Shilpa Medicare Limited has announced the successful completion of its Phase 3 clinical trial for OERIS™ (Ondansetron Extended-Release Injection), a once-weekly injectable designed to prevent chemotherapy-induced nausea and vomiting (CINV). The pivotal Phase 3 study, SMLINJ011, met all primary and secondary endpoints, marking a key milestone for the company’s oncology-supportive care portfolio.
Study details and key findings
The multicenter, randomized, double-blind Phase 3 trial was conducted across leading oncology centers in India, enrolling 240 patients undergoing moderately or highly emetogenic chemotherapy.
- Primary endpoint: Complete response (no emesis episodes through 120 hours post-chemotherapy).
- Results: 89% of patients in the OERIS™ arm achieved a complete response versus 82% in the conventional ondansetron arm.
- Safety: No serious or severe adverse events reported; tolerability was equal to or better than the standard injection.
Innovation and patient convenience
OERIS™ offers a once-weekly formulation that replaces multiple daily doses of ondansetron, providing sustained relief through both the acute and delayed phases of CINV for up to five days. This simplifies treatment, enhances compliance, and reduces hospital resource usage.
Managing Director Vishnukant Bhutada stated, “OERIS™ exemplifies Shilpa’s ability to combine scientific innovation with patient-centric design. This strengthens our oncology supportive care portfolio and reinforces our vision to become a global leader in differentiated and specialty products focusing on patient convenience and compliance.”
Next steps and regulatory roadmap
Following the successful trial, Shilpa Medicare plans to submit the product to the DCGI for approval and pursue global registration through the 505(b)(2) pathway in the United States and other key markets.
About CINV
Chemotherapy-induced nausea and vomiting affect up to 70–80% of cancer patients, and poor symptom control often leads to treatment discontinuation and reduced quality of life. With a market size of USD 375 million, the segment continues to need long-acting, patient-friendly therapies like OERIS™.
Disclaimer: This release includes forward-looking statements subject to regulatory, market, and operational risks. Actual outcomes may differ based on approvals, clinical results, and market conditions.
