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Gilotrif, Giotrif(afatinib)
Gilotrif, Giotrif (afatinib) is a small molecule pharmaceutical. Afatinib was first approved as Gilotrif on 2013-07-12. It is used to treat non-small-cell lung carcinoma and squamous cell 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. In addition, it is known to target receptor tyrosine-protein kinase erbB-2.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
respiratory tract diseasesD012140
Trade Name
FDA
EMA
Gilotrif
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Afatinib dimaleate
Tradename
Company
Number
Date
Products
GILOTRIFBoehringer IngelheimN-201292 RX2013-07-12
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
gilotrifNew Drug Application2019-10-18
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
non-small-cell lung carcinoma—D002289—
squamous cell carcinoma—D002294—
Agency Specific
FDA
EMA
Expiration
Code
AFATINIB DIMALEATE, GILOTRIF, BOEHRINGER INGELHEIM
2025-10-07PED
2025-07-12PED
2025-04-07M-276
2025-01-12ODE-230
2023-10-15PED
2023-04-15ODE-115
Patent Expiration
Patent
Expires
Flag
FDA Information
Afatinib Dimaleate, Gilotrif, Boehringer Ingelheim
100047432030-07-05DP
85458842029-12-19DP
84265862029-10-10DP
95392582026-11-09U-1950
RE434312026-01-13DP
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
— L01EB03: Afatinib
HCPCS
No data
Clinical
Clinical Trials
194 clinical trials
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Mock data
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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 carcinomaD00228912311051974
Squamous cell neoplasmsD0183072411—8
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C504121——16
Squamous cell carcinoma of head and neckD000077195471——11
Head and neck neoplasmsD006258154——10
AdenocarcinomaD000230——2——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C80188——327
Lung neoplasmsD008175C34.9028———9
Pancreatic neoplasmsD010190EFO_0003860C2542———5
Colorectal neoplasmsD01517915———5
Stomach neoplasmsD013274EFO_0003897C1614———5
Esophageal squamous cell carcinomaD00007727713———4
Prostatic neoplasmsD011471C6112———3
Multiple myelomaD009101C90.012———3
Esophageal neoplasmsD004938C15—3———3
Brain neoplasmsD001932EFO_0003833C7122———3
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—7————7
GlioblastomaD005909EFO_00005152————2
SyndromeD0135772————2
Myelodysplastic syndromesD009190D461————1
Myeloid leukemia acuteD015470C92.01————1
Hematologic neoplasmsD0193371————1
Non-hodgkin lymphomaD008228C85.91————1
Primary myelofibrosisD055728D47.41————1
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.01————1
B-cell chronic lymphocytic leukemiaD015451C91.11————1
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Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAFATINIB
INNafatinib
Description
Afatinib is a quinazoline compound having a 3-chloro-4-fluoroanilino group at the 4-position, a 4-dimethylamino-trans-but-2-enamido group at the 6-position, and an (S)-tetrahydrofuran-3-yloxy group at the 7-position. Used (as its dimaleate salt) for the first-line treatment of patients with metastatic non-small cell lung cancer. It has a role as a tyrosine kinase inhibitor and an antineoplastic agent. It is a member of quinazolines, a member of furans, an organofluorine compound, an enamide, an aromatic ether, a tertiary amino compound, a member of monochlorobenzenes and a secondary carboxamide.
Classification
Small molecule
Drug classtyrosine kinase inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CN(C)C/C=C/C(=O)Nc1cc2c(Nc3ccc(F)c(Cl)c3)ncnc2cc1O[C@H]1CCOC1
Identifiers
PDB4G5J
CAS-ID850140-72-6
RxCUI1430438
ChEMBL IDCHEMBL1173655
ChEBI ID61390
PubChem CID10184653
DrugBankDB08916
UNII ID41UD74L59M (ChemIDplus, GSRS)
Target
Agency Approved
EGFR
EGFR
Organism
Homo sapiens
Gene name
EGFR
Gene synonyms
ERBB, ERBB1, HER1
NCBI Gene ID
1956
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
Q9UMG5
Mouse ortholog
Egfr (13649)
epidermal growth factor receptor (Q01279)
Alternate
ERBB2
ERBB2
Organism
Homo sapiens
Gene name
ERBB2
Gene synonyms
HER2, MLN19, NEU, NGL
NCBI Gene ID
2064
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
P04626
Mouse ortholog
Erbb2 (13866)
receptor tyrosine-protein kinase erbB-2 (Q6ZPE0)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1 adverse events reported
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