CDSCO Panel approves Zydus Lifesciences to study Semaglutide Injection
New Delhi: Accepting the bioequivalence study report for Type 2 Diabetes Mellitus, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has recommended Zydus Lifesciences conduct a Phase III clinical trial of Semaglutide Injection 15mg/3ml (synthetic origin).
This recommendation follows the modification in the study protocol stating that retinal examination (fundoscopy) shall be done periodically. This came after Zydus Lifesciences presented a bioequivalence study report 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 injection is used to treat type 2 diabetes. It is used together with diet and exercise to help control 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.
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.
At the recent SEC meeting for endocrinology and metabolism held on 6th February 2025, the expert panel reviewed the firm's presented bioequivalence (BE) study report for type 2 diabetes mellitus before the committee.
After detailed deliberation, the committee recommended accepting the BE Study report and recommended conducting a Phase III clinical trial with the following changes in the study protocol:
ï‚· Retinal examination (fundoscopy) shall be done periodically.
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