Clascoterone (Breezula)
Clascoterone (Breezula) is in Phase 3 for androgenetic alopecia, developed by Cosmo Pharmaceuticals.
An acne drug approved in the US and EU, redeveloped at five times the strength for male pattern hair loss, with two Phase 3s read out and a US filing planned for 2027.
- Developed by
- Cosmo Pharmaceuticals
- Current phase
- Phase 3
- Mechanism
- Androgen receptor
- Indications
- Androgenetic alopecia, Female pattern hair loss
- Also known as
- Breezula, CB-03-01, clascoterone, cortexolone 17α-propionate, cortexolone 17alpha-propionate
- Last public activity
- June 2026
- Copy last reviewed
- September 2026
- Record confidence
- High
Large confirmatory trials. The last step before filing.
Blocks the receptor that androgens (male hormones) use to shrink the follicle.
A research record, not medical advice: being listed here says nothing about whether a treatment works or whether it is right for you. Talk to a dermatologist about your own case.
Why it matters
The same molecule has been FDA-approved since August 2020 as Winlevi, a 1% cream for acne vulgaris from age 12, and EU-approved since October 2025 after an initial refusal over adrenal suppression in adolescents; its label warns of HPA-axis suppression and raised potassium, so the safety record is for a 1% facial cream, not for a 5% scalp solution applied twice daily. Cosmo reported in December 2025 that both Phase 3 studies, over 1,400 men in the US, Germany, Poland and Georgia, met their primary hair-count endpoints against vehicle, with adverse events similar to vehicle, and in April 2026 released twelve-month safety data and said a US filing was planned for early 2027. The numbers are the sponsor's and unpublished; what a hair-count gain means cosmetically is the question the label review will ask.
Where it is approved
Marketing authorisation is granted country by country, for a specific indication. A drug approved for hair loss in one market may be approved only for something else — or not at all — in another.
- United StatesFDAOff-labelWinlevi· prescription only
Acne vulgaris, 12 years and older — not hair loss
Clascoterone is approved at 1% for acne. The hair-loss programme (Breezula) is a higher-strength formulation still in development, and is not authorised anywhere.
Regulator filing ↗
Development history
- Phase 3
First Phase 3 trial on record: NCT05910450 — A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss
ClinicalTrials.gov ↗ - Phase 2
First Phase 2 trial on record: NCT02279823 — A Phase 2 Study to Evaluate the Safety and Efficacy of CB-03-01 Solution, a Comparator Solution and Vehicle Solution in Males With Androgenetic Alopecia
ClinicalTrials.gov ↗
Registered trials
Pulled automatically from ClinicalTrials.gov. Matching is by name and development code, so occasional gaps are possible — tell us if you spot one.
A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (SCALP2)
Cassiopea SpA · n=762 · August 2023
A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss
Cassiopea SpA · n=703 · June 2023
A Phase 2 Study to Evaluate the Safety and Efficacy of CB-03-01 Solution, a Comparator Solution and Vehicle Solution in Males With Androgenetic Alopecia
Intrepid Therapeutics, Inc. · n=95 · October 2014
Listing a trial is not a recommendation to join one. Eligibility, risks and costs vary enormously — discuss any trial with your own doctor first.
Sources
- A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (SCALP2) — ClinicalTrials.gov
- A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (SCALP1) — ClinicalTrials.gov
- Clascoterone 12-month safety results; US FDA filing planned for early 2027 — Company release, April 2026
- Breezula Phase III results: both studies met primary endpoints — Company release, December 2025
- Winlevi (clascoterone), European public assessment report — Regulator filing, October 2025
- Questions and answers on the refusal of the marketing authorisation for Winlevi (clascoterone), April 2025 — Regulator filing, April 2025
- WINLEVI (clascoterone) cream 1% — FDA approval letter, NDA 213433 — Regulator filing, August 2020
- WINLEVI (clascoterone) cream 1%, US prescribing information (HPA-axis suppression and hyperkalemia warnings) — Regulator filing, August 2020
Related programmes
Other programmes in the register with the same mechanism: Androgen receptor.
Cite this page
Hair Pipeline, "Clascoterone (Breezula) — development record", hairpipeline.com/pipeline/clascoterone-breezula