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Clascoterone (Breezula)

An already-approved acne drug being redeveloped at higher strength for hair loss.

Phase 3TopicalAndrogen receptor
Developed by
Cosmo Pharmaceuticals
Current phase
Phase 3

Large confirmatory trials. The last step before filing.

Indications
Androgenetic alopecia, Female pattern hair loss
Also known as
Breezula, CB-03-01, clascoterone
Last public activity
June 2026
Record confidence
High

Why it matters

The regulatory risk here is unusually low: the same molecule has been FDA-approved since August 2020 for acne vulgaris in patients 12 and over, at 1% strength, as Winlevi. Its safety profile in humans is established. What remains unproven is whether the higher hair-loss dose delivers a cosmetically meaningful result — an acne approval says nothing about what it does to hair.

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

  1. 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 ↗

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.

  • NCT05914805Phase 3COMPLETED

    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

  • NCT05910450Phase 3COMPLETED

    A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss

    Cassiopea SpA · n=703 · June 2023

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