Clascoterone is a drug applied to the scalp that blocks the androgen receptor, the docking point DHT uses in the hair follicle. Its maker reports that the 5% solution improved hair counts more than a placebo solution in two phase 3 trials in men, but it has not been approved for hair loss, and we found no approved hair loss product in India.
The phase 3 figures below come from the company’s announcements and a Healio report. The India section draws on a document from India’s drug regulator. Each source is listed at the end.
What Is Clascoterone?
Clascoterone is an androgen receptor inhibitor. Our page on androgenetic alopecia explains how DHT (dihydrotestosterone) acts on hair follicles in male pattern hair loss. Clascoterone competes with DHT for the androgen receptor, so less DHT can attach [4]. The company developing it reports negligible absorption into the bloodstream in its earlier studies [2].
A 1% clascoterone cream, sold as Winlevi, is approved for acne by the US FDA and the European Medicines Agency [2] [4]. The hair loss version is a stronger 5% solution from Cosmo Pharmaceuticals, and it is still investigational [1]. People also search for it as Breezula. The company announcements we read do not use that name.
The acne cream cannot stand in for the 5% solution tested in the hair loss trials, because it is a weaker 1% strength in a cream base. We could not confirm that it is sold in India.
Key points:
- Clascoterone has not been approved for hair loss. The company plans a US filing in early 2027.
- The company reports that in two phase 3 trials of 1,465 men, the 5% solution improved hair counts more than a placebo solution, and that men who had responded and stayed on it for 12 months kept gaining.
- There is no evidence that it regrows hair on scalp that is already bald.
What the Phase 3 Trials Found
The evidence comes from two identically designed phase 3 trials, SCALP 1 and SCALP 2. Together they enrolled 1,465 men at 51 study centres in the United States and Europe [1] [2]. Each man applied either clascoterone 5% solution or a vehicle, which is the same solution without the drug (a placebo). The main measure was target-area hair count: the number of hairs counted in a fixed patch of the scalp.
| Stage | What was compared | Result the company reported |
|---|---|---|
| 6-month topline analysis, one trial | Clascoterone vs vehicle (placebo solution) | 5.39x (539%) relative improvement in target-area hair count |
| 6-month topline analysis, the other trial | Clascoterone vs vehicle | 1.68x (168%) relative improvement in target-area hair count |
| Months 7 to 12, men who had responded | Stayed on clascoterone vs switched to vehicle | 2.39x improvement in target-area hair count for those who stayed on it |
| 12 months | Treatment satisfaction vs the vehicle groups | 24.5% relative improvement |
| 12 months | Safety | Comparable to vehicle, with no significant systemic hormonal side effects |
Sources for the table: [1] [2] [5].
The company reports that both trials reached statistical significance on hair count. It also reports that the patient-reported measure was significant in one trial, showed a positive trend in the other, and was significant when the two were combined [1]. For months 7 to 12, the men who had responded were randomised again, either to stay on clascoterone or to switch to the vehicle. The company reports that those who stayed on it kept gaining hair through month 12, and that those who switched had a measurable decline in hair count [2].
What the 539% Figure Means
The company describes the 539% figure as a relative improvement in target-area hair count versus vehicle. We read that as a comparison of the two groups’ gains, which is different from a fivefold increase in hair. A ratio like this can look large when the comparison group changes very little. The other trial reported 168% [1].
The satisfaction result is more modest. The company reports that men treated for 12 months rated their treatment 24.5% higher, in relative terms, than the vehicle groups [2].
The announcements give no absolute hair counts or application schedule, and no detailed side-effect figures. The company says it plans to submit the full data to a peer-reviewed journal [2], and our PubMed search on 13 October 2026 found no published phase 3 paper. Until that data is out, nobody outside the company can say how visible the change is.
Is Clascoterone Available in India?
No. We found no Indian approval for clascoterone for hair loss as of October 2026. As of its April 2026 announcement, the company had not filed for approval in the United States or Europe. It said a US FDA filing was planned for early 2027 and a European application was being prepared [2]. A filing only starts a review, and we found no date announced for India.
In June 2024, India’s drug regulator, the CDSCO, gave Glenmark Pharmaceuticals permission to run a phase 2 clinical trial in men with androgenetic alopecia. The trial tests two combination solutions for the scalp: clascoterone 7.5% with minoxidil 5%, and clascoterone 7.5% with latanoprost 0.03% [3]. Phase 2 is a mid-stage study, so a product would normally still need larger trials and a separate marketing approval before it reaches a pharmacy. We found no published results from this trial. The phase 3 trials ran in the United States and Europe, so they did not include patients in India.
Clascoterone Price in India
There is no official clascoterone price in India, because we found no approved product. Any price you see quoted is not an official one.
Do not buy products sold online as clascoterone for hair loss. A listing for a clascoterone hair serum already appears in Indian search results. Nothing shows such products are the 5% solution tested in the SCALP trials, and we have not verified what they contain. A product that has not been through drug approval has not had its strength, purity or safety checked by a regulator.
Clascoterone vs Minoxidil vs Finasteride
All three are used or studied for pattern hair loss, and each works differently.
| Clascoterone 5% | Minoxidil | Finasteride | |
|---|---|---|---|
| How it works | Blocks the androgen receptor in the follicle, so less DHT can attach | Works differently. Thought to enhance cell growth in the follicle | Lowers DHT by blocking the enzyme that makes it |
| Form | Solution applied to the scalp | Solution applied to the scalp. Foam in some countries | Taken by mouth once daily. A topical form is also approved in India |
| Status for hair loss | Investigational, not approved | Used for pattern hair loss | Indicated for male pattern hair loss |
| Tested in | Phase 3 in men only | Men and women | Men. Not indicated for women |
| Known drawbacks | No data beyond 12 months, and no detailed side-effect figures yet | Scalp irritation, itching or stinging | Sexual side effects in a small share of men |
| If you stop | The company reports a decline in hair count after switching to vehicle | Gains are normally lost within months | Hair loss is likely to resume |
Sources for the table: clascoterone [1] [2] [4], minoxidil [7], finasteride [8].
The phase 3 trials did not compare clascoterone with minoxidil or finasteride [1], and we found no published result showing which is stronger.
Finasteride is taken by mouth and works by reducing DHT. A small share of men in its trials reported sexual side effects [8], which is why some men avoid it. Clascoterone is applied to the scalp, and the company reports no significant systemic hormonal side effects over 12 months [2]. Whether that makes it a real alternative for men who avoid finasteride will depend on the full data. Our guides to minoxidil and DHT blockers cover the treatments you can use today.
What Clascoterone Will Not Do
There is no evidence it regrows hair on bald scalp. The phase 3 trials enrolled men with mild to moderate hair loss [5]. Because it acts on the DHT receptor, any effect would be on follicles that still produce hair.
It will not rebuild a hairline that has gone. Where the temples or the crown are smooth and bare, the trials offer no evidence that a receptor blocker brings hair back.
You have to keep applying it. The company reports a measurable decline in hair count in men who switched to the vehicle after month 6 [2]. Minoxidil and finasteride behave the same way: the benefit fades after you stop [7] [8].
There is no proof it works in women. The phase 3 programme enrolled men only. A phase 2 study in about 280 women was started in Germany in 2019 [6].
Do not wait for it. A US filing in early 2027 does not tell you whether it will be approved, or when it might reach India. Waiting means going without any treatment in the meantime.
Clascoterone or a Hair Transplant?
A drug like clascoterone can only act on follicles that are still there, while a hair transplant moves healthy follicles from the back and sides of your scalp into areas where the hair has gone.
| Your situation | What usually helps |
|---|---|
| Early thinning, hair still covers the scalp | Medical treatment, to slow the loss and thicken what is there |
| Hair loss that is still getting worse | Medical treatment first, to steady it, before any decision about surgery |
| A hairline or crown that is smooth and bare | A hair transplant for the bare area, with medical treatment to protect the hair around it |
A transplant fills the bare area, but hair that was not transplanted can continue to thin over time. That is why medical treatment still matters after surgery. Whether clascoterone, if approved, suits people who have had a transplant is something no trial we found has tested.
What to Do While You Wait
If you are losing hair now, waiting for a drug whose US filing is only planned may mean losing more.
- Find your stage. Use the baldness calculator or compare your hairline with the Norwood scale.
- Get the cause confirmed. Pattern hair loss is the usual cause in men, but there are others, and the treatment depends on which one you have.
- Start a treatment that is already in use. Minoxidil is used for pattern hair loss in men and women [7], and finasteride is indicated for men [8]. See hair loss treatments ranked by evidence.
- Say what put you off before. If you stopped minoxidil, or you are avoiding finasteride tablets because of side effects, raise it at your assessment. There are other routes to discuss, including topical finasteride, which is approved in India [8], and in-clinic treatments such as PRP.
- Take a photo every three months. Use the same light and angle, so you can tell whether a treatment is holding your hair.
- Look at clascoterone again if it is approved. Do it once the full data and a price are available.
Frequently Asked Questions
Is clascoterone approved for hair loss?
No. Clascoterone 5% solution is investigational and has not been approved for hair loss. The company developing it says a US FDA filing is planned for early 2027 and a European application is being prepared. In the US and EU, the 1% cream sold as Winlevi is approved, for acne.
Is clascoterone available in India, and what does it cost?
We found no approved clascoterone product for hair loss in India, so there is no official price. In June 2024 the CDSCO permitted Glenmark Pharmaceuticals to run a phase 2 trial of clascoterone 7.5% combined with minoxidil or latanoprost in men. That is a trial permission. Marketing approval is a separate step. Do not buy products sold online as clascoterone for hair loss: nothing shows they are the solution tested in the trials, and we have not verified what they contain.
Is clascoterone better than finasteride or minoxidil?
We found no published result showing which is better. The phase 3 trials compared clascoterone with a vehicle solution only. Clascoterone blocks the receptor DHT binds to, finasteride lowers DHT itself, and minoxidil works in a different way.
What are the side effects of clascoterone?
The company reports that over 12 months safety was comparable to the vehicle solution, with no significant systemic hormonal side effects. Detailed figures have not been published. For the approved 1% acne cream, the common side effects listed are local skin reactions, nasopharyngitis, headache and throat pain. Reversible suppression of the adrenal hormone axis was seen at three times the recommended dose, and the cream should not be used in pregnancy [4].
Can clascoterone regrow hair on a bald scalp?
There is no evidence that it can. The phase 3 trials enrolled men with mild to moderate hair loss. Where the scalp is already bare, a hair transplant is the option that puts hair back.
Can women use clascoterone for hair loss?
It has not been shown to work in women. The phase 3 trials enrolled men only. A phase 2 study in about 280 women was started in Germany in 2019.
Should I wait for clascoterone before starting treatment?
No. Whether it will be approved, and when it could reach India, is not known, and waiting means going without treatment in the meantime. Start a treatment that is already in use after a diagnosis, and review clascoterone if it is approved.
Find Out Where Your Hair Loss Stands
The right treatment depends on your stage. Check yours with the free baldness calculator, or book a consultation at any of our 13 clinics in India and Dubai.
If you already have bare areas, a qualified doctor performs every hair transplant at Assure Clinic. Pricing is on a Full Head Results basis, from ₹2 lakh to ₹15 lakh depending on the extent of loss. The hair transplant cost calculator gives you an estimate.
Sources
- Cosmo Pharmaceuticals. Phase III topline results from SCALP 1 and SCALP 2 for clascoterone 5% solution in male hair loss. Press release, 3 December 2025. newsfilecorp.com
- Cosmo Pharmaceuticals. Phase III 12-month data for clascoterone 5% topical solution. Press release, 15 April 2026. newsfilecorp.com
- Central Drugs Standard Control Organization, Government of India. Form CT-06, permission no. CT/ND/19/2024, to Glenmark Pharmaceuticals Ltd. June 2024. cdsco.gov.in
- Clascoterone for acne. Australian Prescriber. 2024;47(5):160-161. doi:10.18773/austprescr.2024.040
- Healio. Male pattern hair loss drug regrows hair up to 1 year without plateau. 22 April 2026. healio.com
- Practical Dermatology. Cassiopea enrolls first patient in phase II trial of clascoterone solution for androgenetic alopecia in females. 13 November 2019. practicaldermatology.com
- DermNet. Minoxidil solution. Updated November 2025. dermnetnz.org
- DermNet. Finasteride. dermnetnz.org
