바카라사이트 정보0061, a GFRA1 receptor agonist, to undergo safety and tolerability evaluation in healthy adults at Seoul National University Hospital
[by Ji, Yong Jun] JW Pharmaceutical announced on February 13 that it has obtained Investigational New Drug (IND) approval from the Ministry of Food and Drug Safety (MFDS) for a Phase 1 clinical trial of its hair loss treatment candidate, ‘JW0061 (development code).’
Following this approval, JW 바카라사이트 정보 will initiate a Phase 1 clinical trial of JW0061 at Seoul National University Hospital, enrolling 104 healthy Korean and Caucasian adult participants. The study is designed to evaluate the safety and tolerability of JW0061 when administered via topical application directly to the scalp. In addition, the trial will investigate its pharmacodynamic profile, including the extent of systemic absorption and metabolic processing in the body.
JW0061 is a first-in-class treatment candidate designed to directly bind to the GFRA1 receptor expressed on hair follicle stem cells, thereby inducing hair growth. Unlike currently available treatments that primarily act through androgen suppression or vasodilation, JW 바카라사이트 정보 is developing a topical formulation intended for use in both male and female patients, utilizing a novel mechanism of action that physiologically activates intrinsic hair growth pathways.
According to JW 바카라사이트 정보, the candidate has demonstrated strong competitive potential, supported by excellent preclinical findings presented at multiple international academic conferences. In a human skin organoid model, JW0061 exhibited a hair follicle induction effect approximately 7.2 times greater than that observed with standard treatments. Furthermore, in animal model studies, it improved hair growth by up to 39%, underscoring its potential as a globally competitive innovative, novel drug.
JW 바카라사이트 정보 has secured patent registrations for JW0061 in multiple jurisdictions, including Korea, Japan, China, Australia, and Brazil. Last month, the company completed patent registration in the United States, thereby securing exclusive rights to the original technology in the U.S. market until 2039.
Based on the outcomes of the Phase 1 clinical trial, JW Pharmaceutical intends to further refine its follow-up clinical development strategy and conduct a phased evaluation of target indications and development strategies. “This IND approval is meaningful in that JW0061 has advanced into the clinical stage based on its demonstrated preclinical performance. We will continue to proceed with clinical development without a hitch with the goal of establishing it as a globally innovative treatment for hair loss,” a JW Pharmaceutical official said.