Scroll

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

Stem definition	Drug id	CAS RN
angiogenesis inhibitors	4903	656247-17-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: BIBF1120 nibtedanib nintedanib nintedanib esylate intedanib BIBF 1120 ofev nintedanib ethanesulfonate vargatef	Molecular weight: 539.64 Formula: C31H33N5O4 CLOGP: 3.08 LIPINSKI: 1 HAC: 9 HDO: 2 TPSA: 94.22 ALOGS: -4.24 ROTB: 8 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

BIBF1120
nibtedanib
nintedanib
nintedanib esylate
intedanib
BIBF 1120
ofev
nintedanib ethanesulfonate
vargatef

Molecular weight: 539.64
Formula: C31H33N5O4
CLOGP: 3.08
LIPINSKI: 1
HAC: 9
HDO: 2
TPSA: 94.22
ALOGS: -4.24
ROTB: 8

Status: ONP

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

Drug dosage:

Dose	Unit	Route
0.38	g	O

ADMET properties:

Show entries

Search:

Property	Value	Reference
t_half (Half-life)	9.50 hours	Lombardo F, Berellini G, Obach RS
CL (Clearance)	19.90 mL/min/kg	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	15 L/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.02 %	Lombardo F, Berellini G, Obach RS

Showing 1 to 4 of 4 entries

Previous1Next

Approvals:

Show entries

Search:

Date	Agency	Company
July 3, 2015	PMDA	Boehringer Ingelheim
Nov. 20, 2014	EMA	Boehringer Ingelheim International GmbH
Oct. 15, 2014	FDA	BOEHRINGER INGELHEIM

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
Diarrhoea	976.93	22.91	934	11917	714432	62761739
Nausea	318.93	22.91	594	12257	853877	62622294
Decreased appetite	266.39	22.91	289	12562	250763	63225408
Malignant neoplasm progression	242.80	22.91	170	12681	81951	63394220
Vomiting	242.07	22.91	416	12435	559201	62916970
Death	160.73	22.91	278	12573	374103	63102068
Weight decreased	123.09	22.91	209	12642	276589	63199582
Drug ineffective	102.72	22.91	42	12809	1044723	62431448
Dyspnoea	97.69	22.91	324	12527	660989	62815182
Drug-induced liver injury	78.30	22.91	65	12786	40157	63436014

Showing 1 to 10 of 58 entries

Previous1 2 3 4 5 6Next

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
Diarrhoea	1491.64	19.90	1333	15729	388579	34551290
Malignant neoplasm progression	440.44	19.90	355	16707	87691	34852178
Decreased appetite	351.43	19.90	418	16644	165974	34773895
Death	259.82	19.90	586	16476	397463	34542406
Weight decreased	246.40	19.90	362	16700	175939	34763930
Pneumothorax	188.69	19.90	117	16945	18975	34920894
Dyspnoea	176.90	19.90	490	16572	376292	34563577
Lung transplant	151.21	19.90	51	17011	1973	34937896
Nausea	137.94	19.90	420	16642	339488	34600381
Cough	118.82	19.90	240	16822	149900	34789969

Showing 1 to 10 of 68 entries

Previous1 2 3 4 5 6 7Next

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
Diarrhoea	2062.82	18.04	1940	24753	878549	78839146
Malignant neoplasm progression	801.23	18.04	522	26171	135468	79582227
Decreased appetite	564.96	18.04	631	26062	341787	79375908
Death	505.04	18.04	770	25923	565744	79151951
Nausea	336.51	18.04	881	25812	956315	78761380
Weight decreased	314.04	18.04	482	26211	354716	79362979
Pneumothorax	241.36	18.04	138	26555	28185	79689510
Dyspnoea	211.83	18.04	697	25996	856328	78861367
Vomiting	194.23	18.04	574	26119	665254	79052441
Drug-induced liver injury	136.96	18.04	138	26555	65979	79651716

Showing 1 to 10 of 121 entries

Previous1 2 3 4 5…13Next

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Show entries

Search:

Source	Code	Description
ATC	L01EX09	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PROTEIN KINASE INHIBITORS Other protein kinase inhibitors
CHEBI has role	CHEBI:35610	antineoplastic agents
CHEBI has role	CHEBI:38637	tyrosine kinase inhibitors
CHEBI has role	CHEBI:48422	angiogenesis antagonist
CHEBI has role	CHEBI:63457	FGFR inhibitors
CHEBI has role	CHEBI:65207	vascular endothelial growth factor receptor inhibitors
FDA EPC	N0000175605	Kinase Inhibitor
FDA MoA	N0000175076	Protein 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
Interstitial fibrosis	indication	125565008
Systemic sclerosis associated interstitial lung disease	indication	233703007	DOID:3082
Non-small cell lung cancer	indication	254637007	DOID:3908
Idiopathic pulmonary fibrosis	indication	700250006	DOID:0050156

Showing 1 to 4 of 4 entries

Previous1Next

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.97	acidic
pKa2	7.77	Basic
pKa3	3.25	Basic

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 100MG BASE	OFEV	BOEHRINGER INGELHEIM	N205832	Oct. 15, 2014	RX	CAPSULE	ORAL	10154990	Jan. 8, 2026	USE OF NINTEDANIB FOR SLOWING THE RATE OF DECLINE IN PULMONARY FUNCTION IN PATIENTS WITH SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE (SSC-ILD)
EQ 150MG BASE	OFEV	BOEHRINGER INGELHEIM	N205832	Oct. 15, 2014	RX	CAPSULE	ORAL	10154990	Jan. 8, 2026	USE OF NINTEDANIB FOR SLOWING THE RATE OF DECLINE IN PULMONARY FUNCTION IN PATIENTS WITH SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE (SSC-ILD)

Showing 1 to 2 of 2 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 100MG BASE	OFEV	BOEHRINGER INGELHEIM	N205832	Oct. 15, 2014	RX	CAPSULE	ORAL	March 9, 2023	TREATMENT FOR CHRONIC FIBROSING INTERSTITIAL LUNG DISEASES WITH A PROGRESSIVE PHENOTYPE
EQ 100MG BASE	OFEV	BOEHRINGER INGELHEIM	N205832	Oct. 15, 2014	RX	CAPSULE	ORAL	Sept. 6, 2026	INDICATED TO SLOW THE RATE OF DECLINE IN PULMONARY FUNCTION IN PATIENTS WITH SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE (SSC-ILD)
EQ 150MG BASE	OFEV	BOEHRINGER INGELHEIM	N205832	Oct. 15, 2014	RX	CAPSULE	ORAL	March 9, 2023	TREATMENT FOR CHRONIC FIBROSING INTERSTITIAL LUNG DISEASES WITH A PROGRESSIVE PHENOTYPE
EQ 150MG BASE	OFEV	BOEHRINGER INGELHEIM	N205832	Oct. 15, 2014	RX	CAPSULE	ORAL	Sept. 6, 2026	INDICATED TO SLOW THE RATE OF DECLINE IN PULMONARY FUNCTION IN PATIENTS WITH SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE (SSC-ILD)

Showing 1 to 4 of 4 entries

Previous1Next

Bioactivity Summary:

Show entries

Search:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Fibroblast growth factor receptor 3	Kinase	P22607	FGFR3_HUMAN	INHIBITOR	Kd	7.03	CHEMBL	CHEMBL
Platelet-derived growth factor receptor beta	Kinase	P09619	PGFRB_HUMAN	INHIBITOR	Kd	7.82	CHEMBL	CHEMBL
Fibroblast growth factor receptor 2	Kinase	P21802	FGFR2_HUMAN	INHIBITOR	Kd	6.46	CHEMBL	CHEMBL
Fibroblast growth factor receptor 4	Kinase	P22455	FGFR4_HUMAN	INHIBITOR	Kd	5.74	CHEMBL	CHEMBL
Vascular endothelial growth factor receptor 1	Kinase	P17948	VGFR1_HUMAN	INHIBITOR	IC50	6.98	SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE
Vascular endothelial growth factor receptor 2	Kinase	P35968	VGFR2_HUMAN	INHIBITOR	IC50	8.30	SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE
Vascular endothelial growth factor receptor 3	Kinase	P35916	VGFR3_HUMAN	INHIBITOR	IC50	8.30	SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE
Platelet-derived growth factor receptor alpha	Kinase	P16234	PGFRA_HUMAN	INHIBITOR	IC50	7.75	SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE
Fibroblast growth factor receptor 1	Kinase	P11362	FGFR1_HUMAN	INHIBITOR	IC50	7.42	SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE
Breakpoint cluster region protein	Kinase	P11274	BCR_HUMAN		Kd	6.52	CHEMBL

Showing 1 to 10 of 225 entries

Previous1 2 3 4 5…23Next

External reference:

Show entries

Search:

ID	Source
015720	NDDF
015723	NDDF
135423438	PUBCHEM_CID
1592736	RXNORM
229920	MMSL
30617	MMSL
4033814	VUID
4033814	VANDF
5936	IUPHAR_LIGAND_ID
656247-18-6	SECONDARY_CAS_RN

Showing 1 to 10 of 25 entries

Previous1 2 3Next

Pharmaceutical products:

Show entries

Search:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Ofev	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0143	CAPSULE	100 mg	ORAL	NDA	31 sections
Ofev	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0143	CAPSULE	100 mg	ORAL	NDA	31 sections
Ofev	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0145	CAPSULE	150 mg	ORAL	NDA	31 sections
Ofev	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0145	CAPSULE	150 mg	ORAL	NDA	31 sections

Showing 1 to 4 of 4 entries

Previous1Next