Torrent Pharmaceutical Gets CDSCO Panel Nod To study Semaglutide Tablets
New Delhi: Torrent Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase III clinical trial of the antidiabetic drug Semaglutide Tablets 3mg, 7 mg, and 14 mg (synthetic origin).
However, the expert panel has recommended modification in the study protocol, suggesting in the exclusion criteria “Subjects with the diagnosis of retinopathy” should be replaced with “Subjects with the diagnosis of unstable retinopathy or maculopathy.”
This came after the firm presented a bioequivalence study report (Protocol No. 22-143 Amendment No. 01 dated 04-Dec-2023) as per BE NOC No. BE/SND/12/2023 dated 15.05.2023 (amendment dated 05.03.2024) along with Phase III clinical trial protocol (Protocol No.: CT/SEMA/DM/2024/3_1, Version No.: 2, Date: 01-Mar-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 bioequivalence study report (Protocol No. 22-143 Amendment No. 01 dated 04-Dec-2023) as per BE NOC No. BE/SND/12/2023 dated 15.05.2023 (amendment dated 05.03.2024) along with Phase III clinical trial protocol (Protocol No.: CT/SEMA/DM/2024/3_1, Version No.: 2, Date: 01-Mar-2025).
After detailed deliberation, the committee recommended accepting the bioequivalence study report and recommended granting permission to conduct a Phase III clinical trial study with the following change in the study protocol:
• In the exclusion criteria, “Subjects with the diagnosis of retinopathy” should be replaced with “Subjects with the diagnosis of unstable retinopathy or maculopathy.”
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