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Drug ReportsIbrutinib
Imbruvica(ibrutinib)
Imbruvica (ibrutinib) is a small molecule pharmaceutical. Ibrutinib was first approved as Imbruvica on 2013-11-13. It is used to treat b-cell chronic lymphocytic leukemia, b-cell lymphoma, mantle-cell lymphoma, and waldenstrom macroglobulinemia in the USA. It has been approved in Europe to treat b-cell chronic lymphocytic leukemia and mantle-cell lymphoma. The pharmaceutical is active against tyrosine-protein kinase BTK. In addition, it is known to target tyrosine-protein kinase Fyn, epidermal growth factor receptor, tyrosine-protein kinase Tec, receptor tyrosine-protein kinase erbB-2, tyrosine-protein kinase Blk, tyrosine-protein kinase ITK/TSK, tyrosine-protein kinase Lyn, tyrosine-protein kinase Yes, proto-oncogene tyrosine-protein kinase Src, tyrosine-protein kinase TXK, tyrosine-protein kinase JAK3, receptor tyrosine-protein kinase erbB-4, cytoplasmic tyrosine-protein kinase BMX, tyrosine-protein kinase Lck, and tyrosine-protein kinase HCK.
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Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
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Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
cardiovascular diseasesD002318
hemic and lymphatic diseasesD006425
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Imbruvica (discontinued: Ibrutinib, Imbruvica)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ibrutinib
Tradename
Company
Number
Date
Products
IMBRUVICAPharmacyclicsN-205552 RX2013-11-13
2 products, RLD, RS
IMBRUVICAPharmacyclicsN-210563 RX2018-02-16
3 products, RLD, RS
IMBRUVICAPharmacyclicsN-217003 RX2022-08-24
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
imbruvicaNew Drug Application2025-10-21
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
b-cell chronic lymphocytic leukemia—D015451C91.1
mantle-cell lymphoma—D020522C83.1
waldenstrom macroglobulinemia—D008258C88.0
b-cell lymphoma—D016393—
Agency Specific
FDA
EMA
Expiration
Code
IBRUTINIB, IMBRUVICA, PHARMACYCLICS INC
2026-02-24PED
2025-08-24NP, NPP
2024-08-02ODE-152
2024-01-18ODE-128
2023-05-06ODE-117
2023-03-04ODE-109
2022-01-29ODE-86
2022-01-25M-236
Patent Expiration
Patent
Expires
Flag
FDA Information
Ibrutinib, Imbruvica, Pharmacyclics Inc
96558572036-03-03DP
100105072036-03-03DP
102133862036-03-03DP
108282592036-03-03DP
97956042034-10-24U-2150 , U-2969 , U-2969, U-2969, U-2969 , U-2969, U-2969, U-2970 , U-2970, U-2970, U-2970 , U-2970 , U-2970, U-3422
104636682034-10-24U-2654, U-2654, U-2654, U-2654, U-2654, U-2654
106953502034-10-24U-2846, U-2846, U-2846, U-2846, U-2846, U-2846
92967532033-10-30DP
95403822033-08-18U-1456, U-1456, U-1491, U-1650, U-1650, U-1684, U-1946, U-1946, U-1947, U-1947
97136172033-06-03DP
97254552033-06-03DP
101065482033-06-03DS, DP
101251402033-06-03DS, DP
102942312033-06-03DP
102942322033-06-03DP
107526342033-06-03DP
109612512033-06-03DP
87540902031-06-03U-1456, U-1456, U-1456, U-1456, U-1456, U-1456
89999992031-06-03U-1491, U-1491, U-1491, U-1491, U-1491, U-1683, U-1684, U-1946, U-1946, U-1946, U-1946, U-1946, U-2228, U-2241, U-2241, U-2241, U-2241, U-2242, U-2242, U-2242, U-2242
91258892031-06-03U-1650, U-1650, U-1650, U-1650, U-1650, U-1745
98018812031-06-03U-1491, U-1491, U-1491, U-1491, U-1491, U-1491, U-2242, U-2242, U-2242, U-2242
98018832031-06-03U-2159, U-2159, U-2159, U-2159, U-2159, U-2159, U-2243, U-2243, U-2243, U-2243
98147212031-06-03U-1947, U-1947, U-1947, U-1947, U-1947, U-1947
100047462031-06-03U-1684, U-1684, U-1684, U-1684, U-1684, U-1684, U-1946, U-1946, U-1946, U-1946, U-1946, U-1946, U-2241, U-2241, U-2241, U-2241, U-2241, U-2241, U-2242, U-2242, U-2242, U-2242, U-2242, U-2242
100164352031-06-03U-1650, U-1650, U-1650, U-1650, U-1650, U-1650
104784392031-06-03U-1456, U-1456, U-1456, U-1456, U-1456, U-1456, U-1650, U-1650, U-1650, U-1650, U-1650, U-1650, U-1684, U-1684, U-1684, U-1684, U-1684, U-1684, U-1946, U-1946, U-1946, U-1946, U-1946, U-1946, U-1947, U-1947, U-1947, U-1947, U-1947, U-1947, U-2241, U-2241, U-2241, U-2241, U-2241, U-2241, U-2242, U-2242, U-2242, U-2242, U-2242, U-2242, U-2665, U-2665, U-2665, U-2665, U-2665, U-2665, U-3422, U-3422, U-3422, U-3422, U-3422, U-3422
106536962031-06-03U-1456, U-1456, U-1456, U-1456, U-1456, U-1456
107513422031-06-03U-1491, U-1491, U-1491, U-1491, U-1491, U-1491, U-1946, U-1946, U-1946, U-1946, U-1946, U-1946, U-2943, U-2943, U-2943, U-2943, U-2943, U-2943, U-2944, U-2944, U-2944, U-2944, U-2944, U-2944
80083092027-11-13DS, DP
85635632027-04-26U-1491, U-1491, U-1491, U-1491, U-1491, U-1491, U-1650, U-1650, U-1650, U-1650, U-1650, U-1650, U-1946, U-1946, U-1946, U-1946, U-1946, U-1946, U-2219, U-2219, U-2241, U-2241, U-2241, U-2241, U-2242, U-2242, U-2242, U-2242
75144442026-12-28DS, DP
84762842026-12-28U-1456, U-1456, U-1456, U-1456, U-1456, U-1456, U-1650, U-1650, U-1650, U-1650, U-1650, U-1650, U-1946, U-1946, U-1946, U-1946, U-1946, U-1946, U-1947, U-1947, U-1947, U-1947, U-1947, U-1947, U-2241, U-2241, U-2241, U-2241
84972772026-12-28U-1456 , U-1456 , U-1456, U-1456 , U-1456 , U-1456 , U-1491 , U-1491, U-1491, U-1491 , U-1491 , U-1491 , U-1650 , U-1650 , U-1650, U-1650 , U-1650, U-1650, U-1946 , U-1946, U-1946, U-1946 , U-1946 , U-1946 , U-1947 , U-1947 , U-1947, U-1947 , U-1947 , U-1947 , U-2241, U-2241 , U-2241 , U-2241, U-2242, U-2242 , U-2242 , U-2242 , U-3422
86977112026-12-28DS, DP
87037802026-12-28U-1491, U-1491, U-1491, U-1491, U-1491, U-1491, U-2242, U-2242, U-2242, U-2242
87354032026-12-28DS, DP
87540912026-12-28DP
89520152026-12-28U-1456, U-1456, U-1456, U-1456, U-1456, U-1456, U-1491, U-1491, U-1491, U-1491, U-1491, U-1491, U-1650, U-1650, U-1650, U-1650, U-1650, U-1650, U-1946, U-1946, U-1946, U-1946, U-1946, U-1946, U-1947, U-1947, U-1947, U-1947, U-1947, U-1947, U-2241, U-2241, U-2241, U-2241, U-2242, U-2242, U-2242, U-2242
89570792026-12-28DS, DP
91812572026-12-28DS, DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EL: Bruton's tyrosine kinase (btk) inhibitors
— L01EL01: Ibrutinib
HCPCS
No data
Clinical
Clinical Trials
424 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
B-cell chronic lymphocytic leukemiaD015451—C91.1568525123166
Mantle-cell lymphomaD020522—C83.131421011283
B-cell lymphomaD016393——192761146
Waldenstrom macroglobulinemiaD008258—C88.0141752135
Non-hodgkin lymphomaD008228—C85.9161761—34
NeoplasmsD009369—C80109—1520
Graft vs host diseaseD006086—D89.813751114
Multiple myelomaD009101—C90.065—1—10
B-cell leukemiaD015448——3211—6
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223—C85.9526917—12127
LeukemiaD007938—C95344813—1695
Lymphoid leukemiaD007945—C91324114—1790
Large b-cell lymphoma diffuseD016403—C83.329264——45
Follicular lymphomaD008224—C8216184——31
RecurrenceD012008——13141—123
B-cell lymphoma marginal zoneD018442—C88.410132——21
Bronchiolitis obliterans syndromeD000092122—D89.811385——13
Myeloid leukemia acuteD015470—C92.0431——7
AnemiaD000740EFO_0004272D64.9131—16
Show 15 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———112———13
Hematologic neoplasmsD019337——65——311
Prolymphocytic leukemiaD015463——47———9
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.046———8
Reactive arthritisD016918EFO_0007460M02.336———8
Plasma cell neoplasmsD054219——46———7
SyndromeD013577——33———6
Burkitt lymphomaD002051—C83.743———6
Central nervous system neoplasmsD016543——34———6
Hodgkin diseaseD006689—C81—6———6
Show 59 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelodysplastic syndromesD009190—D465————5
PreleukemiaD011289——3————3
T-cell lymphomaD016399——2————2
T-cell lymphoma peripheralD016411——2————2
Prolymphocytic leukemia b-cellD054403—C91.32————2
GlioblastomaD005909EFO_0000515—2————2
Myelomonocytic leukemia chronicD015477—C93.11————1
Myelomonocytic leukemia juvenileD054429—C93.31————1
Refractory anemia with excess of blastsD000754—D46.21————1
Refractory anemiaD000753—D46.41————1
Show 19 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Atrial fibrillationD001281EFO_0000275I48.0————55
Sudden death cardiacD016757EFO_0004278—————22
ThrombocytopeniaD013921HP_0001873D69.6————11
LeukopeniaD007970EFO_0004233D72.819————11
CytopeniaD000095542——————11
EchocardiographyD004452——————11
Physiological phenomenaD010829——————11
Gastrointestinal microbiomeD000069196——————11
Nervous system diseasesD009422—G00-G99————11
Rheumatic diseasesD012216—M79.0————11
Show 20 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameIbrutinib
INNibrutinib
Description
Ibrutinib is a member of the class of acrylamides that is (3R)-3-[4-amino-3-(4-phenoxyphenyl)pyrazolo[3,4-d]pyrimidin-1-yl]piperidine in which the piperidine nitrogen is replaced by an acryloyl group. A selective and covalent inhibitor of the enzyme Bruton's tyrosine kinase, it is used for treatment of B-cell malignancies. It has a role as an EC 2.7.10.2 (non-specific protein-tyrosine kinase) inhibitor and an antineoplastic agent. It is a pyrazolopyrimidine, an aromatic amine, an aromatic ether, a member of acrylamides, a N-acylpiperidine and a tertiary carboxamide.
Classification
Small molecule
Drug classtyrosine kinase inhibitors: Bruton's (Btk) inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
C=CC(=O)N1CCC[C@@H](n2nc(-c3ccc(Oc4ccccc4)cc3)c3c(N)ncnc32)C1
Identifiers
PDB—
CAS-ID936563-96-1
RxCUI—
ChEMBL IDCHEMBL1873475
ChEBI ID76612
PubChem CID24821094
DrugBankDB09053
UNII ID1X70OSD4VX (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
BMX
BMX
BLK
BLK
FYN
FYN
TEC
TEC
SRC
SRC
JAK3
JAK3
ERBB4
ERBB4
HCK
HCK
Organism
Homo sapiens
Gene name
BMX
Gene synonyms
NCBI Gene ID
660
Protein name
cytoplasmic tyrosine-protein kinase BMX
Protein synonyms
Bone marrow tyrosine kinase gene in chromosome X protein, BTK-like on X chromosome, Epithelial and endothelial tyrosine kinase, ETK, Etk/Bmx cytosolic tyrosine kinase, NTK38, NTK38 tyrosine kinase
Uniprot ID
P51813
Mouse ortholog
Bmx (12169)
cytoplasmic tyrosine-protein kinase BMX (P97504)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Imbruvica – Pharmacyclics
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Imbruvica – AbbVie
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Imbruvica – Johnson & Johnson
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,999 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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77,512 adverse events reported
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