Intas Gets CDSCO Panel Nod to Conduct Phase III Trial of Semaglutide Injection for Weight Management
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has accepted the Bioequivalence (BE) study report and granted approval to Intas Pharmaceuticals Ltd to conduct a Phase III clinical trial of Semaglutide Injection (Synthetic Origin) for weight management.
The proposal, submitted under file number SND/CT/25/000025, was reviewed during the 10th/25th SEC meeting held on 08 May 2025 at CDSCO headquarters, New Delhi. The firm presented the application with Protocol No. 0131-24, Version 1.0, along with its BE study report.
Semaglutide, a GLP-1 receptor agonist, has been globally recognized for its efficacy in type 2 diabetes treatment and weight reduction. Intas’ proposal focused specifically on the weight management indication, backed by comparative bioequivalence data between its formulation and the reference product.
After detailed deliberation, the expert committee concluded that the bioequivalence data was satisfactory and recommended approval to proceed with the Phase III clinical trial as per the submitted protocol. The upcoming trial will assess the safety and efficacy of various strengths of semaglutide injection in the Indian population.
