JW Pharmaceutical Files South Korean Phase 3 Trial Application for Diabetes Drug Bofanglutide

JW Pharmaceutical has filed a South Korean Phase 3 clinical trial application with the Ministry of Food and Drug Safety for the injectable diabetes treatment Bofanglutide.

JW Pharmaceutical disclosed on the 28th that it had submitted an investigational new drug (IND) application for a Phase 3 clinical trial of injectable Bofanglutide to the Ministry of Food and Drug Safety (MFDS). The trial will enroll patients with type 2 diabetes whose blood glucose is not adequately controlled with combination therapy using metformin and an SGLT-2 inhibitor. The application number is 20260178668.

The trial will use a multicenter, randomized, double-blind, placebo-controlled, parallel-group design. In 174 South Korean patients, injectable Bofanglutide or placebo will be administered as an add-on treatment for 44 weeks to evaluate the superiority of the change in glycated hemoglobin (HbA1c).

The clinical trial is scheduled to begin in January 2027 and end in February 2029.

The company expects injectable Bofanglutide to improve medication adherence and convenience by reducing the annual number of injections from 52 to 26 through biweekly dosing, unlike most existing GLP-1 therapies, which are administered once weekly.

However, JW Pharmaceutical cautioned investors that the statistical probability of a clinical trial drug ultimately receiving approval as a medicine is approximately 10% and urged them to exercise caution when investing.