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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
Doctor of Pharmacy
Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751