MSN Labs Gets SEC Nod to Conduct Phase III Trial of Semaglutide
New Delhi: Reviewing the bioequivalence study of the antidiabetic drug Semaglutide of MSN Laboratories, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended to accept the BE Study report and to conduct Phase III clinical trial of Semaglutide Injection 2mg/3ml (0.68mg/ml), 4mg/3ml (1.34mg/ml) & 8mg/3ml (2.68mg/ml).
This came after the firm has presented the Bioequivalence study report and revised clinical trial protocol vide no. MSN/SEMA/Phase-III/2024-2025, Version No. 2.0, Dated 03.03.2025 for Type 2 Diabetes Mellitus before the committee.
Semaglutide injection is in a class of medications called incretin mimetics. It works by helping the pancreas to release the right amount of insulin when blood sugar levels are high. Insulin helps move sugar from the blood into other body tissues where it is used for energy.
Semaglutide primarily works by mimicking the effects of the natural hormone GLP-1, a glucagon-like peptide-1 receptor agonist. It achieves this by activating GLP-1 receptors, which leads to several metabolic effects, including increased insulin secretion, reduced glucagon release, and slowed gastric emptying.
At the recent SEC meeting for Endocrinology and Metabolism held on 14th May 2025, the expert panel reviewed the Bioequivalence study report and revised clinical trial protocol vide no. MSN/SEMA/Phase-III/2024-2025, Version No. 2.0, Dated 03.03.2025 for Type 2 Diabetes Mellitus before the committee.
After detailed deliberation, the committee recommended to accept the BE Study report and recommended to conduct Phase III clinical trial as presented by the firm.
Also Read: CDSCO Panel Accepts BE Report, Tells Intas Pharma to Conduct Phase III Trial for Semaglutide
