JW Pharmaceutical said on the 13th that it received approval from the Ministery of Food and Drug Safety for a phase 1 clinical trial plan for its hair loss treatment candidate JW0061. The company said the candidate, which promotes follicle proliferation and hair regeneration, could help with androgenetic alopecia and alopecia areata.
The phase 1 trial will begin at Seoul National University Hospital with 104 healthy Korean and Caucasian (white) adults. The candidate will be applied directly to the scalp to check the drug's safety. The study will also evaluate absorption and metabolic processes in the body.
JW0061 binds to hair follicle stem cell receptors to induce hair growth. Unlike existing treatments that relied on male hormone suppression, it physiologically activates the hair growth pathway. In a human skin Organoid (mini-organ) model, its hair follicle formation effect reached 7.2 times that of standard treatments. In animal studies, it improved hair growth speed by up to 39%.
The company completed patent registrations for the candidate in Korea, Japan, China, Australia, Brazil and the United States. Based on the phase 1 results, it plans to detail follow-up clinical plans. A JW Pharmaceutical official said, "We have entered the clinical stage based on preclinical results," adding, "We will develop a global hair loss treatment."