Edaravone
Edaravone, Radicava (edaravone) is a small molecule pharmaceutical. Edaravone was first approved as Radicava on 2017-05-05. It is used to treat amyotrophic lateral sclerosis in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| nutritional and metabolic diseases | D009750 |
Trade Name
FDA
EMA
Edaravone, Radicava, Radicava ors
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Edaravone
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| RADICAVA | Mitsubishi Tanabe Pharma | N-209176 RX | 2017-05-05 | 2 products, RLD, RS |
| RADICAVA ORS | Mitsubishi Tanabe Pharma | N-215446 RX | 2022-05-12 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| edaravone | ANDA | 2025-03-28 |
| radicava | New Drug Application | 2021-12-06 |
| radicava radicava ors | New Drug Application | 2025-08-25 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| amyotrophic lateral sclerosis | EFO_0000253 | D000690 | G12.21 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
EDARAVONE, RADICAVA ORS, MITSUBISHI TANABE | |||
| 2025-05-12 | NP | ||
EDARAVONE, RADICAVA, MITSUBISHI TANABE | |||
| 2024-05-05 | ODE*, ODE-144 | ||
HCPCS
Code | Description |
|---|---|
| J1301 | Injection, edaravone, 1 mg |
Clinical
Clinical Trials
68 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ischemic stroke | D000083242 | — | — | — | 2 | — | 1 | — | 3 |
| Cerebral infarction | D002544 | — | I63 | — | 2 | — | 1 | — | 3 |
| Infarction | D007238 | EFO_0009463 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | 2 | — | 5 | — | 1 | 8 |
| Motor neuron disease | D016472 | EFO_0003782 | G12.2 | 2 | — | 4 | — | 1 | 7 |
| Sclerosis | D012598 | — | — | — | — | 4 | — | — | 4 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 2 | — | — | — | 2 |
| Ischemia | D007511 | EFO_0000556 | — | — | 2 | — | — | — | 2 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 9 | — | — | — | — | 9 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 2 | — | — | — | — | 2 |
| Hepatic insufficiency | D048550 | — | — | 2 | — | — | — | — | 2 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Edaravone |
| INN | edaravone |
| Description | Edaravone is a pyrazolone that is 2,4-dihydro-3H-pyrazol-3-one which is substituted at positions 2 and 5 by phenyl and methyl groups, respectively. It has a role as a radical scavenger and an antioxidant. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC1=NN(c2ccccc2)C(=O)C1 |
Identifiers
| PDB | — |
| CAS-ID | 89-25-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL290916 |
| ChEBI ID | 31530 |
| PubChem CID | 4021 |
| DrugBank | DB12243 |
| UNII ID | S798V6YJRP (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,924 adverse events reported
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