Shilpa Medicare Advances OERIS Ondansetron Injection Toward US Market

Shilpa Medicare Limited is preparing to seek US approval for its Ondansetron Extended-Release Injection (OERIS) within the next two years and is actively exploring licensing partners.

The decision follows a successful Phase 3 trial in India, with OERIS achieving all its primary and secondary endpoint, indicating its potential as a breakthrough therapy to treat chemotherapy-induced nausea and vomiting (CINV).

OERIS is a sustained-release serotonin 5-HT3 receptor antagonist, which is intended to prevent serotonin transmission both in the gut and in the brain and provides long-term relief against acute and delayed CINV.

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As opposed to traditional ondansetron injections, which need repeated doses or subsequent oral therapy, OERIS provides effective antiemetic protection with only single-dose injections lasting up to five days and thus makes the treatment of patients and medical professionals very simple.

The formulation is also safer and more tolerable with a sustained and steady drug release that decreases high peak plasma concentrations that cause adverse effects such as QTc prolongation, constipation, or other concentration-related effects. OERIS reduces chances of cardiac as well as gastrointestinal side effects that are a common occurrence with immediate-release ondansetron by lessening fluctuations between peak and trough levels.

“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,” said Vishnukant Bhutada, Managing Director, Shilpa Medicare Limited.

OERIS reflects Shilpa Medicare’s commitment to scientific innovation and patient-centric oncology solutions, marking another milestone in the company’s growing portfolio of advanced cancer therapies.