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Clascoterone

Generic Name
Clascoterone
Brand Names
Winlevi
Drug Type
Small Molecule
Chemical Formula
C24H34O5
CAS Number
19608-29-8
Unique Ingredient Identifier
XN7MM8XG2M
Background

Clascoterone (cortexolone 17α-propionate, CB-03-01) is a novel antagonist of androgen receptors. It binds to androgen receptors with high affinity. By competing with androgens for binding to androgen receptors, clascoterone works by blocking the androgen receptor signalling cascades that promote acne pathogenesis, such as sebaceous gland proliferation, excess sebum production, and inflammatory pathways. In August 2020, FDA approved clascoterone for the first-in-class topical treatment of acne (acne vulgaris) in male and female patients 12 years and older. Clascoterone is also being investigated as a novel treatment for androgenetic alopecia.

Indication

Clascoterone is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Associated Conditions
Acne Vulgaris
Clinical Trials
Related News

New Guidelines and Therapies Reshape Acne Treatment Approach in 2025

• The American Academy of Dermatology's 2024 updated acne guidelines recommend limiting systemic antibiotic use and emphasize treating all four pillars of acne pathogenesis simultaneously. • Several new FDA-approved acne medications since 2019 have expanded treatment options, including Winlevi (clascoterone), the only topical therapy effective for excessive sebum production. • Dermatology experts now recommend simpler treatment regimens with fewer products that address multiple pathogenic factors, with a growing focus on early intervention to prevent scarring.

UK MHRA Approves Winlevi®, First Novel Acne Treatment in 40 Years

• Winlevi® (clascoterone cream 1%), the first topical androgen receptor inhibitor for acne, receives MHRA approval for patients 12 years and older in the United Kingdom. • Phase III studies demonstrated superior efficacy of Winlevi® over vehicle cream in reducing both inflammatory and non-inflammatory acne lesions, with a favorable safety profile. • The approval represents a significant advancement in acne treatment, offering a new mechanism of action that targets sebum production without systemic anti-androgen effects.

Dermatology Advances: Approvals, Trial Results, and New Guidelines Emerge

• The FDA approved bimekizumab for moderate-to-severe hidradenitis suppurativa, marking the first treatment targeting both IL-17A and IL-17F cytokines. • Subcutaneous nivolumab's PDUFA date was updated, based on Phase 3 data demonstrating noninferiority to intravenous nivolumab in renal cell carcinoma. • New clinical guidelines emphasize image-guided superficial radiation therapy for nonmelanoma skin cancers, improving precision in treating basal and squamous cell carcinoma. • Phase 2b trial results show mRNA-4157 combined with pembrolizumab significantly improves recurrence-free survival in high-risk stage III/IV melanoma patients.

New Topical Treatments Expand Options for Dermatological Conditions: Expert Highlights Ruxolitinib and Roflumilast Advances

• Topical ruxolitinib (Opzelura) demonstrates strong long-term efficacy for atopic dermatitis in patients as young as 2 years old, with FDA approval currently for ages 12+ and vitiligo treatment. • Roflumilast cream 0.15% (Zoryve) receives approval for atopic dermatitis in patients aged 6 and older, while the 0.3% foam formulation is approved for seborrheic dermatitis in patients aged 9+. • Both medications show excellent safety and tolerability profiles, with roflumilast's lower strength formulation specifically designed to address concerns about systemic absorption in younger patients.
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