Archive · 11 Nov 2025
Shilpa Medicare Announces Positive Phase 3 Results for OERIS™ Ondansetron Injection
Imagine getting medicine to stop feeling sick after strong cancer treatments, like chemotherapy.
Normally, you might need several shots or pills every day.
Shilpa Medicare has developed a new medicine called OERIS™ that is given as just one shot.
This shot lasts for a whole week and helps stop both the immediate and later feelings of sickness.
A big study showed that this new shot worked very well, even better than the old way of giving medicine.
It helped 89 out of 100 patients feel completely fine, compared to 82 out of 100 with the old method.
The new medicine was also found to be safe and easy for patients to use, making it more convenient for them and doctors.
This could make life easier for people going through cancer treatment.
Shilpa Medicare's OERIS™ (Ondansetron Extended-Release Injection) has shown positive Phase 3 results for preventing chemotherapy-induced nausea and vomiting (CINV).
The Phase 3 study, involving 240 patients in India, met all primary and secondary endpoints.
OERIS™ demonstrated a complete response rate of 89% compared to 82% for conventional ondansetron injections.
The new injection offers a once-weekly dosing regimen, providing extended antiemetic coverage for up to five days with a single shot.
The company plans to file for regulatory approval and pursue global commercialization for OERIS™.
- Who
- Shilpa Medicare Limited
- What
- announced positive topline Phase 3 results for its novel, once-weekly ondansetron extended-release injection, OERIS™, demonstrating superior convenience, strong efficacy, and excellent safety.
- When
- November 11, 2025
- Where
- India (clinical trial conducted across multiple oncology centers)
- Why
- To evaluate the efficacy and safety of OERIS™ compared to conventional ondansetron injections for preventing chemotherapy-induced nausea and vomiting.
- Drug Name
- OERIS™ (Ondansetron Extended-Release Injection)
- Study Name
- SMLINJ011
- Disease Targeted
- Chemotherapy-Induced Nausea and Vomiting (CINV)
- Trial Phase
- Phase 3
- Number of Patients
- 240
- Primary Endpoint
- Complete response (no emesis episodes through 120 hours post-chemotherapy)
- Complete Response Rate (OERIS™)
- 89%
- Complete Response Rate (Standard Ondansetron)
- 82%