Sun Pharma Gets CDSCO Panel Nod To study Semaglutide solution for Injection
New Delhi: Considering the bioequivalence (BE) study report of the antidiabetic drug Semaglutide solution for injection (synthetic origin) 0.25mg /0.5ml, 0.5 mg /0.5ml, 1 mg/0.5 ml, 1.7 mg/0.75 ml and 2.4 mg/0.75 ml, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted approval to the drug major Sun Pharma for conducting a Phase III clinical trial study.
This came after Sun Pharma presented the BE study report along with revised clinical trial (CT) protocol no. ICR/23/013 ver. 3.0 dated 16th Jan 2025 before the committee.
Semaglutide is a glucagon-like peptide 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. 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 held on 25th March 2025, the expert panel reviewed the BE study report along with revised CT protocol no. ICR/23/013 ver. 3.0 dated 16th Jan 2025.
After detailed deliberation, the committee recommended accepting the bioequivalence study report and recommended granting permission to conduct the Phase III clinical trial study as per the revised protocol presented.