Clascoterone (Breezula): status for hair loss

What is clascoterone?

Clascoterone is an anti-androgen that you apply to the skin. It binds to the androgen receptor in the skin and occupies the site, so that the skin's DHT cannot shrink the hair follicle to the same extent. A stronger version for the scalp is being studied for hair loss under the name Breezula and is not approved for hair loss as of October 2026.

Because it works locally, the idea is to hit the hair follicle without the broad hormonal effect a tablet can give. It shares its target — the androgen receptor — with pyrilutamide, another treatment at the experimental stage.

Does clascoterone work for hair loss?

The scalp version has reported positive phase 3 data, but the figures are company-reported and not yet fully peer-reviewed. A positive series of trials is also not the same as an approval.

The phase 3 results point in a promising direction, but until they are published in a peer-reviewed journal and assessed by a medicines authority, they should be read with caution. It is a recurring feature of new hair loss treatments that company-reported figures can only be fully assessed once the independent data are available.

When could clascoterone arrive?

The manufacturer has stated that an application for approval in the US is expected to be submitted at the earliest in 2027, with a European application later. An approval in Denmark and the EU would, if it happens, come after that.

As with the other treatments, any year for a possible launch is uncertain, and an application is not an approval. See the full overview in our guide to new hair loss treatments.

Is Winlevi for acne the same thing?

No. Clascoterone already exists as a prescription-only cream for acne (Winlevi, approved in the EU and the US, among others), but the acne product and the hair loss version differ in strength, use and the documentation each requires. That a substance is approved for pimples says nothing about whether it is approved — or documented — for hair loss.

It is a common misunderstanding that a substance approved for one use is therefore documented for another. For hair loss, clascoterone is still experimental. Winlevi is neither documented nor intended for use against hair loss, and you should not use an acne cream on your scalp on your own.

Sources

1. Hebert A, Thiboutot D, Stein Gold L, et al. Efficacy and Safety of Topical Clascoterone Cream, 1%, for Treatment in Patients With Facial Acne: Two Phase 3 Randomized Clinical Trials. JAMA Dermatology, 2020;156(6):621-630. pubmed.ncbi.nlm.nih.gov/32320027
2. ClinicalTrials.gov. Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (SCALP2) (phase 3, completed). NCT05914805. clinicaltrials.gov/study/NCT05914805

This article summarises published research. It is general educational information, not medical advice, and it is not a recommendation to start, stop or change any medication. Prescription drugs carry contraindications and interactions; discuss them with a doctor who knows your medical history.