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Sprycel(dasatinib)
Sprycel (dasatinib) is a small molecule pharmaceutical. Dasatinib was first approved as Sprycel on 2006-06-28. It is used to treat lymphoid leukemia and myeloid leukemia in the USA. It has been approved in Europe to treat BCR-ABL positive chronic myelogenous leukemia and precursor cell lymphoblastic leukemia-lymphoma. The pharmaceutical is active against tyrosine-protein kinase ABL1. In addition, it is known to target proto-oncogene tyrosine-protein kinase Src, putative serine/threonine-protein kinase SIK1B, serine/threonine-protein kinase SIK2, and serine/threonine-protein kinase SIK3.
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Drugs Approved for Childhood Cancers
BMS
Top 200 Pharmaceuticals by Retail Sales
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Sprycel (generic drugs available since 2021-11-23)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dasatinib
Tradename
Company
Number
Date
Products
SPRYCELBristol Myers SquibbN-021986 RX2006-06-28
6 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
sprycelNew Drug Application2018-12-21
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
lymphoid leukemia—D007945C91
myeloid leukemia—D007951C92
Agency Specific
FDA
EMA
Expiration
Code
DASATINIB, SPRYCEL, BRISTOL MYERS SQUIBB
2026-06-21PED
2025-12-21ODE-225
2025-05-09PED
2024-11-09ODE-164
Patent Expiration
Patent
Expires
Flag
FDA Information
Dasatinib, Sprycel, Bristol Myers Squibb
74917252026-03-28DS, DP
86801032025-02-04DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EA: Bcr-abl tyrosine kinase inhibitors
— L01EA02: Dasatinib
HCPCS
No data
Clinical
Clinical Trials
319 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 leukemiaD015464EFO_0000340163262757
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.0172781350
Myeloid leukemia chronic-phaseD01546641333124
Hematologic neoplasmsD0193371——1—2
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938C959122—120
Myeloid leukemia acuteD015470C92.0871—215
Prostatic neoplasmsD011471C614121——15
Myeloid leukemia accelerated phaseD0154652—1——3
B-cell leukemiaD015448—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C80168——123
Breast neoplasmsD001943EFO_0003869C50819———21
Non-small-cell lung carcinomaD00228967———11
Pancreatic neoplasmsD010190EFO_0003860C2546———10
B-cell chronic lymphocytic leukemiaD015451C91.157———10
Multiple myelomaD009101C90.063———9
Myelodysplastic syndromesD009190D4644——18
Non-hodgkin lymphomaD008228C85.962———7
MelanomaD00854516———6
GlioblastomaD005909EFO_000051543———6
Show 79 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hodgkin diseaseD006689C814————4
Waldenstrom macroglobulinemiaD008258C88.02————2
Brain neoplasmsD001932EFO_0003833C711———12
AnemiaD000740EFO_0004272D64.91————1
Leukemia myeloid chronic atypical bcr-abl negativeD054438C92.21————1
ThrombocytosisD013922D75.831————1
Bile duct neoplasmsD0016501————1
Gallbladder neoplasmsD005706EFO_0004606C231————1
Mucinous adenocarcinomaD0022881————1
Precursor t-cell lymphoblastic leukemia-lymphomaD0542181————1
Show 25 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Transitional cell carcinomaD002295————11
Liver diseasesD008107EFO_0001421K70-K77————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDASATINIB
INNdasatinib
Description
Dasatinib (anhydrous) is an aminopyrimidine that is 2-methylpyrimidine which is substituted at position 4 by the primary amino group of 2-amino-1,3-thiazole-5-carboxylic acid and at position 6 by a 4-(2-hydroxyethyl)piperazin-1-yl group, and in which the carboxylic acid group has been formally condensed with 2-chloro-6-methylaniline to afford the corresponding amide. A multi-targeted kinase inhibitor, it is used, particularly as the monohydrate, for the treatment of chronic, accelerated, or myeloid or lymphoid blast phase chronic myeloid leukemia. Note that the name 'dasatinib' is used to refer to the monohydrate (USAN) as well as to anhydrous dasatinib (INN). It has a role as a tyrosine kinase inhibitor, an anticoronaviral agent and an antineoplastic agent. It is a secondary amino compound, a tertiary amino compound, an organochlorine compound, an aminopyrimidine, a member of 1,3-thiazoles, a monocarboxylic acid amide, a N-arylpiperazine and a N-(2-hydroxyethyl)piperazine. It is a conjugate base of a dasatinib(1+).
Classification
Small molecule
Drug classtyrosine kinase inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Cc1nc(Nc2ncc(C(=O)Nc3c(C)cccc3Cl)s2)cc(N2CCN(CCO)CC2)n1
Identifiers
PDB7N9G
CAS-ID302962-49-8
RxCUI1546019
ChEMBL IDCHEMBL1421
ChEBI ID49375
PubChem CID3062316
DrugBankDB01254
UNII IDX78UG0A0RN (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
SRC
SRC
LOC102724428
LOC102724428
SIK2
SIK2
SIK3
SIK3
Organism
Homo sapiens
Gene name
SRC
Gene synonyms
SRC1
NCBI Gene ID
6714
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
Q9H5A8
Mouse ortholog
Src (20779)
proto-oncogene tyrosine-protein kinase Src (Q2M4I4)
Variants
Clinical Variant
No data
Financial
Sprycel - Bristol Myers Squibb
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 18,940 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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15,550 adverse events reported
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