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Fotivda(tivozanib)
Fotivda (tivozanib) is a small molecule pharmaceutical. Tivozanib was first approved as Fotivda on 2017-08-24. It is used to treat renal cell carcinoma in the USA. It has been approved in Europe to treat renal cell carcinoma. The pharmaceutical is active against vascular endothelial growth factor receptor 3, vascular endothelial growth factor receptor 2, and vascular endothelial growth factor receptor 1.
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FDA Novel Drug Approvals 2021
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
urogenital diseasesD000091642
Trade Name
FDA
EMA
Fotivda
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tivozanib hydrochloride
Tradename
Company
Number
Date
Products
FOTIVDAAveo PharmaceuticalsN-212904 RX2021-03-10
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
fotivdaNew Drug Application2021-03-12
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
renal cell carcinomaEFO_0000376D002292—
Agency Specific
FDA
EMA
Expiration
Code
TIVOZANIB HYDROCHLORIDE, FOTIVDA, AVEO PHARMS
2026-03-10NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Tivozanib Hydrochloride, Fotivda, Aveo Pharms
115043652039-11-05U-3476
68219872024-04-26DS, DPU-3100
71667222023-11-16DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EK: Vascular endothelial growth factor receptor (vegfr) tyrosine kinase inhibitors
— L01EK03: Tivozanib
HCPCS
No data
Clinical
Clinical Trials
36 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
Renal cell carcinomaD002292254—111
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colorectal neoplasmsD01517921———3
Non-small-cell lung carcinomaD00228921———2
Liver neoplasmsD008113EFO_1001513C22.012———2
Gastrointestinal neoplasmsD005770C26.921———2
Breast neoplasmsD001943EFO_0003869C5021———2
Bile duct neoplasmsD00165022———2
Ovarian neoplasmsD010051EFO_0003893C5612———2
Fallopian tube neoplasmsD005185—2———2
Prostatic neoplasmsD011471C6112———2
SarcomaD01250912———2
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C803———14
Healthy volunteers/patients—2————2
Hepatic insufficiencyD0485501————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTIVOZANIB
INNtivozanib
Description
1-[2-chloro-4-[(6,7-dimethoxy-4-quinolinyl)oxy]phenyl]-3-(5-methyl-3-isoxazolyl)urea is an aromatic ether.
Classification
Small molecule
Drug classangiogenesis inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
COc1cc2nccc(Oc3ccc(NC(=O)Nc4cc(C)on4)c(Cl)c3)c2cc1OC
Identifiers
PDB4ASE
CAS-ID475108-18-0
RxCUI2534233
ChEMBL IDCHEMBL1289494
ChEBI ID—
PubChem CID9911830
DrugBankDB11800
UNII ID172030934T (ChemIDplus, GSRS)
Target
Agency Approved
FLT4
FLT4
KDR
KDR
FLT1
FLT1
Organism
Homo sapiens
Gene name
FLT4
Gene synonyms
VEGFR3
NCBI Gene ID
2324
Protein name
vascular endothelial growth factor receptor 3
Protein synonyms
Feline McDonough Sarcoma (FMS)-like tyrosine kinase 4, FLT-4, fms related tyrosine kinase 4, Fms-like tyrosine kinase 4, primary congenital lymphedema, Tyrosine-protein kinase receptor FLT4, VEGF receptor-3
Uniprot ID
P35916
Mouse ortholog
Flt4 (14257)
vascular endothelial growth factor receptor 3 (P35917)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 812 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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2,325 adverse events reported
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