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 |
|---|---|
| neoplasms | D009369 |
| respiratory tract diseases | D012140 |
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 |
|---|---|---|---|---|
| GILOTRIF | Boehringer Ingelheim | N-201292 RX | 2013-07-12 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| gilotrif | New Drug Application | 2025-11-13 |
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 | |||
| 2025-10-07 | PED | ||
| 2025-07-12 | PED | ||
| 2025-04-07 | M-276 | ||
| 2025-01-12 | ODE-230 | ||
| 2023-10-15 | PED | ||
| 2023-04-15 | ODE-115 | ||
HCPCS
No data
Clinical
Clinical Trials
241 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 | — | — | 21 | 37 | 14 | 5 | 29 | 99 |
| Lung neoplasms | D008175 | — | C34.90 | 13 | 20 | 3 | 1 | 10 | 43 |
| Carcinoma | D002277 | — | C80.0 | 5 | 15 | 3 | 1 | 3 | 25 |
| Squamous cell carcinoma | D002294 | — | — | 5 | 17 | 2 | 1 | 1 | 25 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 5 | 5 | — | 1 | — | 10 |
| Squamous cell neoplasms | D018307 | — | — | 2 | 4 | 1 | 1 | — | 8 |
| Erbb-1 genes | D018773 | — | — | — | — | — | 2 | — | 2 |
| Meningeal carcinomatosis | D055756 | EFO_1001012 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 4 | 13 | 1 | — | — | 17 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 7 | 12 | 1 | — | — | 17 |
| Head and neck neoplasms | D006258 | — | — | 2 | 7 | 4 | — | — | 13 |
| Adenocarcinoma | D000230 | — | — | — | 4 | 3 | — | 2 | 9 |
| Adenocarcinoma of lung | D000077192 | — | — | — | 3 | 1 | — | 1 | 5 |
| Respiratory tract neoplasms | D012142 | EFO_0003853 | D14 | 1 | — | 1 | — | — | 2 |
| Diarrhea | D003967 | — | R19.7 | — | 1 | 1 | — | — | 2 |
| Bronchial neoplasms | D001984 | EFO_1000849 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 21 | 10 | — | — | 3 | 33 |
| Esophageal squamous cell carcinoma | D000077277 | — | — | 2 | 6 | — | — | — | 8 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 2 | 5 | — | — | 1 | 7 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 5 | 3 | — | — | — | 6 |
| Colorectal neoplasms | D015179 | — | — | 2 | 6 | — | — | — | 6 |
| Esophageal neoplasms | D004938 | — | C15 | 1 | 5 | — | — | — | 5 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 2 | 4 | — | — | — | 5 |
| Recurrence | D012008 | — | — | 1 | 2 | — | — | 1 | 4 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | 3 | — | — | — | 4 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | 3 | — | — | — | 4 |
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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 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | — | — | — | 1 | 2 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 1 | — | — | — | 1 | 2 |
| Cholangiocarcinoma | D018281 | — | C22.1 | 2 | — | — | — | — | 2 |
| Glioblastoma | D005909 | EFO_0000515 | — | 2 | — | — | — | — | 2 |
| Syndrome | D013577 | — | — | 2 | — | — | — | — | 2 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | — | — | — | — | 1 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 1 | — | — | — | — | 1 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 1 | — | — | — | — | 1 |
| Primary myelofibrosis | D055728 | — | D47.4 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | — | — | — | — | 1 | 1 |
| Myeloid leukemia | D007951 | — | C92 | — | — | — | — | 1 | 1 |
| Acute disease | D000208 | — | — | — | — | — | — | 1 | 1 |
| Lymphoid leukemia | D007945 | — | C91 | — | — | — | — | 1 | 1 |
| Multiple primary neoplasms | D009378 | — | — | — | — | — | — | 1 | 1 |
| Paronychia | D010304 | EFO_0007421 | L03.0 | — | — | — | — | 1 | 1 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | — | — | 1 | 1 |
| Interstitial lung diseases | D017563 | EFO_0004244 | J84.9 | — | — | — | — | 1 | 1 |
| Cardiotoxicity | D066126 | EFO_1001482 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Afatinib |
| INN | afatinib |
| 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 class | tyrosine 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
| PDB | — |
| CAS-ID | 850140-72-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1173655 |
| ChEBI ID | 61390 |
| PubChem CID | 10184653 |
| DrugBank | DB08916 |
| UNII ID | 41UD74L59M (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
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)
Variants
No data
Financial
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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6,490 adverse events reported
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