Clascoterone (Breezula) for Hair Loss: Still in Trials, Not Available in the UK

Clascoterone is a medicine that blocks the effect of male hormones on the skin. A 1% cream is used for acne in some countries. A stronger 5% scalp solution, called Breezula, has been in trials for male pattern hair loss. It is not licensed for hair loss in the UK and is not on sale here for that use.

Status at time of writing (November 2026)

• Hair loss: no UK licence. In the most recent sources we reviewed, Breezula was still in phase 3 trials. This may have changed, so check for newer announcements.
• Acne: a 1% cream (Winlevi) is approved in the US. We have not confirmed its UK licensing status. Check the MHRA product database and the BNF to see whether a cream is currently available in the UK.
• Trial results: we could not find peer-reviewed phase 3 hair loss results when this page was written. We have not checked company press releases or confirmed whether the phase 3 trials have finished or reported results. We will update this page when we can confirm more.

Two products, one ingredient#

The acne cream and the hair loss solution contain the same active ingredient but are different products. Results from one cannot simply be applied to the other.

Both come from Cassiopea, part of Cosmo Pharmaceuticals, an Italian-Swiss company. The scalp version is five times stronger, so the acne safety data does not automatically carry over.

How it works on the scalp#

In male pattern hair loss, a hormone called DHT attaches to receptors in hair follicles. This makes the follicles shrink, and the hairs grow thinner and shorter over time.

Clascoterone sits on that receptor and blocks DHT from attaching. Finasteride works differently. It lowers how much DHT your body makes.

Clascoterone is designed to act where you apply it. Once it reaches the skin, it breaks down quickly into a form called cortexolone, which has little hormone activity. The aim is to keep the amount reaching the bloodstream low.

What the trials show so far#

Two phase 3 trials of Breezula 5% in men, called SCALP 1 and SCALP 2, were announced by Cosmo in June 2023. They were designed to compare the solution with a dummy solution, with hair count in a set patch of scalp as the main measure.

We have not confirmed the current status of these trials. They may have finished or reported topline results since the 2023 announcement, and any such results may have appeared in company press releases, which we have not checked. We could not find peer-reviewed phase 3 results. Company announcements are not the same as peer-reviewed data, so treat them with caution.

Earlier phase 2 studies, run by the manufacturer, reported more hair growth than with placebo. We cannot quote exact figures because we could not find them in peer-reviewed form.

The acne data is stronger. Two phase 3 trials of about 1,400 people found that the 1% cream cleared more acne than dummy cream over 12 weeks. That says nothing about hair.

Several things are still unknown:

• How well it works compared with finasteride or minoxidil, as no head-to-head trial is published.
• Whether results last over the longer term.
• How safe long-term scalp use is.
• Who funded the work: the main trials are company-sponsored.

A rival topical anti-androgen, pyrilutamide (KX-826), is also in trials. It is at a similar stage and is not licensed in the UK either.

Side effects, in plain English#

The known side effects come from the acne cream. Scalp trial safety data is still emerging.

• Skin reactions: redness, itching, dryness and peeling where it is applied.
• HPA-axis suppression: the HPA axis is the system that controls your body's own cortisol (a stress hormone). Some people in acne studies had it slow down briefly. It recovered when they stopped.
• Hyperkalaemia: a raised potassium level in the blood. It is a listed warning, not a common problem.

Breezula is applied to the scalp at five times the acne strength, so whether more drug reaches the blood is a fair question. It is also not yet clear whether it avoids the sexual side effects some men get with finasteride. Low absorption makes that likely, but only the trials can confirm it.

Licensed, unlicensed and off-label#

A licensed medicine has been checked by the MHRA for a specific use. Using a licensed medicine for something else is off-label. Unlicensed means no UK licence exists at all.

Clascoterone has no UK licence for hair loss. A clinician can legally prescribe an unlicensed medicine in some cases, but only for good reason and while taking responsibility for it. That is not reasonable when licensed treatments exist, and for male pattern hair loss they do.

Cosmo is a European company, so any approval would probably be sought in several markets. The MHRA can take other regulators' decisions into account. We cannot give a date.

Be wary of websites selling "Breezula" or clascoterone. They are not legitimate hair loss products, and what you receive may be fake, contaminated or the wrong strength. A genuine UK pharmacy will appear on the GPhC register. You can search the pharmacy's name or registration number there.

What you can use today#

The NHS does not usually fund treatment for male pattern hair loss, so most men pay privately. NICE CKS covers the condition if you want to see what UK clinicians are advised to do.

For finasteride, the MHRA advises you to speak to a doctor about mood changes, low mood or suicidal thoughts. Sexual side effects can sometimes continue after stopping. You should get a patient alert card with your supply. It is for men only, and women who are or may be pregnant should not handle crushed or broken tablets.

With minoxidil, mild scalp irritation and unwanted facial hair are the usual problems. Stop and get advice if you get chest pain, a fast heartbeat, dizziness or swelling in the hands or feet.

If your hair is falling out in patches, or all over rather than in a pattern, see your GP. Thyroid problems, low iron and shedding after illness or stress can all cause hair loss, and they need different treatment. Our guide on finasteride vs minoxidil explains how the licensed options compare.

If you are a man aged 18 or over with male pattern hair loss, Totiva's hair loss service offers a free consultation, and you only pay if a clinician approves treatment. The service is for men only.