Shilpa Medicare announces positive Phase 3 results for Oeris

OERIS offers extended antiemetic coverage through a single injection that effectively prevents both acute and delayed CINV for up to five days

Shilpa Medicare has announced positive topline Phase 3 results for its novel drug OERIS (Ondansetron Extended-Release Injection), a once-weekly injection for the prevention of chemotherapy-induced nausea and vomiting (CINV).

The multicenter, randomized, double-blind trial, conducted across multiple oncology centers in India, evaluated 240 patients receiving moderately or highly emetogenic chemotherapy. Results showed a complete response in 89% of patients treated with OERIS, compared to 82% in the conventional treatment arm, with no serious adverse events reported. By providing extended antiemetic coverage for up to five days through a single injection, OERIS not only enhances patient convenience and compliance but also streamlines clinical workflows—a breakthrough in supportive cancer care.

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 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."

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.