Shilpa Medicare has planned to pursue regulatory approval in the United States 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 three clinical study in India.

The Phase three trial met all primary and secondary endpoints, demonstrating the efficacy and safety of OERIS, an extended-release antiemetic designed for the treatment of Chemotherapy-Induced Nausea and Vomiting (CINV). It is a 5-HT3 receptor antagonist that works by blocking serotonin-mediated vomiting signals in the gastrointestinal tract and central nervous system.

The study compared OERIS with conventional ondansetron injections, which typically require multiple daily doses or oral follow-up therapy. Results showed that a single dose of the medication provides sustained antiemetic coverage for up to five days, effectively managing both acute and delayed phases of CINV.

Commenting on the development, Vishnukant Bhutada, Managing Director of Shilpa Medicare Limited, said, “By reducing injection frequency and simplifying dosing schedules, OERIS significantly improves patient convenience, lowers treatment burden and enhances compliance, while also optimising healthcare workflow efficiency. We are in the process of filing for regulatory approval in India and will subsequently pursue global registrations and commercial partnerships via the 505(b)(2) pathway in the United States and other key markets.”

The drug has been formulated to enhance safety and tolerability by delivering ondansetron in a controlled, steady manner over time. This release profile helps minimise peak plasma concentrations associated with adverse effects such as QTc prolongation and reduces concentration-dependent side effects, including constipation. By limiting fluctuations between peak and trough drug levels, the formulation may lower the risk of cardiac and gastrointestinal events linked to immediate-release ondansetron.

CINV remains one of the most debilitating side effects of cancer treatment, affecting an estimated 70–80 percent of patients receiving moderately to highly emetogenic chemotherapy. The global market for CINV therapies is estimated to be worth approximately USD 375 million, underscoring the significant unmet need for more convenient and durable treatment options.