JW Pharmaceutical announced on Aug. 18 that it has submitted an Investigational New Drug (IND) application to South Korea’s Ministry of Food and Drug Safety to launch a Phase 3 clinical trial for its novel obesity treatment, bofanglutide.
Scheduled to begin in December, the trial will enroll 300 adult patients in South Korea who are living with obesity or overweight conditions. JW Pharmaceutical plans to evaluate the efficacy and safety of bofanglutide compared to a placebo through March 2029.
Bofanglutide is an investigational candidate belonging to the GLP-1 receptor agonist class. JW Pharmaceutical secured exclusive rights to develop and commercialize the drug in South Korea from China-based Gan & Lee Pharmaceuticals in April. The total transaction value was $81.10 million, which included a $5 million upfront payment. Gan & Lee Pharmaceuticals focuses on building a biopharmaceutical portfolio spanning diabetes and obesity therapies to strengthen its global competitiveness in metabolic health.
The drug operates by binding to GLP-1 receptors in the pancreas to stimulate insulin secretion while delaying gastric emptying to increase satiety—a dual mechanism designed to suppress appetite and drive weight loss.
Designed as a biweekly subcutaneous injection, bofanglutide offers a lower treatment burden than currently marketed once-weekly GLP-1 therapies. By cutting the required annual administration from 52 injections to 26, the drug is expected to significantly enhance patient convenience and long-term treatment adherence.
Earlier Phase 3 clinical trials conducted in China demonstrated robust weight-reduction outcomes. Following 52 weeks of treatment, patients achieved a mean body weight loss from baseline of 15.12% in the 24 mg cohort and 18.54% in the 48 mg cohort.
"We plan to clearly demonstrate in domestic patients as well the strong weight-loss effects and tolerability of bofanglutide confirmed in earlier overseas trials," a JW Pharmaceutical official said.
