LG Chem has submitted a domestic product license application to the Ministry of Food and Drug Safety (MFDS) for 'Zemidapaem Extended-Release (ER) Tablet 50/10/1000mg,' a triple-combination drug for the treatment of type 2 diabetes. The company plans to launch the product in 2027 after completing the approval process.

According to a regulatory filing on the 30th, LG Chem applied for MFDS product approval for Zemidapaem ER Tablet 50/10/1000mg, which contains gemigliptin, dapagliflozin, and metformin as its active ingredients. The exact application date was June 30, 2026, and the drug's indication is the improvement of blood glucose control in type 2 diabetes patients for whom concurrent administration of the three components (gemigliptin, dapagliflozin, and metformin) is appropriate.

LG Chem demonstrated the efficacy and safety of this combination drug through multiple clinical trials.

• Phase 1 Clinical Trial: In patients with inadequate blood glucose control on a combination therapy of metformin and dapagliflozin, the addition of gemigliptin resulted in a superior reduction in glycated hemoglobin (HbA1c) after 24 weeks compared to the placebo group. • Phase 2 Clinical Trial: The dual-combination therapy of gemigliptin and dapagliflozin showed superior blood glucose-lowering effects compared to either monotherapy, with a generally similar safety profile. • Phase 1 Clinical Trial: Conducted in both postprandial and fasting states, the trial confirmed that Zemidapaem ER Tablet is bioequivalent to taking the individual formulations together, and was evaluated as having favorable safety and tolerability.

The company expects that this triple-combination drug will improve dosing convenience for type 2 diabetes patients who need to take multiple medications, thereby contributing to improved medication adherence.

However, LG Chem added that the submission of the clinical trial drug for approval does not guarantee final approval, and that commercialization plans may be altered or discontinued depending on the results of the MFDS's future review.