Shilpa Medicare’s OERIS Shows Strong Phase 3 Results For Chemotherapy-Induced Nausea Relief

Shilpa Medicare Ltd., a leading pharmaceutical company based in Raichur, Karnataka, has reported positive topline results from its Phase 3 clinical trial for OERIS (Ondansetron Extended-Release Injection). This novel formulation is designed to offer once-weekly prophylaxis for chemotherapy-induced nausea and vomiting (CINV), a common and distressing side effect of cancer treatment.

The multicenter, randomized, double-blind trial compared OERIS with standard ondansetron injections across 240 patients undergoing moderately or highly emetogenic chemotherapy.

Major Takeaways From The Trial Results:  

• The Phase 3 study met all primary and secondary endpoints, confirming efficacy and safety  
• OERIS achieved a complete response rate of 89 percent, compared to 82 percent in the control arm  
• No serious or severe adverse events were reported, reinforcing the safety profile  
• The once-weekly dosing offers improved convenience over daily or multiple-dose regimens  
• The trial was conducted across multiple oncology centers in India under protocol SMLINJ011  
• OERIS is part of Shilpa’s oncology supportive-care portfolio, reflecting its focus on differentiated drug delivery systems  
• The company plans to pursue regulatory approvals and commercial rollout following these results

This milestone strengthens Shilpa Medicare’s position in oncology therapeutics and highlights its commitment to patient-centric innovation.

Sources: WebIndia123, PTI News, Lokmat Times, Business Upturn