Sun Pharma Lab gets CDSCO Panel nod to conduct Phase III CT of Semaglutide solution for injection
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to the drug major Sun Pharma Labs to conduct the Phase III clinical trial of Semaglutide solution for injection (Synthetic origin) 0.25 mg/0.5 ml, 0.5 mg/0.5 ml, 1 mg/0.5 ml, 1.7 mg/0.75 ml, and 2.4 mg/0.75 ml.
This came after Sun Pharma Labs presented the amended Phase III clinical trial protocol for weight management before the committee.
Furthermore, the expert panel suggested changes in the CT protocol that the treatment with glucose-lowering agents (s) within 90 days before screening should be removed from the exclusion criteria for non-diabetic patients and retinal examination (fundoscopy) should be done at each visit.
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, slow 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.
In hypercholesterolemia, semaglutide is believed to reduce the progression of atherosclerosis via decreased gut permeability and decreased inflammation. Weight loss is believed to occur via the reduction of appetite and food cravings after semaglutide administration.
At the recent SEC meeting for endocrinology and metabolism held on 13 January 2025, the expert panel reviewed the amended Phase III CT protocol for weight management.
After detailed deliberation, the Committee recommended a grant of permission to conduct a Phase III CT study with the following changes in the CT protocol:
ï‚· Treatment with glucose-lowering agents (s) within 90 days before screening should be removed from the exclusion criteria for non-diabetic patients.
ï‚· Retinal examination (fundoscopy) should be done at each visit.
Furthermore, the expert panel suggested the firm submit a bioequivalence (BE) study report to CDSCO and the BE report should be evaluated by the committee before the initiation of the Phase-III clinical trial.
