Glojour EditorialMyths and facts6 min read

Clascoterone for hair loss: what the 539% headline actually means

Reviewed by a physician · October 28, 2026

Clascoterone is a scalp solution that grew significantly more hair than a placebo solution in two trials with 1,465 men, but it is not approved for hair loss yet: the company plans to file with the FDA in early 2027.

Written by Glojour EditorialPublished October 28, 2026Updated October 28, 2026

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Clascoterone is designed to block the hormone signal that shrinks hair follicles, right at the scalp.12 The two trials were phase 3, and the results so far come from Cosmo Pharmaceuticals, the company behind them. They have not yet been published in a medical journal.123

Where does 539% come from?

It comes from the first results, released in December 2025: one trial showed a 539% relative improvement in hair count over placebo, and the other 168%.14 Both figures compare the hair gained on the drug with the hair gained on placebo, and the company has not published the hair counts behind them.1 The company's CEO told Fierce Pharma that the gap between the two trials comes entirely from different starting hair counts, not from the drug working differently. His reasoning: when two trials see a similar gain in hair count but start from different hair counts, the one that started with fewer hairs shows the bigger percentage.4 Dermatology Times wrote that a gap this size is not unusual in hair research, where results often vary with how advanced the hair loss was, who was enrolled in each region, or how each study site counted.5 So no, it doesn't mean five times more hair on your head.15

What happened after a year, and what are the side effects?

Twelve-month data released in April 2026 showed that men who stayed on it kept gaining hair.2 For the second six months, the men who had responded to clascoterone in the first six were split again: some stayed on clascoterone, and the rest were switched to placebo from month 7.26 Those who were switched lost some of the hair they had gained.2 If you know minoxidil and finasteride, that will sound familiar: they help while you use them.789

Over 12 months, the company reported side effects similar to placebo and no significant hormonal side effects across the body.2 A dermatologist who worked on the trials told Healio that over the year the men on clascoterone had no significant hormonal side effects, such as sexual problems.6 The dermatologist has disclosed financial ties to the company's subsidiary.64 The full safety data have not been published yet.23

How is clascoterone different from finasteride?

Finasteride is a pill that works on hormones across your whole body, while clascoterone is meant to work locally, in the scalp.792 Some men who take finasteride get sexual side effects, such as a lower sex drive or trouble getting an erection.79 Right now only two medicines are FDA-approved for male pattern hair loss: minoxidil and finasteride.7 Clascoterone itself was approved in the US in 2020, as a 1% cream for acne.10 The hair trials tested a 5% solution, not that cream.111 Both trials compared it with placebo, not with finasteride, so there is no data yet on which works better.1112

Had a hair transplant? Read this part

Transplanted follicles come from the back and sides of your head, where hair resists balding, so they tend to stay.1314 The hair around them doesn't get that protection. It can keep thinning, so the fuller look a transplant gives can fade over the years.1516 One caveat: both trials excluded men who had ever had a hair transplant, and men who had used finasteride in the previous six months or minoxidil on the scalp in the previous 12 weeks. So there's no published data yet on using clascoterone after a transplant, or together with either medicine.111217 Ask your own doctor about a plan to protect the hair you still have.15

Is clascoterone available for hair loss yet?

No. You can't get it for hair loss today: it is not approved for that anywhere, and the company only plans to apply in 2027, in the US in the first quarter and in Europe in the second.310 In Turkey, no clascoterone product is licensed at all, not even the acne cream.18 So be careful with anything sold online under this name.

If you're losing hair, have a doctor diagnose it first, because not all hair loss is male pattern.78 And if you're weighing up a transplant, you can ask your own questions on Glojour. Glojour's treatment library covers hair transplants and other procedures.

Myth or fact

Is 539% five times more hair?

Guess, then turn the card. Each answer comes with its source.

  1. 539% means about five times more hair.

    MythIt compares the hair gained on the drug with the hair gained on a placebo solution in one trial, and the company has not published the hair counts behind it. It does not mean five times more hair on your head.

  2. You can buy clascoterone for hair loss online now.

    MythIt is not approved for hair loss anywhere yet. The company plans to apply in the US in the first quarter of 2027 and in Europe in the second quarter, and in Turkey no clascoterone product is licensed at all.

  3. It works like finasteride, just as a lotion.

    It dependsBoth act on the hormone DHT, but in different ways. Finasteride is a pill that lowers DHT in the scalp and the blood; clascoterone is designed to block DHT at the hair follicle, in the scalp. No trial has compared the two.

  4. The hair you gain stays after you stop.

    MythIn the trials, men who had responded in the first six months and were switched to the drug-free solution from month 7 lost some of the hair they had gained. The same is true of minoxidil and finasteride: the benefit lasts only while you use them.

  5. It has been tested in men who already had a hair transplant.

    MythBoth trials excluded men who had ever had a scalp hair transplant, so there is no published data on using it afterwards.

Questions people ask

When will clascoterone be available for hair loss?

There's no date yet. The company plans to apply in the US in the first quarter of 2027 and in Europe in the second quarter, and a regulator would then have to approve it. 23

Can you buy clascoterone for hair loss now?

No. It is not approved for hair loss anywhere yet, and in Turkey no clascoterone product is licensed at all. The only form approved in the US is a 1% cream for acne, which is not the 5% solution tested for hair loss. 131018

Can you use clascoterone after a hair transplant?

There's no published data yet, because both phase 3 trials excluded men who had ever had a hair transplant. Ask your own doctor how to protect the hair around your transplant. 111215

How is clascoterone different from finasteride?

Finasteride is a pill that acts on hormones across the whole body. Clascoterone goes on the scalp and is designed to work there. No trial has compared the two, so nobody can say yet which works better. 2791112

What happens if you stop clascoterone?

In the trials, men who had responded in the first six months and were switched to the drug-free solution from month 7 lost some of the hair they had gained. 2

Does clascoterone have sexual side effects?

No significant ones have been reported so far. A trial investigator told Healio that over 12 months the men on clascoterone had no significant hormonal side effects, such as sexual problems, and the company reported no significant hormonal side effects across the body. The full safety data have not been published yet. 236

This article is general information. Decisions about your own treatment belong with your doctor.

Next steps on Glojour

Sources

Every number and medical claim above links to one of these. Checked October 28, 2026.

  1. Cosmo Pharmaceuticals N.V.. Phase III topline results of SCALP 1 and SCALP 2 for clascoterone 5% solution in male hair lossCompany statement · 2025
  2. Cosmo Pharmaceuticals N.V.. Phase III 12-month results for clascoterone 5% topical solutionCompany statement · 2026
  3. Cosmo N.V.. Half-year 2026 report, including the regulatory submission plan for clascoterone 5% topical solutionCompany statement · 2026
  4. Fierce Pharma. Cosmo shares zoom with results from 2 male-pattern hair loss trialsNews report · 2025
  5. Dermatology Times. Clascoterone 5% Delivers Strong Phase 3 Hair-Growth ResultsNews report · 2025
  6. Healio. Male pattern hair loss drug regrows hair up to 1 year without plateauNews report · 2026
  7. American Academy of Dermatology. What is male pattern hair loss, and can it be treated?Specialty society · 2022
  8. U.S. National Library of Medicine, DailyMed. Drug facts for minoxidil 5% topical foam for men (NDA 021812)Regulator · 2024
  9. U.S. National Library of Medicine, DailyMed. Prescribing information for finasteride 1 mg tablets (NDA 020788)Regulator · 2024
  10. U.S. Food and Drug Administration. Drugs@FDA: approval history of clascoterone cream 1% (NDA 213433)Regulator · 2020
  11. ClinicalTrials.gov, U.S. National Library of Medicine. A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (SCALP1, NCT05910450)Health authority · 2026
  12. ClinicalTrials.gov, U.S. National Library of Medicine. A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (SCALP2, NCT05914805)Health authority · 2025
  13. International Society of Hair Restoration Surgery. Surgical treatments for hair lossSpecialty society
  14. Dermatologic Surgery (Queen D, Avram MR). Hair Transplantation: State of the ArtResearch · 2025
  15. American Academy of Dermatology. A hair transplant can give you permanent, natural-looking resultsSpecialty society
  16. Dermatologic Surgery (Leavitt M et al.). Effects of finasteride (1 mg) on hair transplantResearch · 2005
  17. ClinicalTrials.gov, U.S. National Library of Medicine. 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 (NCT02279823)Health authority · 2017
  18. Türkiye İlaç ve Tıbbi Cihaz Kurumu (TİTCK). Ruhsatlı Beşeri Tıbbi Ürünler Listesi (16.10.2026)Regulator · 2026

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