Last reviewed 2026-04-19 · How we verify

ONO-4578

At a glance

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• 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 (PHASE2)
• A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer) (PHASE2)
• ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer (PHASE1)
• Study of ONO-4578 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors (PHASE1)
• An Open-label, Uncontrolled Study of ONO-4578 and ONO-4538 in Combination With Standard-of-care Modified FOLFIRINOX (mFFX) or Gemcitabine Plus Nab-paclitaxel (GnP) Therapy as First-line Treatment in Patients With Metastatic Pancreatic Cancer (PHASE1)
• Study of ONO-4578 and XELOX/FOLFOX Plus Bevacizumab in Colorectal Cancer (PHASE1)
• An Open-label, Uncontrolled Study of ONO-4578 and ONO-4538 in Combination With Standard-of-care Docetaxel and Ramucirumab as Second-line Therapy in Patients With Advanced or Recurrent Non-small Cell Lung Cancer (PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• ONO-4578 CI brief — competitive landscape report
• ONO-4578 updates RSS · CI watch RSS
• Ono Pharmaceutical Co. Ltd portfolio CI