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Drug ReportsInfigratinib
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 Novel Drug Approvals 2021
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
Trade Name
FDA
EMA
No data
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
TRUSELTIQHelsinn HealthcareN-214622 DISCN2021-05-28
2 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
truseltiqNew Drug Application2022-02-07
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
cholangiocarcinoma—D018281C22.1
Agency Specific
FDA
EMA
Expiration
Code
INFIGRATINIB PHOSPHATE, TRUSELTIQ, HELSINN HLTHCARE
2028-05-28ODE-353
2026-05-28NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Infigratinib Phosphate, Truseltiq, Helsinn Hlthcare
102789692034-12-11DP
111608042034-12-11DP
85520022029-08-25DS, DP
90678962028-08-06DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EN: Fibroblast growth factor receptor (fgfr) tyrosine kinase inhibitors
— L01EN03: Infigratinib
HCPCS
No data
Clinical
Clinical Trials
29 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
CholangiocarcinomaD018281—C22.1131——5
CarcinomaD002277—C80.0121—14
Urinary bladder neoplasmsD001749—C672—1—14
Transitional cell carcinomaD002295——211—14
AchondroplasiaD000130—Q77.4—21——3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C8044———7
AdenocarcinomaD000230——13———3
RecurrenceD012008——13———3
MelanomaD008545———2———2
GlioblastomaD005909EFO_0000515—11———2
GliomaD005910EFO_0000520—21———2
Stomach neoplasmsD013274EFO_0003897C16—2———2
Esophageal neoplasmsD004938—C15—2———2
Gastrointestinal stromal tumorsD046152EFO_0000505C49.A11———1
Renal cell carcinomaD002292EFO_0000376—11———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C501————1
Triple negative breast neoplasmsD064726——1————1
Uterine cervical neoplasmsD002583HP_0030159—1————1
Liver neoplasmsD008113EFO_1001513C22.01————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameInfigratinib
INNinfigratinib
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 classtyrosine kinase inhibitors
Image (chem structure or protein)Loading
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-ID1310746-10-1
RxCUI—
ChEMBL IDCHEMBL1852688
ChEBI ID63451
PubChem CID53235510
DrugBankDB11886
UNII IDA4055ME1VK (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
2260
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
Q9UDF2
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
3791
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
Q14178
Mouse ortholog
Kdr (16542)
vascular endothelial growth factor receptor 2 (Q8VCD0)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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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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