Dr Reddy's Gets SEC Nod for Higher Semaglutide Dose in Ongoing Phase III Study, Govt Sites Mandated
New Delhi: In response to the proposal presented by the Dr Reddy's Laboratories, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended for approval of inclusion of additional strength of the antidiabetic drug Semaglutide Injection 8 mg/3 mL (2.68 mg/mL).
However, this approval is subjected to the condition that 50% Clinical Trial Sites should be Government sites.
This came after the firm presented the proposal to include additional strength of Semaglutide Injection 8mg/3ml (delivers 2mg/dose for each injection) in the ongoing Phase III clinical trial study as per protocol no.: DRL-IND-NDA23-SEM/2024, which was approved vide permission no. CT/SND/13/2024 dated 18.09.2024 & subsequent amendment dated 26.11.2024.
In the matter, firm presented the revised Phase III clinical trial protocol vide no.: DRL-IND-NDA23-SEM/2024, version no. 2.2, dated 05.03.2025 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 proposal to include additional strength of Semaglutide Injection 8mg/3ml (delivers 2mg/dose for each injection) in the ongoing Phase III clinical trial study as per protocol no.: DRL-IND-NDA23-SEM/2024, which was approved vide permission no. CT/SND/13/2024 dated 18.09.2024 & subsequent amendment dated 26.11.2024.
After detailed deliberation, the committee recommended for approval of inclusion of additional strength as per the revised protocol vide no.: DRL-IND-NDA23-SEM/2024, version no. 2.2, dated 05.03.2025 with condition to 50% Clinical Trial Sites should be Government sites.
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