Cipla Gets CDSCO Panel Nod To BE Study, Phase III Trial of Semaglutide for Weight Management
New Delhi: Drug major Cipla has received approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the BE study and Phase III Clinical Trial of Semaglutide Injection, 1 mg/1.5 ml (0.68 mg/ml), 2 mg/1.5 ml (1.34 mg/ml), 4 mg/3 ml (1.34 mg/ml), 6.8 mg/3 ml (2.27 mg/ml) and 9.6 mg/3 ml (3.2 mg /ml).
In addition, the committee recommended the firm to submit BE Study report to CDSCO and BE report should be evaluated from the committee before initiation of Phase-III Clinical Trial.
This came after the firm presented BE study protocol vide no. 0103-01-25 Version No. 03, Dated 14.02.2025 and Phase III CT study protocol vide no. CP/08/24 Version No. 1.0, dated 07.01.2025 for Chronic Weight Management 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 May 14, 2025, the expert panel reviewed BE study protocol vide no. 0103-01-25 Version No. 03, Dated 14.02.2025 and Phase III CT study protocol vide no. CP/08/24 Version No. 1.0, dated 07.01.2025 for Chronic Weight Management before the Committee.
After detailed deliberation, the Committee recommended for grant of permission to conduct the BE study and Phase III Clinical Trial as per the Protocol presented.
"Further, the firm should submit BE Study report to CDSCO and BE report should be evaluated from the committee before initiation of Phase-III Clinical Trial," the expert panel noted.
Also Read: Macleods Gets CDSCO Panel Go Ahead For Semaglutide Trials, Preclinical Data Sought
