JW Pharmaceutical seeks phase 3 approval for Bofanglutide in 174 diabetes patients

JW Pharmaceutical has applied to the Ministry of Food and Drug Safety for approval of a phase 3 clinical trial plan for Bofanglutide, its investigational treatment for type 2 diabetes. The study will enroll 174 domestic patients whose blood sugar remains inadequately controlled despite combination therapy with metformin and SGLT-2 inhibitors. Scheduled to begin in January 2027 and continue through February 2029, the trial will compare the efficacy and safety of Bofanglutide combination therapy with placebo. Bofanglutide is a GLP-1 receptor agonist (drug that activates a blood-sugar-regulating hormone pathway) licensed exclusively to JW Pharmaceutical for domestic development and commercialization from Gan & Lee Pharmaceuticals in April. Its proposed subcutaneous injection is administered once every two weeks, compared with once-weekly dosing for existing GLP-1 therapies, potentially reducing annual injections from 52 to 26. The company said the trial is intended to objectively verify the candidate's efficacy and safety and support a broader metabolic-disorder pipeline spanning obesity and diabetes.

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