Daewoong Pharmaceutical Receives Approval for Phase 3 Clinical Trial of Triple Combination Therapy Including Inavogliflozin

[Asia Economy Reporter Cho Hyun-ui] Daewoong Pharmaceutical announced on the 4th that it has received approval from the Ministry of Food and Drug Safety for a Phase 3 clinical trial plan to administer 'Inavogliflozin,' a new drug under development for diabetes treatment, in combination with metformin and dipeptidyl peptidase-4 (DPP-4) inhibitors.

In this clinical trial, a triple therapy combining Inavogliflozin will be applied to 250 patients with type 2 diabetes whose blood sugar is not sufficiently controlled even with combined administration of metformin and DPP-4 inhibitors, to verify the blood sugar-lowering effect and safety. The trial will be conducted at more than 20 large hospitals nationwide.

Inavogliflozin had previously received approval for a Phase 2 monotherapy clinical trial and a Phase 3 clinical trial plan for combination therapy with metformin. With this clinical approval, Inavogliflozin is expected to be used as a treatment for patients whose blood sugar is not controlled even with existing diabetes medications in combination therapy.

The company aims to launch the drug domestically in 2023. Inavogliflozin has been designated as the first fast-track drug in Korea, allowing for a shortened approval period.

Jeon Seung-ho, CEO of Daewoong Pharmaceutical, stated, "As SGLT-2 inhibitor drugs are expanding their scope to treatments for heart failure and chronic kidney disease, Inavogliflozin will also be expanded to various indications beyond diabetes to broaden treatment benefits."

This content was produced with the assistance of AI translation services.