Sun Pharma Receives CDSCO Approval for Phase IV Trial of High-Dose Esomeprazole Dual Release Formulation
Key Insights
Sun Pharma received CDSCO (search) panel approval to conduct a Phase IV clinical trial for Esomeprazole Dual Release gastro-resistant tablets 80 mg following detailed committee deliberation.
The dual release formulation is designed to provide prolonged acid suppression for improved therapeutic outcomes in acid-related gastrointestinal disorders including GERD (search) and peptic ulcer disease (search).
This post-marketing clinical investigation will generate additional safety and efficacy data under routine clinical use conditions for the higher-dose specialized formulation.
Sun Pharma Laboratories Limited has secured approval from India's Central Drugs Standard Control Organisation (CDSCO (search)) to proceed with a Phase IV clinical trial of its Esomeprazole Dual Release gastro-resistant tablets 80 mg, marking a significant step in post-marketing surveillance for this specialized proton pump inhibitor formulation.
CDSCO Committee Approval
The approval came during the 12th/25 SEC (Gastroenterology & Hepatology) meeting held on August 20, 2025, at CDSCO (search) headquarters. The committee examined Sun Pharma's revised Phase IV clinical trial protocol, which was presented under the SND Division in continuation with an earlier SEC recommendation dated February 27, 2025.
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."
Therapeutic Significance
Esomeprazole is a proton pump inhibitor widely used to reduce gastric acid secretion. The dual release formulation represents an advancement in PPI technology, designed to offer prolonged acid suppression that could potentially improve therapeutic outcomes in acid-related gastrointestinal disorders such as gastroesophageal reflux disease (search) (GERD (search)) and peptic ulcer disease (search).
Post-Marketing Investigation Framework
The Phase IV trial represents a post-marketing clinical investigation intended to generate additional safety and efficacy data under routine clinical use conditions. This approach aligns with regulatory requirements for monitoring the real-world performance of higher-dose or specialized formulations, ensuring that the 80 mg dual release formulation maintains its safety and efficacy profile in diverse patient populations.
Regulatory Pathway Forward
The SEC's decision clears the regulatory pathway for Sun Pharma 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. This approval represents the culmination of a regulatory review process that began with earlier committee recommendations and involved careful examination of the revised protocol.