ONO Pharmaceutical Co Ltd (JP:4528)
:4528
Bevacizumab, Oxaliplatin, Leucovorin, 5-Fluorouracil, Ono-4578, Opdivo
Colorectal Cancer
Phase II
Recruiting
A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer
Apr 21, 2025
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does ONO Pharmaceutical Co Ltd (4528) have in its pipeline
4528 is currently developing the following drugs: Tirabrutinib, Rituximab, Temozolomide, Tirabrutinib, Bevacizumab, Oxaliplatin, Leucovorin, 5-Fluorouracil, Ono-4578, Opdivo. These drug candidates are in various stages of clinical development as the company works toward FDA approval.