Shilpa Medicare reports positive Phase 3 results for OERIS

10 Nov 2025 Evaluate

Shilpa Medicare has successfully completed its fourth complex clinical program SMLINJ011, with positive top-line Phase 3 results for its OERIS (Ondansetron Extended?Release Injection) - an innovative formulation designed to improve prophylaxis of chemotherapy?induced nausea and vomiting (CINV). Following these positive Phase 3 results, the company is preparing for regulatory submission to DCGI (Drug Controller General of India) and plans to pursue global registration and commercial partnerships through the 505(b)(2) pathway in the United States and other key markets.

Unlike existing ondansetron formulations requiring multiple daily doses or oral follow?ups, OERIS delivers sustained antiemetic coverage through a single dose that effectively addresses both acute and delayed phases of CINV for up to five days. By reducing injection frequency and simplifying dosing schedules, OERIS significantly enhances patient convenience, reduces treatment burden, and improves compliance, while optimizing healthcare workflow efficiency.

Shilpa Medicare produces and exports consistently high-quality Active Pharmaceutical Ingredients Fine Chemicals, intermediates, herbal products and speciality chemical products using sophisticated technology, meticulously following international specifications.

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