Precise Biopharma Gets CDSCO Panel Nod To Conduct Phase III Trial of Semaglutide Injection
New Delhi: Accepting the bioequivalence study report, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has opined Precise Biopharma to conduct the Phase III clinical trial of Semaglutide (Synthetic Origin) Injection 2 mg/3 ml (0.68 mg/ml, 0.25 mg and 0.5 mg dose), 4 mg/3 ml (1.34 mg/ml,1 mg dose), and 8 mg/3 ml (2.68 mg/ml. 2 mg dose).
This came after the firm presented a bioequivalence study report along with the revised Phase III clinical trial protocol (protocol vide no. CT/2024/33 Version No. 01, dated 24.01.2025) for Type 2 Diabetes Mellitus 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. 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 along with the revised Phase III clinical trial protocol (protocol vide no. CT/2024/33 Version No. 01, dated 24.01.2025) presented by Precise Biopharma for Type 2 Diabetes Mellitus.
After detailed deliberation, the Committee recommended accepting the BE study report and recommended conducting the Phase III clinical trial as per the revised protocol presented by the firm.
