Kintor Advances With GT20029 Clinical Trials for Hair Loss

A man applying a dropper of topical androgen receptor GT20029 to the crown of his head.

GT20029 is a new topical androgen receptor degrader medication developed by Kintor Pharmaceutical Ltd. for the treatment of pattern hair loss (androgenetic alopecia) and acne vulgaris. GT20029 successfully completed phase I clinical trials in men and women in China and the United States. Phase II clinical trials for this drug are now starting. 

What Is Kintor GT20029?

GT20029 is a topical gel that works as an androgen receptor degrader. This medication is specifically known as a proteolysis-targeting chimera (“PROTAC”) drug. It’s actually the first topical PROTAC drug to ever go through clinical trials.

In a press release, Kintor’s founder, chairman, and CEO, Dr. Tong Youzhi, said that the “major obstacle of PROTAC drugs is oral absorption due to the large molecular weight. Therefore, we developed a topical AR degrader first based on the PROTAC platform.” (1)

How Does GT20029 Work?

GT20029 and other PROTAC drugs work by binding to a protein of interest and causing them to degrade. GT20029 is specifically designed to bind to androgen receptor proteins since androgens are partially responsible for the progression of pattern hair loss and the severity of acne vulgaris. (1)

Each PROTAC molecule is capable of degrading multiple androgen receptor proteins, which means it can be administered effectively at very low dosages, even with infrequent dosing. (1) This makes it unique compared to other androgen receptor blocking medications, from well-established FDA-approved oral finasteride to newer products, like Breezula®, a topical solution being developed by Cosmo Pharmaceuticals.

Can You Use GT20029 for Hair Loss?

Kintor’s GT20029 gel is designed to be used for pattern hair loss. However, phase II clinical trial results will need to be released before it’s possible to know how effective it is for this indication.

However, expectations for this PROTAC drug are high. According to Dr. Tong Youzhi, animal experiments have shown that “the efficacy of GT20029 is superior to other small molecule androgen receptor inhibitors.” (1)

Kintor has stated that its preclinical studies have shown that GT20029 was able to stop the hair follicle miniaturization process that occurs when androgens bind to follicles. This, in turn, prevented hair breakage, thinning, and shedding. GT20029 was also shown to inhibit sebum secretion from the skin’s sebaceous glands. Excess sebum production is another symptom associated with the progression of pattern hair loss. (2,3)

GT20029 Clinical Trial Results (Updated June 2023)

GT20029 received Investigational New Drug clearance from the Chinese Center for Drug Evaluation in April 2021. Shortly after, in July 2021,  it received clearance from the United States Food and Drug Administration. (4)

In November 2022, Kintor announced that phase I trials had been completed after testing GT20029 on over 200 subjects. The goal of these phase I clinical trials was to determine the safety, tolerability, and pharmacokinetics of this drug on healthy men and non-pregnant women. These clinical trials, which were designed as randomized, double-blind, vehicle-controlled, parallel-group dose-escalation studies, tested GT20029 formulated as both a gel and a tincture. (5,6)

Kintor GT20029 Phase II Clinical Trial

Kintor recently started GT20029 phase II clinical trials in China. As of April 2023, they had completed patient enrollment for phase II clinical trials testing the drug on men with androgenetic alopecia. A total of 180 Chinese men will be participating in this 12-week clinical trial. (6)

Kintor has yet to state when GT20029 phase II clinical trials will start in the United States. They have also not stated if there is an intention to perform further tests of this drug on females with acne or androgenetic alopecia.

Is There a Forecasted GT20029 Release Date?

There’s currently no release date forecasted for when you can buy GT20029. The drug still has yet to complete phase II and phase III clinical trials in the United States, so you’ll likely have to wait at least a few more years. If you’re very interested in this hair loss medication, you’re much more likely to obtain GT20029 by joining one of Kintor’s upcoming clinical trials.

If you’re interested in new treatments for pattern hair loss, Kintor is also performing clinical trials on another androgenetic alopecia medication, pyrilutamide (KX-826). This drug is a topical androgen receptor-blocking medication, rather than a topical androgen receptor degrader. Pyrilutamide is in the process of being tested in phase III clinical trials. Like GT20029, it’s also being assessed as a treatment for acne vulgaris, as well. (2)

You can also consider trying more commonly used anti-androgens, like finasteride and dutasteride. Both are available in topical formulations, though topical dutasteride is typically applied alongside microneedling or using mesotherapy.

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