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Futibatinib
Lytgobi (futibatinib) is a small molecule pharmaceutical. Futibatinib was first approved as Lytgobi on 2022-09-30. It is known to target fibroblast growth factor receptor 3, fibroblast growth factor receptor 2, fibroblast growth factor receptor 1, and fibroblast growth factor receptor 4.
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Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Lytgobi
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Futibatinib
Tradename
Company
Number
Date
Products
LYTGOBITaiho OncologyN-214801 RX2022-09-30
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
lytgobiNew Drug Application2023-02-02
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
FUTIBATINIB, LYTGOBI, TAIHO ONCOLOGY
2029-09-30ODE-410
2027-09-30NCE
Patent Expiration
Patent
Expires
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FDA Information
Futibatinib, Lytgobi, Taiho Oncology
104341032036-03-31DS, DP
91089732033-02-23DS, DPU-3456
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
— L01EN04: Futibatinib
HCPCS
No data
Clinical
Clinical Trials
16 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
CholangiocarcinomaD018281C22.1121—14
SarcomaD012509——1——1
Biliary tract neoplasmsD001661C24.9——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C8036———7
Breast neoplasmsD001943EFO_0003869C5012———2
Non-small-cell lung carcinomaD00228921———2
Non-hodgkin lymphomaD008228C85.9—1———1
Multiple myelomaD009101C90.0—1———1
Hepatocellular carcinomaD006528C22.0—1———1
Liver neoplasmsD008113EFO_1001513C22.0—1———1
Stomach neoplasmsD013274EFO_0003897C1611———1
Endometrial neoplasmsD016889EFO_0004230—1———1
Gene rearrangementD015321—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colorectal neoplasmsD0151791————1
Pancreatic ductal carcinomaD0214411————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFUTIBATINIB
INNfutibatinib
Description
Futibatinib, sold under the brand name Lytgobi, is an anti-cancer medication used for the treatment of cholangiocarcinoma (bile duct cancer). It is a kinase inhibitor. It is taken by mouth.
Classification
Small molecule
Drug classtyrosine kinase inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
C=CC(=O)N1CC[C@H](n2nc(C#Cc3cc(OC)cc(OC)c3)c3c(N)ncnc32)C1
Identifiers
PDB—
CAS-ID1448169-71-8
RxCUI—
ChEMBL IDCHEMBL3701238
ChEBI ID—
PubChem CID71621331
DrugBankDB15149
UNII ID4B93MGE4AL (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
FGFR3
FGFR3
FGFR2
FGFR2
FGFR1
FGFR1
FGFR4
FGFR4
Organism
Homo sapiens
Gene name
FGFR3
Gene synonyms
JTK4
NCBI Gene ID
2261
Protein name
fibroblast growth factor receptor 3
Protein synonyms
CD333, FGFR-3, fibroblast growth factor receptor 3-S, hydroxyaryl-protein kinase, tyrosine kinase JTK4
Uniprot ID
Q59FL9
Mouse ortholog
Fgfr3 (14184)
fibroblast growth factor receptor 3 (Q61851)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 281 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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2 adverse events reported
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