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Drug ReportsLenvatinib
Lenvima(lenvatinib)
Kisplyx, Lenvima (lenvatinib) is a small molecule pharmaceutical. Lenvatinib was first approved as Lenvima on 2015-02-13. It is used to treat renal cell carcinoma and thyroid neoplasms in the USA. It has been approved in Europe to treat renal cell carcinoma and thyroid neoplasms. The pharmaceutical is active against vascular endothelial growth factor receptor 3 and vascular endothelial growth factor receptor 2.
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Events Timeline
5D
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3M
6M
YTD
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2Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
urogenital diseasesD000091642
endocrine system diseasesD004700
Trade Name
FDA
EMA
Lenvima
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Lenvatinib mesylate
Tradename
Company
Number
Date
Products
LENVIMAEisaiN-206947 RX2015-02-13
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
lenvimaNew Drug Application2025-01-03
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration
Code
LENVATINIB MESYLATE, LENVIMA, EISAI INC
2025-08-15ODE-196
2024-12-19M-272
2024-08-10I-868
2024-07-21M-269
Patent Expiration
Patent
Expires
Flag
FDA Information
Lenvatinib Mesylate, Lenvima, Eisai Inc
110903862036-02-23U-3519
102597912035-08-26DP
104073932035-08-26DP
111865472035-08-26DP
90062562027-07-27U-1695
76122082026-09-19DS, DP
72532862025-10-24DS, DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EX: Other protein kinase inhibitors in atc
— L01EX08: Lenvatinib
HCPCS
No data
Clinical
Clinical Trials
557 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
CarcinomaD002277—C80.081611—538
Hepatocellular carcinomaD006528—C22.0693—419
Liver neoplasmsD008113EFO_1001513C22.0592—417
Thyroid neoplasmsD013964EFO_0003841—272—414
Renal cell carcinomaD002292EFO_0000376—344—111
Thyroid diseasesD013959—E00-E07—62—311
MelanomaD008545——352——8
Non-small-cell lung carcinomaD002289——125——8
Lung neoplasmsD008175—C34.90115——7
Endometrial neoplasmsD016889EFO_0004230—223—17
Show 9 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C801413——224
Breast neoplasmsD001943EFO_0003869C5023———4
RecurrenceD012008——23———4
Ovarian neoplasmsD010051EFO_0003893C5622———3
GlioblastomaD005909EFO_0000515—12———2
OsteosarcomaD012516——12———2
Adenoid cystic carcinomaD003528———2———2
Stomach neoplasmsD013274EFO_0003897C16—2———2
Biliary tract neoplasmsD001661—C24.9—2———2
Ovarian epithelial carcinomaD000077216——21———2
Show 18 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———4————4
LymphomaD008223—C85.93————3
Renal insufficiencyD051437—N192————2
Cartilage diseasesD002357EFO_0005802M91-M941————1
Female genital neoplasmsD005833——1————1
Bone neoplasmsD001859EFO_0003820D161————1
Lip neoplasmsD008048—C001————1
Soft tissue neoplasmsD012983——1————1
Male genital neoplasmsD005834——1————1
Eye neoplasmsD005134EFO_0003824C69.91————1
Show 5 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Glandular and epithelial neoplasmsD009375——————11
Brain diseasesD001927—G93.40————11
Hepatic encephalopathyD006501—K72.91————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLenvatinib
INNlenvatinib
Description
Lenvatinib is a member of the class of quinolines that is the carboxamide of 4-{3-chloro-4-[(cyclopropylcarbamoyl)amino]phenoxy}-7-methoxyquinoline-6-carboxylic acid. A multi-kinase inhibitor and orphan drug used (as its mesylate salt) for the treatment of various types of thyroid cancer that do not respond to radioiodine. It has a role as a vascular endothelial growth factor receptor antagonist, an orphan drug, an antineoplastic agent, an EC 2.7.10.1 (receptor protein-tyrosine kinase) inhibitor and a fibroblast growth factor receptor antagonist. It is a member of quinolines, an aromatic ether, a monocarboxylic acid amide, an aromatic amide, a member of monochlorobenzenes, a member of cyclopropanes and a member of phenylureas. It is a conjugate base of a lenvatinib(1+).
Classification
Small molecule
Drug classtyrosine kinase inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
COc1cc2nccc(Oc3ccc(NC(=O)NC4CC4)c(Cl)c3)c2cc1C(N)=O
Identifiers
PDB—
CAS-ID417716-92-8
RxCUI—
ChEMBL IDCHEMBL1289601
ChEBI ID85994
PubChem CID9823820
DrugBankDB09078
UNII IDEE083865G2 (ChemIDplus, GSRS)
Target
Agency Approved
FLT4
FLT4
KDR
KDR
Organism
Homo sapiens
Gene name
FLT4
Gene synonyms
VEGFR3
NCBI Gene ID
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
Mouse ortholog
Flt4 (14257)
vascular endothelial growth factor receptor 3 (P35917)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Lenvima – Merck & Co
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 14,540 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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29,813 adverse events reported
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