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 calcium/calmodulin-dependent protein kinase type 1D, serine/threonine-protein kinase 24, tyrosine-protein kinase Fyn, activated CDC42 kinase 1, serine/threonine-protein kinase 4, putative serine/threonine-protein kinase SIK1B, serine/threonine-protein kinase 10, calcium/calmodulin-dependent protein kinase type II subunit gamma, mitogen-activated protein kinase kinase kinase kinase 5, serine/threonine-protein kinase SIK2, serine/threonine-protein kinase SIK3, tyrosine-protein kinase TXK, proto-oncogene tyrosine-protein kinase Src, tyrosine-protein kinase FRK, and tyrosine-protein kinase Lyn.
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Commercial
Therapeutic Areas
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 |
|---|---|---|---|---|
| BOSULIF | CV Sciences | N-217729 RX | 2023-09-26 | 2 products, RLD, RS |
| BOSULIF | CV Sciences | N-203341 RX | 2012-09-04 | 3 products, RLD |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| bosulif | New Drug Application | 2024-12-19 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| bcr-abl positive chronic myelogenous leukemia | EFO_0000340 | D015464 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
BOSUTINIB MONOHYDRATE, BOSULIF, PF PRISM CV | |||
| 2024-12-19 | ODE-163 | ||
HCPCS
No data
Clinical
Clinical Trials
77 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 3 | 7 | 2 | 1 | 5 | 16 |
| Myeloid leukemia | D007951 | — | C92 | 2 | 6 | 1 | 1 | 6 | 14 |
| Leukemia | D007938 | — | C95 | 2 | 6 | 2 | 1 | 3 | 12 |
| Philadelphia chromosome | D010677 | — | — | 2 | 3 | 1 | 1 | — | 6 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia chronic-phase | D015466 | — | — | 2 | 5 | 1 | — | — | 6 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 4 | — | — | — | 5 |
| Neoplasms | D009369 | — | C80 | 1 | 2 | — | — | — | 3 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | 2 | — | — | — | 2 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | — | 1 | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | — | 1 | — | — | — | 1 |
| Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | 1 | 1 | — | — | — | 1 |
| Motor neuron disease | D016472 | EFO_0003782 | G12.2 | 1 | 1 | — | — | — | 1 |
| Sclerosis | D012598 | — | — | 1 | 1 | — | — | — | 1 |
| Myeloid leukemia accelerated phase | D015465 | — | — | 1 | 1 | — | — | — | 1 |
| Blast crisis | D001752 | — | — | 1 | 1 | — | — | — | 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 | — | — | — | 6 | — | — | — | — | 6 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 2 | — | — | — | — | 2 |
| Dementia | D003704 | EFO_0003862 | F03 | 1 | — | — | — | — | 1 |
| Cognitive dysfunction | D060825 | — | G31.84 | 1 | — | — | — | — | 1 |
| Chronic renal insufficiency | D051436 | — | N18 | 1 | — | — | — | — | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
| Acute kidney injury | D058186 | — | N17 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Bosutinib |
| INN | bosutinib |
| 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 class | tyrosine 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
| PDB | — |
| CAS-ID | 380843-75-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL288441 |
| ChEBI ID | 39112 |
| PubChem CID | 5328940 |
| DrugBank | DB06616 |
| UNII ID | 5018V4AEZ0 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
SRC
SRC
TNK2
TNK2
CAMK1D
CAMK1D
FYN
FYN
CAMK2G
CAMK2G
Organism
Homo sapiens
Gene name
SRC
Gene synonyms
SRC1
NCBI Gene ID
Protein name
proto-oncogene tyrosine-protein kinase Src
Protein synonyms
p60-Src, pp60c-src, Proto-oncogene c-Src, protooncogene SRC, Rous sarcoma, tyrosine kinase pp60c-src, tyrosine-protein kinase SRC-1, v-src avian sarcoma (Schmidt-Ruppin A-2) viral oncogene homolog
Uniprot ID
Mouse ortholog
Src (20779)
proto-oncogene tyrosine-protein kinase Src (Q2M4I4)
Variants
No data
Financial
Revenue by drug
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Bosulif – Pfizer
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Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,263 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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7,708 adverse events reported
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