Drugs / Edaravone
Edaravone
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | RADICAVA | — | 2017-05-05 | fda.gov ↗ |
Trials 48 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 114 trials | ||||||
| Phase 1 | NCT07083362 | Aug 2025 → Jan 2026 | ischemic stroke | Beijing Suncadia Pharmaceuticals Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT04776135 | Feb → Apr 2021 | — | Shionogi | Completed | No outcome recorded |
| Phase 1 | NCT04370431 | Apr → Dec 2020 | — | Shanghai Auzone Biological Technology Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04254913 | Jan → Apr 2020 | amyotrophic lateral sclerosis | Shionogi | Completed | No outcome recorded |
| Phase 1 | NCT05342597 | Jun → Jul 2019 | — | Shionogi | Completed | No outcome recorded |
| Phase 1 | NCT04218513 | May 2019 | — | Nanjing Yoko Biomedical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04176224 | Apr → Sep 2019 | amyotrophic lateral sclerosis | Shionogi | Completed | No outcome recorded |
| Phase 1 | NCT03664544 | Nov 2018 → Mar 2019 | — | Shionogi | Completed | No outcome recorded |
| Phase 1 | NCT03495206 | Oct 2018 → Dec 2020 | stroke disorder | Yantai YenePharma Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT04481789 | Oct → Dec 2018 | — | Shionogi | Completed | No outcome recorded |
| Phase 1 | NCT04029090 | Sep → Oct 2018 | — | Shionogi | Completed | No outcome recorded |
| Phase 1 | NCT04481750 | Mar → Aug 2018 | — | Shionogi | Completed | No outcome recorded |
| Phase 1 | NCT03289234 | Nov 2016 → Jul 2018 | — | Shionogi | Completed | No outcome recorded |
| Phase 1 | NCT03289208 | Oct 2016 → Apr 2018 | impaired renal function disease | Shionogi | Completed | No outcome recorded |
| Phase 29 trials | ||||||
| Phase 2 | NCT07692399 | Jul 2026 → Dec 2027 expected | cerebral arteriopathy, autosomal dominant, with subcortical infarcts and leukoencephalopathy, type 1 | Huashan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05953103 | Jul 2023 → Apr 2025 | intracerebral hemorrhage | Simcere Pharmaceutical Co., Ltd | Terminated | No outcome recorded |
| Phase 2 | NCT05323812 | Mar 2023 → Dec 2024 | Alzheimer disease | Treeway B.V. | Completed | No outcome recorded |
| Phase 2 | NCT04984577 | Nov 2021 → Dec 2026 | ischemic stroke | Nanjing Yoko Biomedical Co., Ltd. | Suspended | No outcome recorded |
| Phase 2 | NCT05035953 | Sep 2021 → Sep 2023 | ischemic stroke | Huashan Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT03968042 | Jun 2019 → Dec 2021 | brain injury | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 2 | NCT03346538 | Nov 2017 → May 2018 | ischemic stroke | Shionogi | Terminated | No outcome recorded |
| Phase 2 | NCT01865201 | Mar 2009 → Oct 2011 | encephalomalacia, nasopharyngeal carcinoma | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Completed | No outcome recorded |
| Phase 2 | NCT00821821 | Feb 2009 → Nov 2010 | ischemic stroke | Shionogi | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03272802 | Mar 2017 → Mar 2019 | neuromuscular disease | Isfahan University of Medical Sciences | Unknown | No outcome recorded |
| Phase 315 trials | ||||||
| Phase 3 | NCT07604350 | Jun 2026 → Jun 2030 expected | epilepsy | First Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06674460 | Aug 2025 → Oct 2027 expected | ischemic stroke | Peking Union Medical College Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT05885919 | Jul 2023 → Dec 2024 | ischemic stroke | Xiangya Hospital of Central South University | Unknown | No outcome recorded |
| Phase 3 | NCT05568615 | Oct 2022 → Jun 2023 | amyotrophic lateral sclerosis | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 3 | NCT05249920 | Mar 2022 → Feb 2023 | ischemic stroke | Beijing Tiantan Hospital | Completed | No outcome recorded |
| Phase 3 | NCT05151471 | Jan 2022 → Sep 2023 | amyotrophic lateral sclerosis | Tanabe Pharma America, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT04950920 | Jun 2021 → Aug 2022 | ischemic stroke | Peking University Third Hospital | Completed | No outcome recorded |
| Phase 3 | NCT04569084 | Nov 2020 → Sep 2023 | amyotrophic lateral sclerosis | Shionogi | Terminated | No outcome recorded |
| Phase 3 | NCT04577404 | Oct 2020 → Aug 2023 | amyotrophic lateral sclerosis | Shionogi | Completed | No outcome recorded |
| Phase 3 | NCT04165824 | Nov 2019 → Oct 2021 | amyotrophic lateral sclerosis | Tanabe Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02430350 | May 2015 → Dec 2016 | ischemic stroke | Jiangsu Simcere Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT01492686 | Dec 2011 → Sep 2014 | amyotrophic lateral sclerosis | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 3 | NCT00424463 | Jan 2007 → May 2009 | amyotrophic lateral sclerosis | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 3 | NCT00415519 | Dec 2006 → Jul 2008 | amyotrophic lateral sclerosis | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 3 | NCT00330681 | May 2006 → Sep 2008 | amyotrophic lateral sclerosis | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT07091994 | Aug → Dec 2026 expected | ischemic stroke | Nanfang Hospital, Southern Medical University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07119021 | Aug 2024 → Apr 2027 expected | ischemic stroke | Ruijun Ji | Recruiting | No outcome recorded |
| Phase 4 | NCT06248242 | Jun 2021 → Jun 2024 | ischemic stroke | The Second Hospital of Hebei Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT00200356 | Aug 2004 → Oct 2006 | cerebral infarction | Tanabe Pharma Corporation | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT05540262 | Jan 2022 → Dec 2025 overdue | optic neuritis | First Affiliated Hospital of Guangxi Medical University | Recruiting | No outcome recorded |
| — | NCT05024526 | Apr 2021 → Dec 2022 | ischemic stroke | Lili Cao | Unknown | No outcome recorded |
| — | NCT04202549 | Dec 2019 → Sep 2022 | ischemic stroke | Huisheng Chen | Completed | No outcome recorded |
| — | NCT02644915 | Mar → Sep 2016 | — | Xijing Hospital | Unknown | No outcome recorded |
| — | NCT01894334 | Apr 2013 → Jan 2015 | aortic disorder | Beijing Anzhen Hospital | Unknown | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04219865 Comparator | Jun → Aug 2019 | — | Nanjing Yoko Biomedical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01518231 Comparator | Jan → Dec 2012 | stroke disorder | Zhejiang Hospital | Unknown | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT04391361 Background | Nov 2020 → Sep 2023 | amyotrophic lateral sclerosis | Ruijin Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT01929096 Comparator | Aug 2013 → Dec 2014 | ischemic stroke | Jiangsu Simcere Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT00153946 Comparator | Aug 2004 → Mar 2008 | ischemic stroke | Combination Therapy for Acute Ischemic Stroke Study Group | Completed | No outcome recorded |
| Phase 4 | NCT00265239 Comparator | Apr 2001 → Jun 2007 | myocardial infarction | Kumamoto University | Completed | No outcome recorded |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 55 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Edaravone | “Intra-arterial administration of argatroban (0.2-0.3 mg/min), dexamethasone (0.1 mg/min) and edaravone (0.3 mg/min) for 30 to 60 minutes after thrombectomy” NCT04202549 ↗33“TTYP01 (30 mg edaravone tablet) will be orally administrated at single ascending doses of 60 mg, 120 mg, 180 mg and 240 mg (n=6 per dose)” NCT04370431 ↗ “Sanbexin IV 37.5 mg (edaravone 30 mg + dexborneol 7.5 mg), intravenous, twice daily, for 14 consecutive days” NCT05953103 ↗ “Open-label 24-week extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis.” PMID 28872920 ↗ Oct 2017 “Y-2 sublingual tablets: Edaravone 30mg and d-borneol 6mg.” NCT04950920 ↗ “Oral edaravone” NCT05151471 ↗ |
| Known as | Edaravone Injection | “Edaravone Injection 30mg/dose, one dose every 12 hours, continue for 14 days” NCT04984577 ↗ |
| Known as | EDV | “AIMS: To measure the therapeutic effect of an anti-oxidant, edaravone (EDV), or neurotrophic treatment with nerve growth factor (NGF) as an add-on treatment for alcohol-related...” PMID 38049955 ↗ Dec 2023 |
| Known as | MCI-186 | “Open-label 24-week extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis.” PMID 28872920 ↗ Oct 2017 |
| Known as | MT-1186 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05568615 ↗ |
| Known as | TTYP01 | “TTYP01 (30 mg edaravone tablet) will be orally administrated at single ascending doses of 60 mg, 120 mg, 180 mg and 240 mg (n=6 per dose)” NCT04370431 ↗ |
| Known as | TW001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05323812 ↗ |
| Route | Intravenous | “is intravenously administered” NCT00200356 ↗ |