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

Stem definition	Drug id	CAS RN
	4156	89-25-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: radicava edaravone edarabone methylphenylpyrazolone norantipyrine norphenazone radicut	Edaravone protects neurons from oxidative stress by scavenging free radicals that may cause cellular damage, and this mechanism is expected to be effective both in patients with acute cerebral infarction and in those with ALS Molecular weight: 174.20 Formula: C10H10N2O CLOGP: 1.33 LIPINSKI: 0 HAC: 3 HDO: 0 TPSA: 32.67 ALOGS: -2.27 ROTB: 1 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

radicava
edaravone
edarabone
methylphenylpyrazolone
norantipyrine
norphenazone
radicut

Edaravone protects neurons from oxidative stress by scavenging free radicals that may cause cellular damage, and this mechanism is expected to be effective both in patients with acute cerebral infarction and in those with ALS

Molecular weight: 174.20
Formula: C10H10N2O
CLOGP: 1.33
LIPINSKI: 0
HAC: 3
HDO: 0
TPSA: 32.67
ALOGS: -2.27
ROTB: 1

Status: OFP

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

Drug dosage:

None

ADMET properties:

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Property	Value	Reference
t_half (Half-life)	2.36 hours	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Bocci G, Oprea TI, Benet LZ
CL (Clearance)	1.42 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.89 %	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	0.23 L/kg	Lombardo F, Berellini G, Obach RS
S (Water solubility)	0.03 mg/mL	Bocci G, Oprea TI, Benet LZ

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Approvals:

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Date	Agency	Company	Orphan
April 4, 2001	PMDA	Mitsubishi Tanabe Pharma Corporation
May 5, 2017	FDA	MITSUBISHI TANABE PHARMA DEVELOPMENT AMERICA INC

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FDA Adverse Event Reporting System (Female)

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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
Death	126.53	49.86	64	550	374317	63114091
Cerebral infarction	92.84	49.86	25	589	23868	63464540

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FDA Adverse Event Reporting System (Male)

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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
Death	163.13	39.85	109	804	397940	34558078
Cerebral infarction	86.99	39.85	31	882	27424	34928594
Haemorrhagic infarction	50.30	39.85	9	904	468	34955550
Amyotrophic lateral sclerosis	49.38	39.85	10	903	1008	34955010
Haemorrhagic cerebral infarction	44.89	39.85	9	904	862	34955156
Cerebral hyperperfusion syndrome	40.64	39.85	6	907	91	34955927

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FDA Adverse Event Reporting System (Geriatric)

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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
Cerebral infarction	181.80	35.18	55	1286	45621	79697426
Death	133.45	35.18	94	1247	566420	79176627
Haemorrhagic cerebral infarction	74.76	35.18	14	1327	1465	79741582
Hepatic function abnormal	64.18	35.18	29	1312	73078	79669969
Haemorrhagic infarction	63.19	35.18	11	1330	763	79742284
Amyotrophic lateral sclerosis	47.99	35.18	10	1331	1805	79741242
Respiratory failure	46.66	35.18	32	1309	180879	79562168
Cerebral hyperperfusion syndrome	41.43	35.18	6	1335	126	79742921
Paratonia	41.36	35.18	5	1336	23	79743024
Gastrostomy	39.95	35.18	8	1333	1185	79741862

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	N07XX14	NERVOUS SYSTEM OTHER NERVOUS SYSTEM DRUGS OTHER NERVOUS SYSTEM DRUGS Other nervous system drugs
CHEBI has role	CHEBI:22586	antioxidants
CHEBI has role	CHEBI:48578	free radical scavengers
MeSH PA	D000975	Antioxidants
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D016166	Free Radical Scavengers
MeSH PA	D018696	Neuroprotective Agents
MeSH PA	D020011	Protective Agents

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

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Disease	Relation	SNOMED_ID	DOID
Amyotrophic lateral sclerosis	indication	86044005	DOID:332
Ischemic stroke	indication	422504002

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	0.5	Basic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
105MG/5ML	RADICAVA ORS	MITSUBISHI TANABE	N215446	May 12, 2022	RX	SUSPENSION	ORAL	11478450	Nov. 1, 2039	TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
105MG/5ML	RADICAVA ORS	MITSUBISHI TANABE	N215446	May 12, 2022	RX	SUSPENSION	ORAL	May 12, 2025	NEW PRODUCT
30MG/100ML (0.3MG/ML)	RADICAVA	MITSUBISHI TANABE	N209176	May 5, 2017	RX	SOLUTION	INTRAVENOUS	May 5, 2024	TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS)
60MG/100ML (0.6MG/ML)	RADICAVA	MITSUBISHI TANABE	N209176	Nov. 15, 2018	RX	SOLUTION	INTRAVENOUS	May 5, 2024	FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Polyunsaturated fatty acid lipoxygenase ALOX15	Enzyme		LOX15_MOUSE		IC50	4.47		CHEMBL

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External reference:

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ID	Source
017212	NDDF
11994	IUPHAR_LIGAND_ID
1921877	RXNORM
257218	MMSL
32736	MMSL
4021	PUBCHEM_CID
4036711	VANDF
7362	INN_ID
736496005	SNOMEDCT_US
763587009	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
RADICAVA	HUMAN PRESCRIPTION DRUG LABEL	1	70510-2171	INJECTION	30 mg	INTRAVENOUS	NDA	28 sections
RADICAVA	HUMAN PRESCRIPTION DRUG LABEL	1	70510-2171	INJECTION	30 mg	INTRAVENOUS	NDA	28 sections
RADICAVA	HUMAN PRESCRIPTION DRUG LABEL	1	70510-2171	INJECTION	30 mg	INTRAVENOUS	NDA	28 sections

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