Shilpa Medicare is pursuing US approval within the next two years and is actively seeking licensing partners for its Ondansetron Extended-Release Injection (OERIS).
This follows the successful completion of a Phase III 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 III study evaluated the extended-release injection against conventional ondansetron injections, which require multiple daily doses or oral follow-ups.
OERIS demonstrated sustained antiemetic coverage through a single dose, effective in both the acute and delayed phases of CINV for up to five days.
CINV remains one of the most distressing side effects of cancer therapy, impacting up to 70-80% of patients undergoing moderately or highly emetogenic chemotherapy with a market size of ~£375m.
Poor control of CINV can lead to treatment discontinuation, nutritional imbalance and reduced quality of life.
Despite advances, patient compliance with multi-dose regimens remains a significant challenge — highlighting the need for long-acting solutions such as OERIS.
OERIS formulation is designed to prioritise safety and tolerability by delivering medication steadily with time, minimising peak plasma concentrations that can trigger adverse effects such as 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 optimising 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, 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."