Clascoterone for hair loss: a topical anti-androgen in trials

For more than thirty years, the main medicines for male pattern hair loss have been the same two: minoxidil, which supports hair growth, and finasteride, which lowers the hormone DHT. Clascoterone is one of the first new medicines in a long time to reach large late-stage trials for this condition. It works differently from both, and it is applied to the scalp rather than swallowed.

That has generated a lot of headlines, some of them breathless. This article explains what clascoterone is, what the phase 3 trials reported, how to read the big percentages in the announcements, what is known about safety, and why it is still something to watch rather than something to buy. It is general information, not personal medical advice.

Short answer

• Clascoterone blocks the androgen receptor in the skin. It competes with DHT at the receptor rather than lowering DHT production, as finasteride does ^{1 2}.
• A 1% cream is already approved for acne in the United States, for people aged 12 and over ³.
• A 5% scalp solution has completed two phase 3 trials in a total of 1,465 men with mild to moderate pattern hair loss ^{4 5 6}.
• The company reported that both trials met their main hair count endpoint at six months, with side effects similar to the vehicle (placebo) solution ⁶. Full peer-reviewed results were still awaited at the time of writing.
• It is not approved for hair loss yet. Women were not included in the trials, and proven treatments remain the place to start ⁷.

How clascoterone works

In androgenetic alopecia, DHT binds to androgen receptors in hair follicles in genetically sensitive areas of the scalp. Over time this shrinks the follicles, so hairs grow back thinner and shorter. You can read more in DHT and hair loss.

Existing medicines tackle this in two ways. Finasteride and dutasteride lower the amount of DHT the body makes by blocking the enzyme 5-alpha reductase (see finasteride for hair loss and dutasteride for hair loss). Spironolactone, used in some women, blocks androgen effects throughout the body (see spironolactone for female hair loss).

Clascoterone takes a third route. It is a steroid-like molecule that sits in the androgen receptor itself, so DHT cannot bind and switch on its signals ¹. Laboratory work on human scalp dermal papilla cells, the cells that control the hair follicle, found that clascoterone reduced androgen-driven signalling and lowered production of IL-6, an inflammatory messenger that DHT stimulates in these cells ². Researchers proposed it as a candidate for the first topical anti-androgen for pattern hair loss ^{2 8}.

The idea is that because it is applied to the skin and is thought to break down there, it may act locally with less effect on hormones elsewhere in the body. How well that holds up for a scalp product used twice a day for years is one of the open questions.

From acne cream to scalp solution

Clascoterone first reached patients as a 1% cream for acne, approved in the United States in 2020 ¹. Acne also depends partly on androgens acting on oil glands, so a skin-level androgen blocker made sense there first.

The hair loss product is a different formulation: a solution with a higher concentration, 5% ^{1 6}. Results from the acne cream cannot simply be carried over to the scalp solution, because the dose, area of skin treated and length of use are different.

What the phase 3 trials were

The two trials, called SCALP 1 and SCALP 2, had the same design ^{4 5}:

• Who: men aged 18 and over with mild to moderate pattern hair loss at the crown and temples (Norwood-Hamilton grades III vertex to V) ⁴.
• How many: 703 men in SCALP 1 and 762 in SCALP 2, according to the trial registry, making 1,465 in total ^{4 5}.
• Treatment: 1.5 ml of 5% clascoterone solution or an identical vehicle solution, applied twice a day to the crown and temples ⁴.
• Main measure: the change in non-vellus hair count in a target area of scalp at six months, together with the men's own rating of their hair coverage ⁴.
• Second part: a further six months in which participants continued on clascoterone or vehicle, to look at longer-term safety and whether benefit is maintained ⁴.

Non-vellus hairs are the thicker, visible hairs, as opposed to the fine, almost invisible vellus hairs that miniaturised follicles produce.

What the results announced so far say

In December 2025, the company announced topline six-month results ⁶:

• Both trials reached statistical significance for target area hair count.
• One trial showed a 539% relative improvement versus vehicle, and the other a 168% relative improvement.
• For the men's own ratings, one trial reached statistical significance and the other showed a positive trend; combined across both trials, the result was statistically significant.
• Treatment-emergent adverse events were similar between clascoterone and vehicle, and most were judged not related to the study drug.

The company said it planned regulatory submissions in the United States and Europe after completing the 12-month safety follow-up ⁶.

How to read the big percentages

A "539% relative improvement" sounds dramatic, but it does not mean 539% more hair. It compares how much the hair count changed on clascoterone with how much it changed on vehicle. If the vehicle group changed only a little, even a modest gain on clascoterone produces a large relative figure. This is also why the two identical trials gave such different numbers, 539% and 168%.

To judge how useful a treatment is in real life, you need the absolute numbers: how many extra hairs per square centimetre, how many men saw a visible difference, and how that compares with minoxidil or finasteride. Those details usually appear in the full peer-reviewed publication and the regulator's review, not in a press release.

What is still unknown

• How large the absolute benefit is, and how it compares directly with existing medicines.
• Whether it helps the front hairline, since it was applied to the crown and temples in the trials.
• What happens over several years of use, and what happens after stopping.
• Whether it works in women, who were not enrolled ⁴.
• Whether combining it with minoxidil or finasteride adds benefit.

A 2026 expert review listed clascoterone among several emerging treatments for pattern hair loss and noted that ongoing trials will decide where these new medicines fit ⁷.

Safety: what is known

In the hair loss trials, the company reported that side effects were similar to vehicle and, in comments to the medical press, that no sexual side effects were reported ^{6 9}. That would be an important difference from finasteride, for which sexual side effects are a known concern for some men ¹⁰.

The acne cream label gives a fuller picture of how clascoterone behaves on skin ³:

• Local irritation: redness, itching, scaling or dryness were the most common reactions, though they occurred at similar rates with vehicle cream.
• HPA axis suppression: clascoterone is related to steroid molecules, and in a study using large amounts of cream on acne-prone skin for two weeks, a lowered stress-hormone (cortisol) response was seen in 1 of 20 adults and 2 of 22 adolescents. All recovered within four weeks of stopping. The label notes that use over large areas, prolonged use and covering the skin increase absorption.
• Potassium: raised potassium levels were seen in some people, in similar proportions to vehicle.
• Pregnancy: there are no human data, and animal studies at high doses showed harm to the developing fetus.

None of this means the scalp solution is unsafe. It does show why regulators look closely at long-term safety data for a product that may be used twice daily on a large area of scalp for many years, and why those 12-month results matter.

How it might compare with current options

If clascoterone is approved, it may appeal most to men who want an option that targets DHT without a tablet. Topical finasteride is another approach with a similar aim, discussed in topical finasteride. Minoxidil is covered in minoxidil.

Life in Malaysia

Hair loss news travels fast on social media, and a headline about a "breakthrough" drug can quickly be followed by online sellers offering products said to contain it. At the time of writing, there is no approved clascoterone product for hair loss anywhere, so a "clascoterone hair serum" sold online is either something else, an unregulated preparation, or an acne cream being used in a way it was not tested for.

If you are tempted to wait for clascoterone, remember that pattern hair loss tends to progress slowly over time. Months of waiting without treatment can mean losing ground that is hard to recover. A doctor registered with the Malaysian Medical Council ¹¹ can discuss proven options now and help you decide whether to switch if new medicines become available. A twice-daily scalp product may also be less convenient for people who wear a tudung or helmet for long hours, which is worth thinking about for any topical treatment.

Common myths

• "Clascoterone is the answer everyone has been waiting for." It is a promising medicine still awaiting full results and approval.
• "539% means five times more hair." It is a relative comparison with vehicle, not the amount of hair gained.
• "Because it is a cream, it has no effect on hormones." The acne label describes possible HPA axis suppression with heavy use.
• "The acne cream does the same thing." The hair loss product is a different, stronger formulation that was tested separately.
• "Women can use it too." The hair loss trials included men only.

Common mistakes

• Stopping a treatment that is working to wait for clascoterone.
• Buying online products that claim to contain clascoterone.
• Applying acne cream to the scalp without medical advice.
• Judging a medicine from press release percentages alone.
• Assuming new automatically means better than existing options.

How a doctor assesses hair loss

A doctor will usually ask when the hair loss started, about family history, medicines, diet, recent illness, childbirth or stress, and, for women, menstrual history. Scalp examination, often with dermoscopy, helps confirm androgenetic alopecia and rule out other causes such as inflammation or scarring. Blood tests may be suggested, for example a full blood count, ferritin and thyroid function. Standardised photos at the start and at follow-up help track changes. For an overview of local options, see hair loss treatment in Malaysia.

Questions to ask your doctor

1. Is my hair loss androgenetic alopecia, or something else?
2. Which proven treatments suit me now?
3. Would a DHT-blocking treatment be suitable for me, and in what form?
4. If clascoterone is approved, would it make sense for me?
5. Should I keep my current treatment while new options are reviewed?
6. Are there online products I should avoid?
7. How will my progress be measured?
8. When should my treatment be reviewed?

Bottom line

Clascoterone is a topical medicine that blocks DHT at the androgen receptor in the skin. Two large phase 3 trials in men reported positive six-month results with side effects similar to vehicle, according to the company, and regulatory submissions were planned after the 12-month safety data. Full results, an absolute measure of benefit and a regulator's decision are still to come. Until then, it is a medicine to watch, not one to buy, and a registered doctor ¹¹ can help you start or continue proven treatments in the meantime. It also helps to know how to spot treatments with weak evidence.

Frequently asked questions

What is clascoterone?

Clascoterone is a topical androgen receptor inhibitor. It competes with DHT for the androgen receptor in the skin. A 1% cream is approved in the United States for acne, and a 5% solution is being developed for male pattern hair loss.

Is clascoterone approved for hair loss?

Not at the time of writing. Two phase 3 trials in men have been completed, and the company said it planned regulatory submissions after the 12-month safety data. Approval is a decision for regulators.

What did the phase 3 trials show?

According to the company's topline announcement, both trials met their hair count endpoint at six months, with relative improvements versus vehicle of 539% in one study and 168% in the other. Full peer-reviewed results were still awaited.

What does a 539% relative improvement mean?

It compares the change in hair count on clascoterone with the change on vehicle. A large relative number can come from a small change on vehicle, so absolute hair counts matter for judging real-world benefit.

How is it different from finasteride?

Finasteride is a tablet that lowers DHT production throughout the body. Clascoterone is applied to the scalp and blocks DHT from acting on the receptor in the skin, with the aim of limiting whole-body effects.

Is clascoterone safe?

In the phase 3 hair trials, the company reported adverse events similar to vehicle and no sexual side effects. The acne cream label lists skin irritation and warns that HPA axis suppression may occur, so long-term scalp use needs careful study.

Can women use clascoterone for hair loss?

The phase 3 hair loss trials enrolled men only, so there are no trial results for women with hair loss. Women should not use the acne cream on the scalp without a doctor's advice.

Can I buy clascoterone in Malaysia for hair loss?

There is no approved clascoterone hair loss product to buy. Be wary of online products claiming to contain it. A registered doctor can discuss proven options in the meantime.

Educational content. Not medical advice.