Reviving Dormant Follicles: "Can Hair Loss Now Be Treated With Injections?" K-Bio Disrupts the Market

New Mechanisms Emerging: Follicle Stem Cells, Antibodies, and RNA
Korean Firms Such as JW Pharmaceutical, Olix, and Chong Kun Dang Also Accelerate Development

Competition is heating up in the global pharmaceutical and biotech industries over the development of new drugs for hair loss. The market, which has relied on existing therapies for decades, is now seeing the emergence of new candidates based on innovative mechanisms—for example, activating hair follicle stem cells or using antibodies to control the hair growth cycle. Korean companies are also entering the race, broadening their R&D from first-in-class new drug candidates to long-acting injectable formulations.

According to industry sources on September 8, clinical trials for next-generation hair loss treatments are advancing rapidly, particularly among U.S.-based biotech firms. Investment from major pharmaceutical companies such as Eli Lilly is flowing in, transforming what was once a market with limited treatment options into a new competitive battleground for novel drugs. While traditional treatments have focused on slowing the progression of hair loss, next-generation candidates are taking a more fundamental approach—such as restoring hair follicle function and reactivating growth cycles.

PP405, developed by U.S. company Pellage Pharmaceuticals, works by inhibiting the mitochondrial pyruvate carrier (MPC), which is involved in the energy metabolism of hair follicle stem cells. This mechanism reactivates dormant follicle stem cells. The goal is not merely to slow hair loss, but to return inactive follicles to a growth phase. ABS-201, an antibody therapy from AI-powered drug discovery company AppSci, blocks the prolactin receptor (PRLR). Building on the understanding that prolactin signaling participates in shifting hair from the growth phase to the regression phase, the strategy is to inhibit this signal to prolong the growth phase and restore the function of thinned follicles. Cosmo’s clascoterone, meanwhile, is a topical drug that locally blocks androgen receptors in the scalp instead of lowering male hormones throughout the body. Having progressed to Phase 3 clinical trials, it is considered one of the closest next-generation hair loss therapies to commercialization.

Hair loss is considered a particularly challenging area for drug development, as it involves multiple factors—such as genetics and hormones—and it is difficult to reactivate miniaturized hair follicles. Currently, treatments depend on minoxidil, finasteride, and dutasteride. Minoxidil promotes hair growth, while finasteride and dutasteride reduce the production of dihydrotestosterone (DHT), a hormone involved in hair loss. However, these drugs need to be used long-term to maintain efficacy, and treatment options for female patients remain limited, leaving significant unmet needs.

In Korea, JW Pharmaceutical and Olix are leading the way in developing new mechanisms. JW Pharmaceutical’s JW0061 is a topical formulation that stimulates the GFRA1 receptor in hair follicle stem cells, thereby activating Wnt signaling that is crucial for hair follicle formation and hair growth. This treatment directly stimulates hair growth pathways without reducing male hormones and received Phase 1 clinical trial approval in Korea in February. Olix’s OLX104C uses small interfering RNA (siRNA) technology to reduce androgen receptor expression in the scalp. Unlike finasteride and dutasteride, which lower DHT production, OLX104C inhibits the gene expression needed to create receptors for DHT action.

There is also fierce competition to improve the convenience of existing medications. CKD-843, a long-acting dutasteride injectable from Chong Kun Dang, is undergoing Phase 3 clinical trials in Korea. A single injection is designed to release the drug for about three months. Inventage Lab, in partnership with Daewoong Pharmaceutical, is developing a monthly long-acting injectable of finasteride called IVL3001. The drug received Phase 2 clinical trial approval in Australia in February, and the companies plan to assess its efficacy and establish the appropriate dosage for Phase 3 trials.

An industry official commented, “Despite the large number of patients, there are only a limited number of available treatments for hair loss, and the existing medications require long-term administration, with sustained benefits difficult to maintain if therapy is halted. There is significant attention on whether a truly fundamental therapy—beyond simply slowing hair loss—will emerge.”

This content was produced with the assistance of AI translation services.