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Bosulif(bosutinib)
Bosulif (bosutinib) is a small molecule pharmaceutical. Bosutinib was first approved as Bosulif on 2012-09-04. It is used to treat BCR-ABL positive chronic myelogenous leukemia in the USA. It has been approved in Europe to treat myeloid leukemia. The pharmaceutical is active against tyrosine-protein kinase ABL1. In addition, it is known to target serine/threonine-protein kinase 10, proto-oncogene tyrosine-protein kinase Src, serine/threonine-protein kinase 4, mitogen-activated protein kinase kinase kinase kinase 5, serine/threonine-protein kinase 24, activated CDC42 kinase 1, tyrosine-protein kinase Lyn, calcium/calmodulin-dependent protein kinase type 1D, tyrosine-protein kinase TXK, tyrosine-protein kinase Fyn, tyrosine-protein kinase FRK, calcium/calmodulin-dependent protein kinase type II subunit gamma, putative serine/threonine-protein kinase SIK1B, serine/threonine-protein kinase SIK2, and serine/threonine-protein kinase SIK3.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Bosulif
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Bosutinib monohydrate
Tradename
Company
Number
Date
Products
BOSULIFCV SciencesN-203341 RX2012-09-04
3 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
bosulifNew Drug Application2022-11-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
bcr-abl positive chronic myelogenous leukemiaEFO_0000340D015464—
Agency Specific
FDA
EMA
Expiration
Code
BOSUTINIB MONOHYDRATE, BOSULIF, PF PRISM CV
2024-12-19ODE-163
Patent Expiration
Patent
Expires
Flag
FDA Information
Bosutinib Monohydrate, Bosulif, Pf Prism Cv
111034972034-02-28U-3216, U-3217
77676782026-11-23DS, DP
74171482025-12-11U-1283
79196252025-12-11DP
RE423762024-04-13DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EA: Bcr-abl tyrosine kinase inhibitors
— L01EA04: Bosutinib
HCPCS
No data
Clinical
Clinical Trials
66 clinical trials
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Mock data
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_00003403104—521
LeukemiaD007938C95111——3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C5044———7
Myeloid leukemia chronic-phaseD01546634——16
NeoplasmsD009369C8031———4
Philadelphia chromosomeD01067711——12
DementiaD003704F0311———2
GlioblastomaD005909EFO_000051512———2
Pancreatic neoplasmsD010190EFO_0003860C2521———2
Non-hodgkin lymphomaD008228C85.9—1———1
Multiple myelomaD009101C90.0—1———1
Myeloid leukemia accelerated phaseD01546511———1
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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—16————16
Myeloid leukemia acuteD015470C92.01————1
Amyotrophic lateral sclerosisD000690EFO_0000253G12.211————1
Ovarian neoplasmsD010051EFO_0003893C561————1
Non-small-cell lung carcinomaD0022891————1
Urinary bladder neoplasmsD001749C671————1
Uterine cervical neoplasmsD0025831————1
ThymomaD0139451————1
Peritoneal neoplasmsD0105341————1
MesotheliomaD008654C451————1
Show 5 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myeloid leukemiaD007951C92————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBOSUTINIB
INNbosutinib
Description
Bosutinib is an aminoquinoline that is 4-[(2,4-dichloro-5-methoxyphenyl)amino]-7-[3-(4-methylpiperazin-1-yl)propoxy]quinoline bearing additional cyano and methoxy substituents at positions 3 and 6 respectively. It has a role as an antineoplastic agent and a tyrosine kinase inhibitor. It is a nitrile, a N-methylpiperazine, an aromatic ether, a tertiary amino compound, an aminoquinoline and a dichlorobenzene.
Classification
Small molecule
Drug classtyrosine kinase inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
COc1cc(Nc2c(C#N)cnc3cc(OCCCN4CCN(C)CC4)c(OC)cc23)c(Cl)cc1Cl
Identifiers
PDB3UE4
CAS-ID380843-75-4
RxCUI1307619
ChEMBL IDCHEMBL288441
ChEBI ID39112
PubChem CID5328940
DrugBankDB06616
UNII ID5018V4AEZ0 (ChemIDplus, GSRS)
Target
Agency Approved
ABL1
ABL1
Organism
Homo sapiens
Gene name
ABL1
Gene synonyms
ABL, JTK7
NCBI Gene ID
25
Protein name
tyrosine-protein kinase ABL1
Protein synonyms
Abelson murine leukemia viral oncogene homolog 1, Abelson tyrosine-protein kinase 1, ABL protooncogene 1 nonreceptor tyrosine kinase, BCR-ABL1 p190, BCR/ABL e8a2 fusion, BCR/ABL1 e1a2 fusion protein, bcr/c-abl oncogene protein, c-abl oncogene 1, receptor tyrosine kinase, p150, Proto-oncogene c-Abl, proto-oncogene tyrosine-protein kinase ABL1, v-abl Abelson murine leukemia viral oncogene homolog 1
Uniprot ID
Q45F09
Mouse ortholog
Abl1 (11350)
tyrosine-protein kinase ABL1 (P00520)
Alternate
STK10
STK10
SRC
SRC
STK4
STK4
MAP4K5
MAP4K5
STK24
STK24
TNK2
TNK2
LYN
LYN
CAMK1D
CAMK1D
TXK
TXK
FYN
FYN
FRK
FRK
CAMK2G
CAMK2G
LOC102724428
LOC102724428
SIK2
SIK2
SIK3
SIK3
Organism
Homo sapiens
Gene name
STK10
Gene synonyms
LOK
NCBI Gene ID
6793
Protein name
serine/threonine-protein kinase 10
Protein synonyms
Lymphocyte-oriented kinase
Uniprot ID
Q9UIW4
Mouse ortholog
Stk10 (20868)
serine/threonine-protein kinase 10 (O55098)
Variants
Clinical Variant
No data
Financial
Bosulif - Pfizer
$
€
£
₣
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,402 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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47,532 adverse events reported
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