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 2 and vascular endothelial growth factor receptor 3.
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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| urogenital diseases | D000091642 |
| endocrine system diseases | D004700 |
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 |
|---|---|---|---|---|
| LENVIMA | Eisai | N-206947 RX | 2015-02-13 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| lenvima | New Drug Application | 2020-12-09 |
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
360 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 17 | 51 | 22 | 2 | 23 | 100 |
| Thyroid neoplasms | D013964 | EFO_0003841 | 1 | 12 | 2 | 1 | 4 | 19 | |
| Thrombosis | D013927 | — | 1 | 1 | 1 | 1 | 3 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal cell carcinoma | D002292 | 12 | 17 | 3 | — | — | 26 | ||
| Hepatocellular carcinoma | D006528 | C22.0 | 6 | 14 | 5 | — | 3 | 24 | |
| Non-small-cell lung carcinoma | D002289 | 3 | 10 | 6 | — | — | 16 | ||
| Endometrial neoplasms | D016889 | EFO_0004230 | 3 | 8 | 4 | — | 1 | 16 | |
| Cholangiocarcinoma | D018281 | C22.1 | 1 | 14 | 1 | — | 1 | 16 | |
| Melanoma | D008545 | 7 | 11 | 2 | — | — | 14 | ||
| Squamous cell carcinoma of head and neck | D000077195 | 2 | 4 | 2 | — | — | 7 | ||
| Colorectal neoplasms | D015179 | 2 | 3 | 1 | — | — | 5 | ||
| Esophageal squamous cell carcinoma | D000077277 | 2 | 3 | 1 | — | — | 4 | ||
| Liver transplantation | D016031 | EFO_0010682 | — | 1 | 1 | — | — | 1 |
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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 | 19 | 18 | — | — | 2 | 32 | |
| Biliary tract neoplasms | D001661 | C24.9 | 1 | 11 | — | — | — | 11 | |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 2 | 6 | — | — | — | 8 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 2 | 5 | — | — | — | 6 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 3 | 3 | — | — | — | 5 |
| Small cell lung carcinoma | D055752 | 1 | 5 | — | — | — | 5 | ||
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 2 | 3 | — | — | — | 4 |
| Triple negative breast neoplasms | D064726 | 1 | 3 | — | — | — | 4 | ||
| Papillary thyroid cancer | D000077273 | — | 3 | — | — | — | 3 | ||
| Follicular adenocarcinoma | D018263 | — | 3 | — | — | — | 3 |
Show 46 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 3 | — | — | — | — | 3 | ||
| Lymphoma | D008223 | C85.9 | 3 | — | — | — | — | 3 | |
| Myelodysplastic syndromes | D009190 | D46 | 1 | — | — | — | — | 1 | |
| Myeloid leukemia acute | D015470 | C92.0 | 1 | — | — | — | — | 1 | |
| Hematologic neoplasms | D019337 | 1 | — | — | — | — | 1 | ||
| Non-hodgkin lymphoma | D008228 | C85.9 | 1 | — | — | — | — | 1 | |
| Primary myelofibrosis | D055728 | D47.4 | 1 | — | — | — | — | 1 | |
| Multiple myeloma | D009101 | C90.0 | 1 | — | — | — | — | 1 | |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 1 | — | — | — | — | 1 | |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 1 | — | — | — | — | 1 |
Show 13 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Medullary carcinoma | D018276 | — | — | — | — | 1 | 1 | ||
| Molecular targeted therapy | D058990 | — | — | — | — | 1 | 1 | ||
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | — | — | — | 1 | 1 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | — | 1 | 1 |
| Apoptosis | D017209 | — | — | — | — | 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 | 3WZD |
| CAS-ID | 417716-92-8 |
| RxCUI | 1603296 |
| ChEMBL ID | CHEMBL1289601 |
| ChEBI ID | 85994 |
| PubChem CID | 9823820 |
| DrugBank | DB09078 |
| UNII ID | EE083865G2 (ChemIDplus, GSRS) |
Target
Agency Approved
KDR
KDR
FLT4
FLT4
Organism
Homo sapiens
Gene name
KDR
Gene synonyms
FLK1, VEGFR2
NCBI Gene ID
Protein name
vascular endothelial growth factor receptor 2
Protein synonyms
CD309, Fetal liver kinase 1, fetal liver kinase-1, FLK-1, KDR, Kinase insert domain receptor, kinase insert domain receptor (a type III receptor tyrosine kinase), Protein-tyrosine kinase receptor flk-1, soluble VEGFR2, tyrosine kinase growth factor receptor
Uniprot ID
Mouse ortholog
Kdr (16542)
vascular endothelial growth factor receptor 2 (Q8VCD0)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Lenvima - Merck Sharp & Dohme
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 8,231 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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284,408 adverse events reported
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