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edaravone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 4156 | 89-25-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| Vd (Volume of distribution) | 0.23 L/kg | Lombardo F, Berellini G, Obach RS |
| 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 |
| t_half (Half-life) | 2.36 hours | Lombardo F, Berellini G, Obach RS |
| S (Water solubility) | 0.03 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 0.546 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 0.933 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 104.472 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 7.852 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 30.730 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 31.270 | % | High | 1 |
| herg | hERG pIC50 | 4.018 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 1.837 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 7.586 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 16.860 | % | High | 1 |
| kinase-safety-class | ACVR2A,ACVR2B,AKT2,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,CHEK1,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,GSK3B,ITK,JAK2,MAP2K6,MAP3K21,MAP3K7,MAPK10,MAPK12,MAPK7,MAPK9,MAPKAPK2,MARK4,MET,MTOR,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIK3CD,PIM2,PLK1,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TTK,ULK1 | 50 | |||
| kinase-selectivity-class | AXL,GRK2 | 2 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 1.197 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 45.709 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 34.520 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 1.365 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 26.320 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 20.045 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 95.200 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 14.660 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 941.890 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 5, 2017 | FDA | MITSUBISHI TANABE PHARMA DEVELOPMENT AMERICA INC | |
| April 4, 2001 | PMDA | Mitsubishi Tanabe Pharma Corporation |
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 |
|---|---|---|---|---|---|---|
| Death | 186.99 | 42.81 | 90 | 817 | 456461 | 90171079 |
| Cerebral infarction | 112.50 | 42.81 | 30 | 877 | 26566 | 90600974 |
| Disease progression | 79.06 | 42.81 | 36 | 871 | 156579 | 90470961 |
| Haemorrhagic cerebral infarction | 49.07 | 42.81 | 8 | 899 | 633 | 90626907 |
| Paratonia | 43.96 | 42.81 | 5 | 902 | 23 | 90627517 |
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 |
|---|---|---|---|---|---|---|
| Death | 234.67 | 41.12 | 150 | 1055 | 471035 | 42149095 |
| Cerebral infarction | 87.87 | 41.12 | 33 | 1172 | 31136 | 42588994 |
| Amyotrophic lateral sclerosis | 59.43 | 41.12 | 12 | 1193 | 1100 | 42619030 |
| Disease progression | 58.43 | 41.12 | 41 | 1164 | 143615 | 42476515 |
| Haemorrhagic infarction | 48.70 | 41.12 | 9 | 1196 | 517 | 42619613 |
| Tracheostomy | 48.39 | 41.12 | 10 | 1195 | 1027 | 42619103 |
| Pneumonia aspiration | 45.56 | 41.12 | 24 | 1181 | 50054 | 42570076 |
| Haemorrhagic cerebral infarction | 43.97 | 41.12 | 9 | 1196 | 882 | 42619248 |
| Respiratory failure | 43.89 | 41.12 | 33 | 1172 | 128099 | 42492031 |
| Hepatic function abnormal | 42.10 | 41.12 | 23 | 1182 | 51544 | 42568586 |
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 |
|---|---|---|---|---|---|---|
| Cerebral infarction | 206.90 | 35.46 | 62 | 1721 | 51776 | 110535740 |
| Death | 198.25 | 35.46 | 128 | 1655 | 698741 | 109888775 |
| Haemorrhagic cerebral infarction | 94.60 | 35.46 | 17 | 1766 | 1478 | 110586038 |
| Hepatic function abnormal | 75.25 | 35.46 | 34 | 1749 | 89261 | 110498255 |
| Haemorrhagic infarction | 68.82 | 35.46 | 12 | 1771 | 877 | 110586639 |
| Gastrostomy | 68.38 | 35.46 | 13 | 1770 | 1537 | 110585979 |
| Pneumonia aspiration | 65.48 | 35.46 | 30 | 1753 | 81203 | 110506313 |
| Respiratory failure | 61.62 | 35.46 | 40 | 1743 | 215292 | 110372224 |
| Amyotrophic lateral sclerosis | 58.57 | 35.46 | 12 | 1771 | 2079 | 110585437 |
| Subarachnoid haemorrhage | 44.24 | 35.46 | 17 | 1766 | 29685 | 110557831 |
| Tracheostomy | 44.16 | 35.46 | 9 | 1774 | 1518 | 110585998 |
| Cerebral haemorrhage | 43.12 | 35.46 | 21 | 1762 | 64947 | 110522569 |
| Cerebral hyperperfusion syndrome | 41.82 | 35.46 | 6 | 1777 | 123 | 110587393 |
| Paratonia | 39.31 | 35.46 | 5 | 1778 | 39 | 110587477 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N07XX14 | NERVOUS SYSTEM OTHER NERVOUS SYSTEM DRUGS OTHER NERVOUS SYSTEM DRUGS Other nervous system drugs |
| MeSH PA | D000975 | Antioxidants |
| MeSH PA | D016166 | Free Radical Scavengers |
| MeSH PA | D018696 | Neuroprotective Agents |
| MeSH PA | D020011 | Protective Agents |
| CHEBI has role | CHEBI:22586 | antioxidant |
| CHEBI has role | CHEBI:48578 | radical scavenger |
| CHEBI has role | CHEBI:63726 | neuroprotective agent |
| CHEBI has role | CHEBI:231911 | renoprotective agent |
Related Drugs by ATC class:
N07XX Other nervous system drugs 23 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Amyotrophic lateral sclerosis | indication | 86044005 | DOID:332 |
| Ischemic stroke | indication | 422504002 |
🐶 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)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 105MG/5ML | RADICAVA ORS | SHIONOGI | N215446 | May 12, 2022 | RX | SUSPENSION | ORAL | 11478450 | Nov. 1, 2039 | TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS |
| 105MG/5ML | RADICAVA ORS | SHIONOGI | N215446 | May 12, 2022 | RX | SUSPENSION | ORAL | 12194025 | Nov. 12, 2041 | TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS BY ADMINISTERING A LIQUID EDARAVONE COMPOSITION RELATIVE TO THE TIMING AND TYPE OF FOOD CONSUMPTION |
| 105MG/5ML | RADICAVA ORS | SHIONOGI | N215446 | May 12, 2022 | RX | SUSPENSION | ORAL | 12310946 | Nov. 12, 2041 | TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS BY ADMINISTERING A LIQUID EDARAVONE COMPOSITION RELATIVE TO THE TIMING AND TYPE OF FOOD CONSUMPTION |
| 105MG/5ML | RADICAVA ORS | SHIONOGI | N215446 | May 12, 2022 | RX | SUSPENSION | ORAL | 12478611 | Nov. 12, 2041 | TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS BY ADMINISTERING A LIQUID EDARAVONE COMPOSITION RELATIVE TO THE TIMING AND TYPE OF FOOD CONSUMPTION |
| 105MG/5ML | RADICAVA ORS | SHIONOGI | N215446 | May 12, 2022 | RX | SUSPENSION | ORAL | 12527769 | Nov. 12, 2041 | TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS BY ADMINISTERING A LIQUID EDARAVONE COMPOSITION RELATIVE TO THE TIMING AND TYPE OF FOOD CONSUMPTION |
| 105MG/5ML | RADICAVA ORS | SHIONOGI | N215446 | May 12, 2022 | RX | SUSPENSION | ORAL | 12569469 | Nov. 12, 2041 | TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS BY ADMINISTERING A LIQUID EDARAVONE COMPOSITION RELATIVE TO THE TIMING AND TYPE OF FOOD CONSUMPTION |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 105MG/5ML | RADICAVA ORS | SHIONOGI | N215446 | May 12, 2022 | RX | SUSPENSION | ORAL | May 12, 2029 | TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Polyunsaturated fatty acid lipoxygenase ALOX15 | Enzyme | IC50 | 4.47 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| D01552 | KEGG_DRUG |
| 4036711 | VANDF |
| C0070694 | UMLSCUI |
| CHEBI:31530 | CHEBI |
| CHEMBL290916 | ChEMBL_ID |
| D000077553 | MESH_DESCRIPTOR_UI |
| DB12243 | DRUGBANK_ID |
| 11994 | IUPHAR_LIGAND_ID |
| 7362 | INN_ID |
| S798V6YJRP | UNII |
| 4021 | PUBCHEM_CID |
| 1921877 | RXNORM |
| 257218 | MMSL |
| 32736 | MMSL |
| 387175 | MMSL |
| d08586 | MMSL |
| 017212 | NDDF |
| 736496005 | SNOMEDCT_US |
| 763587009 | SNOMEDCT_US |
| W1P | PDB_CHEM_ID |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Edaravone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-3527 | INJECTION | 30 mg | INTRAVENOUS | ANDA | 24 sections |
| edaravone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 39822-4500 | INJECTION, SOLUTION | 30 mg | INTRAVENOUS | ANDA | 27 sections |
| edaravone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 39822-4510 | INJECTION, SOLUTION | 60 mg | INTRAVENOUS | ANDA | 27 sections |
| Edaravone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66794-259 | INJECTION, SOLUTION | 30 mg | INTRAVENOUS | ANDA | 22 sections |
| Edaravone | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66794-259 | INJECTION, SOLUTION | 30 mg | INTRAVENOUS | ANDA | 22 sections |
| edaravone | Human Prescription Drug Label | 1 | 68083-500 | INJECTION, SOLUTION | 30 mg | INTRAVENOUS | ANDA | 22 sections |
| edaravone | Human Prescription Drug Label | 1 | 68083-501 | INJECTION, SOLUTION | 60 mg | INTRAVENOUS | ANDA | 22 sections |
| RADICAVA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70510-2171 | INJECTION | 30 mg | INTRAVENOUS | NDA | 29 sections |