Pyrilutamide (KX-826) for hair loss: what the 2026 phase III results mean for Malaysians

In March 2026 a Chinese drug company, Kintor Pharmaceutical, announced that its topical hair loss drug pyrilutamide, coded KX-826, met its main goal in a large phase III trial in Chinese men with pattern hair loss. Two months later the full results were presented at the World Congress for Hair Research in Seoul. Because the trial was run entirely in Asian men, the news drew attention in Malaysia, and readers started asking reasonable questions. What exactly is pyrilutamide? Is it like finasteride? Can it be bought here? Should anyone stop their current treatment and wait for it?

This guide explains how pyrilutamide is designed to work, what each of its trials actually showed (including one that failed), how it compares with the treatments available today, and what a sensible plan looks like for a Malaysian reader right now. It is general information, not personal medical advice. For background, see how DHT drives hair loss and clascoterone, another topical anti-androgen.

The short answer

• Pyrilutamide (KX-826) is an experimental topical androgen receptor blocker. It is a liquid applied to the scalp that is designed to stop male hormones from acting on hair follicles, without lowering hormone levels in the blood ^{1 2}.
• The 2026 phase III result was positive. In 666 Chinese men treated for 24 weeks, the 1.0% twice-daily dose raised hair counts by 15.33 hairs/cm², against 4.68 hairs/cm² on placebo ^{1 3}.
• An earlier phase III failed. A 2023 trial of the 0.5% dose did not beat placebo on its main measure, which is a reason for measured expectations ⁴.
• It is not approved anywhere yet. As of August 2026 the company planned to file for approval in China in the second half of 2026 and hoped for a decision in the second half of 2027 ⁵.
• It is not available in Malaysia. Products sold online under "826" names are cosmetics, not the drug tested in these trials ^{6 7}.
• Proven options exist today. Topical minoxidil and, for men, finasteride remain the best-studied treatments for pattern hair loss, and waiting years for a new drug has a real cost ^{8 9}.

What pyrilutamide is

Pyrilutamide is a small molecule developed by Kintor Pharmaceutical, a company listed in Hong Kong. It belongs to a class called androgen receptor antagonists. In the trials it is used as a tincture, an alcohol-based liquid applied directly to the scalp, usually twice a day ^{2 1}.

The company describes it as potentially "first in class" in China, meaning the first topical drug of its kind for hair loss there. That claim is about regulatory status, not proof that it works better than existing treatments. Another topical androgen receptor blocker, clascoterone, has also reported positive phase III results in men, in trials run in the United States and Europe ¹⁰. The two molecules are different, but the idea behind them is similar.

How pattern hair loss works

The hair cycle

Each scalp follicle cycles through a long growing phase (anagen), a short transition (catagen) and a resting phase (telogen), after which the old hair falls out and a new one starts ¹¹. On a healthy scalp the growing phase lasts several years, which is why scalp hair can grow long.

Miniaturisation

In androgenetic alopecia, the medical name for pattern hair loss, follicles in certain areas are genetically sensitive to androgens, the male hormones. Testosterone is converted by an enzyme called 5-alpha reductase into dihydrotestosterone (DHT), a more potent androgen. DHT binds to androgen receptors inside follicle cells. Over many cycles the growing phase shortens and the follicle shrinks, so thick hairs are gradually replaced by thin, short, pale ones ^{12 13}. In men this produces a receding hairline and thinning crown. The process is slow and usually progresses over years.

Where each drug acts

There are two broad ways to block this pathway:

1. Lower DHT production. Finasteride and dutasteride block 5-alpha reductase, so less DHT is made in the scalp and in the body as a whole ¹².
2. Block the receptor. An androgen receptor antagonist sits in the receptor so that DHT and testosterone cannot switch it on. Pyrilutamide and clascoterone work this way ^{2 10}.

Minoxidil works differently again. It does not touch hormones; it is thought to prolong the growing phase and enlarge follicles through effects on blood flow and follicle cells ¹².

Why a topical receptor blocker is attractive

Oral anti-androgens act on the whole body. Finasteride is effective, but a small proportion of men report sexual side effects, and that worry stops many from trying it ¹⁴. A drug that blocks receptors only in the scalp, and that is poorly absorbed into the blood, could in principle give some of the benefit with fewer whole-body effects. Kintor states that pyrilutamide has low skin penetration into the circulation and that its breakdown products have low activity, which is the basis of its safety argument ². That design goal is plausible, but long-term safety data in large numbers of people are still limited.

What the trials actually showed

The main measure in these trials is target area hair count: the number of non-vellus hairs in a marked square centimetre of scalp, counted from close-up photographs. It is objective, but it is not the same as how full a person's hair looks to others.

Phase II in China (2021)

The first published efficacy data came from a randomised, double-blind phase II trial of 120 men with Norwood stage III vertex to V pattern hair loss. Men applied the drug or placebo for 24 weeks. On the 0.5% twice-daily dose, hair counts rose by an average of 22.89 hairs/cm², against 7.54 hairs/cm² on placebo, a difference of 15.34 hairs/cm². Drug-related adverse reactions were reported in 16.1% of participants, mostly itching (5.9%) and contact dermatitis (2.5%), with no serious adverse events ².

The 2023 phase III miss

Kintor then ran a phase III trial of the 0.5% twice-daily dose in Chinese men. In November 2023 the company announced that, although hair counts improved clearly from baseline, the difference against placebo was not statistically significant on the main endpoint. Safety was reported as good ⁴. This is worth knowing. A placebo group in hair trials often improves too, partly because people care for their scalp more carefully during a study, and a drug has to beat that.

The new pivotal trial (2025 to 2026)

Kintor redesigned the programme as a combined phase II/III trial and added a higher 1.0% dose.

• Phase II stage (July 2025). In about 90 men, the 0.5% twice-daily dose raised hair counts by 22.39 hairs/cm² and the 1.0% dose by 21.87 hairs/cm², against 8.73 hairs/cm² on placebo. No drug-related sexual dysfunction was reported ¹⁵.
• Phase III stage (March 2026). In 666 men at 26 centres in China, treated for 24 weeks with 14 days of safety follow-up, the 1.0% dose raised hair counts by 15.33 hairs/cm² and the 0.5% dose by 14.46 hairs/cm², against 4.68 hairs/cm² on placebo. Both differences were statistically significant. The company reported no drug-related serious adverse events and no clinically significant difference in adverse event rates between drug and placebo ^{1 3}.

The final analysis was presented by the lead investigator from Peking University People's Hospital at the World Congress for Hair Research 2026, together with an observational study of pyrilutamide combined with minoxidil ⁶.

How to read these numbers

A gain of about 10 to 11 hairs/cm² over placebo after six months is a real, measurable effect. It is in the general range reported for established topical treatments in trials, although results from different trials cannot be compared directly because the populations, methods and durations differ ⁹. Several limits remain:

• All the efficacy data so far come from men in China. Results in women, and in other populations, are still to be studied ⁵.
• Six months is short for a condition that progresses over decades. Long-term safety and durability data are planned but not yet reported ⁵.
• Most of the detailed results so far come from company announcements and conference presentations. A full peer-reviewed paper of the phase III trial will allow independent scrutiny.
• There is no head-to-head trial against finasteride or minoxidil.

How it compares with current options

Pros, cons and risks

Possible advantages

• Acts locally on the scalp rather than lowering hormones throughout the body.
• No drug-related sexual side effects were reported in the 2025 trial stage, and adverse event rates were similar to placebo in the 2026 phase III ^{15 1}.
• Tested specifically in Asian men, which makes the results directly relevant to many Malaysian readers.
• Could be combined with minoxidil, which works by a different route ⁶.

Limits and unknowns

• Not approved by any regulator yet, including the NPRA in Malaysia ^{5 7}.
• One earlier phase III did not beat placebo, so the size of the benefit should not be overstated ⁴.
• Twice-daily application of an alcohol-based tincture can be inconvenient, and some users had itching or contact dermatitis ².
• Long-term safety beyond the trial period, use in women and use in combination are still being studied ⁵.
• Like every treatment for pattern hair loss, any benefit would be expected to fade if use stops, because the underlying sensitivity remains ¹³.

What to expect if it is approved: a realistic timeline

No one can promise dates, but the company's own plans give a rough outline.

1. Filing in China. Kintor planned to submit its new drug application to China's regulator in the second half of 2026 ⁵.
2. Decision in China. The company hoped for approval in the second half of 2027. Regulators can ask for more data, so this may move ⁵.
3. Other countries. Each country, including Malaysia, makes its own decision. Approval in China does not register a medicine in Malaysia, and the company has not announced a Malaysian filing.
4. Using it. In the trials, results were measured at 24 weeks. As with minoxidil and finasteride, anyone using it would usually need three to six months to see whether shedding slows and about a year to judge the full effect ⁹.

The Malaysian context

It cannot be legally bought as a medicine here. Pyrilutamide is not a registered product in Malaysia. Any medicine sold for a medical claim in Malaysia should be registered with the National Pharmaceutical Regulatory Agency, and its registration status can be checked through the NPRA's online product search ⁷.

Beware of "826" products online. In China, Kintor also sells cosmetic hair care products under "826" and related names. The company itself describes these as cosmetics, separate from the drug KX-826 ^{6 5}. A cosmetic shampoo or scalp lotion has not been through the drug trials described above, so trial results cannot be applied to it. Listings on marketplaces that claim to be "KX-826 tincture" should be treated with caution, because unregistered products may be mislabelled or contaminated.

Climate matters. Malaysia is hot and humid. A twice-daily tincture has to dry on the scalp, and sweat, helmets and frequent washing can interfere with that. Alcohol-based scalp liquids can also irritate some people. These practical points are worth thinking about with any topical treatment, including minoxidil. See itchy scalp on minoxidil.

Getting a proper diagnosis. Not all thinning is pattern hair loss. Shedding after illness, thyroid problems, iron deficiency and scalp conditions need different treatment. A doctor can confirm the diagnosis, and doctors' registration can be checked with the Malaysian Medical Council ¹⁶. This article does not list prices, because the drug is not sold here and no verified Malaysian price exists.

Common myths

"Pyrilutamide is a natural or herbal extract." It is a synthetic drug molecule tested in controlled clinical trials, not a botanical ingredient ².

"Topical means zero side effects." Itching and contact dermatitis occurred in the phase II trial, and long-term data are still limited ².

"It will replace finasteride and minoxidil." There are no head-to-head trials, and established treatments have decades of data behind them ⁹.

"Asian trial results mean it will work for everyone of Asian descent." The trials show average results in Chinese men. Individual responses vary widely, and women have not yet been studied.

"The '826' shampoo is the same thing." It is a cosmetic, not the trial drug ⁶.

"It is better to wait than start anything now." Pattern hair loss progresses, and follicles that have shrunk for years respond less well. Waiting several years with no treatment is rarely a good trade ¹³.

A practical checklist

• Confirm the diagnosis first. Pattern hair loss, shedding and scalp disease are treated differently.
• Take baseline photos in the same light every three months so progress can be judged fairly.
• If you are a man with early pattern hair loss, ask a doctor about evidence-based options available now, such as topical minoxidil and finasteride. See finasteride for hair loss and minoxidil in Malaysia.
• If worried about finasteride side effects, discuss the actual evidence with a doctor. See post-finasteride syndrome.
• Do not buy products labelled pyrilutamide or KX-826 online. Check any product claiming a medical effect against the NPRA register ⁷.
• Read new results with care: look for placebo comparison, trial size and peer review. See combination treatment for how options are usually layered.
• Revisit pyrilutamide when an approval decision is announced, rather than acting on early headlines.

The bottom line

Pyrilutamide is one of the most interesting hair loss drugs in development, because it targets the androgen receptor on the scalp and has now shown a clear advantage over placebo in a large trial of Asian men. It is still investigational, one earlier phase III failed, and it is not available in Malaysia. For now, the sensible move is to use proven treatments with a doctor's guidance, protect the hair you have, and treat pyrilutamide as promising news to follow rather than a reason to wait.

Frequently asked questions

What is pyrilutamide (KX-826)?

It is an experimental topical androgen receptor antagonist developed by Kintor Pharmaceutical. It is applied to the scalp as a liquid and is designed to block male hormones from acting on hair follicles.

Is pyrilutamide available in Malaysia?

No. It is not approved by any regulator yet and is not a registered product in Malaysia. Registration of any medicine can be checked through the NPRA.

How well did it work in trials?

In the 2026 phase III trial of 666 Chinese men, the 1.0% dose raised hair counts by 15.33 hairs per square centimetre after 24 weeks, against 4.68 on placebo. An earlier 2023 phase III of the 0.5% dose did not beat placebo.

How is it different from finasteride?

Finasteride lowers the production of DHT throughout the body. Pyrilutamide is applied to the scalp and blocks the androgen receptor, without lowering hormone levels in the blood.

Does pyrilutamide cause sexual side effects?

No drug-related sexual dysfunction was reported in the 2025 trial stage, and adverse event rates were similar to placebo in the 2026 phase III. Long-term data are still limited, and itching and contact dermatitis have been reported.

When might it be approved?

The company planned to file for approval in China in the second half of 2026 and hoped for a decision in the second half of 2027. Malaysia would make its own separate decision.

Are the '826' shampoos sold online the same drug?

No. The company describes its '826' hair care products as cosmetics, separate from the trial drug KX-826, so the trial results do not apply to them.

Should I wait for pyrilutamide instead of starting treatment now?

Usually not. Pattern hair loss progresses over time, and proven options such as topical minoxidil and, for men, finasteride are available now. A doctor can help choose a plan.

Educational content. Not medical advice.