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.
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