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Drug

Ibrutinib

Approved · EMA
ClassTyrosine-protein kinase BTK inhibitorEmerging researchLate-stage development

Also known as Imbruvica.

2
Research papers
54
Active clinical trials
Tyrosine-protein kinase BTK
Primary target
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

PCI-32765CAN3001: A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study

Clinical trial2026-07-07Results expected Q4 2026 · ClinicalTrials.gov

Ibrutinib-Rituximab or Chemoimmunotherapy for Chronic Lymphocytic Leukemia.

Research2019-08-01The New England journal of medicine

Approval: Imbruvica (EMA)

Regulatory2014-10-21EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Ibrutinib
Aliases & brands
Imbruvica
RxNorm CUI
1442981
ChEMBL ID
CHEMBL1873475
ATC codes
L01EL01
UNII
1X70OSD4VX
Primary mechanism
Tyrosine-protein kinase BTK inhibitor
Regulatory jurisdictions
emamhra

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

INHIBITORTyrosine-protein kinase BTK inhibitor

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2014-10-21
Latest approval
2014-10-21
Authorities
EMA · MHRA
Total events
2
emaEuropean Medicines Agency· 1 event
2014-10-21Approval
Approval: Imbruvica (EMA)
Indication: Imbruvica in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (IMBRUVICA + R-CHOP) alternating with R-DHAP (or R-DHAOx) without Imbruvica,Show full indication

Imbruvica in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (IMBRUVICA + R-CHOP) alternating with R-DHAP (or R-DHAOx) without Imbruvica, followed by Imbruvica monotherapy, is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplantation (ASCT).Imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory MCL.Imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1).Imbruvica as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.Imbruvica as a single agent is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. IMBRUVICA in combination with rituximab is indicated for the treatment of adult patients with WM.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2017-08-15Safety communicationSafety
Drug Safety Update: Ibrutinib (Imbruvica▼): reports of ventricular tachyarrhythmia; risk of hepatitis B reactivation and of opportunistic infections
Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

188 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
188
registered trials across all phases
LATEST COMPLETION 2026
54
Active studies
18
Recruiting
29
Late-stage (III+)
88
Completed
46
Discontinued
PHASE DISTRIBUTIONn = 188
Phase 134Phase 1 / 234Phase 291Phase 2 / 31Phase 327Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20182019
Major research themes1
Immunotherapy1
Journals, researchers & institutions
Top journals
  • Future oncology (London, England)1
  • The New England journal of medicine1
Leading researchers
  • Atwal S1
  • Barr PM1
  • Barrientos J1
  • Braggio E1
  • Buske C1
  • Cashen AF1
  • Cohen A1
  • Coutre SE1
Leading institutions
free-text, unnormalised
  • From Stanford University1
  • Niguarda Cancer Center1
  • Peter MacCallum Cancer Center1
  • Pitié Salpêtrière Hospital1
  • Royal Melbourne Hospital1
  • St James' University Hospital1

Related drugs

4 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Studied across the same disease area as Ibrutinib in the shared literature.

1 shared disease1 shared paper

Studied across the same disease area as Ibrutinib in the shared literature.

1 shared disease1 shared paper

Studied across the same disease area as Ibrutinib in the shared literature.

1 shared disease1 shared paper

Studied across the same disease area as Ibrutinib in the shared literature.

1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.