Alkem Laboratories Gets CDSCO Panel Nod To Study Semaglutide solution for injection
New Delhi: Citing that the retinal examination (fundoscopy) shall be done periodically, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to the drug major Alkem Laboratories for conducting a Phase III clinical trial of semaglutide solution for injection 0.25mg {(1mg /1.5ml)(0.68 mg/ml)}, 0.5mg{(2mg/1.5ml) (1.34mg/ml)}, 1mg {(4mg/3ml)(1.34 mg/ml)}, 1.7mg{(6.8mg/3ml) (2.27mg/ml)} and 2.4mg{(9.6mg/3ml) (3.2mg/ml) (Synthetic origin).
This came after the firm presented the bioequivalence (BE) study waiver based on an earlier BE study report compared with Ozempic (RLD) and Phase-III CT (Protocol no. ALK39-SEM2, Version 1.0, Dated 23/Jul/2024) for weight management before the committee.
Semaglutide is a glucagon-like peptide 1 receptor agonist used to improve glycemic control in type 2 diabetes mellitus, treat obesity, and reduce the risk of major adverse cardiovascular events in selected adults.
GLP-1 is a physiological hormone that promotes glycemic control via several different mechanisms, including insulin secretion, slowing gastric emptying, and reducing postprandial glucagon secretion. The homeostasis of glucose is dependent on hormones such as insulin and amylin, which are secreted by the beta cells of the pancreas.
Semaglutide is 94% similar to human GLP-1. Analogs of this hormone such as semaglutide stimulate the synthesis of insulin by stimulating pancreatic islet cells and reducing glucagon secretion. They directly bind with selectivity to the GLP-1 receptor, causing various beneficial downstream effects that reduce blood glucose in a glucose-dependent fashion.
At the recent SEC meeting for endocrinology and metabolism held on 6th February 2025, the expert panel reviewed the proposal presented by Alkem Laboratories regarding the BE study waiver and Phase-III CT (Protocol no. ALK39-SEM2, Version 1.0, Dated 23/Jul/2024).
After detailed deliberation, the Committee recommended the grant of permission to conduct the Phase III CT Study with the following changes in the CT protocol:
ï‚· Retinal examination (fundoscopy) shall be done periodically.
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