Shilpa Medicare Unveils Breakthrough Phase 3 Success for OERIS: A Game-Changer in Chemotherapy-Induced Nausea Care

Updated: November 16, 2025 03:03

Image Source: The Economic Times

Shilpa Medicare announced positive Phase 3 clinical trial results for OERIS, a novel once-weekly ondansetron extended-release injection targeting chemotherapy-induced nausea and vomiting (CINV). The trial demonstrated superior efficacy, safety, and convenience, marking a milestone in supportive cancer therapy designed to enhance patient compliance and outcomes.

Shilpa Medicare Limited has reported successful completion of the pivotal Phase 3 study for OERIS™️, an innovative once-weekly ondansetron extended-release injection developed to prevent nausea and vomiting caused by chemotherapy. Conducted across multiple oncology centers in India among 240 patients receiving moderately or highly emetogenic chemotherapy, the randomized, double-blind trial met all primary and secondary endpoints.

Key efficacy outcomes revealed that 89% of patients administered OERIS achieved a complete response (no vomiting or need for rescue medication) within 120 hours, surpassing the 82% response rate in the conventional treatment group. Importantly, no serious adverse events were reported, underscoring OERIS's excellent safety profile.

OERIS offers extended antiemetic coverage through a single injection that lasts up to five days, effectively managing both acute and delayed phases of chemotherapy-induced nausea and vomiting. This extended-release formulation minimizes the need for daily dosing or oral follow-ups, providing convenience that improves patient adherence while streamlining clinical workflows.

The Managing Director of Shilpa Medicare, Vishnukant Bhutada, emphasized that OERIS exemplifies the company’s commitment to combining scientific innovation with patient-centric design. With plans to seek regulatory approval in India and pursue global commercialization, OERIS is positioned to bolster Shilpa Medicare’s leadership in oncology-supportive pharmaceuticals.

Important Points:

•⁠ ⁠Phase 3 trial involved 240 cancer patients undergoing moderate to highly emetogenic chemotherapy.

•⁠ ⁠OERIS achieved an 89% complete response rate vs. 82% in the standard treatment arm.

•⁠ ⁠No serious adverse events reported; excellent safety profile confirmed.

•⁠ ⁠Single injection provides up to five days of antiemetic protection covering acute and delayed CINV phases.

•⁠ ⁠Enhances patient convenience, compliance, and reduces the burden of multiple dosing.

•⁠ ⁠Strategic plans underway for regulatory submission in India and global market entry.

•⁠ ⁠Represents a significant advancement in supportive cancer care and oncology drug innovation.

Source: NSE Circular, Indian Pharma Post, PR Newswire, Shilpa Medicare official release.

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