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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| urogenital diseases | D000091642 |
| endocrine system diseases | D004700 |
Trade Name
FDA
EMA
Lenvima
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| lenvima | New Drug Application | 2025-01-03 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| renal cell carcinoma | EFO_0000376 | D002292 | — |
| thyroid neoplasms | EFO_0003841 | D013964 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
LENVATINIB MESYLATE, LENVIMA, EISAI INC | |||
| 2025-08-15 | ODE-196 | ||
| 2024-12-19 | M-272 | ||
| 2024-08-10 | I-868 | ||
| 2024-07-21 | M-269 | ||
HCPCS
No data
Clinical
Clinical Trials
589 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoma | D002277 | — | C80.0 | 6 | 13 | 8 | — | 5 | 30 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 6 | 9 | 3 | — | 4 | 19 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 5 | 9 | 2 | — | 4 | 17 |
| Thyroid neoplasms | D013964 | EFO_0003841 | — | 1 | 7 | 2 | — | 4 | 13 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 3 | 4 | 4 | — | 1 | 11 |
| Thyroid diseases | D013959 | — | E00-E07 | — | 5 | 2 | — | 3 | 10 |
| Non-small-cell lung carcinoma | D002289 | — | — | 2 | 3 | 5 | — | — | 9 |
| Melanoma | D008545 | — | — | 3 | 5 | 2 | — | — | 8 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 3 | 3 | 3 | — | 1 | 8 |
| Colorectal neoplasms | D015179 | — | — | 2 | 3 | 1 | — | — | 4 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 16 | 14 | — | — | 2 | 26 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 3 | — | — | — | 4 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 3 | 3 | — | — | — | 4 |
| Recurrence | D012008 | — | — | 1 | 3 | — | — | — | 3 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | 2 | — | — | — | 2 |
| Osteosarcoma | D012516 | — | — | 1 | 2 | — | — | — | 2 |
| Adenoid cystic carcinoma | D003528 | — | — | — | 2 | — | — | — | 2 |
| Triple negative breast neoplasms | D064726 | — | — | 1 | 2 | — | — | — | 2 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | 2 | — | — | — | 2 |
| Biliary tract neoplasms | D001661 | — | C24.9 | — | 2 | — | — | — | 2 |
Show 15 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 4 | — | — | — | — | 4 |
| Lymphoma | D008223 | — | C85.9 | 3 | — | — | — | — | 3 |
| Renal insufficiency | D051437 | — | N19 | 2 | — | — | — | — | 2 |
| Papillomaviridae | D027383 | — | — | 1 | — | — | — | — | 1 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 1 | — | — | — | — | 1 |
| Fallopian tube neoplasms | D005185 | — | — | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Severity of illness index | D012720 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glandular and epithelial neoplasms | D009375 | — | — | — | — | — | — | 1 | 1 |
| Brain diseases | D001927 | — | G93.40 | — | — | — | — | 1 | 1 |
| Hepatic encephalopathy | D006501 | — | K72.91 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Lenvatinib |
| INN | lenvatinib |
| 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 class | tyrosine kinase inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | COc1cc2nccc(Oc3ccc(NC(=O)NC4CC4)c(Cl)c3)c2cc1C(N)=O |
Identifiers
| PDB | — |
| CAS-ID | 417716-92-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1289601 |
| ChEBI ID | 85994 |
| PubChem CID | 9823820 |
| DrugBank | DB09078 |
| UNII ID | EE083865G2 (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
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£
â‚£
Lenvima – Merck & Co
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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34,755 adverse events reported
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