Clascoterone

FDA Approved

Also known as: Winlevi, CB-03-01, cortexolone 17alpha-propionate

Prescription Only — FDA Approved Medication

Educational Content Only

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. The FDA has not evaluated many of the peptides discussed here. Always consult a licensed healthcare provider before making any health decisions.

Overview

Clascoterone is a topical androgen receptor antagonist and the first FDA-approved topical androgen receptor inhibitor, approved for the treatment of acne vulgaris. Research has also examined its potential for androgenetic alopecia given its local antiandrogen activity without the systemic hormonal effects of oral antiandrogens.

Possible Uses

The following areas have been examined in research contexts. This does not constitute medical advice or imply proven efficacy in humans.

Skin & Wound Healing

Mechanism of Action

Competitively binds androgen receptors in sebaceous glands and hair follicles, blocking dihydrotestosterone (DHT) and testosterone from activating AR-mediated sebum overproduction and follicular inflammation. Topical application limits systemic hormonal effects.

Safety Notes

FDA-approved (Winlevi) for acne vulgaris in patients 12 years and older. Generally well-tolerated. Local skin irritation possible. Minimal systemic absorption with standard use.

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Research Profile

Half-Life

~5 hours (topical formulation)

Administration

topical cream

Legal Status (US)

FDA-approved prescription topical medication (Winlevi).

13 indexed research passages

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