THERAPY DOSSIER · th-0376aaab4d85

Edaravone

Drug · Unknown

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This record is classified as “NO TRAUMA TRANSLATION”. Read the indication and notes below for the specific context.

Evidence & regulatory context

Mechanism: Unknown
Target: Not recorded
Injury models: Chemical/toxin · Ischaemia-reperfusion · Crush · Haemorrhage/shock · Spinal cord injury · TBI · Burn · Radiation
Reported indication: Free-radical scavenger approved for acute ischemic stroke in Japan (2001, Radicut) and China (and other Asian markets); separately approved for ALS (Radicava, US 2017)
First approval: 2017
Development stage: Approved for acute ischemic stroke in Japan/China only (not FDA/EMA); ALS approval is a separate/different indication
ChEMBL record: CHEMBL290916 ↗
ChEMBL max phase: 4 / 4 (development scale, not regulatory approval)
Synonyms: Antipyrine related compound a; C.i. developer 1; Colorex pmp; Developer z; Edaravona; Edaravone; Jarocol pmp; MCI-186; Norphenazone; NSC-12; NSC-26139; NSC-2629; Phenyl methyl pyrazolone; Radicava; Radicava ors
Note: Not recorded

Clinical trials 18

2 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT03968042 ↗Injury indicationPHASE2unknown

Efficacy and safety of nerve growth factor or edaravone in alcohol-induced brain injury

Alcohol-induced Brain Injury

Enrolment: 150 · Results not recorded

NCT03495206 ↗Injury indicationPHASE1unknown

SALVAGE: sublingual Y-2 (edaravone and borneol) tablet for acute ischaemic and haemorrhagic stroke

Acute Stroke · Intracranial Hemorrhages

Enrolment: 24 · Results not recorded

NCT07682922 ↗PHASE4not yet recruiting

Efficacy and Safety of Sublingual Edaravone Dexborneol for Inter-hospital Transfer Acute Ischemic Stroke: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

Acute Ischemic Stroke

Enrolment: 1040 · Results not recorded

NCT00200356 ↗PHASE4completed

Edaravone vs sodium ozagrel comparative post-marketing study in acute ischaemic stroke

Cerebral Infarction

Enrolment: 401 · Results not recorded

NCT02430350 ↗PHASE3completed

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

Acute Ischemic Stroke

Enrolment: 1200 · Results not recorded

NCT05151471 ↗PHASE3terminated

A Phase 3b, Multicenter, Randomized, Double-blind Extension Study to Evaluate the Continued Efficacy and Safety of Oral Edaravone Administered for an Additional Period of up to 48 Weeks Following Study MT-1186-A02 in Subjects With Amyotrophic Lateral Sclerosis (ALS)

ALS

Enrolment: 202 · Results not recorded

NCT04577404 ↗PHASE3completed

Phase 3 open-label safety extension of oral edaravone over 96 weeks in ALS

Amyotrophic Lateral Sclerosis

Enrolment: 124 · Results not recorded

NCT00415519 ↗PHASE3completed

Exploratory study of MCI-186 in ALS severity classification III

Amyotrophic Lateral Sclerosis

Enrolment: 25 · Results not recorded

NCT00330681 ↗PHASE3completed

Confirmatory study of MCI-186 in ALS, double-blind placebo-controlled

Amyotrophic Lateral Sclerosis

Enrolment: 206 · Results not recorded

NCT06315231 ↗PHASE2recruiting

Efficacy and Safety of Edaravone Dexborneol Sublingual Tablet for Post-stroke Cognitive Impairment in Patients With Acute Ischemic Stroke: a Multicenter, Randomized, Double-blind, Placebo-controlled, Exploratory Phase II Clinical Trial.

Post-stroke Cognitive Impairment

Enrolment: 226 · Results not recorded

NCT03346538 ↗PHASE2terminated

Dose-finding study of MCI-186 in acute ischaemic stroke

Acute Ischemic Stroke

Enrolment: 17 · Results not recorded

NCT03289208 ↗PHASE1completed

An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MCI-186 in Subjects With Mild or Moderate Renal Impairment Compared to Subjects With Normal Renal Function

Renal Impairment · Healthy

Enrolment: 30 · Results not recorded

NCT03664544 ↗PHASE1completed

An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MCI-186 in Subjects With Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function

Severe Hepatic Impairment · Healthy

Enrolment: 12 · Results not recorded

NCT05342597 ↗PHASE1completed

Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Subjects (Food Effect Study)

Healthy Adult Subjects

Enrolment: 16 · Results not recorded

NCT04481750 ↗PHASE1completed

Phase I oral edaravone in healthy adult males (single and multiple dose)

Healthy Adults

Enrolment: 74 · Results not recorded

NCT03289234 ↗PHASE1completed

Pharmacokinetics of MCI-186 in subjects with mild or moderate hepatic impairment

Hepatic Impairment · Healthy

Enrolment: 22 · Results not recorded

NCT01894334 ↗Phase not recordedunknown

Mechanism and Early Intervention Research on Acute Lung Injury During Emergence Surgery of Acute Stanford A Aortic Dissection

Acute Aortic Dissection

Enrolment: 220 · Results not recorded

NCT02644915 ↗Phase not recordedunknown

Effect of edaravone on ischaemia-reperfusion injury in kidney transplantation patients

Kidney Transplantation

Enrolment: 150 · Results not recorded

Preclinical evidence 14

6 studies reported at therapy level; 14 evidence entries itemised.

PMID 21040696 ↗2010Reported benefit

Edaravone, a novel antidote against lung injury and pulmonary fibrosis induced by paraquat?

RatChemical/toxinSprague-DawleyMaleAfter paraquat

Model: Paraquat-induced lung injury and pulmonary fibrosis

Edaravone reduced oxidative and inflammatory markers and attenuated paraquat-induced lung injury and fibrosis.

Extraction: extract · Supplied extraction confidence: 0.7. Machine-extracted fields require source verification.

PMID 31678401 ↗2019Reported benefit

Edaravone attenuates lung injury in a hind limb ischemia-reperfusion rat model: A histological, immunohistochemical and biochemical study.

RatIschaemia-reperfusionLimb / skeletal muscleWistarMalen = 30 adult male rats in 3 groups3 mg/kg30 min before induction of ischaemia

Model: Hind limb ischaemia by femoral artery clamping for 2 h followed by 24 h reperfusion, with remote lung injury

Ischaemia/reperfusion caused focal disruption of alveolar architecture, mononuclear and neutrophil infiltration, dilated congested capillaries, and significantly increased iNOS, NF-kappaB and COX-2 immunoreactivity confirmed by RT-qPCR, with ultrastructural alveolar fluid and red cells and septal v…

Extraction: extract · Subtype source: rule · Supplied extraction confidence: 0.75. Machine-extracted fields require source verification.

PMID 28973341 ↗2017Reported benefit

Edaravone Prevents Retinal Degeneration in Adult Mice Following Optic Nerve Injury.

MouseCrushOther / unspecifiedC57BL/6Intraocular injection2 microlitres of 7.2 mM edaravone3 minutes after optic nerve injury

Model: Optic nerve injury (crush) in adult mice

A single intraocular injection of edaravone given 3 minutes after optic nerve injury reduced reactive oxygen species production, retinal ganglion cell death and inner retinal degeneration, and suppressed activation of the ASK1-p38 MAPK pathway.

Extraction: extract · Supplied extraction confidence: 0.65. Machine-extracted fields require source verification.

PMID 25440340 ↗2014Reported benefit

The radical scavenger edaravone improves neurologic function and perihematomal glucose metabolism after acute intracerebral hemorrhage.

RatHaemorrhage/shockUnspecifiedSprague-DawleyMaleAfter blood infusion

Model: Autologous blood infusion model of intracerebral haemorrhage

Edaravone improved forelimb placing and corner turn performance, reduced brain water content at day 3, increased the perihaematomal lesion-to-normal FDG uptake ratio, reduced injury volume and decreased apoptotic cell numbers.

Extraction: extract · Supplied extraction confidence: 0.6. Machine-extracted fields require source verification.

PMID 22310070 ↗2012Mixed findings

Protective effects of edaravone on experimental spinal cord injury in rats.

RatSpinal cord injuryContusionWistar albinoMale

Model: Spinal cord injury induced by a weight-drop method

Edaravone lowered tissue and serum nitric oxide and tissue malondialdehyde and raised tissue superoxide dismutase, glutathione peroxidase and total antioxidant capacity compared with no treatment (p < 0.05), but neurological outcome scores showed no statistically significant improvement in motor fu…

Extraction: extract · Subtype source: llm · Supplied extraction confidence: 0.65. Machine-extracted fields require source verification.

PMID 25754765 ↗2015Reported benefit

Protective effects of edaravone combined puerarin on inhalation lung injury induced by black gunpowder smog.

RatChemical/toxinWistarMalen = 5 groups of male Wistar rats, group size not stated

Model: Black gunpowder smog inhalation acute lung injury

Edaravone or puerarin alone significantly reduced neutrophil infiltration and tissue injury (all p<0.05), and the combination showed additive protection against smog-induced lung injury compared with single treatment.

Extraction: extract · Supplied extraction confidence: 0.7. Machine-extracted fields require source verification.

PMID 20854248 ↗2010