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Drug

Edaravone

Approved · FDA
Emerging researchLate-stage developmentRising momentum
Also known as 1-phenyl-3-methyl-5-oxo-2-pyrazoline, 3-methyl-1-phenyl-2-pyrazolin-5-one, 3-methyl-1-phenyl-5-pyrazolone, 3-methyl-1-phenylpyrazol-5-one+6 more

1-phenyl-3-methyl-5-oxo-2-pyrazoline, 3-methyl-1-phenyl-2-pyrazolin-5-one, 3-methyl-1-phenyl-5-pyrazolone, 3-methyl-1-phenylpyrazol-5-one, Methylphenylpyrazolone, Norphenazone, Phenyl methyl pyrazolone, Phenylmethylpyrazolone, Radicava, 2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one.

RxNorm1921877ChEMBLCHEMBL290916ATCN07XX14UNIIS798V6YJRP
3
Research papers
1
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Approval: EDARAVONE (ANDA218349)

Regulatory2026-07-22FDA

Edaravone-Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) Comparative Post-Marketing Study on Acute Ischemic Stroke

Clinical trial2026-01-07Results posted · ClinicalTrials.gov

Edaravone in the Treatment of Optic Neuritis

Clinical trial2025-12-31Primary completion · ClinicalTrials.gov

A Phase 1, Randomized, Open-Label, Three-Treatment, Three-Period Crossover Study to Assess Bioequivalence and Safety of TTYP01 Tablets to Radicava® Injection, and Radicava ORS® in Healthy Adult Subjects Under Fasting Conditions

Clinical trial2023-12-14Completed · ClinicalTrials.gov

The Safety and Effectiveness of Cholinergic Receptor Block Therapy in the Treatment of Amyotrophic Lateral Sclerosis

Clinical trial2023-09-30Primary completion · ClinicalTrials.gov

Behavioral and Neurological Effects of Edaravone and Noscapine in Albino Wistar Rats.

Research2023-08-24Experimental aging research

Edaravone ameliorates depressive and anxiety-like behaviors via Sirt1/Nrf2/HO-1/Gpx4 pathway.

Research2022-02-07Journal of neuroinflammation

Efficacy and Safety of Nerve Growth Factor or Edaravone on Alcohol-induced Brain Injury

Clinical trial2021-12-01Primary completion · ClinicalTrials.gov

An Experiment to Evaluate the Drug-drug Interaction of Formula Edaravone and Formula 2-Aminoethanesulfonic Acid in Compound Edaravone Injection

Clinical trial2019-05-31Completed · ClinicalTrials.gov

Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS) in a Representative Iranian Population

Clinical trial2019-03-16Primary completion · ClinicalTrials.gov

Compound Edaravone Injection for Acute Ischemic Stroke, a Multi-center, Randomized, Double-blind, Parallel, and Active-controlled PhaseⅢTrial

Clinical trial2016-12-01Completed · ClinicalTrials.gov

Edaravone (radical scavenger) versus sodium ozagrel (antiplatelet agent) in acute noncardioembolic ischemic stroke (EDO trial).

Research2009-03-26Cerebrovascular diseases (Basel, Switzerland)

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Edaravone
Aliases & brands
1-phenyl-3-methyl-5-oxo-2-pyrazoline3-methyl-1-phenyl-2-pyrazolin-5-one3-methyl-1-phenyl-5-pyrazolone3-methyl-1-phenylpyrazol-5-oneMethylphenylpyrazoloneNorphenazonePhenyl methyl pyrazolonePhenylmethylpyrazoloneRadicava2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one
RxNorm CUI
1921877
ChEMBL ID
CHEMBL290916
ATC codes
N07XX14
UNII
S798V6YJRP
Regulatory jurisdictions
fda

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2026-07-22
Latest approval
2026-07-22
Authorities
FDA
Total events
1
fdaU.S. Food and Drug Administration· 1 event
2026-07-22Approval
Approval: EDARAVONE (ANDA218349)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

16 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
16
registered trials across all phases
LATEST COMPLETION 2023
1
Active studies
1
Recruiting
8
Late-stage (III+)
8
Completed
7
Discontinued
PHASE DISTRIBUTIONn = 16
Phase 13Phase 25Phase 2 / 31Phase 31Phase 43Phase N / A3

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Multicenter Randomized Open-Label Comparison Study on the Efficacy and Safety of Argatroban Monotherapy With Argatroban-Edaravone Combination Therapy

CompletedPH IVCombination Therapy for Acute Ischemic Stroke Study Groupn=8142008

Effects of Edaravone in Patients With Acute Myocardial Infarction

CompletedPH IVKumamoto Universityn=1042007

Edaravone-Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) Comparative Post-Marketing Study on Acute Ischemic Stroke

CompletedPH IVTanabe Pharma Corporationn=4012006

Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS) in a Representative Iranian Population

Unknown statusPH II/IIIIsfahan University of Medical Sciencesn=202019

Compound Edaravone Injection for Acute Ischemic Stroke, a Multi-center, Randomized, Double-blind, Parallel, and Active-controlled PhaseⅢTrial

CompletedPH IIIKey trialJiangsu Simcere Pharmaceutical Co., Ltd.n=1,2002016

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 1, Randomized, Open-Label, Three-Treatment, Three-Period Crossover Study to Assess Bioequivalence and Safety of TTYP01 Tablets to Radicava® Injection, and Radicava ORS® in Healthy Adult Subjects Under Fasting Conditions

CompletedPH IShanghai Auzone Biological Technology Co., Ltd.n=292023

An Experiment to Evaluate the Drug-drug Interaction of Formula Edaravone and Formula 2-Aminoethanesulfonic Acid in Compound Edaravone Injection

CompletedPH INanjing Yoko Biomedical Co., Ltd.n=242019

Compound Edaravone Injection for Acute Ischemic Stroke, a Multi-center, Randomized, Double-blind, Parallel, and Active-controlled PhaseⅢTrial

CompletedPH IIIKey trialJiangsu Simcere Pharmaceutical Co., Ltd.n=1,2002016

Compound Edaravone Injection for Acute Ischemic Stroke, a Multi-center, Randomized, Double-blind, Multi-dose, Parallel, and Controlled Phase II Trial

CompletedPH IIJiangsu Simcere Pharmaceutical Co., Ltd.n=4002015

Effect of Edaravone on Radiation-induced Temporal Lobe Necrosis in Patients With Nasopharyngeal Carcinoma After Radiotherapy

CompletedPH IISun Yat-Sen Memorial Hospital of Sun Yat-Sen Universityn=1542012

Multicenter Randomized Open-Label Comparison Study on the Efficacy and Safety of Argatroban Monotherapy With Argatroban-Edaravone Combination Therapy

CompletedPH IVCombination Therapy for Acute Ischemic Stroke Study Groupn=8142008

Research activity

3 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20092024
Major research themes5
Alzheimer Disease1Edaravone1NF-E2-Related Factor 21Noscapine1Sirtuin 11
Journals, researchers & institutions
Top journals
  • Cerebrovascular diseases (Basel, Switzerland)1
  • Experimental aging research1
  • Journal of neuroinflammation1
Leading researchers
  • Dang R1
  • Doshi GM1
  • Godad AP1
  • Hafizur Rehman MR1
  • Ji P1
  • Kobayashi S1
  • Li X1
  • Licinio J1
Leading institutions
free-text, unnormalised
  • Chongqing Key Laboratory of Oral Diseases and Biomedical Sciences1
  • Chongqing University Three Gorges Hospital1
  • College of Medicine1
  • College of Stomatology and Affiliated Stomatological Hospital of Chongqing Medical University1
  • Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital1
  • First Affiliated Hospital of Kunming Medical University1

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Noscapine

Studied across 2 of the same disease areas as Edaravone in the shared literature.

2 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.