In the realm of hair science, the search for novel and effective treatments for hair loss is an ongoing effort. From this, GT-20029 has emerged as a breakthrough, unique from any other hair loss treatment currently available. Distinguishing itself from drugs like finasteride, minoxidil, dutasteride, and pyrilutamide, GT-20029 operates through a unique mechanism of action that targets and neutralizes androgen receptors (AR) in the hair follicle.
GT20029 Phase 2 trials are currently underway, aiming to assess the safety and effectiveness. This comprehensive article will navigate you through all the latest information on GT-20029, its mechanism of action, its potential advantages, and the most recent information about ongoing GT20029 Phase 2 studies.
What is GT-20029?
GT-20029 is a novel topical drug that targets androgen receptors. Developed by Kintor Pharmaceutical, the same company responsible for the development of Pyrilutamide, GT-20029 is designed as a treatment for androgenetic alopecia (AGA) and Acne vulgaris. Currently, the journey through clinical testing is progressing and it has completed Phase 1 trials in both men and women in China and the United States.1
As of 2023, the highly anticipated GT-20029 Phase 2 trials have been launched in China, stoking hopes for millions grappling with the distressing issues of hair loss.2 According to Kintor scientists, the low side effect profile has the potential to redefine the market and has all the advantages that pyrilutamide has over other treatments.1
How does GT20029 work?
GT-20029 represents a departure from the norm when it comes to hair loss treatments. Where conventional therapies often resort to blocking androgen receptors (ARs), GT-20029 introduces a proactive approach. Instead of blocking the ARs, it degrades them. It accomplishes this by leveraging cutting-edge technology known as the Proteolysis Targeting Chimera (PROTAC) platform.3
The PROTAC platform is a complex, yet elegant system composed of three integral parts: a piece that targets the AR, a part that attracts an enzyme called E3 ubiquitin ligase, and a connection between the two. When these three parts join, GT-20029 triggers a process called ubiquitination. This process effectively breaks down the AR, which could stop or slow the process of follicular miniaturization.4
Researchers also think that GT20029 could also effectively inhibit sebaceous gland development and sebum secretion, which is implicated in AGA.5
Is it safe to degrade the AR in the scalp?
The AR in our hair follicles helps manage how our hair grows. After we hit puberty, these receptors encourage the growth of larger, colored hairs from tiny, colorless ones. However, on our scalp, these receptors have the opposite effect. They cause the larger hairs to be replaced by the tiny, colorless ones, which over time, leads to AGA.6
Every hair follicle acts like a mini-organ, responding differently to androgens. In the AGA scalp, these receptors don’t have any known role. So, if they can be targeted specifically to control the hair loss process without affecting other body tissues, it could be a highly effective approach to treating hair loss. Additionally, these receptors in the scalp are always renewing themselves, so it won’t result in a complete loss of receptors in that area. This means it’s theoretically a safe approach to tackling hair loss.7
What are the advantages of GT-20029?
The advantage of GT20029 stems from its mode of action, which could make it effective at lower and less frequent dosages than other hair loss treatments. Unlike AR-receptor antagonists, which must stay in the AR to block DHT, one PROTAC molecule can target multiple AR proteins. Additionally, the treatment could last longer than AR antagonists because new ARs take time to regenerate once depleted.3
Another advantage of GT-20029 lies in its reported targeted action and low systemic absorption. By recruiting only specific AR proteins for degradation, GT-20029 could avoid the issues of drug accumulation and side effects associated with androgen pathway inhibitors like finasteride, pyrilutamide or RU-58841.3
These supposed advantages would make it an appealing option for those who have struggled with side effects. However, with GT-20029 Phase 2 trials underway, whether this ground-breaking mechanism translates into a benefit for patients remains to be seen.
Can GT-20029 Regrow Hair?
According to results presented by Kintor at the 2023 Annual Meeting of the American Academy of Dermatology Association, preclinical studies in mice with AGA found that GT20029 demonstrated a reduction in hair loss compared to the control group, with statistically significant results.5
While these findings indicate the potential efficacy of GT20029 in treating hair loss and acne, these preclinical studies only lay the foundation for further investigation. GT20029 has shown promising potential in stimulating hair regrowth in pre-clinical studies although these results have not yet been formally released. Extensive clinical trials to determine its safety and effectiveness in humans are yet to be completed. However, these initial results provide optimism for the future potential of GT20029 as a topical treatment for hair loss.
What Were the Results of the GT20029 Trial?
Clinical trials are vital for determining a drug’s safety and efficacy and preliminary results from GT-20029 trials have been positive. Phase 1 trials to assess the safety and pharmacokinetics of GT-200291 were conducted in China and the United States. These trials were randomized, double-blind, and placebo-controlled, involving over 100 participants, including healthy subjects and individuals with AGA or acne, and found it to be safe and well tolerated with a good pharmacokinetic profile.1
Participants received different doses of GT-20029 to evaluate how the drug behaves in the body and its detectability in the bloodstream. According to press releases from Kintor, the drug was well tolerated across all dose levels and groups. No severe adverse events were reported, and no subjects withdrew from the trial due to adverse events.8
During the trial, the participants were given a total of GT-20029 doses with varying concentrations ranging from 1mg (0.5% concentration) to 20mg (2% concentration) either once a day (QD) or twice a day (BID) for a period of 14 days. Some participants were given a single dose, while others received a single increasing dose or multiple increasing doses.
Aside from its safety and effectiveness, an equal primary concern for users is systemic absorption, as given the degradation of the AR, any systemic exposure could have profound side effects. No detectable levels in the blood of GT20029 in participants given single ascending doses were reported. After 14 days of continuous administration, systemic exposure remained extremely limited even in those given multiple ascending doses of GT-20029 and the highest recorded blood concentration value (Cmax) did not exceed 0.015 ng/mL.9
GT-20029 is currently undergoing a Phase 2 trial in China to assess its effectiveness and safety in adult males with AGA. The randomized, double-blind, placebo-controlled trial involves 180 male AGA patients treated over 12 weeks.2 As of yet, no results, preliminary or otherwise have been released, but we will give a Phase 2 update as soon as this information becomes available, which is likely to be within the next year.
Is GT20029 safe?
Safety is a paramount concern for both researchers and potential users and is particularly scrutinized in the early phases of a drug’s life cycle. Phase 1 trial results for GT-20029 were promising, with no severe adverse events reported and overall good tolerance of the drug at all tested doses. However, when more data becomes publicly available from the Phase I and ongoing Phase II trials, this will become clearer.
When Will GT20029 Be Released?
All new drugs under development can vary depending on factors such as trial results, regulatory approvals, and market considerations. As of now, specific information regarding the GT20029 release date has not yet been confirmed. Individuals seeking GT20029 as a hair loss treatment should consult with healthcare professionals or specialists in the field to obtain the most accurate and up-to-date information regarding its release and availability.
GT20029: What We Know So Far
To sum up, GT20029 represents a promising breakthrough in the field of hair loss and acne treatment. Its unique mechanism of action shows great potential and preclinical studies have demonstrated its potential to treat hair loss.
Phase 1 clinical trials, evaluating its safety, tolerability, and pharmacokinetics have been promising, with GT20029 being well tolerated and a low rate of adverse events. Importantly, systemic exposure to GT20029 was limited, further supporting its potential as a safe treatment option.
While these findings are encouraging, it is crucial to recognize that further research and larger-scale clinical trials are needed to confirm the safety, efficacy, and long-term effects of GT20029 in human subjects. Nevertheless, the early results and preclinical data provide a strong foundation for continued investigation into the potential of GT20029 as a transformative treatment for hair loss and acne.
As we eagerly await the results of ongoing phase 2 clinical trials, it is important for individuals experiencing hair loss or acne to consult with healthcare professionals and stay informed about the latest developments in the field. GT20029 holds promise as an innovative and targeted solution that could potentially revolutionize the way we approach these common concerns.
- Miranda, B. H., Charlesworth, M. R., Tobin, D. J., Sharpe, D. T., & Randall, V. A. (2018). Androgens trigger different growth responses in genetically identical human hair follicles in organ culture that reflect their epigenetic diversity in life. FASEB journal : official publication of the Federation of American Societies for Experimental Biology, 32(2), 795–806. https://doi.org/10.1096/fj.201700260RR
- Wang, R., Zhong, T., Bian, Q., Zhang, S., Ma, X., Li, L., Xu, Y., Gu, Y., Yuan, A., Hu, W., Qin, C., & Gao, J. (2023). PROTAC Degraders of Androgen Receptor-Integrated Dissolving Microneedles for Androgenetic Alopecia and Recrudescence Treatment via Single Topical Administration. Small methods, 7(1), e2201293. https://doi.org/10.1002/smtd.202201293