Shilpa Medicare Announces Positive Phase 3 Results for OERIS™ — A Novel Once-Weekly Ondansetron Extended-Release Injection for Chemotherapy-Induced Nausea and Vomiting
Shilpa Medicare Limited has announced the successful completion of its fourth complex clinical program, SMLINJO11, with positive topline Phase 3 results for Shilpa’s OERIS™ (Ondansetron Extended-Release Injection). This novel formulation is designed to improve prophylaxis of chemotherapy-induced nausea and vomiting (CINV). The Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections. OERIS™ delivers sustained antiemetic coverage through a single dose, enhancing patient convenience, reducing treatment burden, and improving compliance. 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.
Key Highlights
- Shilpa Medicare announces positive Phase 3 results for OERIS™, a novel once-weekly ondansetron extended-release injection for CINV
- Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections
- OERIS™ delivers sustained antiemetic coverage through a single dose, enhancing patient convenience, reducing treatment burden, and improving compliance
- Shilpa Medicare 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
- 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