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ONO-7913
ONO-7913 is a Small molecule drug developed by Ono Pharmaceutical Co. Ltd. It is currently in Phase 1 development. Also known as: Magrolimab.
ONO-7913 is a small molecule. It is being studied in combination with Venetoclax, Obinutuzumab, and Magrolimab for the treatment of various types of B-cell lymphomas, including Follicular Lymphoma, Marginal Zone Lymphoma, Mantle Cell Lymphoma, Chronic Lymphocytic Lymphoma, and B-Cell Lymphoma.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | ONO-7913 |
|---|---|
| Also known as | Magrolimab |
| Sponsor | Ono Pharmaceutical Co. Ltd |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Testing the Combination of Two Immunotherapy Drugs (Magrolimab and Dinutuximab) in Patients With Relapsed or Refractory Neuroblastoma or Relapsed Osteosarcoma (PHASE1)
- Testing the Addition of an Anti-cancer Drug, Hu5F9-G4 (Magrolimab), to the Usual Chemotherapy Treatment (Mogamulizumab) in T-Cell (a Type of Immune Cell) Lymphoma That Has Returned After Treatment or Does Not Respond to Treatment (PHASE1, PHASE2)
- Study of Magrolimab and Pembrolizumab in Relapsed or Refractory Classic Hodgkin Lymphoma (PHASE2)
- Venetoclax With Obinutuzumab and Magrolimab (VENOM) in Relapsed and Refractory Indolent B-cell Malignancies (PHASE1)
- An Open-label, Uncontrolled Study of ONO-7913 and ONO-4538 in Combination With Modified FOLFIRINOX Therapy, the Standard of Care, as First-line Treatment in Patients With Metastatic Pancreatic Cancer (PHASE1)
- The Study of ONO-7913, ONO-4538 and the Standard of Care as First-line Treatment in Patients Colorectal Cancer (PHASE1)
- ONO-7913 Phase I Study (ONO-7913) (PHASE1)
- Testing the Addition of Immunotherapy With Hu5F9-G4 (Magrolimab) to the Usual PARP Inhibitor, Olaparib for Treatment of Metastatic or Recurrent Breast or Castrate-Resistant Prostate Cancer With BRCA Mutations (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ONO-7913 CI brief — competitive landscape report
- ONO-7913 updates RSS · CI watch RSS
- Ono Pharmaceutical Co. Ltd portfolio CI
Frequently asked questions about ONO-7913
What is ONO-7913?
Who makes ONO-7913?
Is ONO-7913 also known as anything else?
What development phase is ONO-7913 in?
Related
- Manufacturer: Ono Pharmaceutical Co. Ltd — full pipeline
- Also known as: Magrolimab
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing