-A GFRA1 receptor agonist and First-in-Class topical novel drug candidate
-Phase 1 IND approved by the MFDS; safety and tolerability to be evaluated in healthy adults at Seoul National University Hospital
February 2026
JW Pharmaceutical announced on the 13th that it has received Investigational New Drug (IND) approval from the Ministry of Food and Drug Safety (MFDS) for Phase 1 clinical trials of its hair loss treatment candidate, 'JW0061.'
Following this approval, JW Pharmaceutical will initiate a Phase 1 study involving 104 healthy Korean and Caucasian adults at Seoul National University Hospital. The clinical trial aims to evaluate the drug's safety and tolerability when applied topically directly to the scalp. It will also assess the pharmacokinetic (PK) profile of the drug, monitoring its absorption and metabolic processes in the body.
JW0061 is a First-in-Class drug candidate designed to induce hair growth by binding directly to the GFRA1 receptor on hair stem cells. Unlike conventional treatments that rely heavily on androgen suppression or vasodilation, JW0061 employs a novel mechanism that physiologically activates innate hair growth pathways. It is currently being developed as a topical formulation suitable for both men and women.
The compound has consistently proven its competitive edge through outstanding preclinical data presented at multiple international scientific conferences. In human skin organoid models, JW0061 demonstrated a 7.2-fold increase in hair follicle neogenesis compared to standard treatments. Furthermore, in animal models, it accelerated the hair growth rate by up to 39%, firmly establishing its potential as a global breakthrough drug.
JW Pharmaceutical has completed the registration of substance patents for JW0061 in several countries, including South Korea, Japan, China, Australia, and Brazil. Last month, the company further solidified its intellectual property portfolio by securing a U.S. substance patent, ensuring exclusive rights to its proprietary technology in the U.S. market until 2039.
Based on the robust data to be obtained from this Phase 1 trial, JW Pharmaceutical plans to concretize its subsequent clinical development plans and systematically evaluate potential indications and broader development strategies.
“This IND approval holds immense significance, marking JW0061's successful transition from preclinical research into the clinical stage,” a JW Pharmaceutical official stated. “We will seamlessly execute our clinical development to successfully establish JW0061 as a globally recognized, innovative hair loss treatment.”
Meanwhile, JW0061 was previously selected as a supported project by the Korea Drug Development Fund (KDDF) to conduct its non-clinical research phase.