CDSCO Panel Accepts BE Report, Tells Intas Pharma to Conduct Phase III Trial for Semaglutide
New Delhi: In response to a proposal submitted by Intas Pharmaceuticals, the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended acceptance of the bioequivalence (BE) study report and granted permission to conduct a Phase III clinical trial for the antidiabetic drug Semaglutide as per the submitted protocol.
This came after the firm presented its proposal for the Phase III trial of Semaglutide injection in patients with Type 2 Diabetes Mellitus, along with the BE study report. The trial will be conducted according to protocol no. 0130-24, version 1.0, dated 03.02.2025.
Semaglutide is an incretin mimetic, classified as a glucagon-like peptide-1 (GLP-1) receptor agonist. It helps regulate blood sugar by enhancing glucose-dependent insulin secretion, suppressing glucagon, and delaying gastric emptying. These effects support both glycemic control and weight management.
At the recent SEC meeting for Endocrinology and Metabolism held on 14th May 2025, the expert panel reviewed the full submission.
“After detailed deliberation, the committee recommended accepting the BE study report and conducting the Phase III clinical trial as per the submitted protocol,” the SEC stated.
The proposed Semaglutide injection strengths include:
0.68 mg/mL (1 mg/1.5 mL), 1.34 mg/mL (2 mg/1.5 mL and 4 mg/3 mL), 2.27 mg/mL (6.8 mg/3 mL), and 3.2 mg/mL (9.6 mg/3 mL) in prefilled pens.
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