Macleods Gets CDSCO Panel Go Ahead For Semaglutide Trials, Preclinical Data Sought
New Delhi: The Subject Expert Committee (SEC) on Endocrinology and Metabolism, operating under the Central Drugs Standard Control Organisation (CDSCO), has given in-principle approval to the bioequivalence (BE) study protocol and Phase III clinical trial protocol for Semaglutide injection submitted by Macleods Pharmaceuticals Ltd.
At its 8th meeting of 2025, held on 22nd April, the committee reviewed the firm’s submissions for the treatment of weight management. These included:
BE study protocol (Protocol No. BEQ-3990-SEMA-2025, Version 01)
Phase III clinical trial protocol (Protocol No. CT-065-SEMA-2025, Version 01)
While the panel agreed in principle with both protocols, it also directed the firm to submit and present the preclinical subacute toxicity study report before initiating the BE study. It noted;
"After detailed deliberation, the Committee in principle agreed with presented BE protocol and Phase III CT protocol and recommended that firm should submit and present preclinical subacute toxicity study report before initiation of BE study."
According to the submission, the preclinical subacute toxicity study involving two species is currently ongoing.
Semaglutide, an incretin mimetic, acts by mimicking the hormone GLP-1, stimulating insulin secretion, reducing hepatic glucose output, slowing gastric emptying, and suppressing appetite. It is associated with improved glycemic control, weight loss, and a potential reduction in cardiovascular risk.
The application covers multiple strengths of Semaglutide injection, including:
0.25 mg, 0.5 mg, 1 mg (4 mg/3 mL pre-filled pen)
1.7 mg, 2.4 mg (9.6 mg/3 mL pre-filled pen)
The SEC's final approval remains conditional upon the submission of the toxicity study data.
