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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Commercial
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 |
|---|---|---|---|---|
| SPRYCEL | Bristol Myers Squibb | N-021986 RX | 2006-06-28 | 6 products, RLD |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| sprycel | New Drug Application | 2018-12-21 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DASATINIB, SPRYCEL, BRISTOL MYERS SQUIBB | |||
| 2026-06-21 | PED | ||
| 2025-12-21 | ODE-225 | ||
| 2025-05-09 | PED | ||
| 2024-11-09 | ODE-164 | ||
HCPCS
No data
Clinical
Clinical Trials
319 clinical trials
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | 16 | 8 | — | — | 1 | 23 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 8 | 19 | — | — | — | 21 |
| Non-small-cell lung carcinoma | D002289 | 6 | 7 | — | — | — | 11 | ||
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 4 | 6 | — | — | — | 10 |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 5 | 7 | — | — | — | 10 | |
| Multiple myeloma | D009101 | C90.0 | 6 | 3 | — | — | — | 9 | |
| Myelodysplastic syndromes | D009190 | D46 | 4 | 4 | — | — | 1 | 8 | |
| Non-hodgkin lymphoma | D008228 | C85.9 | 6 | 2 | — | — | — | 7 | |
| Melanoma | D008545 | 1 | 6 | — | — | — | 6 | ||
| Glioblastoma | D005909 | EFO_0000515 | 4 | 3 | — | — | — | 6 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hodgkin disease | D006689 | C81 | 4 | — | — | — | — | 4 | |
| Waldenstrom macroglobulinemia | D008258 | C88.0 | 2 | — | — | — | — | 2 | |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | — | — | — | 1 | 2 |
| Anemia | D000740 | EFO_0004272 | D64.9 | 1 | — | — | — | — | 1 |
| Leukemia myeloid chronic atypical bcr-abl negative | D054438 | C92.2 | 1 | — | — | — | — | 1 | |
| Thrombocytosis | D013922 | D75.83 | 1 | — | — | — | — | 1 | |
| Bile duct neoplasms | D001650 | 1 | — | — | — | — | 1 | ||
| Gallbladder neoplasms | D005706 | EFO_0004606 | C23 | 1 | — | — | — | — | 1 |
| Mucinous adenocarcinoma | D002288 | 1 | — | — | — | — | 1 | ||
| Precursor t-cell lymphoblastic leukemia-lymphoma | D054218 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Transitional cell carcinoma | D002295 | — | — | — | — | 1 | 1 | ||
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | DASATINIB |
| INN | dasatinib |
| 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 class | tyrosine 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
| PDB | 7N9G |
| CAS-ID | 302962-49-8 |
| RxCUI | 1546019 |
| ChEMBL ID | CHEMBL1421 |
| ChEBI ID | 49375 |
| PubChem CID | 3062316 |
| DrugBank | DB01254 |
| UNII ID | X78UG0A0RN (ChemIDplus, GSRS) |
Target
Agency Approved
ABL1
ABL1
Organism
Homo sapiens
Gene name
ABL1
Gene synonyms
ABL, JTK7
NCBI Gene ID
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
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
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
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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