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.
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