Infigratinib
Truseltiq (infigratinib) is a small molecule pharmaceutical. Infigratinib was first approved as Truseltiq on 2021-05-28. It is used to treat cholangiocarcinoma in the USA. The pharmaceutical is active against fibroblast growth factor receptor 1, fibroblast growth factor receptor 2, and fibroblast growth factor receptor 3. In addition, it is known to target vascular endothelial growth factor receptor 2 and fibroblast growth factor receptor 4.
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FDA approval date
EMA approval date
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Study first post date
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Commercial
Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Infigratinib phosphate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TRUSELTIQ | Helsinn Healthcare | N-214622 DISCN | 2021-05-28 | 2 products, RLD |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| truseltiq | New Drug Application | 2022-02-07 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| cholangiocarcinoma | — | D018281 | C22.1 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
INFIGRATINIB PHOSPHATE, TRUSELTIQ, HELSINN HLTHCARE | |||
| 2028-05-28 | ODE-353 | ||
| 2026-05-28 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
32 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Achondroplasia | D000130 | — | Q77.4 | — | 4 | 3 | — | — | 6 |
| Cholangiocarcinoma | D018281 | — | C22.1 | 1 | 3 | 1 | — | — | 5 |
| Carcinoma | D002277 | — | C80.0 | 1 | 2 | 1 | — | 1 | 4 |
| Urinary bladder neoplasms | D001749 | — | C67 | 2 | — | 1 | — | 1 | 4 |
| Transitional cell carcinoma | D002295 | — | — | 2 | 1 | 1 | — | 1 | 4 |
| Dwarfism | D004392 | — | E34.31 | — | 3 | 1 | — | — | 3 |
| Lordosis | D008141 | — | M40.5 | — | 1 | 1 | — | — | 1 |
| Congenital limb deformities | D017880 | — | Q74.9 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 4 | 4 | — | — | — | 7 |
| Adenocarcinoma | D000230 | — | — | 1 | 3 | — | — | — | 3 |
| Recurrence | D012008 | — | — | 1 | 3 | — | — | — | 3 |
| Mucopolysaccharidosis iv | D009085 | — | E76.210 | — | 3 | — | — | — | 3 |
| Bone diseases | D001847 | — | M89.9 | — | 3 | — | — | — | 3 |
| Musculoskeletal diseases | D009140 | — | — | — | 3 | — | — | — | 3 |
| Osteochondrodysplasias | D010009 | Orphanet_800 | G71.13 | — | 3 | — | — | — | 3 |
| Melanoma | D008545 | — | — | — | 2 | — | — | — | 2 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | 1 | — | — | — | 2 |
| Inborn genetic diseases | D030342 | EFO_0000508 | — | — | 2 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | — | 1 |
| Triple negative breast neoplasms | D064726 | — | — | 1 | — | — | — | — | 1 |
| Uterine cervical neoplasms | D002583 | — | — | 1 | — | — | — | — | 1 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Infigratinib |
| INN | infigratinib |
| Description | BGJ-398 is a member of the class of phenylureas that is urea in which a hydrogen attached to one of the nitrogens is replaced by a 2,6-dichloro-3,5-dimethoxyphenyl group, while the hydrogens attached to the other nitrogen are replaced by a methyl group and a 6-{[4-(4-ethylpiperazin-1-yl)phenyl]amino}pyrimidin-4-yl group. It is a potent and selective fibroblast growth factor receptor inhibitor. It has a role as a fibroblast growth factor receptor antagonist and an antineoplastic agent. It is an aminopyrimidine, a N-arylpiperazine, a N-alkylpiperazine, a dichlorobenzene and a member of phenylureas. |
| Classification | Small molecule |
| Drug class | tyrosine kinase inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCN1CCN(c2ccc(Nc3cc(N(C)C(=O)Nc4c(Cl)c(OC)cc(OC)c4Cl)ncn3)cc2)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 1310746-10-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1852688 |
| ChEBI ID | 63451 |
| PubChem CID | 53235510 |
| DrugBank | DB11886 |
| UNII ID | A4055ME1VK (ChemIDplus, GSRS) |
Target
Agency Approved
FGFR1
FGFR1
FGFR2
FGFR2
FGFR3
FGFR3
Organism
Homo sapiens
Gene name
FGFR1
Gene synonyms
BFGFR, CEK, FGFBR, FLG, FLT2, HBGFR
NCBI Gene ID
Protein name
fibroblast growth factor receptor 1
Protein synonyms
Basic fibroblast growth factor receptor 1, bFGF-R-1, BFGFR, CD331, FGFR1/PLAG1 fusion, FLT-2, FMS-like tyrosine kinase 2, fms-related tyrosine kinase 2, heparin-binding growth factor receptor, hydroxyaryl-protein kinase, N-sam, Proto-oncogene c-Fgr
Uniprot ID
Mouse ortholog
Fgfr1 (14182)
fibroblast growth factor receptor 1 (Q9QZM7)
Alternate
KDR
KDR
FGFR4
FGFR4
Organism
Homo sapiens
Gene name
KDR
Gene synonyms
FLK1, VEGFR2
NCBI Gene ID
Protein name
vascular endothelial growth factor receptor 2
Protein synonyms
CD309, Fetal liver kinase 1, fetal liver kinase-1, FLK-1, KDR, Kinase insert domain receptor, kinase insert domain receptor (a type III receptor tyrosine kinase), Protein-tyrosine kinase receptor flk-1, soluble VEGFR2, tyrosine kinase growth factor receptor
Uniprot ID
Mouse ortholog
Kdr (16542)
vascular endothelial growth factor receptor 2 (Q8VCD0)
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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69 adverse events reported
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