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.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.