Encyclopedia · antiandrogen
Clascoterone
A topical androgen blocker already approved as an acne cream whose 5% scalp solution reported positive phase 3 results in men; it is not yet approved for hair.
What it is
Clascoterone 1% cream (Winlevi) was approved in the US in August 2020 for acne in people 12 and older. A higher-strength solution for male pattern hair loss was developed by Cassiopea, a spin-out of Cosmo Pharmaceuticals. Dhillon 2020
For hair it is investigational: not approved in the US, EU or UK, and no hair product is for sale. Do not confuse it with the acne cream. The company's 2026 releases do not give the scalp product a brand name.
How it works
It binds the androgen receptor locally in the follicle. In cultured human scalp dermal papilla cells it inhibited androgen-driven receptor activity about as well as finasteride did in a reporter assay, and blocked DHT-induced IL-6 release better than enzalutamide; this was an in-vitro, company-affiliated study. Rosette 2019 It is designed to be inactivated after absorption, giving minimal body-wide exposure (a company statement).
What the studies show
All results below are company-reported; peer-reviewed phase 3 data have not yet been published.
- Two phase 3 trials (1,465 men combined; registry lists 703 and 762): double-blind, vehicle-controlled, in the US and Europe, with 5% solution for 6 months followed by a 6-month extension. Both trials met the co-primary hair count endpoint against vehicle, and adverse events were similar to vehicle. SCALP 1; SCALP 2 Relative improvements quoted in the press (539% and 168%) are large because the vehicle change was small, and the absolute hairs per cm² compared with finasteride or minoxidil is not public.
- 12-month follow-up: men who continued had 2.39 times the hair count improvement of those switched to vehicle after month 6, and hair counts declined after switching, so benefits need continued use. SCALP 1; SCALP 2
Side effects and safety
Reported adverse events were similar to vehicle at 6 and 12 months (company-reported). The trials enrolled men only, so there are no pregnancy or women-specific hair data.
Bottom line
If approved, it would be the first new topical antiandrogen for male pattern hair loss, probably aimed at men who cannot or will not use finasteride. The company planned a US filing in early 2027, so approval is unlikely before 2028. Effect in women and in combination with minoxidil is untested. The evidence assessment is provisional until peer-reviewed data appear. Discuss with a doctor.
Studies 4
Dhillon S. Clascoterone: first approval. Drugs. 2020
Tested: clascoterone 1% cream
Result: Approved in the US in August 2020 for acne; a higher-strength solution for hair loss was in development.
Read the study ↗Rosette C et al. Cortexolone 17alpha-propionate (clascoterone) is an androgen receptor antagonist in dermal papilla cells in vitro. J Drugs Dermatol. 2019
Tested: clascoterone vs finasteride vs enzalutamide
Result: Inhibited androgen-driven receptor activity about as well as finasteride in a reporter assay and blocked DHT-induced IL-6 release better than enzalutamide; company-affiliated.
Read the study ↗Cassiopea / Cosmo Pharmaceuticals. Clascoterone solution in male androgenetic alopecia (SCALP 1). ClinicalTrials.gov NCT05910450
Tested: clascoterone 5% solution vs vehicle
Result: Company-reported positive phase 3 result on the co-primary hair count endpoint (registry entry; peer-reviewed data not yet published).
Read the study ↗Cassiopea / Cosmo Pharmaceuticals. Clascoterone solution in male androgenetic alopecia (SCALP 2). ClinicalTrials.gov NCT05914805
Tested: clascoterone 5% solution vs vehicle
Result: Company-reported positive phase 3 result on the co-primary hair count endpoint (registry entry; peer-reviewed data not yet published).
Read the study ↗Related
- PyrilutamideA topical androgen blocker from the Chinese company Kintor that reported positive pivotal results in China; no peer-reviewed efficacy paper yet.
- GT20029A topical drug that tags the androgen receptor for destruction instead of just blocking it; a 12-week phase 2 in Chinese men showed modest gains.
- RU58841A topical androgen blocker from the 1990s that grew hair in animal and graft models but has no human efficacy trial and is sold online as a research chemical.
- FinasterideA prescription pill (and in some countries a scalp spray) that lowers DHT and is the best-proven drug for stopping male pattern hair loss.
- Antiandrogen comparison for hair lossA side-by-side of the drugs, topicals and supplements that work on the androgen pathway, with who they were studied in and how strong the evidence is.