Shilpa Medicare targets US approval of 5-HT3 receptor antiemetic for chemotherapy-induced nausea and vomiting (CINV)

Shilpa Medicare targets US approval of 5-HT3 receptor antiemetic for chemotherapy-induced nausea and vomiting (CINV)

Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections

Raichur & Hyderabad, India – 08.01.2026:  Shilpa Medicare Limited (BSE: 530549 | NSE: SHILPAMED) announces its intention to pursue a US approval 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 3 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 3 study evaluated the extended release injection against conventional ondansetron injections – which require multiple daily doses or oral follow-ups – and demonstrated sustained antiemetic coverage through a single dose, effective in both acute and delayed phases of CINV for up to five days.

OERIS™ formulation is designed to prioritize safety and tolerability by delivering medication steadily over time, minimizing peak plasma concentrations that can trigger adverse effects like 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 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,” commented Mr. 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.”

-ENDS-

Notes to editors

Study Overview and Key Findings

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

About Chemotherapy-Induced Nausea and Vomiting (CINV)

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 market size of ~USD 375 Million. 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 like OERIS™.

About Shilpa Medicare Limited

Shilpa Medicare Limited (BSE: 530549 | NSE: SHILPAMED) is a leading Indian pharmaceutical company focused on the development, manufacture, and marketing of APIs, formulations, and biologics across oncology, infectious diseases, and specialty segments. With expertise in complex generics, novel drug delivery systems, and CDMO services, Shilpa serves patients in over 80 countries. For more information, visit www.vbshilpa.com