Daewoong Pharmaceutical's Enblo Receives Approval for Phase 3 Trial of Initial Combination Therapy with Metformin

Phase 3 Clinical Trial Targeting 510 Patients With Type 2 Diabetes

Daewoong Pharmaceutical's type 2 diabetes treatment, Enblo, will begin a phase 3 clinical trial to expand its initial combination therapy with metformin.

Daewoong Pharmaceutical Enblo product image. Daewoong Pharmaceutical

On March 5, Daewoong Pharmaceutical announced that it received approval from the Ministry of Food and Drug Safety on March 4 for its phase 3 clinical trial plan (IND) of initial combination therapy with Enblo (active ingredient: inavogliflozin) and metformin hydrochloride extended-release formulation (Metformin XR), aiming to improve blood glucose control in adult patients with type 2 diabetes.

This clinical trial will target adult patients with type 2 diabetes whose blood glucose is not sufficiently controlled by diet and exercise alone. The study has been designed as a multi-center, randomized, double-blind, active-controlled, parallel-group trial.

The purpose of the trial is to confirm whether the therapeutic effect of initial combination therapy with inavogliflozin and metformin is superior to each drug as monotherapy, and to evaluate both efficacy and safety.

A total of 510 patients are expected to participate in the trial. The trial period is planned to last approximately 30 months from the date of approval. Participant recruitment will be conducted on a multinational basis, with some patients to be recruited in Indonesia.

Enblo is a type 2 diabetes treatment in the SGLT-2 inhibitor class developed by Daewoong Pharmaceutical. It is the 36th domestically developed new drug to be approved by the Ministry of Food and Drug Safety in 2022 and is currently being sold in Korea.

Daewoong Pharmaceutical plans to apply for a label change reflecting the results of the initial combination therapy with metformin once the clinical trial is completed. The company expects that, if approved, the combination therapy will help expand treatment options for patients with type 2 diabetes.

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