Key facts (as of October 2026)
- No approval was recorded in the sources reviewed. Kintor's most recent announcement we read (18 March 2026) says it plans to start a new drug application in China.
- Every item below is a sponsor press release, not a peer-reviewed paper or a regulatory decision.
- Trial populations in China using a company formulation say nothing about research material sold by a third party.
- Pyrilutamide is not an approved medicine in the UK or EU.
The short version
- The sponsor reports positive results in several trials, all in China, all as press releases.
- A trial that meets its primary endpoint is not an approval. A new drug application had not been filed at the latest date we read.
- Anything newer should be checked on Kintor's news page and with the regulator.
What has been announced, and by whom
All items below are announcements from Kintor Pharmaceutical. They describe results as the sponsor chose to report them and may omit data.
- 1 December 2022. Phase II in female androgenetic alopecia in China, reported as meeting its primary endpoint. A women-only, China-only study of a different population from the compounds sold here.
- 20 March 2025. A long-term safety Phase III over 52 weeks, reported as reaching its primary endpoint, which is the incidence of treatment-emergent adverse events. It ran at 16 centres in China and was open-label with no control group.
- 18 March 2026. The Phase III stage of a pivotal trial of a 1.0% tincture, reported as reaching its primary endpoint. 666 male participants, 26 centres in China, 24 weeks, vehicle controlled. The company states it plans to communicate and initiate a new drug application submission, so no filing or approval was recorded on that date.
For a trial-by-trial breakdown including the US Phase 2, see pyrilutamide clinical trials and the background in What is pyrilutamide?
What this page does not say
- It does not say pyrilutamide works, is safe for use on people, or will be approved.
- It gives no amount, schedule or method of use. Norwood Labs gives none.
- Results from a trial population in China using a company formulation say nothing about any research material sold by a third party.
Evidence gap
No peer-reviewed full publication of the 2026 pivotal trial was available to us. Until one is, the figures above rest on the sponsor's own wording.
Sources
- Kintor Pharmaceutical, “Long-Term Safety Phase III Clinical Trial Of KX-826 For The Treatment Of AGA Reached Primary Endpoint”, 20 March 2025: en.kintor.com.cn/news_details/9.html
- Kintor Pharmaceutical, “Phase III KX-826 Tincture 1.0% For AGA Reached Primary Endpoint”, 18 March 2026: en.kintor.com.cn/news_details/22.html
- Kintor Pharmaceutical, Phase II in female androgenetic alopecia, 1 December 2022: en.kintor.com.cn/news_details/1803365146613362688.html
Research use only
Norwood Labs sells RU-58841 and pyrilutamide (KX-826) as unlicensed research compounds, strictly for laboratory research use. They are not medicines and are not for human consumption.