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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
1M
3M
6M
YTD
1Y
2Y
5Y
Max
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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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Completion date
Results first 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 Application2024-06-11
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
526 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CarcinomaD002277—C80.04612742455247
Hepatocellular carcinomaD006528—C22.0309937457204
Liver neoplasmsD008113EFO_1001513C22.0258631246169
NeoplasmsD009369—C80273331455
Renal cell carcinomaD002292EFO_0000376—152651444
Thyroid neoplasmsD013964EFO_0003841—31923732
CholangiocarcinomaD018281—C22.112131731
Thyroid diseasesD013959HP_0000820E00-E07—1722526
Endometrial neoplasmsD016889EFO_0004230—41241322
Stomach neoplasmsD013274EFO_0003897C16311—1—15
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RecurrenceD012008——6174—832
MelanomaD008545——8182—122
Lung neoplasmsD008175HP_0100526C34.902126—220
Non-small-cell lung carcinomaD002289——5126——19
AdenocarcinomaD000230——581—114
Squamous cell carcinomaD002294——362——9
Esophageal neoplasmsD004938—C15371——9
Squamous cell carcinoma of head and neckD000077195——352——8
Colorectal neoplasmsD015179——461——7
Kidney neoplasmsD007680EFO_0003865C64141——6
Show 9 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Biliary tract neoplasmsD001661—C24.9121——223
Neoplasm metastasisD009362EFO_0009708—27———8
Small cell lung carcinomaD055752——26——17
Neuroendocrine tumorsD018358EFO_1001901D3A.8—6———6
Ovarian epithelial carcinomaD000077216——35———6
Anaplastic thyroid carcinomaD065646———6———6
Triple negative breast neoplasmsD064726——35———6
Pancreatic neoplasmsD010190EFO_0003860C2534———5
SarcomaD012509——25———5
ImmunotherapyD007167———1——45
Show 76 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223—C85.94————4
Liver diseasesD008107HP_0002910K70-K771———34
Healthy volunteers/patients———4————4
Renal insufficiencyD051437HP_0000083N192————2
LeukemiaD007938—C951————1
Myelodysplastic syndromesD009190—D461————1
Myeloid leukemia acuteD015470—C92.01————1
Myeloproliferative disordersD009196—D47.11————1
Non-hodgkin lymphomaD008228—C85.91————1
Primary myelofibrosisD055728—D47.41————1
Show 31 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Catheter ablationD017115——————33
Medullary carcinomaD018276——————11
Gastrointestinal neoplasmsD005770—C26.9————11
Digestive system neoplasmsD004067——————11
Liver cirrhosisD008103EFO_0001422K74.0————11
Progression-free survivalD000077982——————11
Brain diseasesD001927HP_0001298G93.40————11
Hepatic encephalopathyD006501—K72.91————11
Radiofrequency ablationD000078703——————11
ApoptosisD017209——————11
Show 6 more
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 12,596 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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27,180 adverse events reported
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