JW Pharmaceutical files IND for biweekly obesity drug bofanglutide in Phase 3 trial

JW Pharmaceutical has filed an investigational new drug application with the Ministry of Food and Drug Safety to conduct a domestic Phase 3 clinical trial of bofanglutide, its obesity treatment candidate.

The Phase 3 trial will enroll 300 adults with obesity or overweight across multiple domestic sites in a placebo-controlled design, the company said Tuesday. JW Pharmaceutical plans to begin enrollment in December and evaluate the drug's weight-loss superiority over placebo, as well as its safety profile, through March 2029.

Bofanglutide is a GLP-1 (glucagon-like peptide-1) receptor agonist that JW Pharmaceutical licensed from China's Gan & Lee Pharmaceuticals in April, acquiring exclusive domestic development and commercialization rights. The drug promotes insulin secretion from the pancreas and slows gastric emptying, suppressing appetite and increasing satiety.

A key differentiator is its dosing schedule: unlike existing obesity treatments administered once a week, bofanglutide is being developed as a subcutaneous injection given once every two weeks. The formulation would cut annual injections from 52 to 26, which the company expects to significantly improve patient adherence and convenience.

The drug has already demonstrated weight-loss efficacy. In a prior Phase 3 trial conducted in China — GRADUAL-1 — patients receiving the 24 mg dose lost 15.12 percent of their baseline body weight after 52 weeks, while those on the 48 mg dose lost 18.54 percent, confirming strong efficacy and tolerability.

JW Pharmaceutical aims to carve out a competitive position in the GLP-1 obesity market — currently dominated by global pharmaceutical companies — by offering a differentiated biweekly dosing interval, while expanding its metabolic disease prescription drug portfolio as a future growth driver.

"We plan to clearly demonstrate in domestic patients the strong weight-loss results seen in overseas trials," a company official said. "We will accelerate development to offer an obesity treatment option that combines clinical efficacy with convenience."