By sarms4muscle | 15 May 2024 | 0 Comments

Enavogliflozin, a New Type 2 Diabetes Drug in Development CAS:1415472-28-4 DWP16001, GCC5694A

Drug Name: Enavogliflozin

R&D Code: DWP16001; GCC5694A
CAS: 1415472-28-4
Indication: Type 2 diabetes mellitus
Company: Daewoong Pharmaceutical
Development stage: Phase 3

On January 25, 2022, Daewoong Pharmaceutical (Daewoong) confirmed promising Phase 3 topline results focusing on the therapeutic efficacy of enavogliflozin monotherapy and metformin combination therapy.
Professor Kyungsu Park of Seoul National University Hospital participated in the Phase 3 clinical trial of enavoglilozin as monotherapy (ENHANCE-A study) as a coordinating investigator and principal investigator at 22 institutions. The study was a multicenter, randomized, double-blind, placebo-controlled and therapeutic validation trial that included 160 patients with type 2 diabetes. The primary endpoint was to study the difference in baseline change in glycosylated hemoglobin (HbA1c) between the enavoglilozin and placebo groups. According to the topline report, a p-value of 0.99% was initially observed at 24 weeks after administration, confirming statistical significance (p-value <0.001). Glycosylated hemoglobin is the end product of hemoglobin binding to blood glucose and is the gold standard for determining the severity of diabetes.
In addition, positive findings were observed in another Phase 3 clinical trial of enavoglilozin in combination with metformin by Maharishi Pharma (ENHANCE-M).The ENHANCE-M study was conducted by Prof. Yoon Kyeon-Ho of Seoul Notre Dame Hospital, The Catholic University of Korea, as the coordinating researcher, and the principal investigator at 23 institutions. The trial was conducted in 200 patients with type 2 diabetes who had inadequate glycemic control with metformin. Results based on baseline changes in HbA1c. The group of patients combining Enavogliflozin and Metformin has successfully demonstrated non-inferiority to the group of patients combining Dagliflozin and Metformin. the safety results in the enavoglilozin group have also been confirmed as there were no unintended adverse events or adverse drug reactions.

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