Sun Pharma Gets CDSCO Nod for Oral Semaglutide Trial

Sun Pharma Secures CDSCO Panel Approval to Conduct Phase III Study of Oral Semaglutide

Introduction

Indian pharmaceutical major Sun Pharma has received a green light from the expert panel under the CDSCO—specifically the Subject Expert Committee (SEC) for Endocrinology & Metabolism—to conduct a Phase III clinical study of its oral formulation of Semaglutide in India. This development marks an important step in the evolving treatment landscape of type 2 diabetes mellitus (T2DM) and potentially obesity, as semaglutide is a well-known GLP-1 receptor agonist. Medical Dialogues+1

What the Approval Entails

The approved trial is described as: “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”, protocol number ICR/23/009, version 2.0 dated 18.06.2025. Medical Dialogues+1
Sun Pharma had previously conducted a bioavailability study (SEM10524) in India which was part of the submission to the SEC. Medical Dialogues+1
The SEC has stipulated certain additional safety/monitoring conditions for the trial, including:
- Inclusion of Optical Coherence Tomography (OCT) as part of the eye examination. Medical Dialogues
- Exclusion of subjects with proliferative/unstable retinopathy and maculopathy. Medical Dialogues
- Fasting and post-prandial blood glucose monitoring to be used for dose titration, and HbA1c levels to be assessed after 8-12 weeks of treatment. Medical Dialogues

Why This Matters

Expanding treatment options: Semaglutide, originally developed as an injectable GLP-1 receptor agonist, has shown robust evidence in improving glycaemic control, reducing cardiovascular risk, and supporting weight management. By developing an oral version, Sun Pharma could offer a more convenient administration route for patients. Medical Dialogues+1
India-specific research: Conducting the Phase III trial in India allows data generation specific to the Indian population, which may aid regulatory and market access in India and globally.
Regulatory precedent: The fact that the SEC/CDSCO is approving protocols for oral semaglutide suggests a willingness to evaluate next-generation versions of established therapies.
Safety oversight emphasis: The additional conditions (especially ocular monitoring) show regulatory vigilance around potential adverse effects of GLP-1 drugs in Indian patients.

What’s Next

Sun Pharma will need to submit the revised protocol incorporating the SEC’s recommendations to CDSCO for final clearance before the trial begins. CDSCO+1
Once approved and commenced, the Phase III trial will assess both efficacy and safety of the oral semaglutide tablets relative to an existing branded product (Rybelsus®).
Data from this study could pave the way for a marketing application in India, and potentially globally, depending on regulatory strategy and patent status.

Considerations & Outlook

The success of the trial depends on recruitment, adherence, and safety outcomes, especially given the regulatory focus on certain subpopulations (e.g., those with retinopathy).
Market competition: With many companies exploring semaglutide analogues and orals, the competitive landscape will be intense.
Affordability and access: Assuming a successful outcome, factors like manufacturing cost, pricing strategy, and distribution will determine real-world impact in India.

Conclusion

The approval of Sun Pharma’s Phase III oral semaglutide trial by the CDSCO expert panel is a noteworthy milestone. It underscores India’s growing role in advanced clinical research and signals potential evolution in diabetes management with more patient-friendly dosing options. The eyes of the industry will now turn to how the trial proceeds, what the data show, and how quickly an oral version can reach patients.

Sources / Scientific References

“Sun Pharma Gets CDSCO Panel Approval to Conduct Phase III Study of Oral Semaglutide” — Medical Dialogues, 25 October 2025. Medical Dialogues
SEC (Endocrinology & Metabolism) meeting minutes dated 17.07.2025, documenting Sun Pharma’s protocol submission and recommendations. CDSCO
“Phase III Trial of Semaglutide Injection with Retinal Monitoring” — medpath.com, Jan 19 2025. MedPath

Recent pharma/clinical trial news