Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections
RAICHUR, India, Nov. 11, 2025 /PRNewswire/ -- Shilpa Medicare Limited (BSE: 530549) (NSE: SHILPAMED) announced the successful completion of its fourth complex clinical program SMLINJ011, with positive topline Phase 3 results for Shilpa's OERIS (Ondansetron Extended-Release Injection)-an innovative formulation designed to improve prophylaxis of chemotherapy-induced nausea and vomiting (CINV).
This milestone underscores Shilpa's growing leadership in differentiated drug-delivery systems and oncology supportive-care therapeutics, reflecting the company's commitment to advancing patient-centric innovation.
Study Overview
A Phase III, multicenter, randomized, double-blind, non-inferiority trial was conducted across multiple oncology centers in India to compare OERIS with conventional ondansetron injections in 240 patients receiving moderately or highly emetogenic chemotherapy.
Design & Endpoints
- Population: 240 patients with CINV
- Primary Endpoint: Complete response (no emesis episodes through 120 hours post-chemotherapy)
- Comparator: Multiple doses of conventional ondansetron injection
- Secondary Endpoints: Safety profile, delayed-phase response, patient tolerability
Results
- Complete response: 89% in OERIS arm vs. 82% in standard ondansetron arm
- Adverse events: No serious or severe adverse events reported
- Safety: Comparable or better tolerability than conventional therapy
Transformative Innovation
OERIS offers extended antiemetic coverage through a single injection that effectively prevents both acute and delayed CINV for up to five days, eliminating the need for multiple daily doses or oral follow-ups. This innovation enhances patient convenience, improves compliance, and streamlines clinical workflow.
"We are proud to announce the successful completion of this pivotal Phase 3 study," said Mr. Vishnukant Bhutada, Managing Director, Shilpa Medicare Limited. "OERIS exemplifies Shilpa's ability to combine scientific innovation with patient-centric design, strengthening our oncology-supportive-care portfolio and our vision to become a global leader in specialty pharmaceuticals."
Next Steps
Shilpa plans to file for regulatory approval with the DCGI and pursue global registration and commercialization through the 505(b)(2) pathway in the US and other key markets.
About CINV
CINV affects up to 70-80% of patients undergoing chemotherapy, representing a market of approximately USD 375 million. Poorly controlled CINV can lead to treatment discontinuation and reduced quality of life, underscoring need for long-acting therapies such as OERIS.
About Shilpa Medicare Limited
Shilpa Medicare is a leading Indian pharmaceutical company specializing in APIs, formulations, and biologics across oncology and specialty segments. For more information, visit www.vbshilpa.com.
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