Hanmi Pharm files phase 3 IND for GLP-1 combo in type 2 diabetes

Hanmi Pharmaceutical said Tuesday it has filed an investigational new drug (IND) application with Korea’s Ministry of Food and Drug Safety to run a phase 3 study of efpeglenatide combined with an SGLT2 inhibitor and metformin in adults with type 2 diabetes.

Efpeglenatide, a long-acting GLP-1 therapy built on Hanmi’s Lapscovery platform, was licensed to Sanofi in 2015 for diabetes and returned in 2020. Hanmi says earlier global phase 3 trials in about 6,000 patients support the drug’s potential in glycemic control.

At home, Hanmi has completed enrollment of 448 participants in a phase 3 obesity study and plans to run the diabetes combination study in parallel. The company is positioning efpeglenatide as a treatment that could span obesity and cardiometabolic complications.

Hanmi plans to finish the Korean phase 3 obesity trial in the second half of 2025 and is targeting a domestic launch in the second half of 2026. Manufacturing is slated for the company’s Pyeongtaek Smart Plant.