Drug · Small Molecule

Ibrutinib

CI-DRUG-00000290Explore in graph →NCIt C81934 CHEMBL1873475 CIViC Approved

Regulatory

Approvals (41)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

emaRegulatory1 approval record · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	—	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.	approved	Oct 21, 2014	ema

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 14 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	84	20	39	277	41	CA, EU, US	Nov 13, 2013	2009-02
Non-Hodgkin Lymphoma	Approved	Phase 4	61	18	27	171	5	US	Nov 13, 2013	2010-05
Leukemia	Phase4	Phase 4	34	8	22	109	0	—	—	2009-02
Malignant Central Nervous System Neoplasm	Phase2	Phase 2	8	4	0	15	0

Curated evidence

Clinical evidence (12)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–12 of 12 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
BLK Expression1
Ibrutinib	B Acute Lymphoblastic Leukemia

Clinical trials

Trials with this intervention (285)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 285 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT06649812	Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma	recruiting	Phase 2	120	National Cancer Institute (NCI)NIH	1	Sep 29, 2026	clinicaltrials
NCT03223610	Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma	recruiting

Molecule

Record

Kind: Small Molecule
Mechanism: Tyrosine-protein kinase BTK inhibitor
Targets: 1 gene
UNII: 1X70OSD4VX
Aliases: 2-Propen-1-one, 1-((3R)-3-(4-amino-3-(4-phenoxyphenyl)-1h-pyrazolo(3,4-d)pyrimidin-1-yl)-1-piperidinyl)-, BTK Inhibitor PCI-32765, CRA 032765, CRA-032765, CRA032765, Ibrutinib, Imbruvica, IMBRUVICA, PC-32765, PCI 32765, PCI32765, PCI-32765-00

Data updated 17 hours agoSource updated unknown

Identifiers

Codes (14)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01EL01	IBRUTINIB
DIN (Health Canada)	02434407	IMBRUVICA
DIN (Health Canada)

BTK C481S2
Ibrutinib	Chronic Lymphocytic Leukemia	Predictive	B	Supports Resistance	4	accepted	EID436 Whole exome sequencing of 6 chronic lymphocytic leukemia patients with acquired resistance to ibrutinib determined 5/6 patients harbored a C481S mutation in BTK. PMID 24869598 · Woyach et al., 2014 · Open in CIViC	civic
〃	Chronic Lymphocytic Leukemia	Predictive	B	Supports Resistance	4	accepted	EID1770 In a trial of 308 patients with chronic lymphocytic leukemia treated with ibrutinib, 31 discontinued treatment due to disease progression (13 CLL progression, 18 Richter’s transformation). 11/13 patie… (full text at CIViC) PMID 26182309 · Maddocks et al., 2015 · Open in CIViC	civic