Kintor Pharmaceutical Pyrilutamide (KX-826).

Kintor Pharma: KX-826 and GT20029 for Androgenetic Alopecia

My unique submit on Kintor Pharmaceutical (China) has turn into manner too prolonged after so many common updates. So I’ll now add all new developments right here. This quickly shifting nicely funded firm is in Phase 2 and Phase 3 trials within the US and China for each its two androgenetic alopecia (AGA) merchandise.

Kintor (pipeline here) is conducting hair loss trials for:

  • Two separate androgen receptor (AR) focusing on merchandise: a degrader (GT20029) and an antagonist (KX-826 aka Pyrilutamide).
  • Each of those trials is being carried out in each China and the US.
  • Each of those merchandise is being examined for each men and women with androgenetic alopecia (aka sample hair loss).

i.e., a complete of 8 kinds of scientific trials instances 3 phases in every = 24 developments we’ve to trace. A bit an excessive amount of if all of those do find yourself going down, however a most welcome growth. Over one-half of those 24 potential trials are already completed.

  • The GT20029 product is an androgen receptor degrader (AR Degrader). It is developed utilizing Kintor’s proprietary Proteolysis Targeting Chimera (PROTAC) platform. This is the world’s first topical androgen receptor (AR) compound (AR-PROTAC) to enter scientific trials. GT20029 degrades the AR protein by way of the E3 ubiquitin ligase pathway. During preclinical research, GT20029 didn’t trigger any notable unwanted side effects or systemic drug accumulation.
  • Kintor’s major product for treating male sample hair loss is KX-826 (Pyrilutamide) and is an androgen receptor antagonist (AR Antagonist). KX-826 is presently in Phase 3 scientific trials in each China and the US per the pipeline chart. In China, these trials are performed (see my new replace additional beneath).

Note that Cassiopea’s Breezula (Clascoterone) is an AR antagonist that can also be presently in Phase 3 trials within the US. Kintor’s web site has an interesting article discussing each these competing AR antagonist merchandise and hair loss.

Make certain to additionally learn my associated previous submit on destroying the androgen receptor to reverse hair loss.

Phase 3 Trials for KX-826 (Pyrilutamide)

KX-826 (Pyrilutamide) is presently in probably the most superior stage and has an excellent likelihood of coming to market by the tip of 2024. In Kintor’s pipeline web page, it’s proven to be within the closing stage of Phase 3 trials for males in China; and early stage of Phase 3 trials for males within the US. Moreover, it is usually within the early stage of Phase 3 trials for girls in China.

Kintor can also be endeavor a second Phase 3 trial in China for long-term safety of KX-826, which I mentioned intimately in my unique submit. Even extra thrilling, one my Chinese readers despatched me the beneath partial translation of a brand new October 2023 presentation by Kintor. He mentioned he’s not good in English, however I solely modified a few phrases that complicated in what he despatched me.

KX-826 is a topical androgen receptor (AR) antagonist independently developed by Pioneer Pharmaceutical. It is the primary AR antagonist on the earth to enter part III scientific trials for the therapy of hair loss. KX-826 binds the AR by competing with dihydrotestosterone (DHT) to regionally block androgen-mediated signaling to restrict hair follicle miniaturization and promote peripheral hair development. After reaching the circulatory system, KX-826 is quickly metabolized into inactivated metabolites, which has little affect on the entire physique AR signaling pathway and has good security.

The Phase II scientific trial in China included 120 males with hair loss. Of these, 90 topics have been randomly assigned to KX-826 0.25% twice each day, KX-826 0.5% as soon as each day, and KX-826 0.5%, and the remaining 30 topics have been randomly assigned to placebo. After 24 weeks of therapy, the 0.5% focus group of KX-826 confirmed a major enchancment within the quantity of non-vellus hair within the goal space. An enhance of 22.73 roots per sq. centimeter in comparison with baseline.

Finally, information about Phase III: KX-826 is presently in or deliberate for 5 Phase III scientific trials (two in China and three within the United States). Among them, the Chinese Phase III scientific trial of KX-826 for male alopecia has accomplished the final topic go to, and the corporate is making full efforts to advertise the information collation, library un-blinding and knowledge statistical evaluation of this scientific trial.

Phase 2 Trials for GT2009

In Kintor’s August 22, 2023 replace, they introduced the completion of patient enrollment in Phase II scientific trials of GT20029 for male sample hair loss in China. The present pipeline exhibits that these trials are nearly over in China, and near starting within the US.

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