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-4, and receptor tyrosine-protein kinase erbB-2.
Download report
Favorite
Commercial
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 |
|---|---|---|---|---|
| VIZIMPRO | Mylan | N-211288 RX | 2018-09-27 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| vizimpro | New Drug Application | 2021-07-20 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| non-small-cell lung carcinoma | — | D002289 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DACOMITINIB, VIZIMPRO, PFIZER | |||
| 2025-09-27 | ODE-206, ODE-213 | ||
| 2023-09-27 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
57 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-small-cell lung carcinoma | D002289 | 7 | 13 | 2 | 1 | 3 | 25 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | 4 | 1 | — | — | — | 5 | |
| Squamous cell carcinoma of head and neck | D000077195 | 1 | 2 | — | — | 1 | 4 | ||
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | 3 | — | — | — | 3 |
| Squamous cell neoplasms | D018307 | 1 | 2 | — | — | — | 3 | ||
| Glioblastoma | D005909 | EFO_0000515 | — | 2 | — | — | — | 2 | |
| Small cell carcinoma | D018288 | 1 | 1 | — | — | — | 2 | ||
| Colorectal neoplasms | D015179 | 1 | 1 | — | — | — | 1 | ||
| Penile neoplasms | D010412 | C60 | — | 1 | — | — | — | 1 | |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | 1 | — | — | — | 1 |
| Head and neck neoplasms | D006258 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 5 | — | — | — | — | 5 | ||
| Myelodysplastic syndromes | D009190 | D46 | 1 | — | — | — | — | 1 | |
| Myeloid leukemia acute | D015470 | C92.0 | 1 | — | — | — | — | 1 | |
| Hematologic neoplasms | D019337 | 1 | — | — | — | — | 1 | ||
| Prostatic neoplasms | D011471 | C61 | 1 | — | — | — | — | 1 | |
| Castration-resistant prostatic neoplasms | D064129 | 1 | — | — | — | — | 1 | ||
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
| Non-hodgkin lymphoma | D008228 | C85.9 | 1 | — | — | — | — | 1 | |
| Primary myelofibrosis | D055728 | D47.4 | 1 | — | — | — | — | 1 |
Show 14 more
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | DACOMITINIB |
| INN | dacomitinib |
| 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 class | tyrosine kinase inhibitors |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | COc1cc2ncnc(Nc3ccc(F)c(Cl)c3)c2cc1NC(=O)/C=C/CN1CCCCC1 |
Identifiers
| PDB | 4I23 |
| CAS-ID | 1110813-31-4 |
| RxCUI | 2058849 |
| ChEMBL ID | CHEMBL2110732 |
| ChEBI ID | — |
| PubChem CID | 11511120 |
| DrugBank | DB11963 |
| UNII ID | 2XJX250C20 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
EGFR
EGFR
ERBB4
ERBB4
ERBB2
ERBB2
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
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 2,443 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
13,877 adverse events reported
View more details
Premium feature
Learn more about premium features at pharmakb.com
Learn more