Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections

Shilpa Medicare Limited  announces its intention to pursue a US approval within the next two years and is actively seeking licensing partners for its Ondansetron Extended-Release Injection (OERIS™), following the successful completion of a Phase 3 study in India that met all primary and secondary endpoints. 

OERIS™ is a novel extended-release antiemetic [5-HT3 receptor antagonist] used in the treatment of patients with chemotherapy-induced nausea and vomiting (CINV). By blocking 5-HT3 receptors in the gastrointestinal tract and brain, the drug inhibits serotonin-induced vomiting signals.

The phase 3 study evaluated the extended release injection against conventional ondansetron injections – which require multiple daily doses or oral follow-ups – and demonstrated sustained antiemetic coverage through a single dose, effective in both acute and delayed phases of CINV for up to five days.

OERIS™ formulation is designed to prioritize safety and tolerability by delivering medication steadily over time, minimizing peak plasma concentrations that can trigger adverse effects like QTc prolongation or concentration-dependent issues such as constipation. This smooth release profile reduces fluctuations between peak and trough levels, lowering risks associated with conventional immediate-release ondansetron, including cardiac events or gastrointestinal side effects.

“By reducing injection frequency and simplifying dosing schedules, OERIS™ significantly enhances patient convenience, reduces treatment burden, and improves compliance while optimizing healthcare workflow efficiency. We are now in the process of filing for regulatory approval in India, and will then seek global registration and commercial partnerships through the 505(b)(2) pathway in the United States and other key markets,” commented Mr. Vishnukant Bhutada, Managing Director, Shilpa Medicare Limited. “OERIS™ exemplifies Shilpa’s ability to combine scientific innovation with patient-centric design, and is yet another success for one of our innovative oncology programmes.”