Pyrilutamide

updated

Pyrilutamide (KX-826) is an investigational topical androgen receptor antagonist for androgenetic alopecia, with no drug approval found. Every efficacy figure comes from company filings: the company reported that its 2023 phase III in Chinese men did not separate from placebo, and later results, including a 666-patient phase III stage, are unpublished company statements. A PubMed search on 10 October 2026 found no peer-reviewed report of a human trial of pyrilutamide.

Androgen receptor antagonist (topical)

  • No FDA approval was found: openFDA Drugs@FDA returned no record for pyrilutamide and DailyMed returned no label on 10 October 2026.
  • A PubMed search on 10 October 2026 for pyrilutamide or KX-826 returned 3 records, two narrative reviews and a medicinal chemistry paper, and none reports a human trial. ClinicalTrials.gov returned 7 KX-826 records, and none has posted results.
  • The company reported in 2023 that its phase III in Chinese men (KX-826 0.5% twice daily, 24 weeks) raised hair counts from baseline but not significantly versus placebo.
  • The company reported in 2026 that a seamless phase II/III trial in Chinese men beat vehicle: differences from placebo of 13.66 and 13.14 hairs per cm2 in the phase II stage (90 patients) and 9.78 and 10.65 in the phase III stage (666 patients). The registry entry does not match these statements.
  • A cosmetic product containing KX-826 is sold, per the company's 2025 annual results, and it is not the drug under clinical trial.
  • GT20029 is a different Kintor compound, and its published phase 2 result in 180 Chinese men does not apply to pyrilutamide.

What is pyrilutamide, and has anyone approved it?

Pyrilutamide (KX-826) is an investigational topical androgen receptor antagonist for androgenetic alopecia, sponsored by Suzhou Kintor Pharmaceutical. No drug approval was found: openFDA returned no record and DailyMed no label on 10 October 2026.

Pyrilutamide is C21H15F5N4O2S (482.4 g/mol, CAS 1272719-00-2, PubChem CID 50940514), with the synonym KX-826. It is an investigational androgen receptor antagonist for topical use, sponsored by Suzhou Kintor Pharmaceutical in the registered trials.

openFDA Drugs@FDA returned no record for pyrilutamide and DailyMed returned no label, both on 10 October 2026. The company's filings describe China clinical trials and a US phase 2, and a plan for further trials, not an approval.

A cosmetic product is a separate matter. The company's 2025 annual results say its 2025 revenue of RMB32.7 million came mainly from global sales of a cosmetics brand with KX-826 as its main ingredient, so a cosmetic product containing KX-826 is sold and is not the drug under clinical trial.

PubChem: pyrilutamide identity, synonym KX-826

Chemical identity record

National Library of Medicine. PubChem compound record CID 50940514 (pyrilutamide).

Pyrilutamide: PubChem CID 50940514, C21H15F5N4O2S, 482.4 g/mol, CAS 1272719-00-2, synonym KX-826. It is an investigational androgen receptor antagonist for topical use, sponsored by Suzhou Kintor Pharmaceutical in the registered trials.

Participants / model
Chemical identity, not a clinical population
Treatment
Defined molecule
Follow-up
Not applicable
Study design
NLM chemical record
Funding
not stated in the source

Identity record only; it says nothing about efficacy or safety.

Read the original source
Drugs@FDA and DailyMed, 10 October 2026: no record or label for pyrilutamide

Regulatory record

U.S. Food and Drug Administration, openFDA Drugs@FDA, and DailyMed, U.S. National Library of Medicine: searches run on 10 October 2026 for pyrilutamide.

openFDA Drugs@FDA returned no record for pyrilutamide and DailyMed returned no label, both on 10 October 2026. The company's filings describe China clinical trials and a US phase 2, and a plan for further trials, not an approval.

Participants / model
Not a clinical population
Treatment
Drug applications and labels
Follow-up
Searches run on 10 October 2026
Study design
FDA record searches
Funding
not stated in the source

The absence of a record is a US-scoped statement. Approvals outside the United States are not covered.

Read the original source
Company statement, 30 March 2026: phase II/III gains over vehicle, open-label studies, cosmetic revenue

Regulatory record

Suzhou Kintor Pharmaceutical. 2025 annual results announcement filed with the Hong Kong Stock Exchange on 30 March 2026.

The company reports a seamless phase II/III trial of KX-826 tincture 0.5% and 1.0% twice daily versus vehicle in Chinese men. The phase II stage (90 patients) reported hair-count gains from baseline of 22.39 (0.5%), 21.87 (1.0%) and 8.73 (placebo) hairs per cm2, differences from placebo of 13.66 (P = 0.002) and 13.14 (P = 0.004). The phase III stage (666 patients), announced on 18 March 2026, reported gains of 14.46 (0.5%), 15.33 (1.0%) and 4.68 (placebo) hairs per cm2, differences from placebo of 9.78 and 10.65 (both P < 0.0001). The company reports no drug-related serious adverse events and adverse event rates not clinically different from placebo. The registry entry for this program (NCT06622824) still reads not yet recruiting with a 2024 update, so it does not match the company statements. In a 52-week open-label long-term safety study at 16 China centers (0.5% tincture), the company reports a low overall adverse event rate, no deaths and no drug-related sexual dysfunction adverse reactions, with target-area hair count up from baseline (P < 0.0001), 46% of patients gaining at least 10 hairs per cm2 and 20% gaining at least 20. In an open-label randomized study in 75 men (40 on KX-826 0.5% plus minoxidil 5%, 35 on minoxidil 5% alone), the company reports a 30.54 hairs per cm2 gain with the combination, 10.29 more than minoxidil alone (P = 0.0075). The results also say the group's 2025 revenue of RMB32.7 million came mainly from global sales of a cosmetics brand with KX-826 as its main ingredient, so a cosmetic product containing KX-826 is sold and is not the drug under clinical trial.

Participants / model
Chinese adult men with AGA (90 in the phase II stage, 666 in the phase III stage); Chinese men and women (long-term study); 75 men (combination study)
Treatment
Topical KX-826 tincture 0.5% or 1.0% twice daily versus vehicle; 0.5% tincture in the long-term study; KX-826 0.5% plus minoxidil 5% versus minoxidil 5% alone
Follow-up
24 weeks (phase II/III); 52 weeks (long-term study)
Study design
Company annual results filing (sponsor's own account), not peer reviewed
Funding
not stated in the source

This is a secondary company document, and the figures are unpublished. The long-term and combination studies are open-label, small and unpublished.

Read the original source

What has been reported from studies in people?

No peer-reviewed report of a human trial of pyrilutamide was found. The registered phase 1 and phase 2 studies have no posted results, and every efficacy figure comes from company filings.

Two phase 1 studies were registered and completed, each with 40 healthy men with androgenetic alopecia: single ascending dose (NCT04984707) and multiple ascending dose (NCT04502901, primary outcomes were treatment-emergent adverse events, 19 days). Neither has posted results. Registered studies without posted results are not evidence of safety or pharmacokinetics.

A phase 2 trial of KX-826 in 123 men with AGA in the United States (NCT05218642; 2.5 mg twice daily, 5 mg once daily, 5 mg twice daily, or placebo for 24 weeks; primary outcome change in target area hair count) completed on 13 February 2023 with no results posted. The company's filing says only that the 24-week results compared with baseline were statistically and clinically meaningful, with a favorable safety profile. Change from baseline without a placebo comparison is not evidence of efficacy. A separate China phase 2 in 120 men (NCT05940506) and a phase 2 in 160 Chinese women (NCT06409650) are registered as completed with no results posted.

A PubMed search on 10 October 2026 for pyrilutamide or KX-826 returned 3 records: two narrative reviews and a 2026 medicinal chemistry paper that uses pyrilutamide as a comparator in a mouse hair-growth model. None reports a human trial of pyrilutamide. ClinicalTrials.gov returned 7 records for KX-826, and none has posted results.

Two phase 1 studies, 40 men each: no results posted

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT04502901.

Two phase 1 studies were registered and completed, each with 40 healthy men with androgenetic alopecia: single ascending dose (NCT04984707) and multiple ascending dose (NCT04502901, primary outcomes were treatment-emergent adverse events, 19 days). Neither has posted results. Registered studies without posted results are not evidence of safety or pharmacokinetics.

Participants / model
40 healthy men with androgenetic alopecia per study
Treatment
Topical KX-826, single and multiple ascending doses
Follow-up
19 days in the multiple ascending dose study
Study design
Phase 1 registry records, no posted results
Funding
not stated in the source

No results were posted, so these records show that the studies were run, not what they found.

Read the original source
US phase 2, 123 men: completed 2023, no results posted

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT05218642.

A phase 2 trial of KX-826 in 123 men with AGA in the United States (NCT05218642; 2.5 mg twice daily, 5 mg once daily, 5 mg twice daily, or placebo for 24 weeks; primary outcome change in target area hair count) completed on 13 February 2023 with no results posted. The company's filing says only that the 24-week results compared with baseline were statistically and clinically meaningful, with a favorable safety profile. Change from baseline without a placebo comparison is not evidence of efficacy. A separate China phase 2 in 120 men (NCT05940506) and a phase 2 in 160 Chinese women (NCT06409650) are registered as completed with no results posted.

Participants / model
123 men (United States); 120 men (China); 160 women (China)
Treatment
Topical KX-826 tincture, 2.5 to 5 mg once or twice daily, versus placebo in the US trial
Follow-up
24 weeks
Study design
Trial registry records, with a company statement on the US trial
Funding
not stated in the source

The company statement compares with baseline only. It is not a placebo-controlled result and it is not peer reviewed.

Read the original source
PubMed, 10 October 2026: 3 records, no human trial report; ClinicalTrials.gov: 7 KX-826 records, none with results

PubMed search record

PubMed search run on 10 October 2026: pyrilutamide[tiab] OR KX-826[tiab] OR KX826[tiab] OR "KX 826"[tiab] (3 records). ClinicalTrials.gov search for KX-826 run on 10 October 2026 (7 records).

The PubMed search returned 3 records: two narrative reviews and a 2026 medicinal chemistry paper on soft-drug androgen receptor antagonists that uses pyrilutamide as a comparator in a mouse hair-growth model. None reports a human trial of pyrilutamide. All efficacy numbers for pyrilutamide on this page therefore come from company filings. ClinicalTrials.gov returned 7 records for KX-826 (the registrations described here, plus NCT06622824), and none has posted results.

Participants / model
Records reviewed, not a population
Treatment
Not applicable
Follow-up
Searches run on 10 October 2026
Study design
Literature and registry search
Funding
not stated in the source

A search result shows what PubMed and the registry returned on that date. It is not proof that no unindexed study exists.

Read the original source

What did the 2023 phase III in Chinese men report?

The company reported that hair counts rose from baseline at 24 weeks (P < 0.0001), but that the improvement over placebo at every visit was not statistically significant, only a trend. The company reported no serious adverse events.

On 27 November 2023 the company announced topline results of its phase III trial of KX-826 0.5% twice daily in Chinese men with androgenetic alopecia. The company reported that hair counts rose from baseline at 24 weeks (P < 0.0001), but compared with placebo the improvement at every visit was not statistically significant, only a trend. No serious adverse events were reported. The registry lists the primary outcome as the change from baseline in comparison to placebo, and the company said the placebo comparison was not significant.

This is the company's own account and is not peer reviewed. The trial is probably the one registered as NCT06126965 (same phase, population, twice-daily dosing and 24-week hair count endpoint; 740 enrolled, status unknown), but the registry lists the dose as 5% where the filing says 0.5% and its dates do not line up with the announcement, so the match is an inference.

Company statement, 27 November 2023: phase III rose from baseline but not significantly versus placebo

Regulatory record

Suzhou Kintor Pharmaceutical. Announcement filed with the Hong Kong Stock Exchange on 27 November 2023: topline results of the phase III trial of KX-826 in Chinese men with androgenetic alopecia.

The company reported that hair counts rose from baseline at 24 weeks (P < 0.0001), but compared with placebo the improvement at every visit was not statistically significant, only a trend. No serious adverse events were reported. The registry lists the primary outcome as the change from baseline in comparison to placebo, and the company said the placebo comparison was not significant.

Participants / model
Chinese adult men with androgenetic alopecia
Treatment
Topical KX-826 0.5% twice daily versus placebo
Follow-up
24 weeks
Study design
Company announcement (sponsor's own account), not peer reviewed
Funding
not stated in the source

This is the company's own account. The trial is probably the one registered as NCT06126965 (same phase, population, twice-daily dosing and 24-week hair count endpoint; 740 enrolled, status unknown), but the registry lists the dose as 5% where the filing says 0.5% and its dates do not line up with the announcement, so the match is an inference.

Read the original source

What did the company report from its later program?

The company reported that a seamless phase II/III trial in Chinese men separated from vehicle: differences from placebo of 13.66 and 13.14 hairs per cm2 in the phase II stage (90 patients) and 9.78 and 10.65 in the phase III stage (666 patients). These are unpublished company statements, and the registry entry does not match them.

The company's 2025 annual results, filed on 30 March 2026, report a seamless phase II/III trial of KX-826 tincture 0.5% and 1.0% twice daily versus vehicle in Chinese men. The phase II stage (90 patients) reported hair-count gains from baseline of 22.39 (0.5%), 21.87 (1.0%) and 8.73 (placebo) hairs per cm2, with differences from placebo of 13.66 (P = 0.002) and 13.14 (P = 0.004). The phase III stage (666 patients), announced on 18 March 2026, reported gains of 14.46 (0.5%), 15.33 (1.0%) and 4.68 (placebo) hairs per cm2, with differences from placebo of 9.78 and 10.65 (both P < 0.0001). The company reports no drug-related serious adverse events and adverse event rates not clinically different from placebo.

The registry entry for this program (NCT06622824) still reads not yet recruiting with a 2024 update, so it does not match the company statements.

The company also reports two open-label studies. In a 52-week long-term safety study at 16 China centers (0.5% tincture), it reports a low overall adverse event rate, no deaths and no drug-related sexual dysfunction adverse reactions, with target-area hair count up from baseline (P < 0.0001), 46% of patients gaining at least 10 hairs per cm2 and 20% gaining at least 20. In an open-label randomized study in 75 men (40 on KX-826 0.5% plus minoxidil 5%, 35 on minoxidil 5% alone), it reports a 30.54 hairs per cm2 gain with the combination, 10.29 more than minoxidil alone (P = 0.0075). Both studies are open-label, small and unpublished.

Company statement, 30 March 2026: phase II/III gains over vehicle, open-label studies, cosmetic revenue

Regulatory record

Suzhou Kintor Pharmaceutical. 2025 annual results announcement filed with the Hong Kong Stock Exchange on 30 March 2026.

The company reports a seamless phase II/III trial of KX-826 tincture 0.5% and 1.0% twice daily versus vehicle in Chinese men. The phase II stage (90 patients) reported hair-count gains from baseline of 22.39 (0.5%), 21.87 (1.0%) and 8.73 (placebo) hairs per cm2, differences from placebo of 13.66 (P = 0.002) and 13.14 (P = 0.004). The phase III stage (666 patients), announced on 18 March 2026, reported gains of 14.46 (0.5%), 15.33 (1.0%) and 4.68 (placebo) hairs per cm2, differences from placebo of 9.78 and 10.65 (both P < 0.0001). The company reports no drug-related serious adverse events and adverse event rates not clinically different from placebo. The registry entry for this program (NCT06622824) still reads not yet recruiting with a 2024 update, so it does not match the company statements. In a 52-week open-label long-term safety study at 16 China centers (0.5% tincture), the company reports a low overall adverse event rate, no deaths and no drug-related sexual dysfunction adverse reactions, with target-area hair count up from baseline (P < 0.0001), 46% of patients gaining at least 10 hairs per cm2 and 20% gaining at least 20. In an open-label randomized study in 75 men (40 on KX-826 0.5% plus minoxidil 5%, 35 on minoxidil 5% alone), the company reports a 30.54 hairs per cm2 gain with the combination, 10.29 more than minoxidil alone (P = 0.0075). The results also say the group's 2025 revenue of RMB32.7 million came mainly from global sales of a cosmetics brand with KX-826 as its main ingredient, so a cosmetic product containing KX-826 is sold and is not the drug under clinical trial.

Participants / model
Chinese adult men with AGA (90 in the phase II stage, 666 in the phase III stage); Chinese men and women (long-term study); 75 men (combination study)
Treatment
Topical KX-826 tincture 0.5% or 1.0% twice daily versus vehicle; 0.5% tincture in the long-term study; KX-826 0.5% plus minoxidil 5% versus minoxidil 5% alone
Follow-up
24 weeks (phase II/III); 52 weeks (long-term study)
Study design
Company annual results filing (sponsor's own account), not peer reviewed
Funding
not stated in the source

This is a secondary company document, and the figures are unpublished. The long-term and combination studies are open-label, small and unpublished.

Read the original source

Does the GT20029 trial apply to pyrilutamide?

No. GT20029 is a different Kintor compound, an androgen receptor degrader, so its published phase 2 result cannot be attributed to pyrilutamide.

GT20029 is a different Kintor compound and not pyrilutamide. Its phase 2 in 180 Chinese men (0.5% or 1.0% gel, once daily or twice weekly, 12 weeks) found significant hair-count gains over placebo in 2 of the 4 active groups (P = 0.032 and P = 0.023), with similar and mostly mild adverse events. The authors are company-affiliated. A 2023 review lists both compounds as topical androgen receptor antagonists under study, which is a pipeline description, not a shared result.

GT20029, a different compound: 180 Chinese men, gains over placebo in 2 of 4 active groups

Randomized controlled trial

Hu R et al. J Dermatolog Treat. 2025;36(1):2574304. PMID 41328006.

GT20029 is a different Kintor compound (an androgen receptor degrader) and not pyrilutamide. Its phase 2 in 180 Chinese men found significant hair-count gains over placebo in 2 of the 4 active groups (P = 0.032 and P = 0.023), with similar and mostly mild adverse events.

Participants / model
180 Chinese men with androgenetic alopecia
Treatment
Topical GT20029 gel 0.5% or 1.0%, once daily or twice weekly, or placebo
Follow-up
12 weeks
Study design
Randomized placebo-controlled trial of a different compound, company-affiliated authors
Funding
not stated in the source

A trial of GT20029 must not be attributed to pyrilutamide.

Read the original source
Narrative reviews: pyrilutamide investigational, clinical data early and heterogeneous

Human study

Burshtein J et al. Front Pharmacol. 2026;17:1776134. PMID 41919230.

A 2023 review lists pyrilutamide and GT20029 as topical androgen receptor antagonists under study, and a 2026 review calls pyrilutamide an investigational option that gives targeted androgen receptor modulation without systemic hormonal suppression, adding that clinical data are early and heterogeneous. Neither abstract gives pyrilutamide trial numbers.

Participants / model
Reviews of androgenetic alopecia therapy
Treatment
Not drug-specific
Follow-up
Not applicable
Study design
Narrative reviews
Funding
not stated in the source

These are pipeline descriptions, not trial reports.

Read the original source

Do the data show strong efficacy and good tolerability for pyrilutamide?

Partly. Experimental is accurate. Strong efficacy is not shown: the company reported that its 2023 phase III showed no significant difference from placebo, and the favorable numbers are unpublished company statements. Good tolerability rests on company reports with no independent data.

Sellers describe pyrilutamide (KX-826) as an experimental topical treatment for androgenetic alopecia with strong early efficacy and good tolerability. Experimental is accurate: no approval was found, and the compound is in trials.

Strong efficacy is not shown. The company reported that its 2023 phase III in Chinese men did not separate from placebo at any visit. The later phase II/III figures, a placebo difference of about 10 hairs per cm2 in the 666-patient phase III stage, are unpublished company statements, and no registry record has posted results.

Good tolerability rests on company reports of no drug-related serious adverse events and no drug-related sexual dysfunction adverse reactions. No independent safety data were found, and no human trial has been published in a peer-reviewed journal.

Company statement, 27 November 2023: phase III rose from baseline but not significantly versus placebo

Regulatory record

Suzhou Kintor Pharmaceutical. Announcement filed with the Hong Kong Stock Exchange on 27 November 2023: topline results of the phase III trial of KX-826 in Chinese men with androgenetic alopecia.

The company reported that hair counts rose from baseline at 24 weeks (P < 0.0001), but compared with placebo the improvement at every visit was not statistically significant, only a trend. No serious adverse events were reported. The registry lists the primary outcome as the change from baseline in comparison to placebo, and the company said the placebo comparison was not significant.

Participants / model
Chinese adult men with androgenetic alopecia
Treatment
Topical KX-826 0.5% twice daily versus placebo
Follow-up
24 weeks
Study design
Company announcement (sponsor's own account), not peer reviewed
Funding
not stated in the source

This is the company's own account. The trial is probably the one registered as NCT06126965 (same phase, population, twice-daily dosing and 24-week hair count endpoint; 740 enrolled, status unknown), but the registry lists the dose as 5% where the filing says 0.5% and its dates do not line up with the announcement, so the match is an inference.

Read the original source
Company statement, 30 March 2026: phase II/III gains over vehicle, open-label studies, cosmetic revenue

Regulatory record

Suzhou Kintor Pharmaceutical. 2025 annual results announcement filed with the Hong Kong Stock Exchange on 30 March 2026.

The company reports a seamless phase II/III trial of KX-826 tincture 0.5% and 1.0% twice daily versus vehicle in Chinese men. The phase II stage (90 patients) reported hair-count gains from baseline of 22.39 (0.5%), 21.87 (1.0%) and 8.73 (placebo) hairs per cm2, differences from placebo of 13.66 (P = 0.002) and 13.14 (P = 0.004). The phase III stage (666 patients), announced on 18 March 2026, reported gains of 14.46 (0.5%), 15.33 (1.0%) and 4.68 (placebo) hairs per cm2, differences from placebo of 9.78 and 10.65 (both P < 0.0001). The company reports no drug-related serious adverse events and adverse event rates not clinically different from placebo. The registry entry for this program (NCT06622824) still reads not yet recruiting with a 2024 update, so it does not match the company statements. In a 52-week open-label long-term safety study at 16 China centers (0.5% tincture), the company reports a low overall adverse event rate, no deaths and no drug-related sexual dysfunction adverse reactions, with target-area hair count up from baseline (P < 0.0001), 46% of patients gaining at least 10 hairs per cm2 and 20% gaining at least 20. In an open-label randomized study in 75 men (40 on KX-826 0.5% plus minoxidil 5%, 35 on minoxidil 5% alone), the company reports a 30.54 hairs per cm2 gain with the combination, 10.29 more than minoxidil alone (P = 0.0075). The results also say the group's 2025 revenue of RMB32.7 million came mainly from global sales of a cosmetics brand with KX-826 as its main ingredient, so a cosmetic product containing KX-826 is sold and is not the drug under clinical trial.

Participants / model
Chinese adult men with AGA (90 in the phase II stage, 666 in the phase III stage); Chinese men and women (long-term study); 75 men (combination study)
Treatment
Topical KX-826 tincture 0.5% or 1.0% twice daily versus vehicle; 0.5% tincture in the long-term study; KX-826 0.5% plus minoxidil 5% versus minoxidil 5% alone
Follow-up
24 weeks (phase II/III); 52 weeks (long-term study)
Study design
Company annual results filing (sponsor's own account), not peer reviewed
Funding
not stated in the source

This is a secondary company document, and the figures are unpublished. The long-term and combination studies are open-label, small and unpublished.

Read the original source
PubMed, 10 October 2026: 3 records, no human trial report; ClinicalTrials.gov: 7 KX-826 records, none with results

PubMed search record

PubMed search run on 10 October 2026: pyrilutamide[tiab] OR KX-826[tiab] OR KX826[tiab] OR "KX 826"[tiab] (3 records). ClinicalTrials.gov search for KX-826 run on 10 October 2026 (7 records).

The PubMed search returned 3 records: two narrative reviews and a 2026 medicinal chemistry paper on soft-drug androgen receptor antagonists that uses pyrilutamide as a comparator in a mouse hair-growth model. None reports a human trial of pyrilutamide. All efficacy numbers for pyrilutamide on this page therefore come from company filings. ClinicalTrials.gov returned 7 records for KX-826 (the registrations described here, plus NCT06622824), and none has posted results.

Participants / model
Records reviewed, not a population
Treatment
Not applicable
Follow-up
Searches run on 10 October 2026
Study design
Literature and registry search
Funding
not stated in the source

A search result shows what PubMed and the registry returned on that date. It is not proof that no unindexed study exists.

Read the original source

How does pyrilutamide work, and is its exposure known?

Pyrilutamide is an investigational androgen receptor antagonist applied to the scalp, which a 2026 review describes as aiming for targeted modulation without systemic hormonal suppression. No pharmacokinetic or systemic exposure numbers were found in a primary source.

Pyrilutamide is an investigational androgen receptor antagonist for topical use. A 2026 review calls it an investigational option that gives targeted androgen receptor modulation without systemic hormonal suppression, and adds that clinical data are early and heterogeneous. That is a description of the intended design, not a measured result.

No pharmacokinetic or systemic exposure numbers were found in a primary source. The registered phase 1 single and multiple ascending dose studies, each with 40 men, have no posted results, so what they measured is not public.

PubChem: pyrilutamide identity, synonym KX-826

Chemical identity record

National Library of Medicine. PubChem compound record CID 50940514 (pyrilutamide).

Pyrilutamide: PubChem CID 50940514, C21H15F5N4O2S, 482.4 g/mol, CAS 1272719-00-2, synonym KX-826. It is an investigational androgen receptor antagonist for topical use, sponsored by Suzhou Kintor Pharmaceutical in the registered trials.

Participants / model
Chemical identity, not a clinical population
Treatment
Defined molecule
Follow-up
Not applicable
Study design
NLM chemical record
Funding
not stated in the source

Identity record only; it says nothing about efficacy or safety.

Read the original source
Narrative reviews: pyrilutamide investigational, clinical data early and heterogeneous

Human study

Burshtein J et al. Front Pharmacol. 2026;17:1776134. PMID 41919230.

A 2023 review lists pyrilutamide and GT20029 as topical androgen receptor antagonists under study, and a 2026 review calls pyrilutamide an investigational option that gives targeted androgen receptor modulation without systemic hormonal suppression, adding that clinical data are early and heterogeneous. Neither abstract gives pyrilutamide trial numbers.

Participants / model
Reviews of androgenetic alopecia therapy
Treatment
Not drug-specific
Follow-up
Not applicable
Study design
Narrative reviews
Funding
not stated in the source

These are pipeline descriptions, not trial reports.

Read the original source
Two phase 1 studies, 40 men each: no results posted

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT04502901.

Two phase 1 studies were registered and completed, each with 40 healthy men with androgenetic alopecia: single ascending dose (NCT04984707) and multiple ascending dose (NCT04502901, primary outcomes were treatment-emergent adverse events, 19 days). Neither has posted results. Registered studies without posted results are not evidence of safety or pharmacokinetics.

Participants / model
40 healthy men with androgenetic alopecia per study
Treatment
Topical KX-826, single and multiple ascending doses
Follow-up
19 days in the multiple ascending dose study
Study design
Phase 1 registry records, no posted results
Funding
not stated in the source

No results were posted, so these records show that the studies were run, not what they found.

Read the original source
PubMed, 10 October 2026: 3 records, no human trial report; ClinicalTrials.gov: 7 KX-826 records, none with results

PubMed search record

PubMed search run on 10 October 2026: pyrilutamide[tiab] OR KX-826[tiab] OR KX826[tiab] OR "KX 826"[tiab] (3 records). ClinicalTrials.gov search for KX-826 run on 10 October 2026 (7 records).

The PubMed search returned 3 records: two narrative reviews and a 2026 medicinal chemistry paper on soft-drug androgen receptor antagonists that uses pyrilutamide as a comparator in a mouse hair-growth model. None reports a human trial of pyrilutamide. All efficacy numbers for pyrilutamide on this page therefore come from company filings. ClinicalTrials.gov returned 7 records for KX-826 (the registrations described here, plus NCT06622824), and none has posted results.

Participants / model
Records reviewed, not a population
Treatment
Not applicable
Follow-up
Searches run on 10 October 2026
Study design
Literature and registry search
Funding
not stated in the source

A search result shows what PubMed and the registry returned on that date. It is not proof that no unindexed study exists.

Read the original source

What risks and side effects have been reported?

Only the company has reported adverse events: no serious adverse events in the 2023 phase III, no drug-related serious adverse events in the later program, and no drug-related sexual dysfunction adverse reactions in a 52-week open-label study. No independent safety data were found, and the phase 1 safety studies have no posted results.

The company reported no serious adverse events in its 2023 phase III, and no drug-related serious adverse events and adverse event rates not clinically different from placebo in its later phase II/III program. In a 52-week open-label study at 16 China centers it reported a low overall adverse event rate, no deaths and no drug-related sexual dysfunction adverse reactions. These are unpublished company statements.

The two registered phase 1 studies, whose primary outcomes were treatment-emergent adverse events, have no posted results. Adverse event reports for GT20029 do not apply to pyrilutamide, which is a different compound. A cosmetic product containing KX-826 is sold and is not the drug under clinical trial, so its use is not covered by these reports.

Company statement, 27 November 2023: phase III rose from baseline but not significantly versus placebo

Regulatory record

Suzhou Kintor Pharmaceutical. Announcement filed with the Hong Kong Stock Exchange on 27 November 2023: topline results of the phase III trial of KX-826 in Chinese men with androgenetic alopecia.

The company reported that hair counts rose from baseline at 24 weeks (P < 0.0001), but compared with placebo the improvement at every visit was not statistically significant, only a trend. No serious adverse events were reported. The registry lists the primary outcome as the change from baseline in comparison to placebo, and the company said the placebo comparison was not significant.

Participants / model
Chinese adult men with androgenetic alopecia
Treatment
Topical KX-826 0.5% twice daily versus placebo
Follow-up
24 weeks
Study design
Company announcement (sponsor's own account), not peer reviewed
Funding
not stated in the source

This is the company's own account. The trial is probably the one registered as NCT06126965 (same phase, population, twice-daily dosing and 24-week hair count endpoint; 740 enrolled, status unknown), but the registry lists the dose as 5% where the filing says 0.5% and its dates do not line up with the announcement, so the match is an inference.

Read the original source
Company statement, 30 March 2026: phase II/III gains over vehicle, open-label studies, cosmetic revenue

Regulatory record

Suzhou Kintor Pharmaceutical. 2025 annual results announcement filed with the Hong Kong Stock Exchange on 30 March 2026.

The company reports a seamless phase II/III trial of KX-826 tincture 0.5% and 1.0% twice daily versus vehicle in Chinese men. The phase II stage (90 patients) reported hair-count gains from baseline of 22.39 (0.5%), 21.87 (1.0%) and 8.73 (placebo) hairs per cm2, differences from placebo of 13.66 (P = 0.002) and 13.14 (P = 0.004). The phase III stage (666 patients), announced on 18 March 2026, reported gains of 14.46 (0.5%), 15.33 (1.0%) and 4.68 (placebo) hairs per cm2, differences from placebo of 9.78 and 10.65 (both P < 0.0001). The company reports no drug-related serious adverse events and adverse event rates not clinically different from placebo. The registry entry for this program (NCT06622824) still reads not yet recruiting with a 2024 update, so it does not match the company statements. In a 52-week open-label long-term safety study at 16 China centers (0.5% tincture), the company reports a low overall adverse event rate, no deaths and no drug-related sexual dysfunction adverse reactions, with target-area hair count up from baseline (P < 0.0001), 46% of patients gaining at least 10 hairs per cm2 and 20% gaining at least 20. In an open-label randomized study in 75 men (40 on KX-826 0.5% plus minoxidil 5%, 35 on minoxidil 5% alone), the company reports a 30.54 hairs per cm2 gain with the combination, 10.29 more than minoxidil alone (P = 0.0075). The results also say the group's 2025 revenue of RMB32.7 million came mainly from global sales of a cosmetics brand with KX-826 as its main ingredient, so a cosmetic product containing KX-826 is sold and is not the drug under clinical trial.

Participants / model
Chinese adult men with AGA (90 in the phase II stage, 666 in the phase III stage); Chinese men and women (long-term study); 75 men (combination study)
Treatment
Topical KX-826 tincture 0.5% or 1.0% twice daily versus vehicle; 0.5% tincture in the long-term study; KX-826 0.5% plus minoxidil 5% versus minoxidil 5% alone
Follow-up
24 weeks (phase II/III); 52 weeks (long-term study)
Study design
Company annual results filing (sponsor's own account), not peer reviewed
Funding
not stated in the source

This is a secondary company document, and the figures are unpublished. The long-term and combination studies are open-label, small and unpublished.

Read the original source
Two phase 1 studies, 40 men each: no results posted

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT04502901.

Two phase 1 studies were registered and completed, each with 40 healthy men with androgenetic alopecia: single ascending dose (NCT04984707) and multiple ascending dose (NCT04502901, primary outcomes were treatment-emergent adverse events, 19 days). Neither has posted results. Registered studies without posted results are not evidence of safety or pharmacokinetics.

Participants / model
40 healthy men with androgenetic alopecia per study
Treatment
Topical KX-826, single and multiple ascending doses
Follow-up
19 days in the multiple ascending dose study
Study design
Phase 1 registry records, no posted results
Funding
not stated in the source

No results were posted, so these records show that the studies were run, not what they found.

Read the original source
GT20029, a different compound: 180 Chinese men, gains over placebo in 2 of 4 active groups

Randomized controlled trial

Hu R et al. J Dermatolog Treat. 2025;36(1):2574304. PMID 41328006.

GT20029 is a different Kintor compound (an androgen receptor degrader) and not pyrilutamide. Its phase 2 in 180 Chinese men found significant hair-count gains over placebo in 2 of the 4 active groups (P = 0.032 and P = 0.023), with similar and mostly mild adverse events.

Participants / model
180 Chinese men with androgenetic alopecia
Treatment
Topical GT20029 gel 0.5% or 1.0%, once daily or twice weekly, or placebo
Follow-up
12 weeks
Study design
Randomized placebo-controlled trial of a different compound, company-affiliated authors
Funding
not stated in the source

A trial of GT20029 must not be attributed to pyrilutamide.

Read the original source

Why does pyrilutamide sit in C tier?

C fits a plausible topical mechanism and several human studies, but every efficacy figure is a company statement, no human trial is published, and no registry record has posted results. The company reported that its 2023 phase III did not beat placebo.

The mechanism is plausible, and several human trials exist. One of them, per the company, separated from vehicle by about 10 hairs per cm2 at 24 weeks in 666 Chinese men. But every efficacy figure is a company statement, no human trial has been published in a peer-reviewed journal, no registry record has posted results, and the compound is not approved anywhere found.

The company reported that its 2023 phase III did not beat placebo, and the later favorable results are unpublished. No filing or approval decision is documented in the sources reviewed.

Company statement, 27 November 2023: phase III rose from baseline but not significantly versus placebo

Regulatory record

Suzhou Kintor Pharmaceutical. Announcement filed with the Hong Kong Stock Exchange on 27 November 2023: topline results of the phase III trial of KX-826 in Chinese men with androgenetic alopecia.

The company reported that hair counts rose from baseline at 24 weeks (P < 0.0001), but compared with placebo the improvement at every visit was not statistically significant, only a trend. No serious adverse events were reported. The registry lists the primary outcome as the change from baseline in comparison to placebo, and the company said the placebo comparison was not significant.

Participants / model
Chinese adult men with androgenetic alopecia
Treatment
Topical KX-826 0.5% twice daily versus placebo
Follow-up
24 weeks
Study design
Company announcement (sponsor's own account), not peer reviewed
Funding
not stated in the source

This is the company's own account. The trial is probably the one registered as NCT06126965 (same phase, population, twice-daily dosing and 24-week hair count endpoint; 740 enrolled, status unknown), but the registry lists the dose as 5% where the filing says 0.5% and its dates do not line up with the announcement, so the match is an inference.

Read the original source
Company statement, 30 March 2026: phase II/III gains over vehicle, open-label studies, cosmetic revenue

Regulatory record

Suzhou Kintor Pharmaceutical. 2025 annual results announcement filed with the Hong Kong Stock Exchange on 30 March 2026.

The company reports a seamless phase II/III trial of KX-826 tincture 0.5% and 1.0% twice daily versus vehicle in Chinese men. The phase II stage (90 patients) reported hair-count gains from baseline of 22.39 (0.5%), 21.87 (1.0%) and 8.73 (placebo) hairs per cm2, differences from placebo of 13.66 (P = 0.002) and 13.14 (P = 0.004). The phase III stage (666 patients), announced on 18 March 2026, reported gains of 14.46 (0.5%), 15.33 (1.0%) and 4.68 (placebo) hairs per cm2, differences from placebo of 9.78 and 10.65 (both P < 0.0001). The company reports no drug-related serious adverse events and adverse event rates not clinically different from placebo. The registry entry for this program (NCT06622824) still reads not yet recruiting with a 2024 update, so it does not match the company statements. In a 52-week open-label long-term safety study at 16 China centers (0.5% tincture), the company reports a low overall adverse event rate, no deaths and no drug-related sexual dysfunction adverse reactions, with target-area hair count up from baseline (P < 0.0001), 46% of patients gaining at least 10 hairs per cm2 and 20% gaining at least 20. In an open-label randomized study in 75 men (40 on KX-826 0.5% plus minoxidil 5%, 35 on minoxidil 5% alone), the company reports a 30.54 hairs per cm2 gain with the combination, 10.29 more than minoxidil alone (P = 0.0075). The results also say the group's 2025 revenue of RMB32.7 million came mainly from global sales of a cosmetics brand with KX-826 as its main ingredient, so a cosmetic product containing KX-826 is sold and is not the drug under clinical trial.

Participants / model
Chinese adult men with AGA (90 in the phase II stage, 666 in the phase III stage); Chinese men and women (long-term study); 75 men (combination study)
Treatment
Topical KX-826 tincture 0.5% or 1.0% twice daily versus vehicle; 0.5% tincture in the long-term study; KX-826 0.5% plus minoxidil 5% versus minoxidil 5% alone
Follow-up
24 weeks (phase II/III); 52 weeks (long-term study)
Study design
Company annual results filing (sponsor's own account), not peer reviewed
Funding
not stated in the source

This is a secondary company document, and the figures are unpublished. The long-term and combination studies are open-label, small and unpublished.

Read the original source
PubMed, 10 October 2026: 3 records, no human trial report; ClinicalTrials.gov: 7 KX-826 records, none with results

PubMed search record

PubMed search run on 10 October 2026: pyrilutamide[tiab] OR KX-826[tiab] OR KX826[tiab] OR "KX 826"[tiab] (3 records). ClinicalTrials.gov search for KX-826 run on 10 October 2026 (7 records).

The PubMed search returned 3 records: two narrative reviews and a 2026 medicinal chemistry paper on soft-drug androgen receptor antagonists that uses pyrilutamide as a comparator in a mouse hair-growth model. None reports a human trial of pyrilutamide. All efficacy numbers for pyrilutamide on this page therefore come from company filings. ClinicalTrials.gov returned 7 records for KX-826 (the registrations described here, plus NCT06622824), and none has posted results.

Participants / model
Records reviewed, not a population
Treatment
Not applicable
Follow-up
Searches run on 10 October 2026
Study design
Literature and registry search
Funding
not stated in the source

A search result shows what PubMed and the registry returned on that date. It is not proof that no unindexed study exists.

Read the original source
Drugs@FDA and DailyMed, 10 October 2026: no record or label for pyrilutamide

Regulatory record

U.S. Food and Drug Administration, openFDA Drugs@FDA, and DailyMed, U.S. National Library of Medicine: searches run on 10 October 2026 for pyrilutamide.

openFDA Drugs@FDA returned no record for pyrilutamide and DailyMed returned no label, both on 10 October 2026. The company's filings describe China clinical trials and a US phase 2, and a plan for further trials, not an approval.

Participants / model
Not a clinical population
Treatment
Drug applications and labels
Follow-up
Searches run on 10 October 2026
Study design
FDA record searches
Funding
not stated in the source

The absence of a record is a US-scoped statement. Approvals outside the United States are not covered.

Read the original source

Studies and sources

PubChem: pyrilutamide identity, synonym KX-826

Chemical identity record

National Library of Medicine. PubChem compound record CID 50940514 (pyrilutamide).

Pyrilutamide: PubChem CID 50940514, C21H15F5N4O2S, 482.4 g/mol, CAS 1272719-00-2, synonym KX-826. It is an investigational androgen receptor antagonist for topical use, sponsored by Suzhou Kintor Pharmaceutical in the registered trials.

Participants / model
Chemical identity, not a clinical population
Treatment
Defined molecule
Follow-up
Not applicable
Study design
NLM chemical record
Funding
not stated in the source

Identity record only; it says nothing about efficacy or safety.

Read the original source
Drugs@FDA and DailyMed, 10 October 2026: no record or label for pyrilutamide

Regulatory record

U.S. Food and Drug Administration, openFDA Drugs@FDA, and DailyMed, U.S. National Library of Medicine: searches run on 10 October 2026 for pyrilutamide.

openFDA Drugs@FDA returned no record for pyrilutamide and DailyMed returned no label, both on 10 October 2026. The company's filings describe China clinical trials and a US phase 2, and a plan for further trials, not an approval.

Participants / model
Not a clinical population
Treatment
Drug applications and labels
Follow-up
Searches run on 10 October 2026
Study design
FDA record searches
Funding
not stated in the source

The absence of a record is a US-scoped statement. Approvals outside the United States are not covered.

Read the original source
Two phase 1 studies, 40 men each: no results posted

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT04502901.

Two phase 1 studies were registered and completed, each with 40 healthy men with androgenetic alopecia: single ascending dose (NCT04984707) and multiple ascending dose (NCT04502901, primary outcomes were treatment-emergent adverse events, 19 days). Neither has posted results. Registered studies without posted results are not evidence of safety or pharmacokinetics.

Participants / model
40 healthy men with androgenetic alopecia per study
Treatment
Topical KX-826, single and multiple ascending doses
Follow-up
19 days in the multiple ascending dose study
Study design
Phase 1 registry records, no posted results
Funding
not stated in the source

No results were posted, so these records show that the studies were run, not what they found.

Read the original source
US phase 2, 123 men: completed 2023, no results posted

Trial registry record

ClinicalTrials.gov, U.S. National Library of Medicine. Study record NCT05218642.

A phase 2 trial of KX-826 in 123 men with AGA in the United States (NCT05218642; 2.5 mg twice daily, 5 mg once daily, 5 mg twice daily, or placebo for 24 weeks; primary outcome change in target area hair count) completed on 13 February 2023 with no results posted. The company's filing says only that the 24-week results compared with baseline were statistically and clinically meaningful, with a favorable safety profile. Change from baseline without a placebo comparison is not evidence of efficacy. A separate China phase 2 in 120 men (NCT05940506) and a phase 2 in 160 Chinese women (NCT06409650) are registered as completed with no results posted.

Participants / model
123 men (United States); 120 men (China); 160 women (China)
Treatment
Topical KX-826 tincture, 2.5 to 5 mg once or twice daily, versus placebo in the US trial
Follow-up
24 weeks
Study design
Trial registry records, with a company statement on the US trial
Funding
not stated in the source

The company statement compares with baseline only. It is not a placebo-controlled result and it is not peer reviewed.

Read the original source
Company statement, 27 November 2023: phase III rose from baseline but not significantly versus placebo

Regulatory record

Suzhou Kintor Pharmaceutical. Announcement filed with the Hong Kong Stock Exchange on 27 November 2023: topline results of the phase III trial of KX-826 in Chinese men with androgenetic alopecia.

The company reported that hair counts rose from baseline at 24 weeks (P < 0.0001), but compared with placebo the improvement at every visit was not statistically significant, only a trend. No serious adverse events were reported. The registry lists the primary outcome as the change from baseline in comparison to placebo, and the company said the placebo comparison was not significant.

Participants / model
Chinese adult men with androgenetic alopecia
Treatment
Topical KX-826 0.5% twice daily versus placebo
Follow-up
24 weeks
Study design
Company announcement (sponsor's own account), not peer reviewed
Funding
not stated in the source

This is the company's own account. The trial is probably the one registered as NCT06126965 (same phase, population, twice-daily dosing and 24-week hair count endpoint; 740 enrolled, status unknown), but the registry lists the dose as 5% where the filing says 0.5% and its dates do not line up with the announcement, so the match is an inference.

Read the original source
Company statement, 30 March 2026: phase II/III gains over vehicle, open-label studies, cosmetic revenue

Regulatory record

Suzhou Kintor Pharmaceutical. 2025 annual results announcement filed with the Hong Kong Stock Exchange on 30 March 2026.

The company reports a seamless phase II/III trial of KX-826 tincture 0.5% and 1.0% twice daily versus vehicle in Chinese men. The phase II stage (90 patients) reported hair-count gains from baseline of 22.39 (0.5%), 21.87 (1.0%) and 8.73 (placebo) hairs per cm2, differences from placebo of 13.66 (P = 0.002) and 13.14 (P = 0.004). The phase III stage (666 patients), announced on 18 March 2026, reported gains of 14.46 (0.5%), 15.33 (1.0%) and 4.68 (placebo) hairs per cm2, differences from placebo of 9.78 and 10.65 (both P < 0.0001). The company reports no drug-related serious adverse events and adverse event rates not clinically different from placebo. The registry entry for this program (NCT06622824) still reads not yet recruiting with a 2024 update, so it does not match the company statements. In a 52-week open-label long-term safety study at 16 China centers (0.5% tincture), the company reports a low overall adverse event rate, no deaths and no drug-related sexual dysfunction adverse reactions, with target-area hair count up from baseline (P < 0.0001), 46% of patients gaining at least 10 hairs per cm2 and 20% gaining at least 20. In an open-label randomized study in 75 men (40 on KX-826 0.5% plus minoxidil 5%, 35 on minoxidil 5% alone), the company reports a 30.54 hairs per cm2 gain with the combination, 10.29 more than minoxidil alone (P = 0.0075). The results also say the group's 2025 revenue of RMB32.7 million came mainly from global sales of a cosmetics brand with KX-826 as its main ingredient, so a cosmetic product containing KX-826 is sold and is not the drug under clinical trial.

Participants / model
Chinese adult men with AGA (90 in the phase II stage, 666 in the phase III stage); Chinese men and women (long-term study); 75 men (combination study)
Treatment
Topical KX-826 tincture 0.5% or 1.0% twice daily versus vehicle; 0.5% tincture in the long-term study; KX-826 0.5% plus minoxidil 5% versus minoxidil 5% alone
Follow-up
24 weeks (phase II/III); 52 weeks (long-term study)
Study design
Company annual results filing (sponsor's own account), not peer reviewed
Funding
not stated in the source

This is a secondary company document, and the figures are unpublished. The long-term and combination studies are open-label, small and unpublished.

Read the original source
GT20029, a different compound: 180 Chinese men, gains over placebo in 2 of 4 active groups

Randomized controlled trial

Hu R et al. J Dermatolog Treat. 2025;36(1):2574304. PMID 41328006.

GT20029 is a different Kintor compound (an androgen receptor degrader) and not pyrilutamide. Its phase 2 in 180 Chinese men found significant hair-count gains over placebo in 2 of the 4 active groups (P = 0.032 and P = 0.023), with similar and mostly mild adverse events.

Participants / model
180 Chinese men with androgenetic alopecia
Treatment
Topical GT20029 gel 0.5% or 1.0%, once daily or twice weekly, or placebo
Follow-up
12 weeks
Study design
Randomized placebo-controlled trial of a different compound, company-affiliated authors
Funding
not stated in the source

A trial of GT20029 must not be attributed to pyrilutamide.

Read the original source
Narrative reviews: pyrilutamide investigational, clinical data early and heterogeneous

Human study

Burshtein J et al. Front Pharmacol. 2026;17:1776134. PMID 41919230.

A 2023 review lists pyrilutamide and GT20029 as topical androgen receptor antagonists under study, and a 2026 review calls pyrilutamide an investigational option that gives targeted androgen receptor modulation without systemic hormonal suppression, adding that clinical data are early and heterogeneous. Neither abstract gives pyrilutamide trial numbers.

Participants / model
Reviews of androgenetic alopecia therapy
Treatment
Not drug-specific
Follow-up
Not applicable
Study design
Narrative reviews
Funding
not stated in the source

These are pipeline descriptions, not trial reports.

Read the original source

Why is Pyrilutamide in C tier?

C fits a plausible topical mechanism and several human studies, but every efficacy figure is a company statement. No human trial has been published in a peer-reviewed journal, no registry record has posted results, and the company reported that its 2023 phase III did not beat placebo. The later program reports separation from vehicle, but those numbers are unpublished and no approval or filing decision is documented.