Drugs / Edaravone
Edaravone
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed amyotrophic lateral sclerosis 28 1 milestone | |||||
| Filed | Other | — | amyotrophic lateral sclerosis 28 | 2025-02-28 | “Filling for a Oral Edaravone Formulation for the treatment of ALS in Korea” tanabe-pharma.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | RADICAVA | — | 2017-05-05 | fda.gov ↗ |
Trials 47
| 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 28 trials · 2 met primary | ||||||
| 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 | NCT04984577 | Nov 2021 → Dec 2026 | ischemic stroke | Nanjing Yoko Biomedical Co., Ltd. | Suspended | No outcome recorded Stop: Business |
| 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 | Mixed |
| Phase 2 | NCT03346538 | Nov 2017 → May 2018 | ischemic stroke | Shionogi | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT01865201 | Mar 2009 → Oct 2011 | encephalomalacia, nasopharyngeal carcinoma | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Completed | Met primary |
| Phase 2 | NCT00821821 | Feb 2009 → Nov 2010 | ischemic stroke | Shionogi | Completed | Met primary |
| 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 · 3 met primary · 4 missed | ||||||
| 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 | Missed primary |
| Phase 3 | NCT05151471 | Jan 2022 → Sep 2023 | amyotrophic lateral sclerosis | Tanabe Pharma America, Inc. | Terminated | Missed primary |
| Phase 3 | NCT04950920 | Jun 2021 → Aug 2022 | ischemic stroke | Peking University Third Hospital | Completed | Met primary |
| Phase 3 | NCT04569084 | Nov 2020 → Sep 2023 | amyotrophic lateral sclerosis | Shionogi | Terminated | Missed primary |
| 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 | Met primary |
| Phase 3 | NCT01492686 | Dec 2011 → Sep 2014 | amyotrophic lateral sclerosis | Tanabe Pharma Corporation | Completed | Met primary |
| 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 | Missed primary |
| Phase 44 trials · 1 met primary | ||||||
| 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 | Met primary |
| Phase not applicable5 trials · 1 missed | ||||||
| — | 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 | Missed primary |
| — | NCT02644915 | Mar → Sep 2016 | — | Xijing Hospital | Unknown | No outcome recorded |
| — | NCT01894334 | Apr 2013 → Jan 2015 | aortic disorder | Beijing Anzhen Hospital | Unknown | No outcome recorded |
| Comparator or background therapy6 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 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 | Missed primary |
| 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 |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2025-12-12 | Tanabe Pharma Corporation | Regulatory Radicut Suspension Approved in Korea for the Treatment of ALS tanabe-pharma.com ↗
Radicut Suspension Approved in Korea for the Treatment of ALS |
| 2025-03-13 | Tanabe Pharma Corporation | Regulatory Filling for a Oral Edaravone Formulation for the treatment of ALS in Korea tanabe-pharma.com ↗ |
| 2024-12-02 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory China NMPA approves Simcere’s Sanbexin® sublingual tablets for the treatment of Acute Ischemic Stroke simcere.com ↗
Simcere Pharmaceutical announced that Sanbexin ® sublingual tablets (generic name: edaravone and dexborneol sublingual tablets), an innovative drug for stroke, has been approved for marketing by the National Medical Products Administration. |
| 2024-09-03 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Breakthrough Therapy designation for Sanbexin sublingual tablets granted by the United Stated Food and Drug Administration simcere.com ↗
On September 2, 2024, Simcere Pharmaceuticals Group Ltd. (2096.HK) announced that Sanbexin Sublingual Tablets (Edaravone and Dexborneol sublingual tablets), an innovative drug for stroke, has been granted the Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of Acute Ischemic Stroke (AIS). |
| 2024-04-09 | Tanabe Pharma Corporation | Regulatory RADICAVA ORS® as Orphan drug designation and approval in US tanabe-pharma.com ↗
The period of exclusive approval is seven years from May 12, 2022, the date of approval of New Drug Application (NDA). |
| 2022-12-02 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Results PHASE III CLINICAL STUDY OF SANBEXIN SUBLINGUAL TABLETS ACHIEVED EXPECTED EFFICACY ENDPOINTS simcere.com ↗
Preliminary analysis shows that, compared with placebo, Sanbexin sublingual tablets have significantly improved the recovery of neurological function and ability to live independently following treatment in AIS patients, achieving expected efficacy endpoints with an excellent safety profile. |
| 2021-09-03 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Results Latest Study Data of Sanbexin® Released at ESOC 2021 simcere.com ↗
Edaravone dexborneol group showed largely higher proportion of mRS score ≤1 on D90 than edaravone group (59.41% versus 51.45%; OR 1.38 [95% CI, 1.02–1.87]; P=0.036). |
| 2021-02-17 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Results The Clinical Study Data for Sanbexin® was Published in the International Leading Neurology Medical Journal “STROKE” simcere.com ↗
The clinical trial data showed that edaravone and dexborneol concentrated solution for injection has better efficacy and comparable safety as compared to edaravone injection. |
| 2020-07-30 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Sanbexin® (Edaravone and Dexborneol Concentrated Solution for Injection) was Approved by NMPA on the Chinese Market simcere.com ↗
On July 30, 2020, the category Ⅰ innovative drug Sanbexin ® （edaravone and dexborneol concentrated solution for injection) developed by Simcere was approved to be sold in the market by the National Medical Products Administration (NMPA), with the approval reference number “National Medicine Zhunzi H20200007”. |
| 2010-01-19 | Tanabe Pharma Corporation | Regulatory Approval for New Dosage Form of RADICUT®, Cerebral Neuroprotectant "RADICUT® BAG for I.V. infusion 30mg" tanabe-pharma.com ↗
the Company received, as of January 15, 2010, approval for the manufacture and marketing of “RADICUT® BAG for I.V. infusion 30 mg,” |
All press releases naming this drug 14 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 54 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 NCT04254913 ↗ |
| 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 ↗ |
| Route | Intravenous | “is intravenously administered” NCT00200356 ↗ |