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Drug ReportsDacomitinib
Vizimpro(dacomitinib)
Vizimpro (dacomitinib) is a small molecule pharmaceutical. Dacomitinib was first approved as Vizimpro on 2018-09-27. It is used to treat non-small-cell lung carcinoma in the USA. It has been approved in Europe to treat non-small-cell lung carcinoma. It is known to target epidermal growth factor receptor, receptor tyrosine-protein kinase erbB-2, and receptor tyrosine-protein kinase erbB-4.
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Events Timeline
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Completion date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
respiratory tract diseasesD012140
Trade Name
FDA
EMA
Vizimpro
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dacomitinib
Tradename
Company
Number
Date
Products
VIZIMPROPfizerN-211288 RX2018-09-27
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
vizimproNew Drug Application2023-10-13
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
non-small-cell lung carcinoma—D002289—
Agency Specific
FDA
EMA
Expiration
Code
DACOMITINIB, VIZIMPRO, PFIZER
2025-09-27ODE-206, ODE-213
2023-09-27NCE
Patent Expiration
Patent
Expires
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FDA Information
Dacomitinib, Vizimpro, Pfizer
77722432028-08-26DS, DP
105961622026-02-02U-3338
106033142026-02-02U-3337
86238832025-05-05U-1403
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EB: Epidermal growth factor receptor (egfr) tyrosine kinase inhibitors
— L01EB07: Dacomitinib
HCPCS
No data
Clinical
Clinical Trials
64 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289——71341630
Lung neoplasmsD008175HP_0100526C34.907841524
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CarcinomaD002277—C80.033——17
NeoplasmsD009369—C8052———7
Squamous cell carcinomaD002294——24——17
Neoplasm metastasisD009362EFO_0009708—23———5
Brain neoplasmsD001932EFO_0003833C71—4———4
Squamous cell neoplasmsD018307——13———4
Squamous cell carcinoma of head and neckD000077195——12——14
AdenocarcinomaD000230——21———3
RecurrenceD012008——11———2
GlioblastomaD005909EFO_0000515——2———2
Show 8 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———7————7
LeukemiaD007938—C951————1
Myelodysplastic syndromesD009190—D461————1
Myeloid leukemia acuteD015470—C92.01————1
Hematologic neoplasmsD019337——1————1
Prostatic neoplasmsD011471—C611————1
Castration-resistant prostatic neoplasmsD064129——1————1
Breast neoplasmsD001943EFO_0003869C501————1
Pancreatic neoplasmsD010190EFO_0003860C251————1
Myeloproliferative disordersD009196—D47.11————1
Show 26 more
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDacomitinib
INNdacomitinib
Description
Dacomitinib is a member of the class of quinazolines that is 7-methoxyquinazoline-4,6-diamine in which the amino group at position 4 is substituted by a 3-chloro-4-fluorophenyl group and the amino group at position 6 is substituted by an (E)-4-(piperidin-1-yl)but-2-enoyl group. It has a role as an epidermal growth factor receptor antagonist and an antineoplastic agent. It is a member of quinazolines, a member of piperidines, an enamide, a member of monochlorobenzenes, a member of monofluorobenzenes, a tertiary amino compound, a secondary amino compound and a secondary carboxamide.
Classification
Small molecule
Drug classtyrosine kinase inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
COc1cc2ncnc(Nc3ccc(F)c(Cl)c3)c2cc1NC(=O)/C=C/CN1CCCCC1
Identifiers
PDB—
CAS-ID1110813-31-4
RxCUI—
ChEMBL IDCHEMBL2110732
ChEBI ID—
PubChem CID11511120
DrugBankDB11963
UNII ID2XJX250C20 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
ERBB4
ERBB4
Organism
Homo sapiens
Gene name
ERBB4
Gene synonyms
HER4
NCBI Gene ID
Protein name
receptor tyrosine-protein kinase erbB-4
Protein synonyms
avian erythroblastic leukemia viral (v-erb-b2) oncogene homolog 4, human epidermal growth factor receptor 4, p180erbB4, Proto-oncogene-like protein c-ErbB-4, Tyrosine kinase-type cell surface receptor HER4, v-erb-a erythroblastic leukemia viral oncogene homolog 4, v-erb-b2 avian erythroblastic leukemia viral oncogene homolog 4
Uniprot ID
Mouse ortholog
Erbb4 (13869)
receptor tyrosine-protein kinase erbB-4 (Q61527)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,222 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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662 adverse events reported
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