Iressa(gefitinib)
Gefitinib, Iressa (gefitinib) is a small molecule pharmaceutical. Gefitinib was first approved as Iressa on 2003-05-05. 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. The pharmaceutical is active against epidermal growth factor receptor.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| respiratory tract diseases | D012140 |
Trade Name
FDA
EMA
Gefitinib, Iressa (discontinued: Iressa)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Gefitinib
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| IRESSA | AstraZeneca | N-206995 RX | 2015-07-13 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| gefitinib | ANDA | 2024-04-22 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| non-small-cell lung carcinoma | — | D002289 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J8565 | Gefitinib, oral, 250 mg |
Clinical
Clinical Trials
419 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 carcinoma | D002289 | — | — | 42 | 107 | 54 | 10 | 31 | 218 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 29 | 84 | 34 | 6 | 26 | 162 |
| Carcinoma | D002277 | — | C80.0 | 8 | 19 | 3 | 1 | 6 | 31 |
| Neoplasms | D009369 | — | C80 | 11 | 11 | 5 | 1 | 4 | 31 |
| Adenocarcinoma | D000230 | — | — | — | 10 | 7 | 1 | 3 | 21 |
| Small cell lung carcinoma | D055752 | — | — | 2 | 2 | 1 | 1 | — | 5 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Head and neck neoplasms | D006258 | — | — | 7 | 17 | 1 | — | 3 | 25 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 24 | 1 | — | — | 25 |
| Adenocarcinoma of lung | D000077192 | — | — | — | 8 | 6 | — | 4 | 18 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 7 | 6 | — | 2 | 13 |
| Squamous cell carcinoma | D002294 | — | — | 3 | 8 | 1 | — | 1 | 13 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | 8 | 5 | — | 1 | 12 |
| Colorectal neoplasms | D015179 | — | — | 5 | 8 | 1 | — | — | 10 |
| Esophageal neoplasms | D004938 | — | C15 | 2 | 8 | 1 | — | — | 10 |
| Squamous cell neoplasms | D018307 | — | — | 1 | 4 | 2 | — | — | 7 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 2 | 2 | 1 | — | 1 | 6 |
Show 5 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | — | C61 | 2 | 10 | — | — | 1 | 11 |
| Glioblastoma | D005909 | EFO_0000515 | — | 4 | 8 | — | — | — | 9 |
| Recurrence | D012008 | — | — | — | 6 | — | — | 2 | 8 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 6 | — | — | — | 6 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | 5 | — | — | — | 5 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | — | 5 | — | — | — | 5 |
| Central nervous system neoplasms | D016543 | — | — | 2 | 3 | — | — | — | 4 |
| Nervous system neoplasms | D009423 | — | — | 2 | 3 | — | — | — | 4 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 1 | 4 | — | — | — | 4 |
| Ovarian epithelial carcinoma | D000077216 | — | — | — | 4 | — | — | — | 4 |
Show 65 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Disease progression | D018450 | — | — | 1 | — | — | — | 1 | 2 |
| Oropharyngeal neoplasms | D009959 | — | — | 1 | — | — | — | 1 | 2 |
| Laryngeal neoplasms | D007822 | EFO_0003817 | C32 | 1 | — | — | — | 1 | 2 |
| Laryngeal diseases | D007818 | — | J38.7 | 1 | — | — | — | 1 | 2 |
| Lymphoma | D008223 | — | C85.9 | 1 | — | — | — | — | 1 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
| Meningeal carcinomatosis | D055756 | EFO_1001012 | — | 1 | — | — | — | — | 1 |
| Meningitis | D008581 | HP_0001287 | G03 | 1 | — | — | — | — | 1 |
Show 2 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | — | — | — | — | 1 | 1 |
| Acute disease | D000208 | — | — | — | — | — | — | 1 | 1 |
| Lymphoid leukemia | D007945 | — | C91 | — | — | — | — | 1 | 1 |
| Germ-line mutation | D018095 | — | — | — | — | — | — | 1 | 1 |
| Multiple primary neoplasms | D009378 | — | — | — | — | — | — | 1 | 1 |
| Molecular targeted therapy | D058990 | — | — | — | — | — | — | 1 | 1 |
| Bronchial neoplasms | D001984 | EFO_1000849 | — | — | — | — | — | 1 | 1 |
| Basal cell carcinoma | D002280 | — | — | — | — | — | — | 1 | 1 |
| Adenoid cystic carcinoma | D003528 | — | — | — | — | — | — | 1 | 1 |
| Anaplastic thyroid carcinoma | D065646 | — | — | — | — | — | — | 1 | 1 |
Show 14 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Gefitinib |
| INN | gefitinib |
| Description | Gefitinib is a member of the class of quinazolines that is quinazoline which is substituted by a (3-chloro-4-fluorophenyl)nitrilo group, 3-(morpholin-4-yl)propoxy group and a methoxy group at positions 4,6 and 7, respectively. An EGFR kinase inhibitor used for the treatment of non-small cell lung cancer. It has a role as an epidermal growth factor receptor antagonist and an antineoplastic agent. It is an aromatic ether, a member of monochlorobenzenes, a member of monofluorobenzenes, a secondary amino compound, a tertiary amino compound, a member of quinazolines and a member of morpholines. |
| 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)c2cc1OCCCN1CCOCC1 |
Identifiers
| PDB | — |
| CAS-ID | 184475-35-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL939 |
| ChEBI ID | 49668 |
| PubChem CID | 123631 |
| DrugBank | DB00317 |
| UNII ID | S65743JHBS (ChemIDplus, GSRS) |
Target
Agency Approved
EGFR
EGFR
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)
Alternate
No data
Variants
No data
Financial
Revenue by drug
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Iressa – AstraZeneca
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Estimated US medical usage
Gefitinib
Total medical expenditures per year (USD, in millions)
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Number of purchases
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 43,961 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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10,615 adverse events reported
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