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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Commercial
Therapeutic Areas
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 |
|---|---|---|---|---|
| SPRYCEL | Bristol Myers Squibb | N-021986 RX | 2006-06-28 | 6 products, RLD |
| PHYRAGO | Handa Pharma | N-216099 RX | 2023-12-05 | 6 products, RLD |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| dasatinib | ANDA | 2025-03-04 |
| dasatinib dasatinib | ANDA | 2025-02-25 |
| phyrago | New Drug Application | 2024-12-13 |
| sprycel | New Drug Application | 2024-07-31 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| myeloid leukemia | — | D007951 | C92 |
| lymphoid leukemia | — | D007945 | C91 |
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
393 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 17 | 28 | 6 | 1 | 9 | 53 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 11 | 18 | 6 | 1 | 10 | 41 |
| Myeloid leukemia | D007951 | — | C92 | 11 | 18 | 5 | 1 | 7 | 38 |
| Myeloid leukemia chronic-phase | D015466 | — | — | 3 | 4 | 2 | 1 | 3 | 13 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoid leukemia | D007945 | — | C91 | 5 | 10 | 1 | — | — | 12 |
| Philadelphia chromosome | D010677 | — | — | 4 | 7 | 2 | — | — | 10 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 3 | 5 | 2 | — | — | 8 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | 6 | 1 | — | — | 7 |
| Myeloid leukemia accelerated phase | D015465 | — | — | — | 1 | 1 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 6 | 13 | — | — | — | 14 |
| Neoplasms | D009369 | — | C80 | 8 | 3 | — | — | — | 11 |
| Non-small-cell lung carcinoma | D002289 | — | — | 4 | 7 | — | — | — | 9 |
| Lung neoplasms | D008175 | — | C34.90 | 3 | 5 | — | — | — | 6 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 3 | 5 | — | — | — | 6 |
| Lymphoma | D008223 | — | C85.9 | 1 | 4 | — | — | 1 | 5 |
| Glioblastoma | D005909 | EFO_0000515 | — | 5 | 2 | — | — | — | 5 |
| Blast crisis | D001752 | — | — | 2 | 3 | — | — | — | 4 |
| Multiple myeloma | D009101 | — | C90.0 | 2 | 1 | — | — | — | 3 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | 3 | — | — | — | 3 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Plasma cell neoplasms | D054219 | — | — | 2 | — | — | — | — | 2 |
| Colorectal neoplasms | D015179 | — | — | 2 | — | — | — | — | 2 |
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Gliosarcoma | D018316 | — | — | 2 | — | — | — | — | 2 |
| Head and neck neoplasms | D006258 | — | — | 1 | — | — | — | — | 1 |
| Waldenstrom macroglobulinemia | D008258 | — | C88.0 | 1 | — | — | — | — | 1 |
| Central nervous system diseases | D002493 | — | G96.9 | 1 | — | — | — | — | 1 |
| Brain diseases | D001927 | — | G93.40 | 1 | — | — | — | — | 1 |
| Glioma | D005910 | EFO_0000520 | — | 1 | — | — | — | — | 1 |
| Astrocytoma | D001254 | EFO_0000271 | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pleural effusion | D010996 | — | J90 | — | — | — | — | 1 | 1 |
| Urinary bladder neoplasms | D001749 | — | C67 | — | — | — | — | 1 | 1 |
| 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 | — |
| 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
No data
Alternate
SRC
SRC
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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Sprycel – Bristol Myers Squibb
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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34,630 adverse events reported
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