Pyrilutamide (KX-826) 1.0% and 0.5%

[jondoeuk]

New data: ''Analysis results of the 90 patients enrolled in the Phase II Stage showed that: regarding efficacy, compared to the placebo group, both 0.5% BID (i.e. twice a day) group and 1.0% BID group demonstrated statistically significant therapeutic efficacy and clinical significance. The target area non-vellus hair counts (“TAHC”) of the 0.5% BID group showed an increase of 22.39 hairs/cm2 from baseline, the TAHC of the 1.0% BID group showed an increase of 21.87 hairs/cm2 from baseline, the TAHC of the placebo group showed an increase of 8.73 hairs/cm2 from baseline. The TAHC of the 0.5% BID group showed an increase of 13.66 hairs/cm2 from placebo group, with statistically significant results (P=0.002). The TAHC of the 1.0% BID group showed an increase of 13.14 hairs/cm2 from placebo group, with statistically significant results (P=0.004).

The hair growth assessment (“HGA”) indicators from investigators of 0.5% BID group and 1.0% BID group both experienced significant improvement from placebo group, with a significant therapeutic effect. The results showed that after the treatment of 24 weeks, compared to the placebo group, the HGA indicator of the 0.5% BID group displayed statistically significant results (P=0.000); compared to the placebo group, the HGA indicator of the 1.0% BID group displayed statistically significant results (P=0.013).

In terms of safety, KX-826 tincture exhibited satisfactory safety and tolerability in the clinical trial, with a low incidence of overall adverse events. No drug-related sexual dysfunction adverse reactions were observed during the entire study period, which indicated an excellent favorable safety profile without observing any new safety signals.'' https://en.kintor.com.cn/news_details/15.html

 

[jondoeuk]

In addition to the ongoing clinical development, pyrilutamide has been introduced to the market as a cosmetic product under the brand name Koshine https://www.koshinemall.com?sca_ref=7290283.HUfjZVF7fCV5W

 

[bulli103]

the new data is fake.......as many people tried different dosages, icluded myself (for over 1 year, different batches)....pyri doesn`t work at all....safe your money

 

[jondoeuk]

the new data is fake.......as many people tried different dosages, icluded myself (for over 1 year, different batches)....pyri doesn`t work at all....safe your money

Different batches? Who did you buy it from?

 

[jondoeuk]

A clinical observational trial found that pyrilutamide plus minoxidil was superior. From it: ''After 24 weeks of treatment, the TAHC of the Combination Drugs Group showed an increase of 30.54 hairs/cm2 from baseline, which was 10.29 hairs/cm2 more than the Minoxidil Group, with statistically significant results (P=0.0075).'' https://en.kintor.com.cn/news_details/10.html

 

[jondoeuk]

Long-term (52-week trial) data. The results demonstrated excellent safety and efficacy. Key highlights:

46% of patients saw a ≥10 hairs/cm2 change in total area hair count (TAHC) from baseline.
20% of patients saw a ≥20 hairs/cm2 change in TAHC.

This trial involved a total of 16 clinical research centers in China and used 0.5% BID (twice per day) https://en.kintor.com.cn/news_details/9.html

 

[jondoeuk]

Good news

''The Pivotal Clinical Trial is a multi-center, randomized, double-blind, vehicle-controlled phase II/III study with adaptive designs to evaluate the efficacy and safety of KX-826 tincture 1.0% and 0.5% for the topical treatment of male adults with Androgenetic Alopecia in China. The Pivotal Clinical Trial adopts a phase II/III operational seamless design, with Professor Jianzhong Zhang and Professor Cheng Zhou from Peking University People’s Hospital serving as the lead principal investigators. The Phase III Stage involved 26 clinical research centers in China and a 24-week treatment period at the prescribed dosages, followed by a 14-day safety observation period. Analysis results of the 666 patients enrolled in the Phase III Stage showed that:

In terms of efficacy: compared to the placebo group, both 1.0% BID (i.e. twice a day) group and 0.5% BID group demonstrated statistically significant therapeutic efficacy and clinical significance. The target area non-vellus hair counts (“TAHC”) of the 1.0% BID group showed an increase of 15.33 hairs/cm 2 from baseline, the TAHC of the 0.5% BID group showed an increase of 14.46 hairs/cm 2 from baseline, and the TAHC of the placebo group showed an increase of 4.68 hairs/cm 2 from baseline. The TAHC of the 1.0% BID group showed an increase of 10.65 hairs/cm 2 from the placebo group, with statistically significant results (P<0.0001). The TAHC of the 0.5% BID group showed an increase of 9.78 hairs/cm 2 from the placebo group, with statistically significant results (P<0.0001).

In terms of safety: both 1.0% BID group and 0.5% BID group exhibited excellent safety and tolerability in the clinical trial, and no drug-related serious adverse events were observed. There were no clinically significant differences in the incidence of adverse events among 1.0% BID group, 0.5% BID group, and the placebo group.

Based on results of previous clinical trials, the Company plans to communicate and initiate the NDA submission for KX-826 1.0% to the drug regulatory authorities in the PRC in the near term.'' https://en.kintor.com.cn/news_details/22.html