Treatment of Acute Ischemic Stroke With Edaravone Dexborneol Sublingual Tablets in Small Vessel Disease: A Randomized, Double-Blind, Placebo-Controlled Study

This study is a multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of Edaravone Dexborneol Sublingual Tablets in patients with acute ischemic stroke due to small vessel disease (TASTE-SVD).
The study will enroll approximately 600 participants aged 30 to 80 years who have experienced a recent small subcortical infarct (RSSI) confirmed by MRI. Participants will be randomized in a 1:1 ratio into either the Edaravone Dexborneol Sublingual Tablets group or the placebo group, with a 24-week treatment period followed by a 28-week follow-up.
The primary endpoint is a hierarchical composite endpoint at week 24, including all-cause mortality, modified Rankin Scale (mRS) score ≥2, recurrent stroke, changes in MoCA score, and changes in VaDAS-Cog score.
Secondary endpoints include additional functional and cognitive assessments at 24 and 52 weeks, as well as MRI markers of white matter hyperintensities, new infarctions, microbleeds, and brain atrophy. Safety assessments will include adverse events (AEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs).
The study aims to determine whether Edaravone Dexborneol Sublingual Tablets improve functional outcomes and cognitive performance in patients with small vessel disease-related stroke.

Start Date01 Aug 2025

Sponsor / Collaborator

Peking Union Medical College Hospital

NCT07091994

/ Not yet recruitingPhase 4IIT

A Prospective, Multicentre, Randomized Controlled Trial of Edaravone Dexborneol in Acute Ischemic Stroke With Active Malignancy

This multicenter randomized controlled trial aims to evaluate the efficacy and safety of edaravone dexborneol injection in patients with acute ischemic stroke (AIS) complicated by active malignancies. The study will primarily investigate whether this combined antioxidant and anti-inflammatory treatment can improve neurological functional recovery and assess its safety profile in this high-risk population. Researchers will compare outcomes between the edaravone dexborneol treatment group and a control group receiving standard therapy to determine if the intervention provides superior neuroprotective effects. Participants will receive the assigned treatment regimen, undergo serial neurological assessments and imaging studies to monitor stroke progression and recovery, and be closely followed for safety evaluations. The findings may offer evidence-based therapeutic options for managing this challenging clinical scenario where current treatment alternatives are limited.

Start Date01 Aug 2025

Sponsor / Collaborator

Nanfang Hospital

ChiCTR2500109257

/ Not yet recruitingNot ApplicableIIT

Exploratory Study on Sublingual Edaravone Dexborneol in Improving the Effective Reperfusion Rate of Large Vessel Occlusion in Acute Ischemic Stroke

Start Date01 Jul 2025

Sponsor / Collaborator

The First Affiliated Hospital of Chengdu Medical College

100 Clinical Results associated with Edaravone/Dexborneol

100 Translational Medicine associated with Edaravone/Dexborneol

100 Patents (Medical) associated with Edaravone/Dexborneol

Literatures (Medical) associated with Edaravone/Dexborneol

01 Nov 2025·TOXICOLOGY AND APPLIED PHARMACOLOGY

S100A11 mediates the protective effects of edaravone dexborneol on docetaxel-induced cognitive impairment in rats by inhibiting the MAPK signaling pathway

Article

Author: Lu, Yinliang ; Tang, Hanmin ; Jia, Jiantao ; Han, Suxia ; Gao, Chengyi ; Liu, Ping

Cognitive impairment is a common side effect of docetaxel (DTX)-based chemotherapy. The novel neuroprotective agent edaravone dexborneol (ED) was found to alleviate the adverse phenotype caused by DTX. However, the underlying mechanism remains unexplored. By analyzing mRNA-sequencing data, we noticed that the expression of S100 calcium-binding protein A11 (S100A11), a protector of the nervous system, was decreased in DTX-treated rats with cognitive damage, but ED administration reversed the trend. Therefore, we speculated that S100A11 might be involved in the protective effects of ED on DTX-induced cognitive impairment. Sprague-Dawley rats were intraperitoneally injected with DTX to induce cognitive impairment, followed by intraperitoneal injection of ED after DTX induction. The results showed that ED treatment mitigated cognitive impairment caused by DTX. Next, adenoviruses carrying sequences encoding S100A11 were given to rats receiving DTX treatment. S100A11 overexpression alleviated cognitive dysfunction of DTX-treated rats, as evidenced by the decreased escape latency and swimming distance, and the increased number of platform crossings. Mechanically, S100A11 overexpression inhibited neuronal apoptosis by inactivating the MAPK signaling pathway. Further rescue experiments showed that S100A11 knockdown reversed the defensive role of ED in DTX-induced neuronal damage. In conclusion, ED ameliorates cognitive dysfunction caused by DTX by upregulating the S100A11 expression and subsequently inactivating the MAPK signaling pathway.

26 Aug 2025·NEUROLOGY

Clinical and Safety Outcomes of Edaravone Dexborneol in Acute Ischemic Stroke

Article

Author: Zhang, Qian ; Mo, Ran ; Hao, Junwei ; Wu, Yifan ; Song, Haiqing ; Ma, Gaoting ; Chang, Hong ; Ma, Qingfeng ; Wu, Yue ; Yao, Xiaoxi ; Song, Zhiwei ; Zuo, Yingting ; Gao, Daiquan ; Ren, Yi ; Jiang, Ziying ; Lei, Shaoyuan ; Xie, Weizheng ; Meng, Shujuan ; Wang, Pingping ; Guo, Yansu ; Nguyen, Thanh N. ; Yuan, Guangxiong ; Liu, Haijie ; Zhong, Lianmei

BACKGROUND AND OBJECTIVES:

Although edaravone dexborneol, a multitarget cytoprotective drug, has demonstrated benefits in previous clinical trials, its actual clinical efficacy and safety in patients with acute ischemic stroke (AIS) remain unclear. This study aimed to test the hypothesis that edaravone dexborneol is associated with better outcomes in patients with AIS in real-world clinical practice.

METHODS:

We conducted a prospective, multicenter, real-world cohort study at 72 centers in China from January 14 to July 4, 2023. We included patients age 18 years or older, with AIS within 14 days of onset, and a prestroke modified Rankin Scale (mRS) of 0 or 1. Patients were divided into those receiving edaravone dexborneol (the exposed group) or not (the unexposed group). Clinical outcomes included favorable functional outcome (mRS score 0-1) at 90 days, symptomatic intracerebral hemorrhage (sICH) during the hospital, and all-cause mortality within 90 days. Multivariable logistic regression, propensity score matching (PSM), and inverse probability of treatment weighting (IPTW) analyses were conducted.

RESULTS:

Of 4,401 participants (2,904 men [66.8%]; median [interquartile range] age, 65 [57-72] years), 3,017 (68.6%) were treated with edaravone dexborneol. The exposed group was younger (65 [56-72] years vs 66 [58-74] years), had higher NIH Stroke Scale (3 [2-7] vs 3 [1-5]), and had shorter time from onset to admission (7.0 [2.5-24.0] hours vs 10.4 [2.8-48.0] hours). The exposed group had a higher proportion of patients with favorable functional outcome at 90 days compared with the unexposed group (68.6% [2,071/3,017] vs 66.0% [914/1,384], adjusted odds ratio [aOR] 1.23 [95% CI 1.06-1.43]). Moreover, sICH rates (0.4% vs 0.6%, aOR 0.44 [95% CI 0.14-1.44]) and mortality within 90 days (2.1% vs 3.3%, adjusted hazard ratio 0.89 [95% CI 0.58-1.37]) were similar in both groups. PSM and IPTW analyses yielded results consistent with the multivariate adjustment model.

DISCUSSION:

In this observational cohort study involving Chinese patients with AIS, edaravone dexborneol was associated with significantly better functional outcome at 90 days. Verification of our findings is warranted in other populations.

TRIAL REGISTRATION INFORMATION:

This trial is registered with Effectiveness and Safety of Edaravone Dexborneol in Acute Ischemic Stroke, number NCT05644223; submitted for registration on November 30, 2022; first patient enrollment was on January 14, 2023.

CLASSIFICATION OF EVIDENCE:

This study provides Class III evidence that treatment of patients with AIS with edaravone dexborneol is associated with significantly better functional outcome at 90 days measured using the mRS.

01 Aug 2025·NAUNYN-SCHMIEDEBERGS ARCHIVES OF PHARMACOLOGY

Efficacy and safety of edaravone dexborneol in acute ischemic stroke: systematic review and meta-analysis of randomized controlled trials

Review

Author: Abouelmagd, Moaz Elsayed ; Tarakhan, Husam ; Wagdy, Mohamed ; Alnajjar, Asmaa Zakria ; Aldemerdash, Mohamed A ; Shata, Abdelrahman ; Kashbour, Muataz

INTRODUCTION:

Stroke is a leading cause of global morbidity and mortality, with acute ischemic stroke (AIS) accounting for most cases. Despite advancements in reperfusion therapies, many patients do not achieve sufficient reperfusion, necessitating effective neuroprotective interventions. This meta-analysis evaluates the efficacy and safety of Edaravone Dexborneol (ED) compared to standard therapies in AIS treatment.

METHODS:

A systematic review and meta-analysis were conducted according to PRISMA guidelines, including randomized controlled trials (RCTs) investigating ED in AIS. Primary outcomes included Modified Rankin Scale (mRS ≤ 1) at 90 days and changes in National Institutes of Health Stroke Scale (NIHSS) scores. Pooled effect sizes were calculated using random-effects models.

RESULTS:

Five RCTs with 2,535 patients (1,263 ED, 1,272 control) were included. ED significantly improved the odds of achieving mRS ≤ 1 at 90 days (OR = 1.47, 95% CI [1.25-1.74], p < 0.00001). While NIHSS score changes at 14 days were not significant (p = 0.35), ED showed significant improvement at 30 days (MD = -1.77, 95% CI [-2.82 to -0.72], p = 0.0009). ED also significantly reduced the risk of hemorrhagic transformation (OR = 0.47, 95% CI [0.24-0.92], p = 0.03) and mortality rates were lower in the ED group but not statistically significant (OR = 0.66, 95% CI [0.41-1.06], p = 0.08, I² = 1%).

CONCLUSION:

ED demonstrates significant neuroprotective benefits in AIS by improving functional outcomes and reducing the risk of hemorrhagic transformation. However, further studies with larger sample sizes must confirm these findings and optimize treatment protocols.

News (Medical) associated with Edaravone/Dexborneol

04 Dec 2024

·www.prnewswire.com

China NMPA approves Simcere's Sanbexin® sublingual tablets for the treatment of Acute Ischemic Stroke

NANJING, China, Dec. 4, 2024 /PRNewswire/ -- On November 2, 2024, 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. This product is indicated for the improvement of neurological symptoms, daily activities, and functional impairment due to acute ischemic stroke. Continue Reading Packaging of Sanbexin® sublingual tablets Sanbexin® sublingual tablets is a dual-target brain cytoprotective agent composed of edaravone and dexborneol. These two active ingredients exert synergistic anti-oxidant and anti-inflammatory effects, which can significantly reduce brain cell damage caused by acute ischemic stroke. The sublingual tablets are designed for quick disintegration once in contact with saliva under the tongue. This facilitates the active ingredients' rapid absorption into the blood and brain through the sublingual venous plexus. Compared to conventional oral formulations, sublingual tablets bypass the first-pass hepatic metabolism, which is conducive to higher drug bioavailability and faster onset of action. Previously, Sanbexin® injection was approved for marketing in China in 2020. As the world's only innovative drug approved for stroke since 2015, it has helped over 3 million patients in the past 4 years. The phase III clinical trial led by Professor Fan Dongsheng of Peking University Third Hospital showed that the patients in the Sanbexin® sublingual tablets group after 14 consecutive days of drug administration, obtained a significantly higher proportion of functional independence outcome at 90 days post-treatment than those in the placebo group (64.4% vs. 54.7%,). The latest data was published in JAMA Neurology on February 19, 2024. Professor Fan Dongsheng, Principal Investigator of TASTE-SL and Professor at Peking University Third Hospital mentioned:"Sanbexin® sublingual tablets has shown significant effects and good safety in improving recovery of cerebral cells and independent living ability during the acute phase in patients with acute ischemic stroke. The more convenient administration allows for sequential therapy with Sanbexin® injection, facilitating stroke patients to receive a complete course of brain cytoprotection in and outside of the hospital during the acute phase of stroke." Professor Wang Yongjun, Director of Beijing Tiantan Hospital, Capital Medical University "The average length of hospital stay for stroke patients in China is about one week, while clinical studies suggest that brain cytoprotective drugs need to be used for 14 consecutive days. Sanbexin® sublingual tablets is easy to take, allowing patients to receive treatment at home. This can better reduce disability among patients and is also expected to lower medical costs." In August 2024, Sanbexin® sublingual tablets was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for AIS, making it the world's first innovative drug in the field of stroke treatment to have received such acknowledgment. Currently, a global multi-centered clinical trial of Sanbexin® sublingual tablets is under preparation. "The approval of Sanbexin® sublingual tablets in China is believed to significantly reduce the number of stroke-related disabilities in China." Professor Gregory W. Albers, Director of the Stroke Center and the Medical Center at Stanford University commented, " We are planning to conduct a large-scale Phase III clinical trial of Sanbexin® sublingual tablets in the United States, hoping to replicate the success of the trial in China and help reduce the global burden of stroke-related disabilities." Dr. Marc Fisher, former President of the World Stroke Organization and Professor at Harvard Medical School, commented on this new approval:"Sanbexin® has gradually gained popularity in China and is now available in a sublingual tablets formulation, with clinical data confirming its safety and efficacy. We are hoping to see trials of Sanbexin® sublingual tablets conducted outside China. If the trial results are positive and it receives approval in other countries, such as the U.S., it will have a huge impact globally on the treatment of acute ischemic stroke." The Sanbexin® sublingual tablets, with its convenient delivery method, will make stroke prevention and treatment more comprehensive and accessible. Its therapeutic area is expected to be expanded to pre-hospital emergency treatment for the acute phase of stroke, as well as to the treatment for the sub-acute and chronic phases of cerebrovascular diseases, to further promote the recovery of neurological functions and to improve the functional prognosis of stroke patients. SOURCE Simcere Pharmaceutical Group Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug ApprovalBreakthrough TherapyClinical Result

30 Oct 2024

·www.prnewswire.com

World Stroke Congress | TASTE-2 significantly reduces stroke disability

NANJING, China, Oct. 30, 2024 /PRNewswire/ -- Oct 24th 2024, Simcere Pharmaceuticals Group Ltd. (2096.HK) announced that a new clinical study with major clinical findings regarding Sanbexin (edaravone and dexborneol concentrated solution for injection) has been published at the 16th World Stroke Conference (WSC). According to the latest data, the administration of edaravone dexborneol (Sanbexin®) in patients with acute ischemic stroke (AIS) before receiving endovascular thrombectomy significantly improved neuro-function recovery and reduced disability from stroke. Continue Reading Professor Yongjun Wang presented a late-breaking oral presentation at WCS Presented as a WCS late-breaking oral presentation by Professor Yongjun Wang from Beijing Tiantan Hospital, the study entitled "Treatment of Acute ischemic Stroke with Edaravone dexborneal 2" ("TASTE-2") has caught wide spread attention among neurology academic circle in the world. Stroke is the leading cause of death and disability in adults in China, while AIS accounts for about 70% of all strokes. About 40% of AIS patients fall into the category of large vessel occlusion (LVO), a subtype of AIS with higher disability and mortality. After stroke, reperfusion treatments (e.g., thrombolysis and thrombectomy) are used to restores blood supply to the brain as soon as possible. The endovascular thrombectomy (EVT), an important advance in reperfusion therapy in recent years, can achieve recanalization in about 70% to 90% of patients with the LVO stroke, but only half of these patients achieve favorable brain function recovery A significant proportion of the patients who received EVT remain disabled to varying degrees after 90 days of treatment. TASTE-2 study is a multicenter, double-blind, randomized, placebo-controlled clinical study. From March 2022 to May 2023, a total of 1362 AIS patients with a large-vessel occlusion (LVO) in the anterior circulation were enrolled. Patients were randomly allocated (1:1) to receive edaravone dexborneol (edaravone, 30 mg; (+)-dexborneol, 7.5 mg) or placebo prior to EVT and continued twice a day over a consecutive period of 10-14 days. As a primary efficacy outcome, 379 (55.0%) patients in the edaravone dexborneol group and 333 (49.6%) in the placebo group achieved a mRS 0-2 at day-90 (odds ratio [OR] 1.24, 95% CI 1.00-1.54; risk ratio [RR] 1.11, 95% CI 1.00-1.23). All safety outcomes were similar between both groups. This suggests that Edaravone dexborneol could improve the favorable functional outcome at 90 days in AIS patients within 24-hour of symptom onset who underwent EVT. Sanbexin® (Edaravone dexborneol Concentrated Solution for Injection) is a multi-targeted brain cell protection agent developed by Simcere Pharmaceutical Co., Ltd, and is the only approved innovative drug in the field of stroke treatment worldwide since 2015. Composed of edaravone and dexborneol, two active ingredients with synergistic anti-oxidant and anti-inflammatory effects, the drug can significantly reduce brain cell injury or impairment caused by AIS. According to the recommendations of the Stroke Academic Roundtable Meeting (STAIR), brain cytoprotectants can reduce ischemic brain injury, especially when combined with thrombectomy. The scientific community has also been working on brain cytoprotective agents for stroke treatment for decades. However, due to the complexity of stroke pathophysiology, single-target drugs have been found to have limited efficacy and difficult to be developed clinically. On the other hand, the clinical study of multi-target brain cytoprotectants continue to progress. Previously, the TASTE study led by Professor Yongjun Wang's team in Beijing Tiantan Hospital and the TASTE-SL study led by Professor Dongsheng Fan in Peking University Third Hospital confirmed the efficacy of edaravone dexborneol injection and sublingual tablets in AIS patients who do not receive reperfusion treatment. The latest results of the TASTE-2 study provide key clinical medical evidence for Sanbexn® as a multi-target brain cell protection strategy combined with reperfusion in the treatment of acute ischemic stroke. Sanbexin® is expected to be used as a concomitant drug for endovascular treatment such as thrombectomy, particularly before reperfusion, to further improve the effect of stroke treatment and reduce stroke disability. SOURCE Simcere Pharmaceutical Group Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalClinical Study

25 Oct 2024

·www.prnewswire.com

TASTE-2 World Stroke Congress | Sanbexin ® combined with thrombectomy significantly reduces stroke disability

NANJING, China, Oct. 25, 2024 /PRNewswire/ -- On October 24, 2024, TASTE-2, a Chinese innovative stroke drug study led by Professor Wang Yongjun from Beijing Tiantan Hospital, was published in an oral report at the 16th World Stroke Conference (WSC): brain cell protection combined with edaravone dexborneol (Sanbexin ®) in patients with acute ischemic stroke before endovascular thrombectomy significantly improved the proportion of patients who recovered neurological independence at 90 days and reduced the proportion of patients with disability. Continue Reading Professor Wang Yongjun from Beijing Tiantan Hospital gave oral lectures on behalf of the research team at the 16th WSC Conference on Late Breaking and SRTThrombectomy plus Sanbexin ® for further stroke reduction Stroke is the leading cause of death and disability in adults in China, and acute ischemic stroke (AIS) accounts for about 70% of all strokes. Among them, about 40% of patients belong to the risk subtype of large vessel occlusion (LVO), with higher disability and mortality. After stroke, treatment with "reperfusion", which is represented by thrombolysis and thrombectomy, restores blood supply to the brain as soon as possible. Endovascular thrombectomy (EVT) is an important advance in reperfusion therapy in recent years, which can achieve recanalization in about 70% to 90% of patients with LVO stroke, but only nearly half of patients recover well. A significant proportion of patients with EVT remain disabled to varying degrees after 90 days of treatment. The oral report on 2024WSC showed that a multicenter, double-blind, randomized, placebo-controlled TASTE-2 study enrolled 1362 patients with moderate-severe stroke treated with EVT. Edaravone dexborneol, a brain cell protection was used before EVT, and the proportion of patients with functional score 2 below 90 days was 55.0% vs. 49.6% compared with placebo, which was statistically significant and safe. This suggests that brain cell protection prior to stroke thrombectomy may further improve treatment outcomes in patients with large vessel occlusive stroke and help them regain self-care ability. TASTE-2 Primary Efficacy Results: There was a significant difference between the treatment and placebo groups in the proportion of patients who were functionally independent (90-day mRS 0 to 2), OR = 1.24 (1.00 to 1.54), p = 0.047; RR = 1.11 (1.00 to 1.23), p = 0.047 Sanbexin ® (Edaravone dexborneol Concentrated Solution for Injection) is a multi-target brain cell protection developed by Simcere Pharmaceutical Co., Ltd. The drug contains two active ingredients, edaravone and dexborneol, which efficiently penetrate the blood-brain barrier, reduce cascade damage caused by AIS through dual effects of anti-inflammation and free radical scavenging, and extend the existing treatment window from 24 hours to 48 hours. As the only innovative drug approved for marketing and sales in the field of stroke treatment worldwide since 2015, this drug has been developed for 12 years. The latest results of the TASTE-2 study provide key clinical medical evidence for Sanbexin ® as a multi-target brain cell protection strategy combined with reperfusion in the treatment of acute ischemic stroke and also trigger lively on-site discussion in international academia. According to the recommendations of the Stroke Academic Roundtable Meeting (STAIR), brain cytoprotectants reduce ischemic brain injury, especially when combined with thrombectomy. The scientific community has also been working on brain cytoprotective agents for stroke treatment for a long time. However, for the complex pathophysiological mechanism of stroke, single-target drugs have limited efficacy and are difficult to develop clinically. Corresponding to this, multi-target brain cytoprotectants continue to progress in clinical practice. Previously, the TASTE study led by Professor Yongjun Wang 's team from Beijing Tiantan Hospital and the TASTE-SL study led by Professor Dongsheng Fan from Peking University Third Hospital confirmed the efficacy of edaravone dexborneol injection and sublingual tablets in AIS patients without thrombectomy, respectively. The data were published in STROKE (Stroke) and JAMA Neurology (American Medical Association Journal of Neurology), in 2021 and 2024. In the future, Sanbexin ® is expected to be used as a concomitant drug for endovascular treatment such as thrombectomy and administered before reperfusion to further improve the effect of stroke treatment and reduce stroke disability. SOURCE Simcere Pharmaceutical Group Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalClinical ResultClinical Study

100 Deals associated with Edaravone/Dexborneol

External Link

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acute Ischemic Stroke	China	Nanjing Simcere Dongyuan Pharmaceutical Co. Ltd.	01 Dec 2024
Brain Infarction	China	Nanjing Simcere Dongyuan Pharmaceutical Co. Ltd.	29 Jul 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Androgen-Insensitivity Syndrome	Phase 3	-	Simcere Pharmaceutical Group Ltd.	28 Dec 2023
Cognitive Dysfunction	Phase 2	China	Simcere Pharmaceutical Group Ltd.	08 Apr 2024
Cerebral Hemorrhage	Phase 2	-	Jiangsu Simcere Pharmaceutical Co., Ltd.	01 Mar 2021
Hypertensive Encephalopathy	Phase 2	-	Jiangsu Simcere Pharmaceutical Co., Ltd.	01 Mar 2021
Intracranial Hemorrhages	Phase 1	United States	Yantai Yinuoyi Biomedical Technology Co., Ltd.	25 Oct 2018
Amyotrophic Lateral Sclerosis	IND Application	United States	Neurodawn Pharmaceutical Co., Ltd.	-
Cognition Disorders	IND Application	United States	Neurodawn Pharmaceutical Co., Ltd.	-
Alzheimer Disease	Preclinical	China	Nanjing University	21 Jun 2025
Neuroinflammation	Preclinical	China	Yangtze University	15 Mar 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04667637 (Pubmed \| Nat Commun)	Phase 2	Ischemic stroke	-	Edaravone dexborneol	fcubvbsenl(hcggrandvp): unadjusted odds ratio = 1.37 (95% CI, 0.76 - 2.44), P-Value = 0.29	Negative	10 Mar 2025
				Placebo
ISC2025	Not Applicable	Acute Ischemic Stroke	-	Edaravone Dexborneol	dlvyexnbtn(uxazcbmzdh) = quxwdkclxn zfwzdgmbtd (uijgpvljck )	Positive	30 Jan 2025
				No Edaravone Dexborneol	dlvyexnbtn(uxazcbmzdh) = tzogutcnic zfwzdgmbtd (uijgpvljck )
ISC2025	Not Applicable	Acute Ischemic Stroke	4,684	Edaravone Dexborneol	dzwsmaoaqa(thybcpkubb): adjusted common odds ratio = 1.02 (95% CI, 1.02 - 1.64), P-Value = 1.30	Positive	30 Jan 2025
				No Edaravone Dexborneol
NCT04950920 (TASTE-SL, Literature) Manual	Phase 3	Acute Ischemic Stroke	914	Edaravone Dexborneol	gpkkikzroo(wmzdhbrlvd) = ktyuzdktie fwgjxinzsn (krhebisbiu ) View more	Positive	19 Feb 2024
				Placebo	gpkkikzroo(wmzdhbrlvd) = vealtyyewj fwgjxinzsn (krhebisbiu ) View more
CTR20210233 (Corporate Publications) Manual	Phase 3	Acute Ischemic Stroke	-	先必新	bmuihcpudy(prwqqggjcd) = 初步分析显示，相对于安慰剂，先必新舌下片显著改善AIS患者治疗后神经功能恢复及独立生活能力，达到预期疗效终点 xpcsgwvkmo (xuipmrmmvp ) Met	Positive	01 Dec 2022
				Placebo
NEWS Manual	Not Applicable	Acute Ischemic Stroke	94	先必新	wwdmqsbfit(lmvdvwmzvj) = shwypvrrah wyxznixuta (dbsgdcnsvk, 4.11) View more	Positive	06 May 2022
				先必新+Alteplase	wwdmqsbfit(lmvdvwmzvj) = vdibeaocao wyxznixuta (dbsgdcnsvk, 2.15) View more
NCT02430350 (Cochrane Database Syst Rev \| Pubmed \| Stroke) Manual	Phase 3	Acute Ischemic Stroke	1,165	Edaravone+Dexborneol	nizgbxakgs(fvglzjcghk) = geemxwtwdb xrsrjgobtl (iwigmcwjdf ) View more	Superior	01 Mar 2021
				Edaravone	nizgbxakgs(fvglzjcghk) = ljcntavids xrsrjgobtl (iwigmcwjdf )
NCT01929096 (Pubmed) Manual	Phase 2	Acute Ischemic Stroke	385	Edaravone Dexborneol	kogxhbzydm(kdknwpcyek): P-Value = 0.6799 View more	Positive	22 Apr 2019
				Edaravone

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