Hair
4 min read
Clascoterone (Breezula): the new hair loss drug – and how it compares with minoxidil and finasteride
By the editors
After almost 30 years without a new mechanism against hereditary hair loss, a new drug may be on its way. Clascoterone 5% (working name Breezula) is a solution you apply to the scalp, and it has passed two large phase 3 trials. Here is what the numbers really mean, when it could arrive, and how it compares with minoxidil, finasteride and dutasteride.
What is clascoterone?
Hereditary hair loss in men (androgenetic alopecia) is mainly caused by the hormone DHT gradually shrinking the hair follicles on the crown and at the temples. Finasteride and dutasteride are tablets that lower DHT throughout the body. Clascoterone works differently: it blocks the spot where DHT attaches inside the follicle itself (the androgen receptor), and it acts locally, where you apply it.
The substance is not entirely new. A weaker cream (1%) has been approved in the US for acne since 2020 under the name Winlevi. What is new is a stronger solution made for the scalp.
What did the trials show?
Drugmaker Cosmo Pharmaceuticals tested clascoterone 5% in two trials, SCALP 1 and SCALP 2, with a total of 1,465 men over 18 in the US and Europe. Participants received either clascoterone or a solution with no active ingredient (placebo), and neither they nor the doctors knew who got which.
- After 6 months (December 2025): Both trials showed clearly more hair in the measured area than placebo. The company reported a relative improvement of 539% in one trial and 168% in the other.
- After 12 months (April 2026): Men who kept using it still had more hair than those who switched to placebo after six months (a 239% relative improvement). Side effects were on par with placebo after a year as well.
Read the numbers right “539%” does not mean five times as much hair. It means the increase in hair count in a small measured area was about five times larger than in the placebo group, which also gained a little hair. The real difference in how your hair looks is less dramatic than the percentage. The figures also come from the company’s own announcements.
When could it arrive?
Cosmo says it will apply for approval from the US Food and Drug Administration (FDA) in early 2027, and that an application to the European Medicines Agency (EMA) is being prepared. Reviewing such an application normally takes about a year. Realistically, clascoterone for hair loss is unlikely to reach pharmacies in Europe or the UK before 2028. The trials only included men.
How it compares with today’s treatments
| Treatment | How it works | Availability | Known for |
|---|---|---|---|
| Minoxidil (liquid/foam) | Increases blood flow and extends the growth phase. Not hormonal. | Over the counter at pharmacies (5%) | Well documented. Works for as long as you use it, and you may shed more hair in the first weeks. |
| Minoxidil (tablet, low dose) | The same active ingredient, taken as a tablet | Prescription only, used off-label | Produced the most “thick” hairs after 24 weeks in a large 2022 comparison |
| Finasteride 1 mg | Lowers DHT throughout the body | Prescription only | The best long-term evidence. In 2025 the EMA confirmed suicidal thoughts as a side effect (frequency unknown), and packs are to include a patient card. Sexual side effects occur in a minority. |
| Dutasteride 0.5 mg | Lowers DHT even more strongly | Approved for enlarged prostate, not for hair loss | Ranked most effective after 24 weeks in the same comparison, but with little long-term data for hair |
| Clascoterone 5% | Blocks DHT locally in the follicle | Not approved yet | Two positive phase 3 trials. No head-to-head comparison with the others. |
The key point: no trial has tested clascoterone directly against minoxidil, finasteride or dutasteride. So we cannot say whether it is better or worse. What we do know is that it works better than placebo, and that so far it does not seem to cause the side effects many people fear with the tablets.
More news on the way
- A minoxidil tablet made for hair loss (VDPHL01, Veradermics): In a trial with 519 men, those taking the tablet gained around 30–33 hairs per cm² after six months, against around 7 with placebo. Results from a new phase 3 trial are expected in the second half of 2026.
- PP405 (Pelage): A gel meant to “wake up” the stem cells in the hair follicle. In a small trial with 78 people, 31% of the men with more advanced hair loss had over 20% denser hair after eight weeks, against none on placebo. Phase 3 is due to start in 2026.
- Pyrilutamide (KX-826, Kintor): Works the same way as clascoterone. It met its goal in a phase 3 trial in 2026, and the company plans to apply for approval in China.
Our verdict
Clascoterone is the most exciting hair loss news in a long time, because it goes after DHT without lowering the hormone throughout the body. For men who have held off on finasteride for fear of side effects, it could become a real alternative. But it is not here yet, the percentages are dressed up, and we do not know how it performs against what already exists.
No cope: if you are losing hair now, there is no reason to wait for 2028. The sooner you start, the more hair you have left to keep. Talk to your GP or a dermatologist about minoxidil and possibly finasteride. And do not buy “clascoterone” or other research chemicals online. It is not approved, you do not know what you are getting, and it is not safe.
This article is for information only and is not medical advice. Hair loss can have causes other than genetics, such as illness, nutrient deficiencies or medication. The drugs mentioned require a prescription, except minoxidil liquid. Looksmaxing does not sell medicines.