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.

health-canada-dpdRegulatory41 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as IMBRUVICA (DIN 02540215) under ATC L01EL01 IBRUTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Nov 13, 2023	health-canada-dpd
CA Health Canada	—	Marketed in Canada as IMBRUVICA (DIN 02434407) under ATC L01EL01 IBRUTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Nov 19, 2014	health-canada-dpd
CA Health Canada	—	Marketed in Canada as IMBRUVICA (DIN 02486776) under ATC L01EL01 IBRUTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd

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 18 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
NCT03223610	Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma	recruiting	Phase 1 / Phase 2	155	National Cancer Institute (NCI)NIH	1	Sep 28, 2026	clinicaltrials
NCT03462719	A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

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 21 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