JW Pharmaceutical Receives Phase 1 IND Approval for Hair Loss Treatment Candidate "JW0061"

JW Pharmaceutical announced on the 13th that it has received approval from the Ministry of Food and Drug Safety for the phase 1 clinical trial plan (IND) of its investigational hair loss treatment candidate, "JW0061".

Exterior view of JW Pharmaceutical headquarters.

With this approval, JW Pharmaceutical will initiate a phase 1 clinical study of JW0061 at Seoul National University Hospital in 104 healthy adult subjects, both Korean and Caucasian. The purpose of the trial is to confirm the safety and tolerability of JW0061 through topical administration applied directly to the scalp, and to evaluate its pharmacokinetic characteristics, including absorption and metabolism in the body.

JW0061 is a first-in-class drug candidate that directly binds to the GFRA1 receptor of hair follicle stem cells to induce hair growth. Unlike existing therapies that rely on inhibiting male hormones or dilating blood vessels, it is evaluated as having a new mechanism of action that physiologically activates the hair-growth pathway. It is being developed as a topical formulation that can be used by both men and women.

The company has demonstrated its competitiveness by presenting preclinical data at multiple international conferences. It explained that, in a human skin organoid (organoid) model, JW0061 showed a hair follicle generation effect 7.2 times greater than the standard treatment, and in animal models it improved the rate of hair growth by up to 39%.

JW Pharmaceutical has completed registration of substance patents for JW0061 in Korea, as well as in Japan, China, Australia, and Brazil. Last month, it also completed registration of a U.S. substance patent for JW0061, thereby securing exclusive rights to the underlying technology in the U.S. market until 2039.

Based on the data obtained from the phase 1 trial, JW Pharmaceutical plans to refine its subsequent clinical development plan and to review indications and development strategies step by step. A JW Pharmaceutical official said, "This IND approval is significant in that JW0061 has advanced from the preclinical stage into the clinical stage based on its preclinical achievements," adding, "We will proceed with clinical development without delay so that it can be developed into a global first-in-class hair loss treatment."

Meanwhile, JW0061 had previously been selected as a project supported by the National New Drug Development Program, under which nonclinical studies were conducted.

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