Daewoong Pharmaceutical Receives Phase 1 Approval for Inavogliflozin-Metformin Combination Diabetes Treatment

Daewoong Pharmaceutical Headquarters Building Exterior (Photo by Daewoong Pharmaceutical)

[Asia Economy Reporter Chunhee Lee] Daewoong Pharmaceutical is advancing the development of a combination drug that merges the diabetes treatment agents inavogliflozin and metformin to enhance medication convenience.

Daewoong Pharmaceutical announced on the 10th that it has received approval from the Ministry of Food and Drug Safety for a Phase 1 clinical trial of the combination drug containing the two components.

This clinical trial is a bioequivalence study comparing the efficacy of co-administration of each component versus administration as a combination drug. The company plans to quickly complete Phase 1 and launch both the inavogliflozin monotherapy and the combination drug including metformin simultaneously. The clinical trial for the inavogliflozin monotherapy is currently in the final stages, and the company expects to release it next year.

Inavogliflozin is a novel SGLT-2 inhibitor diabetes treatment drug being developed by Daewoong Pharmaceutical, the first among domestic pharmaceutical companies. In a Phase 2 clinical trial involving patients with type 2 diabetes whose blood sugar was not adequately controlled, inavogliflozin monotherapy demonstrated superior blood glucose-lowering effects through additional reductions in glycated hemoglobin compared to existing SGLT-2 inhibitors. The clinical trial conducted on Korean subjects also confirmed a low incidence of side effects, proving its safety. Daewoong Pharmaceutical aims to develop inavogliflozin as a 'best-in-class' SGLT-2 inhibitor and launch it domestically next year.

Furthermore, the development of this combination drug seeks to improve patient medication convenience. Metformin is the most standard drug used in diabetes treatment, and co-administration with SGLT-2 inhibitors is currently one of the most commonly used therapies. The domestic market for the combination of these two components is estimated to be around 50 billion KRW. Alongside this, the company recently completed a clinical trial for a triple combination including a DPP-4 inhibitor component and is also pursuing development of a triple combination drug.

A Daewoong Pharmaceutical representative stated, “By developing both monotherapy and combination new drugs for diabetes treatment, we will provide medical professionals with diverse options and ensure medication convenience for patients. In addition to 'Pexuclu,' a gastroesophageal reflux disease treatment scheduled for release this year, we will accelerate the development of our diabetes drug lineup to firmly secure Daewoong Pharmaceutical’s future growth engine.”

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