JW Pharmaceutical Submits IND for Phase 3 Trial of Biweekly Obesity Treatment

"Bofanglutide" to Be Tested in 300 Adult Obese and Overweight Patients
Dosing Frequency Reduced by Half... Improved Compliance and Convenience Expected

JW Pharmaceutical announced on August 18 that it has submitted a clinical Phase 3 trial plan (IND) for its obesity treatment drug candidate "Bofanglutide" to the Ministry of Food and Drug Safety.

Chungwoe Pharmaceutical headquarters located in Galhyeon-dong, Gwacheon-si, Gyeonggi-do. Chungwoe Pharmaceutical

This clinical trial will be conducted on 300 Korean adult patients who are either obese or overweight. The company plans to begin the trial in December 2026 and will evaluate the superiority and safety of Bofanglutide compared to the placebo group through March 2029.

Bofanglutide is a new drug candidate classified as a GLP-1 receptor agonist. JW Pharmaceutical secured exclusive domestic development and commercialization rights for Bofanglutide from China's Gan & Lee Pharmaceuticals in April. The drug acts on GLP-1 receptors in the pancreas, promoting insulin secretion and delaying gastric emptying, which increases satiety. As a result, it helps suppress appetite and induce weight loss.

Unlike existing GLP-1 class drugs used for obesity treatment that are administered once a week, this medication is being developed as a subcutaneous injection administered once every two weeks. This reduces the annual number of doses from the conventional 52 to 26—a reduction by half—which is expected to improve patient compliance and convenience.

The drug's efficacy has already been demonstrated in earlier trials. According to results from a Phase 3 clinical trial (GRADUAL-1) conducted in China, Bofanglutide showed significant weight reduction compared to baseline after 52 weeks of administration (a -15.12% reduction in the 24 mg group, and a -18.54% reduction in the 48 mg group), confirming its excellent clinical efficacy and tolerability.

JW Pharmaceutical also plans to sequentially pursue additional Phase 3 clinical trials for indications beyond obesity, as part of its efforts to strengthen its portfolio of original specialty medicines in the field of metabolic diseases.

A company official stated, "We plan to clearly demonstrate the excellent weight loss effects and tolerability of Bofanglutide observed in overseas trials among Korean patients as well," and added, "We will accelerate development to provide a new obesity treatment option that combines clinical effectiveness with superior dosing convenience."

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