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Shilpa Medicare Announces Positive Phase 3 Results for OERIS™ -- A Novel Once-Weekly Ondansetron Extended-Release Injection for Chemotherapy-Induced Nausea and Vomiting (CINV)
Shilpa Medicare Limited (BSE: 530549) (NSE: SHILPAMED) announced the successful completion of its fourth complex clinical program SMLINJ011, with positive topline Phase 3 results for Shilpa's OERIS™ (Ondansetron Extended-Release Injection)—an innovative formulation designed to improve prophylaxis of chemotherapy-induced nausea and vomiting (CINV).
About this update from Shilpa Medicare Limited
[{"type":"text","content":"Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections","length":171,"tagName":"p"},{"type":"text","content":"RAICHUR, India, Nov. 11, 2025 /PRNewswire/ -- Shilpa Medicare Limited (BSE: 530549) (NSE: SHILPAMED) announced the successful completion of its fourth complex clinical program SMLINJ011, with positive topline Phase 3 results for Shilpa's OERIS™ (Ondansetron Extended-Release Injection)—an innovative formulation designed to improve prophylaxis of chemotherapy-induced nausea and vomiting (CINV).","length":404,"tagName":"p"},{"type":"image","alt":"Shilpa Medicare Limited Logo","displaySize":"","headline":null,"caption":"Shilpa Medicare Limited Logo","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":126,"url":"https://media.zenfs.com/en/prnewswire.com/f939b94993067bbf4761a4f4b89263c3"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/alvVE1_m1Bo0TFjZ51v.gg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTIyMjtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/f939b94993067bbf4761a4f4b89263c3","width":400,"height":126}}},{"type":"text","content":"This milestone underscores Shilpa's growing leadership in differentiated drug-delivery systems and oncology supportive-care therapeutics, reflecting the company's commitment to advancing patient-centric innovation.","length":222,"tagName":"p"},{"type":"text","content":"Study Overview ","length":14,"tagName":"p"},{"type":"text","content":"A Phase III, multicenter, randomized, double-blind, non-inferiority trial was conducted across multiple oncology centers in India to compare OERIS™ with conventional ondansetron injections in 240 patients receiving moderately or highly emetogenic chemotherapy.","length":260,"tagName":"p"},{"type":"text","content":"Design & Endpoints","length":22,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Population: 240 patients with CINV","length":39,"tagName":"p"}]},{"val":[{"type":"text","content":"Primary Endpoint: Complete response (no emesis episodes through 120 hours post-chemotherapy)","length":92,"tagName":"p"}]},{"val":[{"type":"text","content":"Comparator: Multiple doses of conventional ondansetron injection","length":69,"tagName":"p"}]},{"val":[{"type":"tex...