Sun Pharma Gets CDSCO Panel Approval to Conduct Phase III Study of Oral Semaglutide
New Delhi: Pharmaceutical major Sun Pharma Laboratories has got the go ahead from the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) to conduct the phase III clinical study to evaluate the efficacy and safety of oral Semaglutide tablets of Sun Pharma Laboratories in comparison to Rybelsus (Semaglutide) Tablets in Type 2 Diabetes Mellitus.
This came after the drug major Sun Pharma Laboratories presented the proposal to conduct Phase III clinical trial titled “A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Oral Semaglutide Tablets of Sun Pharma Laboratories Limited in Comparison to Rybelsus (Semaglutide) Tablets in Type 2 Diabetes Mellitus” as per Protocol Number-ICR/23/009, Version 2.0 dated 18.06.2025 along with the results of Bioavailability Study (SEM10524) conducted in India by the firm in India.
However, following a thorough review, the expert panel suggested to include Optical Coherence Tomography (OCT) as part of the eye examination. Furtermore, the committee stated that subjects with proliferative/unstable retinopathy and maculopathy to be excluded from the trial.
In addition to the above, the expert panel suggested that fasting and postprandial blood glucose monitoring should be used for dose titration and HbA1c levels should be assessed after completion of 08-12 weeks of study treatment.
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 17th July 2025, the expert panel reviewed the proposal presented by Sun Pharma Laboratories to conduct Phase III clinical trial titled “A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Oral Semaglutide Tablets of Sun Pharma Laboratories Limited in Comparison to Rybelsus (Semaglutide) Tablets in Type 2 Diabetes Mellitus” along with the results of Bioavailability Study (SEM10524) conducted in India by the firm in India.
After detailed deliberation, the committee recommended grant of permission to conduct the Phase III clinical trial as per the presented protocol with the following changes:
1. Inclusion of Optical Coherence Tomography (OCT) as part of the eye examination.
2. Subjects with proliferative/unstable retinopathy and maculopathy to be excluded from the trial.
3. Fasting and postprandial blood glucose monitoring should be used for dose titration. HbA1c levels should be assessed after completion of 08-12 weeks of study treatment.
In line with the above, the expert panel suggested the firm to submit revised protocol to CDSCO for further evaluation.
