CDSCO Panel Approves Emcure's Phase III Clinical Trial of Semaglutide, Mandates Govt Trial Sites

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) 2mg/ 1.5ml (1.34 mg/ml), 4 mg/ 3ml (1.34 mg/ml) & 8 mg/ 3 ml (2.68 mg/ml) for type 2 diabetes mellitus.

However, this nod came with condition that detailed rescue medication, withdrawal criteria and hypoglycemia management should be mentioned in the protocol. Furthermore, the expert panel stated that fasting and postprandial blood sugar levels should be used for dose titration.

In addition, the expert panel suggested that 50% Govt. clinical trial sites geographically distributed should be included in clinical trial study.

This occurred after the firm presented bioequivalence study report along with the Phase-III clinical trial protocol (Protocol No. ECTS/25/001, Version No. 00, Dated 28.02.2025) for type 2 diabetes mellitus before the committee.

Semaglutide is a glucagon-like peptide 1 (GLP-1) analog used to manage type 2 diabetes along with lifestyle changes, such as dietary restrictions and increased physical activity. Semaglutide is always intended to be used with a reduced calorie diet and increased physical activity. It is indicated to improve glycemic control in adults diagnosed with type 2 diabetes mellitus.

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. The homeostasis of glucose is dependent on hormones such as insulin and amylin, which are secreted by the beta cells of the pancreas. 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. They directly bind with selectivity to the GLP-1 receptor, causing various beneficial downstream effects that reduce blood glucose in a glucose-dependent fashion.

At the recent SEC meeting for endocrinology and metabolism, the expert panel reviewed the bioequivalence study report of Semaglutide Injection (Synthetic Origin) 2mg/ 1.5ml (1.34 mg/ml), 4 mg/ 3ml (1.34 mg/ml) & 8 mg/ 3 ml (2.68 mg/ml) along with the Phase-III clinical trial protocol (Protocol No. ECTS/25/001, Version No. 00, Dated 28.02.2025) for type 2 diabetes mellitus.

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. Fasting and postprandial blood sugar levels should be used for dose titration.

3. 50% Govt. CT sites geographically distributed shall be included in Clinical trial study.