Competition among domestic pharmaceutical and biotechnology companies to develop next-generation hair loss treatments is heating up, with several firms moving beyond traditional oral medications to explore topical and long-acting injectable options.
JW Pharmaceutical announced on the 12th that it has received approval from the Ministry of Food and Drug Safety (MFDS) to begin a Phase 1 clinical trial for its investigational hair loss treatment, JW0061. The trial, approved under an Investigational New Drug (IND) application, will involve 104 healthy adult participants and is scheduled to begin next month at Seoul National University Hospital.
JW0061 is designed as a topical therapy applied directly to the scalp. Unlike conventional treatments that primarily target hormonal pathways, the new candidate is engineered to act on hair follicle stem cells, which are fundamental to hair formation. The compound binds to the GFRA1 receptor found on these stem cells, activating biological signals believed to support follicle regeneration and stimulate hair growth.
Most currently available therapies for male-pattern hair loss are oral medications that work by lowering levels of dihydrotestosterone (DHT), a hormone metabolite known to shrink hair follicles and lead to progressively thinner hair. However, long-term use of such drugs has, in some cases, been associated with side effects including reduced sexual function and mood-related symptoms.
JW Pharmaceutical said the localized nature of JW0061 could help minimize systemic exposure. “Because it is applied directly to the scalp and acts only on the affected area, we expect relatively fewer side effects compared to oral treatments,” the company stated.
The company holds U.S. patent protection for JW0061 through May 2039 and has secured additional patents in nine countries, including South Korea, Japan, China, Australia, and Brazil.
Other firms are also pursuing alternative treatment strategies. Biotech company OliX is developing OLX104C, an injectable therapy administered once a month directly into areas of the scalp affected by hair loss. The treatment uses RNA interference technology to suppress the expression of androgen receptors (AR), a key driver of male-pattern baldness, thereby blocking the hormonal signaling linked to hair loss progression.
Meanwhile, Chong Kun Dang is advancing CKD-843, an injectable formulation containing dutasteride, the same active ingredient used in the oral medication Avodart. Designed for sustained release, the injection gradually delivers the drug over time, with therapeutic effects lasting from one to three months. CKD-843 is currently undergoing Phase 3 clinical trials.
Industry observers note that these emerging therapies reflect a broader shift toward localized and longer-acting solutions aimed at improving convenience and reducing systemic side effects, potentially reshaping the treatment landscape for androgenetic alopecia.
