Scroll

lenvatinib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
tyrosine kinase inhibitors	4942	417716-92-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: E-7080 E 7080 lenvatinib lenvima ER-203492-00 E7080 lenvatinib mesylate lenvatinib mesilate	a receptor tyrosine kinase (RTK) inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4) Molecular weight: 426.86 Formula: C21H19ClN4O4 CLOGP: 3.05 LIPINSKI: 0 HAC: 8 HDO: 3 TPSA: 115.57 ALOGS: -4.84 ROTB: 6 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

E-7080
E 7080
lenvatinib
lenvima
ER-203492-00
E7080
lenvatinib mesylate
lenvatinib mesilate

a receptor tyrosine kinase (RTK) inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4)

Molecular weight: 426.86
Formula: C21H19ClN4O4
CLOGP: 3.05
LIPINSKI: 0
HAC: 8
HDO: 3
TPSA: 115.57
ALOGS: -4.84
ROTB: 6

Status: ONP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
18	mg	O

ADMET properties:

None

Approvals:

Show entries

Search:

Date	Agency	Company
Feb. 13, 2015	FDA	EISAI INC
March 26, 2015	PMDA	Eisai Co., Ltd.
May 28, 2015	EMA	Eisai Europe Ltd

Showing 1 to 3 of 3 entries

Previous1Next

FDA Adverse Event Reporting System (Female)

Show entries

Search:

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Hypertension	1785.27	26.03	1091	18606	278212	63191113
Malignant neoplasm progression	1747.41	26.03	727	18970	81394	63387931
Proteinuria	1114.39	26.03	357	19340	18788	63450537
Hypothyroidism	1049.84	26.03	420	19277	42212	63427113
Palmar-plantar erythrodysaesthesia syndrome	879.81	26.03	313	19384	22702	63446623
Platelet count decreased	651.33	26.03	420	19277	115702	63353623
Decreased appetite	600.78	26.03	546	19151	250506	63218819
Immune-mediated hypothyroidism	313.87	26.03	58	19639	250	63469075
Diarrhoea	274.06	26.03	649	19048	714717	62754608
Hepatic encephalopathy	225.63	26.03	96	19601	11186	63458139

Showing 1 to 10 of 103 entries

Previous1 2 3 4 5…11Next

FDA Adverse Event Reporting System (Male)

Show entries

Search:

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Malignant neoplasm progression	879.50	20.87	554	17649	87492	34851236
Decreased appetite	851.15	20.87	696	17507	165696	34773032
Hepatic encephalopathy	799.81	20.87	297	17906	14388	34924340
Proteinuria	765.52	20.87	307	17896	18335	34920393
Hypertension	726.72	20.87	585	17618	135858	34802870
Palmar-plantar erythrodysaesthesia syndrome	683.96	20.87	275	17928	16520	34922208
Diarrhoea	409.75	20.87	726	17477	389186	34549542
Hypothyroidism	391.15	20.87	199	18004	20703	34918025
Tumour haemorrhage	277.74	20.87	90	18113	2872	34935856
Dysphonia	190.41	20.87	130	18073	23253	34915475

Showing 1 to 10 of 80 entries

Previous1 2 3 4 5…8Next

FDA Adverse Event Reporting System (Geriatric)

Show entries

Search:

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Hypertension	2018.38	22.43	1323	27113	329669	79386283
Malignant neoplasm progression	1954.31	22.43	955	27481	135035	79580917
Proteinuria	1481.73	22.43	522	27914	31980	79683972
Palmar-plantar erythrodysaesthesia syndrome	1173.98	22.43	442	27994	32692	79683260
Hypothyroidism	1064.87	22.43	469	27967	51923	79664029
Decreased appetite	1022.58	22.43	896	27540	341522	79374430
Hepatic encephalopathy	673.33	22.43	271	28165	23895	79692057
Platelet count decreased	482.03	22.43	460	27976	194204	79521748
Diarrhoea	426.41	22.43	953	27483	879536	78836416
Tumour haemorrhage	352.88	22.43	107	28329	4037	79711915

Showing 1 to 10 of 149 entries

Previous1 2 3 4 5…15Next

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Show entries

Search:

Source	Code	Description
ATC	L01EX08	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PROTEIN KINASE INHIBITORS Other protein kinase inhibitors
CHEBI has role	CHEBI:35610	antineoplastic agents
CHEBI has role	CHEBI:62434	ALK inhibitor
CHEBI has role	CHEBI:63457	FGFR inhibitors
CHEBI has role	CHEBI:65207	vascular endothelial growth factor receptor inhibitors
CHEBI has role	CHEBI:71031	orphan drugs
FDA EPC	N0000175605	Kinase Inhibitor
FDA MoA	N0000020000	Receptor Tyrosine Kinase Inhibitors
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D004791	Enzyme Inhibitors

Showing 1 to 10 of 11 entries

Previous1 2Next

Drug Use | Suggest Off label Use Form| |View source of the data|

Show entries

Search:

Disease	Relation	SNOMED_ID	DOID
Liver cell carcinoma	indication	109841003	DOID:684
Endometrial carcinoma progressing after chemotherapy	indication	254878006	DOID:2871
Follicular thyroid carcinoma	indication	255028004	DOID:3962
Papillary thyroid carcinoma	indication	255029007	DOID:3969
Hurthle cell carcinoma of thyroid	indication	423158009	DOID:8161
Renal cell carcinoma	indication	702391001	DOID:4450
Thymic carcinoma	indication	722670005
Breastfeeding (mother)	contraindication	413712001

Showing 1 to 8 of 8 entries

Previous1Next

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Show entries

Search:

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	12.09	acidic
pKa2	12.74	acidic
pKa3	13.02	acidic
pKa4	4.67	Basic

Showing 1 to 4 of 4 entries

Previous1Next

Orange Book patent data (new drug applications)

Show entries

Search:

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 10MG BASE	LENVIMA	EISAI INC	N206947	Feb. 13, 2015	RX	CAPSULE	ORAL	9006256	July 27, 2027	METHOD FOR TREATING THYROID CARCINOMA INCLUDING DIFFERENTIATED THYROID CANCER
EQ 10MG BASE	LENVIMA	EISAI INC	N206947	Feb. 13, 2015	RX	CAPSULE	ORAL	11090386	Feb. 23, 2036	TREATMENT WITH LENVIMA BY ADMINISTERING LENVIMA AS A SUSPENSION
EQ 4MG BASE	LENVIMA	EISAI INC	N206947	Feb. 13, 2015	RX	CAPSULE	ORAL	9006256	July 27, 2027	METHOD FOR TREATING THYROID CARCINOMA INCLUDING DIFFERENTIATED THYROID CANCER
EQ 4MG BASE	LENVIMA	EISAI INC	N206947	Feb. 13, 2015	RX	CAPSULE	ORAL	11090386	Feb. 23, 2036	TREATMENT WITH LENVIMA BY ADMINISTERING LENVIMA AS A SUSPENSION

Showing 1 to 4 of 4 entries

Previous1Next

Orange Book exclusivity data (new drug applications)

Show entries

Search:

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 10MG BASE	LENVIMA	EISAI INC	N206947	Feb. 13, 2015	RX	CAPSULE	ORAL	July 21, 2024	REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY 309/KEYNOTE-775 TO SUPPORT PMR 3696-1 AND 3700-1
EQ 10MG BASE	LENVIMA	EISAI INC	N206947	Feb. 13, 2015	RX	CAPSULE	ORAL	Aug. 10, 2024	LENVATINIB IN COMBINATION WITH PEMBROLIZUMAB, IS INDICATED FOR THE FIRST-LINE TREATMENT OF ADULT PATIENTS WITH ADVANCED RENAL CELL CARCINOMA (RCC)
EQ 10MG BASE	LENVIMA	EISAI INC	N206947	Feb. 13, 2015	RX	CAPSULE	ORAL	Dec. 19, 2024	REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY E7080-G000-211 TO SUPPORT PMR 2865-1
EQ 10MG BASE	LENVIMA	EISAI INC	N206947	Feb. 13, 2015	RX	CAPSULE	ORAL	Aug. 15, 2025	INDICATED FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC)
EQ 4MG BASE	LENVIMA	EISAI INC	N206947	Feb. 13, 2015	RX	CAPSULE	ORAL	July 21, 2024	REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY 309/KEYNOTE-775 TO SUPPORT PMR 3696-1 AND 3700-1
EQ 4MG BASE	LENVIMA	EISAI INC	N206947	Feb. 13, 2015	RX	CAPSULE	ORAL	Aug. 10, 2024	LENVATINIB IN COMBINATION WITH PEMBROLIZUMAB, IS INDICATED FOR THE FIRST-LINE TREATMENT OF ADULT PATIENTS WITH ADVANCED RENAL CELL CARCINOMA (RCC)
EQ 4MG BASE	LENVIMA	EISAI INC	N206947	Feb. 13, 2015	RX	CAPSULE	ORAL	Dec. 19, 2024	REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY E7080-G000-211 TO SUPPORT PMR 2865-1
EQ 4MG BASE	LENVIMA	EISAI INC	N206947	Feb. 13, 2015	RX	CAPSULE	ORAL	Aug. 15, 2025	INDICATED FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC)

Showing 1 to 8 of 8 entries

Previous1Next

Bioactivity Summary:

Show entries

Search:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Proto-oncogene tyrosine-protein kinase receptor Ret	Kinase	P07949	RET_HUMAN	INHIBITOR	Ki	8.82	CHEMBL	DRUG LABEL
Mast/stem cell growth factor receptor Kit	Kinase	P10721	KIT_HUMAN	INHIBITOR	IC50	7	SCIENTIFIC LITERATURE	DRUG LABEL
Vascular endothelial growth factor receptor 1	Kinase	P17948	VGFR1_HUMAN	INHIBITOR	IC50	7.66	SCIENTIFIC LITERATURE	DRUG LABEL
Vascular endothelial growth factor receptor 2	Kinase	P35968	VGFR2_HUMAN	INHIBITOR	IC50	8.40	SCIENTIFIC LITERATURE	DRUG LABEL
Vascular endothelial growth factor receptor 3	Kinase	P35916	VGFR3_HUMAN	INHIBITOR	IC50	8.28	SCIENTIFIC LITERATURE	DRUG LABEL
Platelet-derived growth factor receptor alpha	Kinase	P16234	PGFRA_HUMAN	INHIBITOR	IC50	7.29	SCIENTIFIC LITERATURE	DRUG LABEL
Fibroblast growth factor receptor 1	Kinase	P11362	FGFR1_HUMAN	INHIBITOR	IC50	7.34	SCIENTIFIC LITERATURE	DRUG LABEL
Mitogen-activated protein kinase 14	Kinase	Q16539	MK14_HUMAN		Kd	6.66	CHEMBL
Mitogen-activated protein kinase kinase kinase kinase 5	Kinase	Q9Y4K4	M4K5_HUMAN		Kd	5.51	CHEMBL
Receptor-interacting serine/threonine-protein kinase 2	Kinase	O43353	RIPK2_HUMAN		Kd	7.96	CHEMBL

Showing 1 to 10 of 30 entries

Previous1 2 3Next

External reference:

Show entries

Search:

ID	Source
LEV	PDB_CHEM_ID
015899	NDDF
015900	NDDF
1603296	RXNORM
232716	MMSL
294829	MMSL
294831	MMSL
30895	MMSL
4034239	VUID
4034239	VANDF

Showing 1 to 10 of 27 entries

Previous1 2 3Next

Pharmaceutical products:

Show entries

Search:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Lenvima	HUMAN PRESCRIPTION DRUG LABEL	1	62856-704	CAPSULE	4 mg	ORAL	NDA	32 sections
Lenvima	HUMAN PRESCRIPTION DRUG LABEL	1	62856-704	CAPSULE	4 mg	ORAL	NDA	32 sections
Lenvima	HUMAN PRESCRIPTION DRUG LABEL	1	62856-704	CAPSULE	4 mg	ORAL	NDA	32 sections
Lenvima	HUMAN PRESCRIPTION DRUG LABEL	1	62856-704	CAPSULE	4 mg	ORAL	NDA	32 sections
Lenvima	HUMAN PRESCRIPTION DRUG LABEL	1	62856-708	CAPSULE	4 mg	ORAL	NDA	32 sections
Lenvima	HUMAN PRESCRIPTION DRUG LABEL	1	62856-708	CAPSULE	4 mg	ORAL	NDA	32 sections
Lenvima	HUMAN PRESCRIPTION DRUG LABEL	1	62856-708	CAPSULE	4 mg	ORAL	NDA	32 sections
Lenvima	HUMAN PRESCRIPTION DRUG LABEL	1	62856-708	CAPSULE	4 mg	ORAL	NDA	32 sections
Lenvima	HUMAN PRESCRIPTION DRUG LABEL	1	62856-710	CAPSULE	10 mg	ORAL	NDA	32 sections
Lenvima	HUMAN PRESCRIPTION DRUG LABEL	1	62856-710	CAPSULE	10 mg	ORAL	NDA	32 sections

Showing 1 to 10 of 20 entries

Previous1 2Next