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JNJ-54179060
JNJ-54179060 is a Small molecule drug developed by Janssen Research & Development, LLC. It is currently in Phase 1 development. Also known as: ibrutinib.
JNJ-54179060 is being studied in clinical trials for various blood cancers, including chronic lymphocytic leukemia, non-Hodgkin lymphoma, mantle-cell lymphoma, and Waldenstrom macroglobulinemia. The exact mechanism of JNJ-54179060 is unknown, as its modality is listed as "Unknown" in the ChEMBL database.
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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). -
Big-pharma sponsor
+3.0pp
Janssen Research & Development, LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | JNJ-54179060 |
|---|---|
| Also known as | ibrutinib |
| Sponsor | Janssen Research & Development, LLC |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia (PHASE2)
- A Long-term Extension Study of PCI-32765 (Ibrutinib) (PHASE3)
- A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring (PHASE1)
- A Study of Ibrutinib With Rituximab in Relapsed or Refractory Mantle Cell Lymphoma (PHASE2)
- A Study of the MALT1 Inhibitor JNJ-67856633 and Ibrutinib in Combination in B-cell NHL and CLL (PHASE1)
- A Study of Ibrutinib (PCI-32765) in Chinese Participants With Relapse or Refractory Waldenstrom's Macroglobulinemia (WM) (PHASE4)
- A Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of the Combination of Ibrutinib With Nivolumab in Participants With Hematologic Malignancies (PHASE1, PHASE2)
- A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma (PHASE3)
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:
- JNJ-54179060 CI brief — competitive landscape report
- JNJ-54179060 updates RSS · CI watch RSS
- Janssen Research & Development, LLC portfolio CI
Frequently asked questions about JNJ-54179060
What is JNJ-54179060?
Who makes JNJ-54179060?
Is JNJ-54179060 also known as anything else?
What development phase is JNJ-54179060 in?
Related
- Manufacturer: Janssen Research & Development, LLC — full pipeline
- Also known as: ibrutinib
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing