JW Pharmaceutical announced on January 19 that it has completed registration of a U.S. patent for 'JW0061,' a candidate for hair loss treatment that targets the GFRA1 receptor.
The newly registered patent covers novel heterocyclic derivatives of JW0061, as well as its salts or isomers. This substance patent protects the technology used for the treatment and prevention of various types of hair loss, including androgenetic alopecia and alopecia areata. The patent is valid until May 2039, granting JW Pharmaceutical exclusive rights in the U.S. market for an extended period.
Including this U.S. patent, JW Pharmaceutical has completed substance patent registrations for JW0061 in a total of nine countries, including South Korea, Japan, China, Australia, and Brazil. Patent examinations are still underway in regions such as Europe and Canada.
JW0061 is an innovative first-in-class drug candidate, currently being developed as a topical GFRA1 agonist. This substance directly binds to the GFRA1 receptor expressed in hair stem cells, activating downstream signaling pathways and thereby promoting follicle formation and hair growth.
Notably, JW0061 is designed based on a mechanism that physiologically activates the body's natural hair growth pathways. This sets it apart from existing treatments based on androgen suppression or vasodilation, and it is being developed as an innovative therapeutic option suitable for both men and women.
JW Pharmaceutical has presented the preclinical results of JW0061 at numerous international conferences, including the Society for Investigative Dermatology (SID) in the United States. Studies using human skin organoids and animal models of androgenetic alopecia have demonstrated superiority in hair growth rate and follicle formation compared to standard treatments. In particular, the human skin organoid tests showed up to 7.2 times greater follicle formation than standard treatments, while animal models exhibited up to a 39% improvement in efficacy, underscoring the competitiveness of JW0061 as an innovative drug candidate.
Based on these preclinical achievements, JW Pharmaceutical recently submitted an Investigational New Drug (IND) application for a Phase 1 clinical trial of JW0061 to the Ministry of Food and Drug Safety.
A JW Pharmaceutical representative stated, "JW0061 is a next-generation hair loss treatment candidate that targets the GFRA1 receptor. The registration of this U.S. patent signifies official recognition of our proprietary technology's competitiveness in the world's largest market. We will proceed with clinical development as planned to establish JW0061 as a globally innovative hair loss treatment."
Meanwhile, JW0061 was selected as a national new drug development project and has undergone non-clinical research with government support.
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