Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate the therapeutic utility, neuroprotective capacity, bioequivalence, and safety profile of edaravone. These studies encompass indications such as acute ischemic stroke, cerebral hemorrhage, amyotrophic lateral sclerosis, optic neuritis, and chemo brain, alongside pharmacokinetic assessments in healthy adults. Sponsored by academic research centers and pharmaceutical entities, this clinical research includes completed, actively recruiting, terminated, and suspended trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07604350 NOT_YET_RECRUITING
Post-stroke Epilepsy; Post-stroke Seizure
First Affiliated Hospital of Wenzhou Medical University
 2026-06 PHASE3
NCT07682922 NOT_YET_RECRUITING
Acute Ischemic Stroke
Xinqiao Hospital of Chongqing
 2026-07-01 PHASE4
NCT07454473 RECRUITING
Chemo Brain
Chuansheng Zhao
 2026-03-02 PHASE4
NCT07692399 NOT_YET_RECRUITING
CADASIL
Huashan Hospital
 2026-07 PHASE2
NCT07801976 NOT_YET_RECRUITING
Healthy Volunteer
St. Jude Children's Research Hospital
 2026-10 EARLY_PHASE1
NCT06674460 RECRUITING
Cerebral Small Vessel Disease; Ischemic Stroke
Peking Union Medical College Hospital
 2025-08-01 PHASE3
NCT07119021 RECRUITING
Ischemic Stroke
Ruijun Ji
 2024-08-01 PHASE4
NCT04984577 SUSPENDED
Acute Ischemic Stroke
Nanjing Yoko Biomedical Co., Ltd.
 2021-11-15 PHASE2
NCT07091994 NOT_YET_RECRUITING
Ischemic Stroke, Acute; Active Malignancies
Nanfang Hospital, Southern Medical University
 2026-08-01 PHASE4
NCT06315231 RECRUITING
Post-stroke Cognitive Impairment
Simcere Pharmaceutical Co., Ltd
 2024-04-08 PHASE2
NCT06645522 NOT_YET_RECRUITING
Acute Ischemic Stroke
Yi Yang
 2024-10-30 PHASE4
NCT07083362 COMPLETED
Acute Ischemia Stroke
Beijing Suncadia Pharmaceuticals Co., Ltd
 2025-08-06 PHASE1
NCT05540262 RECRUITING
Optic Neuritis
First Affiliated Hospital of Guangxi Medical University
 2022-01-15
NCT05953103 TERMINATED
Subjects With Cerebral Hemorrhage
Simcere Pharmaceutical Co., Ltd
 2023-07-03 PHASE2
NCT06176781 UNKNOWN
Subjects With Acute Ischemic Stroke
Simcere Pharmaceutical Co., Ltd
 2023-12-28 PHASE3
NCT05885919 UNKNOWN
Ischemic Stroke, Acute; Treatment Outcome
Xiangya Hospital of Central South University
 2023-07-01 PHASE3
NCT06248242 UNKNOWN
Acute Ischemic Stroke
The Second Hospital of Hebei Medical University
 2021-06-01 PHASE4
NCT06107205 Completed
Healthy Adult Subjects
Auzone Biological Technology Pty Ltd
 2023-11-07 Phase 1
NCT04391361 UNKNOWN
Amyotrophic Lateral Sclerosis; Respiratory Function; Scopolamine
Ruijin Hospital
 2020-11-01 PHASE2
NCT04569084 TERMINATED
ALS
Shionogi
 2020-11-13 PHASE3
NCT05151471 TERMINATED
ALS
Shionogi
 2022-01-11 PHASE3
NCT05035953 UNKNOWN
Stroke, Ischemic
Huashan Hospital
 2021-09-13 PHASE2
NCT04577404 COMPLETED
Amyotrophic Lateral Sclerosis (ALS)
Shionogi
 2020-10-29 PHASE3
NCT05953103 Recruiting
Subjects With Cerebral Hemorrhage
Simcere Pharmaceutical Co. Ltd
 2023-07-03 Phase 2
NCT05568615 COMPLETED
ALS
Shionogi
 2022-10-26 PHASE3
NCT04714177 UNKNOWN
Intracerebral Hemorrhage
First Affiliated Hospital, Sun Yat-Sen University
 2021-03-01 PHASE2
NCT05249920 COMPLETED
Acute Ischemic Stroke; Mechanical Thrombectomy; Edaravone Dexborneol; Phase III
Beijing Tiantan Hospital
 2022-03-18 PHASE3
NCT05024526 UNKNOWN
Acute Ischemic Stroke
Lili Cao
 2021-04-01
NCT04817527 UNKNOWN
Stroke, Ischemic
First Affiliated Hospital Xi'an Jiaotong University
 2021-10-01 PHASE2
NCT04667637 COMPLETED
Stroke; Endovascular Thrombectomy
Hui-Sheng Chen
 2021-02-23 PHASE2
NCT05410457 Recruiting
Ischemic Stroke
Nanjing First Hospital Nanjing Medical University
 2022-05-24 --
NCT03968042 UNKNOWN
Alcohol-induced Brain Injury
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
 2019-06-30 PHASE2
NCT04165824 COMPLETED
ALS
Shionogi
 2019-11-18 PHASE3
NCT04776135 COMPLETED
Healthy Adult Subjects
Shionogi
 2021-02-26 PHASE1
NCT04776135 Completed
Healthy Adult Subjects
Mitsubishi Tanabe Pharma Corporation
 2021-02-26 Phase 1
NCT03495206 UNKNOWN
Stroke, Acute; Intracranial Hemorrhages
Yantai YenePharma Co., Ltd.
 2018-10-25 PHASE1
NCT04254913 COMPLETED
Japanese Patients With ALS
Shionogi
 2020-01-24 PHASE1
NCT04254913 Completed
Japanese Patients With ALS
Mitsubishi Tanabe Pharma Corporation
 2020-01-24 Phase 1
NCT04176224 COMPLETED
Japanese Patients With ALS
Shionogi
 2019-04-17 PHASE1
NCT04219865 COMPLETED
Pharmacokinetics
Nanjing Yoko Biomedical Co., Ltd.
 2019-06-05 PHASE1
NCT05342597 COMPLETED
Healthy Adult Subjects
Shionogi
 2019-06-10 PHASE1
NCT05342597 Completed
Healthy Adult Subjects
Mitsubishi Tanabe Pharma Corporation
 2019-06-10 Phase 1
NCT04218513 COMPLETED
Drug-drug Interaction
Nanjing Yoko Biomedical Co., Ltd.
 2019-05-10 PHASE1
NCT04493281 COMPLETED
Healthy Adult Subjects
Shionogi
 2019-03-22 PHASE1
NCT03272802 UNKNOWN
Neuromuscular Diseases
Isfahan University of Medical Sciences
 2017-03-16 PHASE2; PHASE3
NCT04481789 COMPLETED
Healthy Adult Subjects
Shionogi
 2018-10-17 PHASE1
NCT04481750 COMPLETED
Healthy Adult Subjects
Shionogi
 2018-03-20 PHASE1
NCT02430350 COMPLETED
Acute Ischemic Stroke
Jiangsu Simcere Pharmaceutical Co., Ltd.
 2015-05 PHASE3
NCT02644915 UNKNOWN
Kidney Transplantation
Xijing Hospital
 2016-03
NCT01894334 UNKNOWN
Acute Aortic Dissection
Beijing Anzhen Hospital
 2013-04
NCT01929096 COMPLETED
Acute Ischemic Stroke
Jiangsu Simcere Pharmaceutical Co., Ltd.
 2013-08 PHASE2
NCT01518231 UNKNOWN
Stroke
Zhejiang Hospital
 2012-01 PHASE1
NCT01865201 COMPLETED
Nasopharyngeal Carcinoma; Brain Necrosis
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
 2009-03 PHASE2
NCT00153946 COMPLETED
Stroke
Combination Therapy for Acute Ischemic Stroke Study Group
 2004-08 PHASE4
NCT00200356 COMPLETED
Cerebral Infarction
Shionogi
 2004-08-31 PHASE4
NCT00265239 COMPLETED
Myocardial Infarction; Reperfusion Injury
Kumamoto University
 2001-04 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-05-22)

Check the Edaravone product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Edaravone functions as a free radical scavenger that directly quenches active oxygen species and traps hydroxyl radicals, thereby inhibiting lipoxygenase-mediated arachidonic acid metabolism and suppressing cellular lipid peroxidation. This antioxidant activity prevents oxidative membrane damage and endothelial cell toxicity, ultimately preserving neuronal viability and reducing tissue damage in conditions such as acute ischemic stroke and amyotrophic lateral sclerosis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.