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Last update 08 May 2025

Edaravone/Dexborneol

Last update 08 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Compound edaravone, Edaravone Dexborneol, Edaravone and Dexborneol

+ [11]

Target

CPT1A x PRDX1

Action

agonists

Mechanism

CPT1A agonists(Carnitine palmitoyltransferase 1A agonists), PRDX1 agonists(peroxiredoxin 1 agonists), Neuroprotectants

Therapeutic Areas

Nervous System DiseasesCardiovascular DiseasesOther Diseases+ [1]

Active Indication

Acute Ischemic StrokeBrain InfarctionCognitive Dysfunction+ [4]

Inactive Indication

Intracranial Hemorrhages

Originator Organization

Simcere Pharmaceutical Group Ltd.

Active Organization

Simcere Pharmaceutical Group Ltd.

Nanjing Yoko Pharmaceutical Group Co. Ltd.

Neurodawn Pharmaceutical Co., Ltd.

+ [5]

Inactive Organization

Nanjing Youke Biomedical Research Co., Ltd.

Jiangsu Simcere Pharmaceutical Co., Ltd.

License Organization

Yantai Yinuoyi Biomedical Technology Co., Ltd.

Neurodawn Pharmaceutical Co., Ltd.

Nanjing Simcere Dongyuan Pharmaceutical Co. Ltd.

Drug Highest PhaseApproved

First Approval Date

China (29 Jul 2020),

Brain Infarction

RegulationSpecial Review Project (China), Breakthrough Therapy (United States)

Structure/Sequence

Molecular FormulaC10H18O

InChIKeyDTGKSKDOIYIVQL-QXFUBDJGSA-N

CAS Registry464-45-9

View All Structures (2)

Clinical Trials associated with Edaravone/Dexborneol

NCT06674460

/ Not yet recruitingPhase 3IIT

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 Jun 2025

Sponsor / Collaborator

Peking Union Medical College Hospital

ChiCTR2400092364

/ SuspendedNot ApplicableIIT

Clinical efficacy of edaravone dexborneol combined with hyperbaric oxygen therapy (HBOT) in the treatment of acute ischemic stroke based on real-world data - A study on clinical efficacy of edaravone dexborneol combined with hyperbaric oxygen therapy (HBOT) in the treatment of acute ischemic stroke

Start Date15 Nov 2024

Sponsor / Collaborator

Jingzhou Central Hospital

NCT06645522

/ Not yet recruitingPhase 4IIT

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

The purpose of this study is to determine the efficacy and safety of edaravone dexborneol in treating acute ischemic stroke.

Start Date30 Oct 2024

Sponsor / Collaborator

The First Hospital of Jilin University

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 May 2025·Phytomedicine

Edaravone dexborneol exerts anti-epileptic effects on rodent temporal lobe epilepsy by promoting NMDAR deactivation and inhibiting oxidative stress

Article

Author: Tan, Tao ; Li, Yuqian ; Pan, Lechen ; Wang, Xinshi ; Guo, Ang ; Li, Yiqian ; Xie, Chenglong ; Chen, Roumeng ; Lin, Li ; Li, Peijun ; Xu, Yuchen ; Xu, Huiqin ; Huang, Wenting ; Qiu, Wanhua

BACKGROUNDDisease-modifying treatments with anti-epileptic effects are currently unavailable and urgently required for temporal lobe epilepsy (TLE). Combined therapy targeting multiple mechanisms may offer a promising anti-epileptic strategy, given the complex processes underlying epileptogenesis.PURPOSEThis study evaluates the effects of Edaravone Dexbroneol, a combination of Edaravone and Dexborneol in 4:1, on rat and mouse TLE models and an in vitro epileptiform activity model.METHODSThe Pilocarpine-induced rat TLE model and the Kainic acid-induced mouse TLE model were used to assess the in vivo effect of Edaravone and/or Dexbornel. Primary neurons were utilized to evaluate the in vitro effect of drugs using calcium imaging, electrophysiological and biochemical analyses, as well as RNA sequencing.RESULTSTreatment of Edaravone Dexbornel during the latent period significantly alleviated epileptic seizures in rodents, mitigated cognitive impairment, and inhibited neuronal loss and astrocytic activation. In vitro, Edaravone Dexborneol inhibited the action potentials and protected primary hippocampal neurons from Mg²⁺-free-induced neurite injury. All these effects were significantly more pronounced in the group treated with the Edaravone Dexborneol mixture compared to either drug used individually. Furthermore, Edaravone can significantly inhibit Mg²⁺-free-induced calcium oscillations in primary neurons, probably by promoting the deactivation of NMDA receptors. RNA sequencing and RT-PCR analysis revealed that synergetic regulation of lipid metabolism, oxidative stress, apoptosis, and calcium signaling probably underlay the neuroprotective effect of Edaravone Dexbornel on epileptic neurons.CONCLUSIONEdaravone Dexborneol exhibits antiepileptic effects and may fill the gap in disease-modifying treatments for TLE.

01 Feb 2025·Journal of physiology and pharmacology : an official journal of the Polish Physiological Society

Effect of edaravone dexborneol combined with interventional thrombectomy on nerve function, cerebral hemodynamics, and serum levels of serum amyloid A, lipoprotein-associated phospholipase A2, and soluble CD40 ligand in elderly patients with ischemic stroke.

Article

Author: Li, D Z ; Shu, Z G ; Zhou, X ; Liu, S C

This study investigated the effect of edaravone dexborneol (ED) combined with interventional thrombectomy in the treatment of ischemic stroke (IS) in the elderly and its effects on nerve function, cerebral hemodynamic status, and levels of serum amyloid A (SAA), lipoprotein-associated phospholipase A2 (LP-PLA2), and soluble CD40 ligand (sCD40L). One hundred elderly patients with IS were divided into the control group and observation group by random number table method. The control group received conventional treatment after interventional thrombectomy, and the observation group received conventional treatment and ED treatment after interventional thrombectomy. After 14 days of treatment, the therapeutic effect was evaluated according to the National Institutes of Health Stroke Scale (NIHSS). Neurological function, serum brain-derived neurotrophic factor (BDNF), nerve growth factor (NGF), neuron-specific enolase (NSE), cerebral haemodynamics, indices of oxidative stress, and serum levels of SAA, LP-PLA2, and sCD40L before and after treatment in both groups were compared. The total effective rate of clinical efficacy was higher and the NIHSS score was lower in the observation group than in the control group (P<0.05). The observation group exhibited higher mean blood velocity and mean blood flow, alongside lower characteristic impedance and dynamic resistance, compared to the control group (P<0.05). SAA, LP-PLA2, and sCD40L in the observation group were lower than those in the control group (P<0.05). BDNF, NGF, and SOD in the observation group were higher than those in the control group, and NSE, MDA, and NEF were lower (P<0.05). ED combined with interventional thrombectomy in the treatment of IS in the elderly can improve nerve function, alleviate oxidative stress reaction, reduce levels of SAA, LP-PLA2, and sCD40L, and alleviate inflammatory response.

01 Dec 2024·Stroke and Vascular Neurology

Rationale and design of Treatment of Acute Ischaemic Stroke with Edaravone Dexborneol II (TASTE-2): a multicentre randomised controlled trial

Article

Author: Dong, Qiang ; Gu, Hong-Qiu ; Xu, Anding ; Wang, Yongjun ; Yang, Yi ; Wang, Chunjuan ; Wang, Ning ; Wang, Feng

BackgroundEdaravone dexborneol is believed to be a novel cytoprotective drug, demonstrating a synergistic combination of antioxidative and anti-inflammatory properties in animal models. The Treatment of Acute Ischaemic Stroke with Edaravone Dexborneol (TASTE) trial demonstrated its superior efficacy over edaravone alone for acute ischaemic stroke (AIS) patients. However, its efficacy in individuals undergoing endovascular therapy (EVT) remains uncertain.AimTo clarify the rationale and design of the TASTE II (TASTE-2) trial.DesignThe TASTE-2 is a multicentre, double-blind, randomised, placebo-controlled trial designed to evaluate the efficacy and safety of edaravone dexborneol in patients with AIS and large-vessel occlusion in the anterior circulation. The eligible participants, presenting with a National Institute of Health Stroke Scale score between 6 and 25 (range 0–42, with larger values suggesting severe neurological dysfunction) and an Alberta Stroke Program Early Computed Tomography Score ranging from 6 to 10 (range 0–10, with smaller values suggesting larger infarction) within the initial 24 hours after symptom onset, will be randomly allocated to either the edaravone dexborneol group or the placebo group in equal proportions prior to thrombectomy. The treatment will be continuously administered for a duration of 10–14 days. A follow-up period of 90 days will be implemented for all participants.Study outcomesThe primary efficacy outcome is defined as achieving favourable functional independence, measured by a modified Rankin Scale of 0–2 at 90 days. The primary safety outcome focuses on the incidence of serious adverse events.DiscussionThe TASTE-2 trial will provide evidence to determine whether the administration of edaravone dexborneol in AIS patients undergoing EVT could yield significant improvements in neurological function.

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

KEGG	Wiki	ATC	Drug Bank
-	-	N07XX14	-

R&D Status

Approved

10 top approved records.

to view more data

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.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Acute Ischemic Stroke	NDA/BLA	China	Neurodawn Pharmaceutical Co., Ltd.	-
Cognitive Dysfunction	Phase 2	China	Simcere Pharmaceutical Group Ltd.	08 Apr 2024
Brain Infarction	Phase 1	China	Nanjing Yoko Pharmaceutical Group Co. Ltd.	22 May 2019
Brain Infarction	Phase 1	China	Guangdong South China New Drug Creation Center	22 May 2019
Amyotrophic Lateral Sclerosis	IND Application	United States	Neurodawn Pharmaceutical Co., Ltd.	-
Cognition Disorders	IND Application	United States	Neurodawn Pharmaceutical Co., Ltd.	-
Neuroinflammation	Preclinical	China	Yangtze University	15 Mar 2024
Cerebral Hemorrhage	Preclinical	-	Jiangsu Simcere Pharmaceutical Co., Ltd.	01 Mar 2021
Intracranial Hemorrhages	Preclinical	United States	Yantai Yinuoyi Biomedical Technology Co., Ltd.	25 Oct 2018

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	(jnyicmneek): unadjusted odds ratio = 1.37 (95% CI, 0.76 - 2.44), P-Value = 0.29	Negative	10 Mar 2025
				Placebo
EXPAND (ISC2025)	Not Applicable	Acute Ischemic Stroke	-	Edaravone Dexborneol	mppqrkfjxv(zrjsttvffo) = psngivktqj rgsyskscoa (xoduktgnbl )	Positive	30 Jan 2025
				No Edaravone Dexborneol	mppqrkfjxv(zrjsttvffo) = wweffxikha rgsyskscoa (xoduktgnbl )
EXPAND (ISC2025)	Not Applicable	Acute Ischemic Stroke	4,684	Edaravone Dexborneol	wfsxtympzx(jtdhxwefdk): 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	(asgfattfth) = cnlywqfccv dgysowtmlj (favxqivbrf ) View more	Positive	19 Feb 2024
				Placebo	(asgfattfth) = gqkudtwxhz dgysowtmlj (favxqivbrf ) View more
CTR20210233 (Corporate Publications) Manual	Phase 3	Acute Ischemic Stroke	-	先必新	(spolkynfdy) = 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 aemmrkirfo (tjygubikfd ) Met	Positive	01 Dec 2022
				Placebo
NEWS Manual	Not Applicable	Acute Ischemic Stroke	94	先必新	(axaipchxqb) = etfpxjawht zejkbjlhkw (rjkvjdxvbh, 4.11) View more	Positive	06 May 2022
				先必新+Alteplase	(axaipchxqb) = fpumyneyjk zejkbjlhkw (rjkvjdxvbh, 2.15) View more
NCT02430350 (TASTE, Cochrane Database Syst Rev \| Pubmed \| Stroke) Manual	Phase 3	Acute Ischemic Stroke	1,165	Edaravone+Dexborneol	(iabhzexqke) = lomrtxopid txpppzumcl (cuoyfbpirb ) View more	Superior	01 Mar 2021
				Edaravone	(iabhzexqke) = tarzherrxe txpppzumcl (cuoyfbpirb )
NCT01929096 (Pubmed) Manual	Phase 2	Acute Ischemic Stroke	385	Edaravone Dexborneol	(fvduypnjqe): P-Value = 0.6799 View more	Positive	22 Apr 2019
				Edaravone

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