Clascoterone
A topical androgen-receptor inhibitor approved for acne, now being tested in a Phase 3 hair-loss programme. It is not approved for hair loss.
Clascoterone Biological Classification
Investigated within physiological and chemical models.
What kind of compound
Small molecule
Topical androgen-receptor inhibitor (cortexolone 17α-propionate), supplied as a 1% cream.
Human testing on file
1human record
0 animal · 2 total indexed. Phase 3 trials registered or reported.
Regulatory position
FDA-approved for acne vulgaris, not androgenetic alopecia. Phase 3 hair-loss trial completed without published results.
Studied for
Topical androgen-receptor inhibition for AGA
Reviewed 13 November 2026
Known safety concerns in this file
- The acne label lists local skin reactions; the product is applied to the skin, not injected.
- Systemic androgen suppression is a theoretical concern with any topical antiandrogen; the hair-loss trial was designed to measure it.
- Hair-loss safety data are not available here as a peer-reviewed report.
Commonly compared with
- Pyrilutamide — Investigational topical androgen-receptor blocker.
- Finasteride — Approved oral 5-alpha-reductase inhibitor.
- RU58841 — Unapproved topical antiandrogen with unpublished trials.
What is Clascoterone?
A topical androgen-receptor inhibitor approved for acne, now being tested in a Phase 3 hair-loss programme. It is not approved for hair loss. A topical androgen-receptor inhibitor approved as a 1% cream for acne. A Phase 3 programme in male androgenetic alopecia completed in January 2026, but no hair-loss approval or peer-reviewed result exists.
Why are people interested in it?
It is an approved topical androgen-receptor inhibitor in dermatology, so its hair-loss trial is a direct test of whether local androgen blockade can help without the systemic effects of oral drugs.
Primary Research Categories
- Hair-follicle research
- Small-molecule drugs
- Approved drug substances
How does it work in the body?
Blocks androgen receptors in the skin. The hair-loss hypothesis is that local blockade reduces follicular androgen signalling. The acne approval does not establish a hair-growth mechanism.
Biological Pathway Overview
Clascoterone Receptor & Target Interactions
This compound is evaluated in scientific research for its interactions with target cellular receptors and signaling cascades. Consult the evidence section below for specific peer-reviewed papers.
Androgen receptor
Named in the published mechanism discussion for this compound.
DHT signalling
Named in the published mechanism discussion for this compound.
Follicular miniaturisation
Named in the published mechanism discussion for this compound.
Key Distinction: An investigational or unapproved compound has no approved indication, and a proposed mechanism is not a demonstrated clinical effect.
What has actually been demonstrated in humans?
A Phase 3, vehicle-controlled trial in men with androgenetic alopecia completed in January 2026. No peer-reviewed hair-loss results were indexed at this review.
Pharmaceutical Reality vs. Unregulated Research Chemicals
FDA-approved for acne vulgaris, not androgenetic alopecia. Phase 3 hair-loss trial completed without published results. Peer-reviewed Phase 3 efficacy and safety results in androgenetic alopecia.
What is still uncertain or unknown?
Peer-reviewed Phase 3 efficacy and safety results in androgenetic alopecia. Whether scalp androgen blockade produces hair benefit without meaningful systemic effects. Long-term safety and durability.
Research at a Glance
Open the full evidence file (2 records)2 records in this file
- CLINICAL TRIAL1
- REGULATORY1
Publication span: 2022–2026
What Has Actually Been Studied
- Topical clascoterone solution for androgenetic alopecia in males (Phase 3) (ClinicalTrials.gov, 2026) — Phase 3 randomised, double-blind, vehicle-controlled trial with a single-blind extension (registry record).
- WINLEVI (clascoterone) cream — prescribing information (FDA approved labelling, 2022) — Approved product labelling.
What is Still Unknown
What we know
Editorial reading of the records below, labelled as Therapept analysis. How records are built
What remains uncertain
Preparation and Handling
Lyophilized peptides ship as freeze-dried powders; whatever happens next involves diluents, concentrations and storage conditions that are compound- and product-specific.
United States Regulatory Status
FDA-approved drug substance
Application: NDA 213433 (WINLEVI) — approved 26 August 2020
Approved Indication: WINLEVI (clascoterone) cream 1% is FDA-approved for the topical treatment of acne vulgaris in patients 12 years and older. It is not approved for androgenetic alopecia.
- WINLEVI 1% cream, NDA 213433, approved 26 August 2020 for acne vulgaris in patients 12 years and older.
- The approved indication is acne, not hair loss. Regulatory approval for one skin condition does not transfer to another.
- Phase 3 trial NCT05910450 in men with androgenetic alopecia is registered as completed, with a six-month blinded phase and a six-month single-blind extension.
- Therapept has not indexed a peer-reviewed publication of the androgenetic alopecia results. Registry completion is not a result and is not an approval.
Technical Chemical SpecificationsClick to view CAS, sequence, and molecular formulas
- Molecular weight
- 402.5 g/mol
- Sequence length
- Not recorded
- CAS number
- Unknown
- PubChem CID
- None assigned
- Compound class
- Topical androgen-receptor inhibitor (cortexolone 17α-propionate), supplied as a 1% cream
- Sequence
- Unknown / Unassigned
- Molecular formula
- C24H34O5
- Molecular weight
- 402.5 g/mol
- CAS number
- Unknown
- PubChem CID
- Unknown
Sources
Last reviewed 13 November 2026 · Compiled by Therapept Editorial · How these records are built