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:

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

FDA Adverse Event Reporting System (Female)

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
Malaise	210.45	26.03	423	19274	415531	63053794
Dysphonia	203.68	26.03	146	19551	47468	63421857
Thyroiditis	189.56	26.03	57	19640	2409	63466916
Hepatic function abnormal	187.24	26.03	126	19571	37016	63432309
Gastrointestinal perforation	186.07	26.03	61	19636	3430	63465895
Cholecystitis	179.32	26.03	90	19607	15287	63454038
Hyperthyroidism	177.36	26.03	88	19609	14585	63454740
Drug ineffective	177.04	26.03	53	19644	1044712	62424613
Blood pressure increased	167.77	26.03	228	19469	161834	63307491
Blood thyroid stimulating hormone increased	163.26	26.03	67	19630	7127	63462198
Pyrexia	160.16	26.03	409	19288	470069	62999256
Renal impairment	151.91	26.03	161	19536	88194	63381131
Stomatitis	125.41	26.03	183	19514	138542	63330783
Cardiac failure	121.60	26.03	144	19553	88998	63380327
Adrenal insufficiency	118.09	26.03	72	19625	17843	63451482
Interstitial lung disease	106.68	26.03	113	19584	61795	63407530
Tumour haemorrhage	105.40	26.03	33	19664	1598	63467727
Pneumothorax	101.19	26.03	63	19634	16198	63453127
Myocarditis	96.19	26.03	52	19645	10273	63459052
Fistula	95.87	26.03	52	19645	10341	63458984
Condition aggravated	89.88	26.03	10	19687	402207	63067118
Thrombocytopenia	88.56	26.03	164	19533	150993	63318332
Posterior reversible encephalopathy syndrome	82.98	26.03	57	19640	17288	63452037
Ascites	80.39	26.03	80	19617	40648	63428677
Colitis	79.05	26.03	86	19611	48442	63420883
Tracheal fistula	74.52	26.03	13	19684	37	63469288
Nephrotic syndrome	72.01	26.03	35	19662	5541	63463784
Drug hypersensitivity	71.24	26.03	7	19690	310680	63158645
Pain	67.01	26.03	79	19618	740549	62728776
Immune-mediated myocarditis	66.45	26.03	16	19681	284	63469041
Swelling	66.41	26.03	5	19692	275373	63193952
Hypersensitivity	66.04	26.03	7	19690	292678	63176647
Immune-mediated hepatic disorder	62.51	26.03	17	19680	498	63468827
Weight increased	62.14	26.03	5	19692	260787	63208538
Cholecystitis acute	61.72	26.03	36	19661	8224	63461101
Thyroid disorder	61.37	26.03	45	19652	15117	63454208
Protein urine present	60.31	26.03	32	19665	6088	63463237
Rheumatoid arthritis	60.10	26.03	5	19692	253814	63215511
Fatigue	58.07	26.03	471	19226	887557	62581768
Intestinal perforation	56.48	26.03	39	19658	11924	63457401
Adrenocorticotropic hormone deficiency	56.36	26.03	15	19682	404	63468921
Immune-mediated enterocolitis	55.98	26.03	22	19675	2089	63467236
Arthropathy	54.57	26.03	5	19692	234787	63234538
Cerebral haemorrhage	54.52	26.03	57	19640	30672	63438653
Off label use	53.73	26.03	79	19618	674383	62794942
Alopecia	53.48	26.03	19	19678	337517	63131808
Toxicity to various agents	53.07	26.03	7	19690	247243	63222082
Immune-mediated hyperthyroidism	52.98	26.03	11	19686	95	63469230
Dehydration	52.81	26.03	145	19552	173209	63296116
Joint swelling	52.67	26.03	18	19679	327648	63141677
Hypertensive crisis	52.21	26.03	41	19656	15245	63454080
Infusion related reaction	50.26	26.03	8	19689	245513	63223812
Immune-mediated hepatitis	49.85	26.03	18	19679	1353	63467972
Large intestine perforation	48.11	26.03	31	19666	8451	63460874
Small intestinal perforation	48.09	26.03	18	19679	1497	63467828
Oesophageal fistula	47.67	26.03	11	19686	161	63469164
Sinusitis	47.27	26.03	7	19690	226646	63242679
Product dose omission issue	45.00	26.03	9	19688	234304	63235021
Hyponatraemia	44.95	26.03	104	19593	111796	63357529
Drug intolerance	44.58	26.03	20	19677	308641	63160684
Oral pain	43.94	26.03	49	19648	28345	63440980
Weight decreased	43.88	26.03	186	19511	276612	63192713
Enterocolitis	42.81	26.03	28	19669	7830	63461495
Fall	42.05	26.03	36	19661	392298	63077027
Mucosal inflammation	39.58	26.03	60	19637	46868	63422457
Nasopharyngitis	39.09	26.03	15	19682	254242	63215083
Arterial haemorrhage	38.98	26.03	16	19681	1701	63467624
Vomiting	38.66	26.03	301	19396	559316	62910009
Hypopituitarism	37.76	26.03	14	19683	1134	63468191
Discomfort	37.73	26.03	4	19693	167370	63301955
Female genital tract fistula	36.52	26.03	25	19672	7534	63461791
Cerebral infarction	34.87	26.03	40	19657	23853	63445472
Depression	34.81	26.03	9	19688	196483	63272842
Immune-mediated encephalitis	34.46	26.03	9	19688	225	63469100
Cholangitis	33.22	26.03	21	19676	5540	63463785
Eastern Cooperative Oncology Group performance status worsened	33.01	26.03	13	19684	1241	63468084
Tumour lysis syndrome	32.63	26.03	25	19672	8965	63460360
Tracheal haemorrhage	32.42	26.03	8	19689	158	63469167
Immune-mediated dermatitis	31.43	26.03	8	19689	180	63469145
Pruritus	31.04	26.03	40	19657	361413	63107912
Nausea	29.28	26.03	398	19299	854073	62615252
Taste disorder	29.12	26.03	28	19669	13634	63455691
Peritonitis	28.97	26.03	31	19666	17123	63452202
Asthma	28.87	26.03	3	19694	127558	63341767
Myelosuppression	28.55	26.03	36	19661	23667	63445658
Epistaxis	28.54	26.03	67	19630	72658	63396667
Musculoskeletal stiffness	28.18	26.03	11	19686	184607	63284718
Bronchitis	28.12	26.03	3	19694	124932	63344393
Dizziness	28.07	26.03	57	19640	429868	63039457
Abdominal pain	27.99	26.03	171	19526	293285	63176040
Neutrophil count decreased	27.85	26.03	57	19640	56349	63412976
Pleural effusion	26.41	26.03	76	19621	93134	63376191
Amylase increased	26.05	26.03	19	19678	6326	63462999

FDA Adverse Event Reporting System (Male)

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
Liver carcinoma ruptured	176.23	20.87	36	18167	155	34938573
Malaise	170.65	20.87	328	17875	185497	34753231
Blood pressure increased	146.97	20.87	204	17999	87898	34850830
Fatigue	145.26	20.87	472	17731	370181	34568547
Oesophageal varices haemorrhage	136.46	20.87	54	18149	3092	34935636
Hepatic function abnormal	130.33	20.87	137	18066	44226	34894502
Ascites	124.82	20.87	137	18066	46434	34892294
Stomatitis	117.30	20.87	127	18076	42387	34896341
Cholecystitis	112.91	20.87	70	18133	10618	34928110
Drug ineffective	106.22	20.87	53	18150	456698	34482030
Hepatic failure	94.96	20.87	103	18100	34428	34904300
Cholangitis	94.56	20.87	58	18145	8631	34930097
Ammonia increased	91.64	20.87	45	18158	4324	34934404
Adrenal insufficiency	82.22	20.87	64	18139	13983	34924745
Pneumothorax	80.60	20.87	72	18131	19020	34919708
Blood bilirubin increased	78.14	20.87	98	18105	38198	34900530
Blood thyroid stimulating hormone increased	77.99	20.87	40	18163	4215	34934513
Platelet count decreased	71.46	20.87	178	18025	119539	34819189
Dehydration	71.13	20.87	187	18016	129782	34808946
Interstitial lung disease	70.69	20.87	124	18079	65158	34873570
Drug interaction	70.02	20.87	16	18187	225930	34712798
Condition aggravated	69.63	20.87	9	18194	192187	34746541
Toxicity to various agents	66.62	20.87	12	18191	200350	34738378
Oral pain	64.82	20.87	50	18153	10777	34927951
Tumour rupture	60.44	20.87	16	18187	245	34938483
Tracheal fistula	55.23	20.87	13	18190	119	34938609
Off label use	52.77	20.87	86	18117	419438	34519290
Cholecystitis acute	50.47	20.87	35	18168	6404	34932324
Portal vein thrombosis	48.27	20.87	28	18175	3760	34934968
Thyroiditis	45.60	20.87	23	18180	2339	34936389
Gastrointestinal perforation	45.15	20.87	27	18176	3836	34934892
Immune-mediated hepatitis	44.03	20.87	22	18181	2193	34936535
Epistaxis	43.90	20.87	95	18108	58156	34880572
Weight decreased	43.24	20.87	194	18009	176107	34762621
Tracheo-oesophageal fistula	42.79	20.87	14	18189	460	34938268
Nephrotic syndrome	42.13	20.87	33	18170	7270	34931458
Completed suicide	39.68	20.87	3	18200	98165	34840563
Hyperammonaemia	39.41	20.87	30	18173	6337	34932391
Vomiting	37.76	20.87	239	17964	247382	34691346
Protein urine present	37.69	20.87	27	18176	5201	34933527
Taste disorder	36.32	20.87	30	18173	7125	34931603
Pneumonitis	36.17	20.87	64	18139	33814	34904914
Neutropenia	35.05	20.87	19	18184	156759	34781969
Liver disorder	31.02	20.87	59	18144	32938	34905790
Pyrexia	30.35	20.87	285	17918	332728	34606000
Liver abscess	30.12	20.87	21	18182	3874	34934854
Nausea	29.55	20.87	288	17915	339620	34599108
Cerebral infarction	29.48	20.87	52	18151	27403	34911325
Hyperhidrosis	28.73	20.87	3	18200	75689	34863039
Fall	27.91	20.87	39	18164	202846	34735882
Renal impairment	27.79	20.87	110	18093	94403	34844325
Arterial haemorrhage	27.62	20.87	12	18191	870	34937858
Immune-mediated hypothyroidism	27.38	20.87	9	18194	300	34938428
Rhythm idioventricular	26.96	20.87	9	18194	315	34938413
Duodenal perforation	26.31	20.87	13	18190	1265	34937463
Tumour lysis syndrome	26.14	20.87	38	18165	17021	34921707
Colitis	25.55	20.87	59	18144	37691	34901037
Overdose	25.22	20.87	8	18195	91051	34847677
Protein induced by vitamin K absence or antagonist II increased	25.18	20.87	5	18198	18	34938710
Haemobilia	25.02	20.87	9	18194	395	34938333
Cholangitis acute	24.33	20.87	11	18192	877	34937851
Oesophageal fistula	23.65	20.87	8	18195	292	34938436
Tumour necrosis	23.29	20.87	12	18191	1276	34937452
Haemoptysis	22.91	20.87	54	18149	34952	34903776
Depression	22.83	20.87	11	18192	97087	34841641
Weight increased	22.71	20.87	10	18193	93023	34845705
Product dose omission issue	22.03	20.87	18	18185	119693	34819035
Asthenia	21.84	20.87	209	17994	245042	34693686
Hyperthyroidism	21.46	20.87	27	18176	10539	34928189
Intentional product use issue	21.15	20.87	3	18200	59813	34878915

FDA Adverse Event Reporting System (Geriatric)

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
Immune-mediated hypothyroidism	294.77	22.43	64	28372	599	79715353
Malaise	266.18	22.43	557	27879	489312	79226640
Dysphonia	262.65	22.43	193	28243	56679	79659273
Hepatic function abnormal	252.71	22.43	209	28227	72898	79643054
Cholecystitis	230.79	22.43	126	28310	22086	79693866
Drug ineffective	213.86	22.43	61	28375	1080852	78635100
Pneumothorax	177.46	22.43	116	28320	28207	79687745
Blood thyroid stimulating hormone increased	174.79	22.43	80	28356	9628	79706324
Ascites	154.07	22.43	161	28275	75401	79640551
Thyroiditis	154.01	22.43	59	28377	4546	79711406
Blood pressure increased	148.01	22.43	268	28168	211092	79504860
Gastrointestinal perforation	140.92	22.43	60	28376	6077	79709875
Pyrexia	134.55	22.43	537	27899	678172	79037780
Adrenal insufficiency	127.67	22.43	95	28341	28392	79687560
Liver carcinoma ruptured	127.58	22.43	26	28410	173	79715779
Condition aggravated	124.55	22.43	16	28420	501108	79214844
Renal impairment	123.26	22.43	210	28226	157573	79558379
Hyperthyroidism	122.39	22.43	84	28352	22125	79693827
Stomatitis	119.52	22.43	199	28237	146558	79569394
Tracheal fistula	112.73	22.43	23	28413	154	79715798
Oesophageal varices haemorrhage	112.69	22.43	46	28390	4190	79711762
Toxicity to various agents	105.83	22.43	13	28423	421527	79294425
Cholecystitis acute	104.10	22.43	63	28373	13388	79702564
Nephrotic syndrome	101.36	22.43	58	28378	11116	79704836
Interstitial lung disease	96.11	22.43	156	28280	112444	79603508
Cardiac failure	95.42	22.43	186	28250	154656	79561296
Colitis	95.35	22.43	124	28312	73183	79642769
Dehydration	94.43	22.43	246	28190	247941	79468011
Blood bilirubin increased	92.39	22.43	116	28320	66116	79649836
Cholangitis	89.10	22.43	56	28380	12720	79703232
Immune-mediated hepatitis	88.12	22.43	37	28399	3619	79712333
Fistula	83.49	22.43	54	28382	12886	79703066
Tracheo-oesophageal fistula	79.93	22.43	22	28414	584	79715368
Drug interaction	73.68	22.43	28	28408	415155	79300797
Weight increased	73.52	22.43	7	28429	277379	79438573
Drug hypersensitivity	73.09	22.43	10	28426	298906	79417046
Off label use	72.04	22.43	134	28302	907081	78808871
Fatigue	71.44	22.43	570	27866	929157	78786795
Hypersensitivity	71.17	22.43	6	28430	262233	79453719
Posterior reversible encephalopathy syndrome	70.31	22.43	65	28371	26216	79689736
Hepatic failure	69.61	22.43	97	28339	61115	79654837
Pain	69.13	22.43	90	28346	703712	79012240
Arterial haemorrhage	65.36	22.43	27	28409	2534	79713418
Hyponatraemia	65.25	22.43	174	28262	177674	79538278
Immune-mediated myocarditis	62.02	22.43	21	28415	1132	79714820
Rheumatoid arthritis	61.80	22.43	3	28433	208467	79507485
Oesophageal fistula	61.74	22.43	17	28419	452	79715500
Product dose omission issue	61.18	22.43	8	28428	247529	79468423
Cerebral haemorrhage	60.57	22.43	88	28348	57585	79658367
Immune-mediated enterocolitis	60.34	22.43	31	28405	4799	79711153
Cerebral infarction	57.42	22.43	76	28360	45600	79670352
Sinusitis	57.36	22.43	3	28433	195498	79520454
Vomiting	56.44	22.43	418	28018	665410	79050542
Protein urine present	55.12	22.43	38	28398	10074	79705878
Hypertensive crisis	54.84	22.43	51	28385	20719	79695233
Fall	54.68	22.43	56	28380	487573	79228379
Ammonia increased	54.58	22.43	34	28402	7601	79708351
Infusion related reaction	53.30	22.43	9	28427	230228	79485724
Large intestine perforation	53.11	22.43	43	28393	14524	79701428
Myocarditis	52.88	22.43	51	28385	21682	79694270
Immune-mediated hepatic disorder	51.79	22.43	20	28416	1574	79714378
Pneumonitis	51.46	22.43	84	28352	60776	79655176
Intestinal perforation	50.34	22.43	45	28391	17381	79698571
Small intestinal perforation	49.57	22.43	24	28412	3273	79712679
Drug intolerance	48.18	22.43	17	28419	264102	79451850
Arthropathy	48.18	22.43	4	28432	177107	79538845
Joint swelling	47.10	22.43	22	28414	288624	79427328
Tumour lysis syndrome	46.95	22.43	50	28386	23889	79692063
Portal vein thrombosis	46.91	22.43	28	28408	5799	79710153
Swelling	46.91	22.43	10	28426	216701	79499251
Immune-mediated hyperthyroidism	46.47	22.43	11	28425	156	79715796
Treatment failure	45.97	22.43	4	28432	170482	79545470
Haemoptysis	45.60	22.43	76	28360	55923	79660029
Hyperammonaemia	43.11	22.43	34	28402	11059	79704893
Weight decreased	42.89	22.43	244	28192	354954	79360998
Nasopharyngitis	41.96	22.43	19	28417	253862	79462090
Depression	41.20	22.43	13	28423	216777	79499175
Overdose	40.90	22.43	8	28428	184198	79531754
Alopecia	40.33	22.43	16	28420	231339	79484613
Adrenocorticotropic hormone deficiency	40.15	22.43	16	28420	1369	79714583
Abdominal pain	39.65	22.43	256	28180	389313	79326639
Tumour rupture	39.20	22.43	12	28424	467	79715485
Pancreatitis	38.15	22.43	79	28357	68496	79647456
Epistaxis	37.77	22.43	106	28330	111409	79604543
Eastern Cooperative Oncology Group performance status worsened	37.11	22.43	17	28419	2048	79713904
Insomnia	36.55	22.43	21	28415	245149	79470803
Pulmonary embolism	35.50	22.43	138	28298	171516	79544436
Intentional product use issue	35.07	22.43	6	28430	152106	79563846
Amylase increased	34.48	22.43	30	28406	11179	79704773
Asthma	34.25	22.43	4	28432	135091	79580861
Musculoskeletal stiffness	34.14	22.43	10	28426	174998	79540954
Liver disorder	34.10	22.43	78	28358	72339	79643613
Primary adrenal insufficiency	33.89	22.43	9	28427	208	79715744
Hyperhidrosis	32.76	22.43	7	28429	151485	79564467
Paraesthesia	32.75	22.43	11	28425	176312	79539640
Immune-mediated dermatitis	32.74	22.43	11	28425	579	79715373
Injection site pain	32.54	22.43	4	28432	129834	79586118
Dizziness	32.47	22.43	89	28347	526352	79189600
Upper gastrointestinal haemorrhage	32.15	22.43	55	28381	41325	79674627
Urticaria	31.96	22.43	13	28423	185188	79530764
Contusion	31.91	22.43	7	28429	148769	79567183
Myelosuppression	31.89	22.43	54	28382	40242	79675710
Cancer pain	31.66	22.43	21	28415	5224	79710728
Duodenal perforation	30.23	22.43	15	28421	2157	79713795
Immune-mediated encephalitis	30.16	22.43	10	28426	505	79715447
Immune-mediated renal disorder	30.12	22.43	8	28428	185	79715767
Oxygen saturation decreased	29.95	22.43	5	28431	129042	79586910
Thrombocytopenia	29.89	22.43	179	28257	265080	79450872
Mucosal inflammation	29.78	22.43	76	28360	75504	79640448
Taste disorder	29.19	22.43	32	28404	15791	79700161
Aspartate aminotransferase increased	29.10	22.43	112	28324	138529	79577423
Discomfort	28.86	22.43	5	28431	125612	79590340
Cholangitis acute	28.75	22.43	13	28423	1519	79714433
Wheezing	28.26	22.43	4	28432	116660	79599292
Enterocolitis	27.91	22.43	30	28406	14482	79701470
Ileus	27.52	22.43	40	28396	26171	79689781
Anxiety	27.29	22.43	29	28407	248483	79467469
Pruritus	27.20	22.43	63	28373	394585	79321367
Nausea	26.72	22.43	484	27952	956712	78759240
Immune-mediated pancreatitis	26.65	22.43	8	28428	291	79715661
Malignant pleural effusion	26.58	22.43	16	28420	3364	79712588
Hypopituitarism	26.50	22.43	16	28420	3383	79712569
Oral pain	25.67	22.43	43	28393	31755	79684197
Oesophageal perforation	25.34	22.43	12	28424	1559	79714393
Tumour associated fever	24.75	22.43	10	28426	887	79715065
Female genital tract fistula	24.71	22.43	19	28417	5956	79709996
Rhythm idioventricular	24.52	22.43	9	28427	615	79715337
Liver abscess	24.49	22.43	19	28417	6035	79709917
Tracheal haemorrhage	24.01	22.43	9	28427	653	79715299
Gastric perforation	23.98	22.43	16	28420	4021	79711931
Peripheral swelling	23.87	22.43	37	28399	269580	79446372
Tumour pain	23.75	22.43	13	28423	2286	79713666
Gastrointestinal haemorrhage	23.73	22.43	110	28326	147609	79568343
Thyroid disorder	23.45	22.43	27	28409	14052	79701900
Lipase increased	23.20	22.43	29	28407	16437	79699515
Asthenia	22.97	22.43	281	28155	511408	79204544
Bronchitis	22.81	22.43	9	28427	130635	79585317
Peritonitis	22.75	22.43	38	28398	27998	79687954
Influenza	22.52	22.43	9	28427	129597	79586355

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01EX08	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PROTEIN KINASE INHIBITORS Other protein kinase inhibitors
FDA MoA	N0000020000	Receptor Tyrosine Kinase Inhibitors
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D047428	Protein Kinase Inhibitors
FDA EPC	N0000175605	Kinase Inhibitor
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

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

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

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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

Orange Book patent data (new drug applications)

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 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 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	11090386	Feb. 23, 2036	TREATMENT WITH LENVIMA BY ADMINISTERING LENVIMA AS A SUSPENSION

Orange Book exclusivity data (new drug applications)

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 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 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 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 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 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 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	Aug. 15, 2025	INDICATED FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC)

Bioactivity Summary:

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
STE20-like serine/threonine-protein kinase	Kinase	Q9H2G2	SLK_HUMAN		Kd	5.41	CHEMBL
Epithelial discoidin domain-containing receptor 1	Kinase	Q08345	DDR1_HUMAN		Kd	7.34	CHEMBL
Protein-tyrosine kinase 6	Kinase	Q13882	PTK6_HUMAN		Kd	6.76	CHEMBL
MAP kinase-activated protein kinase 2	Kinase	P49137	MAPK2_HUMAN		Kd	7.20	CHEMBL
Discoidin domain-containing receptor 2	Kinase	Q16832	DDR2_HUMAN		Kd	6.66	CHEMBL
Epidermal growth factor receptor	Kinase	P00533	EGFR_HUMAN	INHIBITOR	IC50	5.19	SCIENTIFIC LITERATURE
Mitogen-activated protein kinase kinase kinase kinase 2	Kinase	Q12851	M4K2_HUMAN		Kd	6.24	CHEMBL
Serine/threonine-protein kinase/endoribonuclease IRE1	Kinase	O75460	ERN1_HUMAN		Kd	5.65	CHEMBL
Dual specificity mitogen-activated protein kinase kinase 5	Kinase	Q13163	MP2K5_HUMAN		Kd	5.54	CHEMBL
Ferrochelatase, mitochondrial	Enzyme	P22830	HEMH_HUMAN		Kd	5.55	CHEMBL
Receptor-interacting serine/threonine-protein kinase 3	Kinase	Q9Y572	RIPK3_HUMAN		Kd	6.50	CHEMBL
Mitogen-activated protein kinase kinase kinase 6	Kinase	O95382	M3K6_HUMAN		Kd	5.80	CHEMBL
Platelet-derived growth factor receptor beta	Kinase	P09619	PGFRB_HUMAN	INHIBITOR	IC50	7.41	SCIENTIFIC LITERATURE
Aurora kinase B	Kinase	Q96GD4	AURKB_HUMAN		Kd	5.75	CHEMBL
Ribosyldihydronicotinamide dehydrogenase [quinone]	Enzyme	P16083	NQO2_HUMAN		Kd	5.82	CHEMBL
Tyrosine-protein kinase ABL1	Kinase	P00519	ABL1_HUMAN		Kd	5.42	CHEMBL
Carbonic anhydrase 5A, mitochondrial	Enzyme	P35218	CAH5A_HUMAN		Ki	6.88	CHEMBL
Breakpoint cluster region protein	Kinase	P11274	BCR_HUMAN		Kd	5.39	CHEMBL
Serine/threonine-protein kinase 10	Kinase	O94804	STK10_HUMAN		Kd	6.10	CHEMBL
TRAF2 and NCK-interacting protein kinase	Kinase	Q9UKE5	TNIK_HUMAN		Kd	6.25	CHEMBL

External reference:

ID	Source
EE083865G2	UNII
D09919	KEGG_DRUG
4034239	VUID
N0000191429	NUI
857890-39-2	SECONDARY_CAS_RN
4034239	VANDF
C2986924	UMLSCUI
CHEBI:85994	CHEBI
LEV	PDB_CHEM_ID
CHEMBL1289601	ChEMBL_ID
9823820	PUBCHEM_CID
DB09078	DRUGBANK_ID
CHEMBL2105704	ChEMBL_ID
9361	INN_ID
C531958	MESH_SUPPLEMENTAL_RECORD_UI
7426	IUPHAR_LIGAND_ID
1603296	RXNORM
232716	MMSL
294829	MMSL
294831	MMSL
30895	MMSL
d08346	MMSL
015899	NDDF
015900	NDDF
714108002	SNOMEDCT_US
714109005	SNOMEDCT_US
735068004	SNOMEDCT_US

Pharmaceutical products:

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
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
Lenvima	HUMAN PRESCRIPTION DRUG LABEL	1	62856-712	CAPSULE	4 mg	ORAL	NDA	32 sections
Lenvima	HUMAN PRESCRIPTION DRUG LABEL	1	62856-712	CAPSULE	4 mg	ORAL	NDA	32 sections
Lenvima	HUMAN PRESCRIPTION DRUG LABEL	1	62856-712	CAPSULE	4 mg	ORAL	NDA	32 sections
Lenvima	HUMAN PRESCRIPTION DRUG LABEL	1	62856-712	CAPSULE	4 mg	ORAL	NDA	32 sections
Lenvima	HUMAN PRESCRIPTION DRUG LABEL	1	62856-720	CAPSULE	10 mg	ORAL	NDA	32 sections
Lenvima	HUMAN PRESCRIPTION DRUG LABEL	1	62856-720	CAPSULE	10 mg	ORAL	NDA	32 sections
Lenvima	HUMAN PRESCRIPTION DRUG LABEL	1	62856-720	CAPSULE	10 mg	ORAL	NDA	32 sections
Lenvima	HUMAN PRESCRIPTION DRUG LABEL	1	62856-720	CAPSULE	10 mg	ORAL	NDA	32 sections