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 cytoplasmic tyrosine-protein kinase BMX, tyrosine-protein kinase Blk, tyrosine-protein kinase Fyn, epidermal growth factor receptor, tyrosine-protein kinase Tec, receptor tyrosine-protein kinase erbB-2, 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, tyrosine-protein kinase Lck, and tyrosine-protein kinase HCK.

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Therapeutic Areas

Therapeutic Area	MeSH
neoplasms	D009369
cardiovascular diseases	D002318
hemic and lymphatic diseases	D006425
immune system diseases	D007154
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Imbruvica (generic drugs available since 2021-03-31)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Ibrutinib

Tradename	Company	Number	Date	Products
IMBRUVICA	Pharmacyclics	N-205552 RX	2013-11-13	2 products, RLD, RS
IMBRUVICA	Pharmacyclics	N-210563 RX	2018-02-16	4 products, RLD, RS
IMBRUVICA	Pharmacyclics	N-217003 RX	2022-08-24	1 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
imbruvica	New Drug Application	2020-12-05

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
b-cell chronic lymphocytic leukemia	—	D015451	C91.1
b-cell lymphoma	—	D016393	—
mantle-cell lymphoma	—	D020522	C83.1
waldenstrom macroglobulinemia	—	D008258	C88.0

Agency Specific

FDA

EMA

Expiration	Code
IBRUTINIB, IMBRUVICA, PHARMACYCLICS INC
2026-02-24	PED
2025-08-24	NP, NPP
2024-08-02	ODE-152
2024-01-18	ODE-128
2023-05-06	ODE-117
2023-03-04	ODE-109
2022-01-29	ODE-86
2022-01-25	M-236

Patent Expiration

Patent	Expires	Flag	FDA Information
Ibrutinib, Imbruvica, Pharmacyclics Inc
9655857	2036-03-03	DP
10010507	2036-03-03	DP
10213386	2036-03-03	DP
10828259	2036-03-03	DP
9795604	2034-10-24		U-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
10463668	2034-10-24		U-2654, U-2654, U-2654, U-2654, U-2654, U-2654
10695350	2034-10-24		U-2846, U-2846, U-2846, U-2846, U-2846, U-2846
9296753	2033-10-30	DP
9540382	2033-08-18		U-1456, U-1456, U-1491, U-1650, U-1650, U-1684, U-1946, U-1946, U-1947, U-1947
9713617	2033-06-03	DP
9725455	2033-06-03	DP
10106548	2033-06-03	DS, DP
10125140	2033-06-03	DS, DP
10294231	2033-06-03	DP
10294232	2033-06-03	DP
10752634	2033-06-03	DP
10961251	2033-06-03	DP
8754090	2031-06-03		U-1456, U-1456, U-1456, U-1456, U-1456, U-1456
8999999	2031-06-03		U-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
9125889	2031-06-03		U-1650, U-1650, U-1650, U-1650, U-1650, U-1745
9801881	2031-06-03		U-1491, U-1491, U-1491, U-1491, U-1491, U-1491, U-2242, U-2242, U-2242, U-2242
9801883	2031-06-03		U-2159, U-2159, U-2159, U-2159, U-2159, U-2159, U-2243, U-2243, U-2243, U-2243
9814721	2031-06-03		U-1947, U-1947, U-1947, U-1947, U-1947, U-1947
10004746	2031-06-03		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-2241, U-2241, U-2241, U-2241, U-2241, U-2241, U-2242, U-2242, U-2242, U-2242, U-2242, U-2242
10016435	2031-06-03		U-1650, U-1650, U-1650, U-1650, U-1650, U-1650
10478439	2031-06-03		U-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
10653696	2031-06-03		U-1456, U-1456, U-1456, U-1456, U-1456, U-1456
10751342	2031-06-03		U-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
8008309	2027-11-13	DS, DP
8563563	2027-04-26		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-2219, U-2219, U-2241, U-2241, U-2241, U-2241, U-2242, U-2242, U-2242, U-2242
7514444	2026-12-28	DS, DP
8476284	2026-12-28		U-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
8497277	2026-12-28		U-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
8697711	2026-12-28	DS, DP
8703780	2026-12-28		U-1491, U-1491, U-1491, U-1491, U-1491, U-1491, U-2242, U-2242, U-2242, U-2242
8735403	2026-12-28	DS, DP
8754091	2026-12-28	DP
8952015	2026-12-28		U-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
8957079	2026-12-28	DS, DP
9181257	2026-12-28	DS, 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

337 clinical trials

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Indications Phases 4

Indication	MeSH	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
B-cell chronic lymphocytic leukemia	D015451	C91.1	41	62	22	1	9	118
Mantle-cell lymphoma	D020522	C83.1	26	30	10	1	3	60
Waldenstrom macroglobulinemia	D008258	C88.0	8	13	6	1	—	26
Non-hodgkin lymphoma	D008228	C85.9	9	9	2	1	—	19
B-cell lymphoma	D016393		3	5	1	1	—	10
Neoplasms	D009369	C80	4	4	—	1	—	7
Graft vs host disease	D006086	D89.81	2	4	2	1	—	7
B-cell leukemia	D015448		1	—	1	1	—	3

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Large b-cell lymphoma diffuse	D016403		C83.3	24	17	2	—	—	34
Follicular lymphoma	D008224		C82	13	13	3	—	—	25
Lymphoma	D008223		C85.9	7	7	3	—	—	14
Lymphoid leukemia	D007945		C91	1	3	1	—	—	5
Myeloid leukemia acute	D015470		C92.0	1	3	1	—	—	4
Pancreatic neoplasms	D010190	EFO_0003860	C25	2	2	1	—	—	3
Prolymphocytic leukemia t-cell	D015461		C91.6	—	2	1	—	—	3
Anemia	D000740	EFO_0004272	D64.9	1	—	1	—	—	2
Chronic hepatitis b	D019694	EFO_0004197	B18.1	—	—	1	—	—	1
Immune system diseases	D007154		D89.9	—	—	1	—	—	1

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Multiple myeloma	D009101		C90.0	5	5	—	—	—	7
Reactive arthritis	D016918	EFO_0007460	M02.3	2	5	—	—	—	7
Leukemia	D007938		C95	1	7	—	—	—	7
Precursor cell lymphoblastic leukemia-lymphoma	D054198		C91.0	2	3	—	—	—	5
Prolymphocytic leukemia	D015463			2	4	—	—	—	5
B-cell lymphoma marginal zone	D018442		C88.4	2	3	—	—	—	5
Burkitt lymphoma	D002051		C83.7	4	2	—	—	—	5
Hodgkin disease	D006689		C81	—	5	—	—	—	5
Myelodysplastic syndromes	D009190		D46	2	1	—	—	—	3
Hematologic neoplasms	D019337			3	2	—	—	—	3

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—			11	—	—	—	—	11
Prolymphocytic leukemia b-cell	D054403		C91.3	2	—	—	—	—	2
Glioblastoma	D005909	EFO_0000515		2	—	—	—	—	2
Myelomonocytic leukemia chronic	D015477		C93.1	1	—	—	—	—	1
T-cell lymphoma peripheral	D016411		C84.9	1	—	—	—	—	1
Aids-related lymphoma	D016483	EFO_1001365		1	—	—	—	—	1
T-cell lymphoma	D016399			1	—	—	—	—	1
Hiv infections	D015658	EFO_0000764	B20	1	—	—	—	—	1
Castleman disease	D005871	EFO_1001332	D47.Z2	1	—	—	—	—	1
Lymphomatoid granulomatosis	D008230		C83.8	1	—	—	—	—	1

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Indications Without Phase

No data

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	IBRUTINIB
INN	ibrutinib
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 class	tyrosine kinase inhibitors: Bruton's (Btk) inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	C=CC(=O)N1CCC[C@@H](n2nc(-c3ccc(Oc4ccccc4)cc3)c3c(N)ncnc32)C1

Identifiers

PDB	6L8L
CAS-ID	936563-96-1
RxCUI	1442981
ChEMBL ID	CHEMBL1873475
ChEBI ID	76612
PubChem CID	24821094
DrugBank	DB09053
UNII ID	1X70OSD4VX (ChemIDplus, GSRS)

Target

Agency Approved

BTK

Organism

Homo sapiens

Gene name

BTK

Gene synonyms

AGMX1, ATK, BPK

NCBI Gene ID

695

Protein name

tyrosine-protein kinase BTK

Protein synonyms

agammaglobulinaemia tyrosine kinase, Agammaglobulinemia tyrosine kinase, ATK, B-cell progenitor kinase, BPK, Bruton agammaglobulinemia tyrosine kinase, Bruton tyrosine kinase, Bruton's tyrosine kinase, dominant-negative kinase-deficient Brutons tyrosine kinase

Uniprot ID

Q32ML5

Mouse ortholog

Btk (12229)

tyrosine-protein kinase BTK (Q61365)

Alternate

BMX

BLK

FYN

EGFR

TEC

ERBB2

ITK

LYN

YES1

SRC

TXK

JAK3

ERBB4

LCK

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

Clinical Variant

No data

Financial

Imbruvica - Pharmacyclics

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Imbruvica - AbbVie

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Imbruvica - Johnson & Johnson

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Tabular view

Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Additional graphs summarizing 10,609 documents

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Safety

Black-box Warning

No Black-box warning

Adverse Events

Top Adverse Reactions

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1,912 adverse events reported

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