Sun Pharma Gets CDSCO Panel Nod for Phase IV Trial of Esomeprazole Dual Release Tablets 80 mg
New Delhi: Sun Pharma has received approval from the Subject Expert Committee (SEC), under the Central Drugs Standard Control Organisation (CDSCO), to conduct a Phase IV clinical trial of Esomeprazole Dual Release Gastro-resistant Tablets 80 mg, based on its revised study protocol.
According to the minutes of the 12th/25 SEC (Gastroenterology & Hepatology) meeting held on August 20, 2025, at CDSCO headquarters, the proposal was taken up under the SND Division.
In continuation with earlier SEC (Gastroenterology & Hepatology) recommendation dated 27/02/2025, the firm presented revised protocol for Phase-IV clinical trial of Esomeprazole Dual release gastro-resistant tablets 80 mg before the Committee.
The committee carefully examined the revised Phase IV clinical trial protocol presented by Sun Pharma. After detailed deliberation, the SEC issued its recommendation, stating:
“After detailed deliberation, the Committee recommended to grant the permission to conduct Phase IV clinical trial as per protocol presented by the firm.”
Esomeprazole is a proton pump inhibitor (PPI) widely used to reduce gastric acid secretion. Dual release formulations are designed to offer prolonged acid suppression, potentially improving therapeutic outcomes in acid-related gastrointestinal disorders such as gastroesophageal reflux disease (GERD) and peptic ulcer disease.
The Phase IV trial represents a post-marketing clinical investigation intended to generate additional safety and efficacy data under routine clinical use conditions. This aligns with regulatory requirements for monitoring the real-world performance of higher-dose or specialized formulations.
The SEC’s decision clears the way for Sun Pharma Laboratories Limited to move forward with its Phase IV clinical trial of Esomeprazole Dual Release Gastro-resistant Tablets 80 mg in accordance with the approved study protocol.
