Emcure Pharma Gets CDSCO Panel Nod for Phase III Trial of Semaglutide in Chronic Weight Management
New Delhi: Accepting the bioequivalence (BE) study report, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has granted approval to the drug major Emcure Pharmaceuticals to conduct the Phase III clinical trial of Semaglutide Injection (Synthetic Origin) for chronic weight management.
However, this nod came with condition that detailed rescue medication, withdrawal criteria and hypoglycemia management should be mentioned in the protocol. In addition, the expert panel suggested that 50% Govt. clinical trial sites geographically distributed should be included in clinical trial study.
This occurred as the drug major Emcure Pharmaceuticals presented bioequivalence study report along with the Phase-III clinical trial protocol (Protocol No. ECTS/25/002, Version No. 00, Dated 13.02.2025) for chronic weight management before the committee.
Semaglutide is a glucagon-like peptide 1 (GLP-1) receptor agonist used to improve glycemic control in type 2 diabetes mellitus, treat obesity, and reduce the risk of major adverse cardiovascular events in selected adults.
GLP-1 is a physiological hormone that promotes glycemic control via several different mechanisms, including insulin secretion, slowing gastric emptying, and reducing postprandial glucagon secretion. Semaglutide is 94% similar to human GLP-1. Analogs of this hormone such as semaglutide stimulate the synthesis of insulin by stimulating pancreatic islet cells and reducing glucagon secretion.
Semaglutide works by mimicking the action of the GLP-1 hormone, which regulates appetite, insulin secretion, and gastric emptying. By slowing down stomach emptying and reducing hunger, semaglutide helps individuals eat less and feel full longer, leading to significant weight loss.
At the recent SEC meeting for endocrinology and metabolism, the expert panel reviewed the bioequivalence study report of Semaglutide Injection (Synthetic Origin) 1 mg/ 1.5 ml (0.68 mg/ml), 2 mg/ 1.5 ml (1.34 mg/ml), 4 mg/ 3 ml (1 .34 mg/ml), 6.8 mg/ 3 ml (2.27 mg/ml) and 9.6 mg/ 3 ml (3.2 mg/ml) presented by the firm along with the Phase-III clinical trial protocol (Protocol No. ECTS/25/002, Version No. 00, Dated 13.02.2025) for chronic weight management.
After detail deliberation, the committee recommended to accept the BE study report and recommended to conduct the Phase III clinical trial as per protocol presented by the firm with following changes/conditions:
1. Detailed rescue medication, withdrawal criteria and Hypoglycemia management should be mentioned in the protocol.
2. 50% Govt. CT sites geographically distributed shall be included in Clinical trial study.
