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AboutPricing
Drug ReportsDasatinib
Sprycel(dasatinib)
Dasatinib, Phyrago, 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 putative serine/threonine-protein kinase SIK1B, proto-oncogene tyrosine-protein kinase Src, serine/threonine-protein kinase SIK2, and serine/threonine-protein kinase SIK3.
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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Events
FDA approval date
EMA approval date
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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
hemic and lymphatic diseasesD006425
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Dasatinib, Phyrago, Sprycel
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
PHYRAGOHanda PharmaN-216099 RX2023-12-05
6 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
dasatinibANDA2025-03-04
dasatinib dasatinibANDA2025-02-25
phyragoNew Drug Application2024-12-13
sprycelNew Drug Application2024-07-31
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
myeloid leukemia—D007951C92
lymphoid leukemia—D007945C91
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
400 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_0000340—27506430107
LeukemiaD007938—C95304711228103
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.02838121675
Myeloid leukemia chronic-phaseD015466——1024431049
Lymphoid leukemiaD007945—C91162361343
Blast crisisD001752——95—1—14
Multiple myelomaD009101—C90.075—1—13
Hematologic neoplasmsD019337——33—1—6
Immunoblastic lymphadenopathyD007119EFO_1001350C86.53——1—4
Myeloproliferative disordersD009196—D47.11——1—2
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myeloid leukemiaD007951—C9216151—2147
Philadelphia chromosomeD010677——8132—222
Myeloid leukemia acuteD015470—C92.01191—320
Prostatic neoplasmsD011471—C614131——16
LymphomaD008223—C85.94101—113
Myeloid leukemia accelerated phaseD015465——711——9
Gastrointestinal stromal tumorsD046152EFO_0000505C49.A121—37
Precursor t-cell lymphoblastic leukemia-lymphomaD054218——431——7
Residual neoplasmD018365——131——4
Bronchiolitis obliterans syndromeD000092122—D89.811122——4
Show 6 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C802112——232
Breast neoplasmsD001943EFO_0003869C50819———21
RecurrenceD012008——911——220
B-cell chronic lymphocytic leukemiaD015451—C91.178———13
Neoplasm metastasisD009362EFO_0009708—49———13
Non-small-cell lung carcinomaD002289——68———12
Pancreatic neoplasmsD010190EFO_0003860C2546———10
Non-hodgkin lymphomaD008228—C85.975———10
Myelodysplastic syndromesD009190—D4644——18
Lung neoplasmsD008175—C34.9037———8
Show 114 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hodgkin diseaseD006689—C814————4
Waldenstrom macroglobulinemiaD008258—C88.04————4
Extranodal nk-t-cell lymphomaD054391—C86.03————3
Sezary syndromeD012751—C84.13————3
B-cell lymphoma marginal zoneD018442—C88.43————3
Follicular lymphomaD008224—C823————3
Mantle-cell lymphomaD020522—C83.13————3
Large-cell lymphoma anaplasticD017728—C84.63————3
Mycosis fungoidesD009182—C84.03————3
Hairy cell leukemiaD007943—C91.43————3
Show 37 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal insufficiencyD051437—N19————11
FatigueD005221—R53.83————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)Loading
Structure (InChI/SMILES or Protein Sequence)
Cc1nc(Nc2ncc(C(=O)Nc3c(C)cccc3Cl)s2)cc(N2CCN(CCO)CC2)n1
Identifiers
PDB—
CAS-ID302962-49-8
RxCUI1546019
ChEMBL IDCHEMBL1421
ChEBI ID49375
PubChem CID3062316
DrugBankDB01254
UNII IDX78UG0A0RN (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
SRC
SRC
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
No data
Financial
Revenue by drug
$
€
£
â‚£
Sprycel – Bristol Myers Squibb
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 25,243 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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36,636 adverse events reported
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