For almost three decades, the number one target of hair loss treatments has been to reduce dihydrotestosterone (DHT). Initially via Finasteride (Propecia) that was approved as a hair loss treatment by the US FDA in 1997; and later on via the stronger Dutasteride (Avodart). Note that Dutasteride is only officially approved as a hair loss treatment in Japan and South Korea, but used off-label for that purpose across the world.
Since 2020, the main focus in new upcoming hair loss treatments has shifted towards targeting the androgen receptor (AR). For those who get side effects from Finasteride or Dutasteride, these new treatments are eagerly awaited.
In this post, I highlight the main products currently in trials that target the AR in order to stop hair loss. I also cover one AR silencing cosmetic that is already on the market in some countries.
Breezula (AR Inhibitor) from Cosmo Pharmaceuticals
Ireland-based Cosmo Pharmaceuticals’ Breezula (clascoterone) androgen receptor inhibitor product has been in clinical trials for over a decade. In 2024, Cosmo began Phase 3 trials for Breezula in four countries. The drug inhibits testosterone and dihydrotestosterone from binding to local hair follicle androgen receptors on the scalp. In the past, Breezula was known as CB-03-01 when owned by Cassiopea (Italy).
In 2020, the FDA approved Cosmo Pharma’s clascoterone 1% cream Winlevi to treat acne. Breezula contains a higher concentration of clascoterone in comparison to Winlevi.
Pyrilutamide/KX-826 (AR Antagonist) from Kintor Pharmaceutical
China-based Kintor Pharmaceutical is undertaking numerous hair loss related clinical trials in China and the US. The company’s main product is Pyrilutamide (KX-826), a topical androgen receptor antagonist. It is currently in Phase 3 clinical trials for men in both the US and China; as well as Phase 3 clinical trials for women in China.
GT20029 (AR Degrader) from Kintor Pharmaceutical
Kintor is also currently undertaking Phase 2 clinical trials for its androgen receptor degrader product GT20029 in China. US Phase 2 trials are also being planned. GT20029 is developed using Kintor’s proprietary Proteolysis Targeting Chimera (PROTAC) platform. GT20029 degrades the AR protein via the E3 ubiquitin ligase pathway.
OLX104C (AR Inhibitor) from OliX Pharmaceuticals
South Korea’s OliX Pharmaceuticals is currently finishing Phase 1 clinical trials in Australia for its androgen receptor inhibiting product OLX104C. This hair loss treatment is based on self-delivering asymmetric siRNA (cp-asiRNA) technology. OLX104C reduces the expression of androgen receptors when administered topically to the scalp.
CosmeRNA (AR Silencer) from Bioneer
South Korea based Bioneer’s CosmeRNA is a cosmetic product that targets the androgen receptor via the use of proprietary RNA interference technology. Bioneer describes this as self-assembled micelle inhibitory RNA (SAMiRNA) nanoparticle-type siRNA. CosmeRNA was released in Western Europe in 2023 without being tested in any clinical trials due to its classification as a cosmetic. The manufacturer did publish a study in Nature in 2022 that concluded that weekly treatment with SAMiRNA to silence the androgen receptor ameliorates androgenetic alopecia.
In conclusion, the focus of hair loss treatments has shifted from targeting dihydrotestosterone (DHT) to the androgen receptor (AR). Innovative products like Breezula, Pyrilutamide/KX-826, GT20029, OLX104C, and CosmeRNA offer new hope for those seeking alternatives to traditional therapies. While some are in clinical trials and others are already on the market, cautious optimism and rigorous evaluation are essential to ensure both efficacy and safety. Collaboration between industry, academia, and regulatory bodies will be key in advancing these treatments to meet the diverse needs of individuals experiencing hair loss.
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Anand, the visionary behind HairLossCure2020 (HLC2020) since 2013, brings more than just a blog—he offers a testament to resilience and dedication. Having relied on hair loss medications for over two decades, his journey is fueled by a personal quest to regrow his hair and advance regenerative medicine.
HLC2020 stands as the premier destination for the latest news and analysis on new hair loss treatments, clinical trials, and groundbreaking research. hairlosscure2020.com