Daewoong Pharmaceutical Receives Simultaneous Phase 3 Approval for Diabetes Drug as Monotherapy and Combination Therapy
[Asia Economy Reporter Cho Hyun-ui] Daewoong Pharmaceutical announced on the 6th that it has simultaneously received approval for Phase 3 clinical trials of the new drug for type 2 diabetes treatment, 'Inavogliflozin,' for both monotherapy and combination therapy.
Accordingly, Daewoong Pharmaceutical will evaluate the efficacy and safety of Inavogliflozin as a monotherapy and in combination with 'Metformin' for type 2 diabetes.
The monotherapy clinical trial will be conducted on approximately 140 patients with type 2 diabetes at over 30 large hospitals nationwide, including Seoul National University Hospital.
In the combination therapy clinical trial, Inavogliflozin will be administered to about 190 patients with type 2 diabetes whose blood sugar control is insufficient with Metformin. The trial is scheduled to be conducted at over 30 large hospitals nationwide, including the Catholic University of Korea St. Mary's Hospital.
Inavogliflozin selectively inhibits sodium-glucose cotransporter 2 (SGLT-2), which is involved in glucose reabsorption in the kidneys, thereby directly excreting glucose through urine.
Previously, patients who received Inavogliflozin in Phase 2 clinical trials showed a reduction in glycated hemoglobin (HbA1c) compared to the placebo group. The clinical results were presented online last month at the 'International Conference on Diabetes and Metabolic Diseases' (ICDM) hosted by the Korean Diabetes Association.
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Seungho Jeon, CEO of Daewoong Pharmaceutical, stated, “Daewoong Pharmaceutical plans to focus its research and development capabilities to establish Inavogliflozin, an SGLT-2 diabetes new drug, as the best-in-class drug.” He added, “We will strive to provide Inavogliflozin as a good treatment option for patients with type 2 diabetes, targeting not only the domestic but also the global market.”
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