Sun Pharma Labs Gets CDSCO Panel Nod Phase-III clinical trial of Semaglutide solution for injection

New Delhi: Sun Pharma Labs has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase-III Clinical Trial of Semaglutide Solution for Injection (Synthetic Origin) 2 mg/1.5 ml, 4 mg/3 ml, 8 mg/3 ml.

This approval was accompanied by a modification to the study design requiring retinal examinations (fundoscopies) at every visit. This came after the firm presented the bioequivalence (BE) study report and revised Phase III clinical trial protocol for Type 2 diabetes mellitus before the Committee.

Semaglutide belongs to a class of medications known as glucagon-like peptide-1 receptor agonists, or GLP-1 RAs. It mimics the GLP-1 hormone, released in the gut in response to eating. Semaglutide improves the efficiency of incretin function by activating GLP-1 receptors. It acts by numerous mechanisms, like augmented insulin secretion (glucose-dependent), inhibition of glucagon release and suppressed hepatic gluconeogenesis, thereby reducing both fasting and postprandial glucose.