Shilpa Medicare Limited is targeting US approval for its Ondansetron Extended-Release Injection (OERIS), following a successful Phase 3 study in India that met all primary and secondary endpoints. The study demonstrated sustained efficacy, improved safety, and enhanced patient convenience compared with conventional ondansetron injections.

OERIS, a 5-HT3 receptor antagonist, provides sustained antiemetic coverage for up to five days through a single dose, effective in both acute and delayed phases of chemotherapy-induced nausea and vomiting (CINV). The extended-release formulation delivers medication steadily, reducing peak plasma concentrations that can trigger adverse effects such as QTc prolongation or gastrointestinal issues. This approach also simplifies dosing schedules compared with conventional ondansetron, which requires multiple daily injections or oral follow-ups.

“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,” said Vishnukant Bhutada, managing director of 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.”

The company is actively seeking licensing partners to support US approval and subsequent commercialisation. OERIS is part of Shilpa Medicare’s broader oncology pipeline, reflecting a focus on therapies that balance clinical efficacy with patient-friendly treatment formats.