatology • Rosacea

Comparison of Topical Clascoterone and Adapalene for Mild Acne Vulgaris (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Khyber Teaching Hospital

New P1 trial • Acne Vulgaris • Dermatology

New Agents for Acne Treatment and Updates to Isotretinoin Guidelines. (PubMed, Pediatr Clin North Am) - "New topical treatments include tazarotene lotion, trifarotene, combined microencapsulated benzoyl peroxide and tretinoin, minocycline foam, topical dapsone, and clascoterone cream. More recent systemic options include subantimicrobial doxycycline, sarecycline, combined oral contraceptives, spironolactone, and isotretinoin-lidose."

Journal • Review • Acne Vulgaris

Emerging pharmacotherapies for Androgenetic Alopecia. (PubMed, Expert Opin Pharmacother) - "These include topical androgen-receptor antagonists and degraders (clascoterone, GT20029), biologics targeting prolactin receptor inhibition (HMI-115, ABS-201), anagen-inducing injectables (AMP-303), metabolic and follicular activators (PP405, ET-02), thyroid hormone receptor-β agonists (KB-141), optimized potassium channel opener delivery systems (extended-release and sublingual minoxidil) and modulation of longevity pathways using rapamycin and metformin. Collectively, these newer pharmacotherapeutics aim to improve efficacy, safety, and patient adherence. Ongoing and future clinical trials will determine their definitive role in reshaping the therapeutic landscape of androgenetic alopecia."

Journal • Review • Alopecia • Immunology

Hormonal acne therapies in pediatrics. (PubMed, Curr Opin Pediatr) - "Recognition of acne as a chronic inflammatory condition has supported the increasing use of hormonal therapies as an important treatment option in selected adolescent patients."

Journal • Acne Vulgaris • Dermatology • Inflammation • Pediatrics

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

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

Efficacy and Safety of Clascoterone Cream 1% and Adapalene Gel 0.3% in Patients With Acne. (PubMed, J Drugs Dermatol) - P4 | "This open-label pilot study shows promising results for combination treatment with clascoterone cream 1% and adapalene gel 0.3% for the treatment of patients with acne. &nbsp."

Journal • Acne Vulgaris • Dermatology

Efficacy and Safety of Clascoterone Cream 1% and Clindamycin 1.2%/Benzoyl Peroxide 5% Gel Treatment in Patients With Acne. (PubMed, J Drugs Dermatol) - "Based on data from 9 patients, combination treatment with clascoterone cream 1% and clindamycin 1.2%/benzoyl peroxide 5% gel is safe and effective to treat patients with acne. &nbsp."

Journal • Acne Vulgaris • Dermatology

Clascoterone for testosterone-associated acne in transgender individuals: a double-masked randomized placebo-controlled trial (SID 2026) - P1/2 | "There were no Grade 3 or higher AEs in subjects who received clascoterone. This is the first interventional trial for dermatology-related effects of GAHT and provides useful data for larger studies, multi-center studies."

Clinical • Late-breaking abstract • Acne Vulgaris

Clascoterone topical solution 5% modulates androgen receptor-regulated proteins in the secretory proteome of male pattern hair loss (SID 2026) - "These ex vivo studies using a model of MPHL indicate that clascoterone 5% solution influences a broad range of androgen-regulated proteins, supporting potential therapeutic benefits for MPHL. Further research into clascoterone's mechanism of action in treating MPHL is ongoing."

Alopecia

Clascoterone and androgenic alopecia: mechanistic rationale and therapeutic potential (EADV-Sp 2026) - "Current treatment - minoxidil and 5α-reductase inhibitors - have limited efficacy...Although clinical trials on clascoterone for AGA have been conducted, results are not yet publicly available, preventing definitive conclusions on efficacy and safety. Nevertheless, there is a need for further studies to confirm its effectiveness and long-term safety in patients with AGA."

Acne Vulgaris • Alopecia • Immunology • Inflammation

Clascoterone for Steroid-related Acne Vulgaris in Transgender Male Patients Receiving Masculinizing Hormone Therapy (clinicaltrials.gov) - P1/2 | N=18 | Active, not recruiting | Sponsor: Stanford University | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2025 ➔ Jun 2026

Enrollment closed • Trial completion date • Acne Vulgaris • Dermatology

Adverse Events Associated with Clascoterone: A Real-World Pharmacovigilance Study of the Food and Drug Administration Adverse Event Reporting System. (PubMed, Ther Innov Regul Sci) - "Our study provides broader data support for the safety of clascoterone and offers important insights to enhance the clinical use and minimize potential adverse effects."

Adverse events • Journal • Real-world evidence • Acne Vulgaris • Dermatology

Severe acne induced by clascoterone: A case report. (PubMed, JAAD Case Rep) - No abstract available

Journal • Acne Vulgaris • Dermatology

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