Sun Pharma Laboratories Receives CDSCO Panel Approval
Sun Pharma Laboratories has received approval from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) to conduct a phase III clinical study.
The study aims to evaluate the efficacy and safety of oral Semaglutide tablets compared to Rybelsus (Semaglutide) Tablets in Type 2 Diabetes Mellitus.
- Study title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Phase 3 Study
- Protocol Number: ICR/23/009, Version 2.0
- Date: 18.06.2025
The proposal was presented along with the results of the Bioavailability Study (SEM10524) conducted in India.
Author's summary: Sun Pharma gets approval for phase III study.
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