Cipla Gets CDSCO Panel Nod to Begin Phase III Study of Semaglutide Injection
New Delhi: Drug major Cipla Limited has received clearance from the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) to initiate a Phase III clinical trial for its Semaglutide Injection after the committee accepted the firm's Bioequivalence (BE) study results.
The approval covers multiple strengths of Semaglutide Injection, including 1 mg/1.5 ml (0.68 mg/ml), 2 mg/1.5 ml (1.34 mg/ml), 4 mg/3 ml (1.34 mg/ml), 6.8 mg/3 ml (2.27 mg/ml), and 9.6 mg/3 ml (3.2 mg/ml).
This decision comes in light of the SEC’s earlier recommendation dated 14 May 2025, wherein Cipla was advised to conduct a BE study and submit its results for evaluation prior to the initiation of the Phase III clinical trial.
At the recent meeting, the firm presented the BE study report before the Committee for review.
Earlier, the Medical Dialogues Team reported that during the SEC meeting for Endocrinology and Metabolism held on 14 May 2025, Cipla had presented the BE study protocol (Vide No. 0103-01-25, Version 03, dated 14.02.2025) along with the Phase III clinical trial protocol (Vide No. CP/08/24, Version 1.0, dated 07.01.2025) for the proposed indication of chronic weight management.
At that stage, the Committee had granted permission to conduct the BE study and advised that the BE study report be submitted to CDSCO for evaluation before commencement of Phase III trials.
Semaglutide Injection belongs to a class of medicines known as incretin mimetics and acts as a glucagon-like peptide-1 (GLP-1) receptor agonist. It works by stimulating insulin secretion when blood glucose levels are high, reducing glucagon release, and slowing gastric emptying, thereby improving glycaemic control and supporting weight management.
At the recent SEC meeting for Endocrinology and Metabolism held on 09.12.2025, the expert panel reviewed the BE study report presented by Cipla to initiate a Phase III clinical trial for its Semaglutide Injection.
After detailed deliberation, the Committee accepted the BE study results and recommended to initiate Phase III clinical trial as per the earlier SEC recommendation.
