Tukysa(tucatinib)
Tukysa (tucatinib) is a small molecule pharmaceutical. Tucatinib was first approved as Tukysa on 2020-04-17. It is used to treat breast neoplasms in the USA. It has been approved in Europe to treat breast neoplasms and neoplasm metastasis. The pharmaceutical is active against receptor tyrosine-protein kinase erbB-2. In addition, it is known to target epidermal growth factor receptor and receptor tyrosine-protein kinase erbB-4.
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Events Timeline
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YTD
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2Y
5Y
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Events
FDA approval date
EMA approval date
Patent expiration date
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
Trade Name
FDA
EMA
Tukysa
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| tukysa | New Drug Application | 2024-11-04 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| breast neoplasms | EFO_0003869 | D001943 | C50 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
TUCATINIB, TUKYSA, SEAGEN | |||
| 2030-01-19 | ODE-422 | ||
| 2027-04-17 | ODE-309 | ||
| 2026-01-19 | I-906 | ||
| 2025-04-17 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
70 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 7 | 11 | 1 | — | 1 | 16 |
| Invasive hydatidiform mole | D002820 | — | D39.2 | 1 | 1 | 1 | — | — | 2 |
| Adenocarcinoma | D000230 | — | — | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 1 | 3 | — | — | — | 4 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | 3 | — | — | — | 3 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | — | 2 | — | — | — | 2 |
| Multiple myeloma | D009101 | — | C90.0 | — | 2 | — | — | — | 2 |
| Meningeal neoplasms | D008577 | EFO_0003851 | C70 | — | 2 | — | — | — | 2 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 2 | — | — | — | 2 |
| Central nervous system diseases | D002493 | — | G96.9 | 1 | 1 | — | — | — | 1 |
| Colorectal neoplasms | D015179 | — | — | — | 1 | — | — | — | 1 |
| Colonic neoplasms | D003110 | — | C18 | — | 1 | — | — | — | 1 |
| Carcinoma | D002277 | — | C80.0 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Drug interactions | D004347 | — | — | 2 | — | — | — | — | 2 |
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Tucatinib |
| INN | tucatinib |
| Description | Tucatinib, sold under the brand name Tukysa, is an anticancer medication used for the treatment of HER2-positive breast cancer. It is a small molecule inhibitor of HER2. It was developed by Array BioPharma and licensed to Cascadian Therapeutics (formerly Oncothyreon, subsequently part of Seattle Genetics).
|
| Classification | Small molecule |
| Drug class | tyrosine kinase inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cc1cc(Nc2ncnc3ccc(NC4=NC(C)(C)CO4)cc23)ccc1Oc1ccn2ncnc2c1 |
Identifiers
| PDB | — |
| CAS-ID | 937263-43-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3989868 |
| ChEBI ID | — |
| PubChem CID | 51039094 |
| DrugBank | DB11652 |
| UNII ID | 234248D0HH (ChemIDplus, GSRS) |
Target
Agency Approved
ERBB2
ERBB2
Organism
Homo sapiens
Gene name
ERBB2
Gene synonyms
HER2, MLN19, NEU, NGL
NCBI Gene ID
Protein name
receptor tyrosine-protein kinase erbB-2
Protein synonyms
c-erb B2/neu protein, CD340, herstatin, human epidermal growth factor receptor 2, Metastatic lymph node gene 19 protein, MLN 19, neuro/glioblastoma derived oncogene homolog, neuroblastoma/glioblastoma derived oncogene homolog, p185erbB2, Proto-oncogene c-ErbB-2, Proto-oncogene Neu, Tyrosine kinase-type cell surface receptor HER2, v-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2, v-erb-b2 avian erythroblastic leukemia viral oncoprotein 2, v-erb-b2 erythroblastic leukemia viral oncogene homolog 2, neuro/glioblastoma derived oncogene homolog
Uniprot ID
Mouse ortholog
Erbb2 (13866)
receptor tyrosine-protein kinase erbB-2 (Q6ZPE0)
Alternate
EGFR
EGFR
ERBB4
ERBB4
Organism
Homo sapiens
Gene name
EGFR
Gene synonyms
ERBB, ERBB1, HER1
NCBI Gene ID
Protein name
epidermal growth factor receptor
Protein synonyms
avian erythroblastic leukemia viral (v-erb-b) oncogene homolog, cell growth inhibiting protein 40, cell proliferation-inducing protein 61, EGFR vIII, epidermal growth factor receptor tyrosine kinase domain, erb-b2 receptor tyrosine kinase 1, Proto-oncogene c-ErbB-1, Receptor tyrosine-protein kinase erbB-1
Uniprot ID
Mouse ortholog
Egfr (13649)
epidermal growth factor receptor (Q01279)
Variants
No data
Financial
Estimated US medical usage
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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6,549 adverse events reported
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