Shilpa Medicare Announces Positive Phase 3 Results for OERIS™

* Shilpa Medicare Limited announced positive Phase 3 results for OERIS™ (Ondansetron Extended-Release Injection), a novel once-weekly injection for Chemotherapy-Induced Nausea and Vomiting (CINV). * The Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety compared to conventional ondansetron injections. * The study was a multicenter, randomized, double-blind, non-inferiority trial conducted across multiple oncology centers in India with 240 patients. * 89% of patients in the OERIS™ arm achieved a complete response (no emesis episodes through 120 hours post-chemotherapy) compared to 82% in the standard ondansetron arm. * No serious or severe adverse events were reported, and OERIS™ showed comparable or better tolerability than conventional therapy. * Shilpa Medicare is preparing for regulatory submission to DCGI and plans to pursue global registration and commercial partnerships through the 505(b)(2) pathway in the United States and other key markets. * Mr. Vishnukant Bhutada, Managing Director, stated that OERIS™ exemplifies Shilpa’s ability to combine scientific innovation with patient-centric design, strengthening their oncology-supportive-care portfolio.