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.
Semaglutide injection is used to treat type 2 diabetes. It is used together with diet and exercise to help control your blood sugar. This medicine is also used to lower the risk of heart attack, stroke, or death in patients with type 2 diabetes, obesity, and heart or blood vessel disease.
At the recent SEC for Endocrinology and Metabolism held on 13th January 2025, the expert panel reviewed the BE study report and revised Phase-III clinical trial protocol for type 2 diabetes mellitus.
After detailed deliberation, the Committee recommended accepting the BE study report and recommended conducting the Phase-III clinical trial with the following change in the study protocol:
ï‚· Retinal examination (fundoscopy) should be done at each visit.
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