Sun Pharma's Phase IV Study on Dual Release Pantoprazole for GERD Gets CDSCO Panel Acceptance
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has accepted the results of Sun Pharma's Phase IV clinical trial on Dual Release Gastro-Resistant Pantoprazole 80mg for the treatment of partial or non-responders to standard proton pump inhibitor (PPI) doses in gastroesophageal reflux disease (GERD). The panel noted that the findings will not be used for regulatory approvals.
The trial, titled “Dual Release Gastro-Resistant Pantoprazole 80mg for Treatment of Partial or Non-Responders to Standard Dose of Proton Pump Inhibitor (PPI) in Gastroesophageal Reflux Disease (GERD) – A Prospective pH-Metry/Impedance Controlled Study”, was reviewed at the SEC (Gastroenterology & Hepatology) meeting held on 24 July 2025.
Sun Pharma informed the committee that the study was conducted solely to generate additional data and information, not for regulatory submissions.
Pantoprazole, a proton pump inhibitor, works by binding irreversibly and specifically to the proton pump, reducing gastric acid secretion. It is used to treat erosive esophagitis and other conditions involving excess stomach acid, including GERD.
After detailed deliberation, the SEC recommended: “To accept the result of the Phase IV CT study and same may not be used for regulatory approvals.”
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