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Last update 18 Mar 2025

Edaravone/Dexborneol

Last update 18 Mar 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Compound edaravone, Edaravone and Dexborneol, Edaravone combination

+ [10]

Target-

Mechanism

Neuroprotectants

Therapeutic Areas

Nervous System DiseasesCardiovascular DiseasesOther Diseases+ [1]

Active Indication

Acute Ischemic StrokeBrain InfarctionCognitive Dysfunction+ [3]

Inactive Indication

Intracranial Hemorrhages

Originator Organization

Simcere Pharmaceutical Group Ltd.

Active Organization

Guangdong South China New Drug Creation Center

Neurodawn Pharmaceutical Co., Ltd.

Simcere Pharmaceutical Group Ltd.

+ [4]

Inactive Organization

Nanjing Youke Biomedical Research Co., Ltd.

Jiangsu Simcere Pharmaceutical R&D Co., Ltd.

Jiangsu Simcere Pharmaceutical Co., Ltd.

Drug Highest PhaseApproved

First Approval Date

CN (29 Jul 2020),

Brain Infarction

RegulationBreakthrough Therapy (US), Breakthrough Therapy (CN), Special Review Project (CN)

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 Sublingual Edaravone Dexborneol in Small Vessel Disease

The objective of this clinical trial is to evaluate the efficacy and safety of Edaravone Dexborneol Sublingual Tablets in treating acute ischemic cerebral small vessel disease (CSVD). The trial seeks to address the following primary questions:
* Does Edaravone Dexborneol improve patient cognitive function as measured by changes in the Montreal Cognitive Assessment (MoCA) score from baseline after 24 weeks of treatment?
* What are the safety profiles of Edaravone Dexborneol, including adverse events, treatment-related adverse events, and serious adverse events?
The study will employ a multicenter, randomized, double-blind, placebo-controlled, phase II design to compare Edaravone Dexborneol Sublingual Tablets with a placebo. Participants will:
* Receive either Edaravone Dexborneol Sublingual Tablets or a placebo twice daily for 24 weeks
* Undergo regular visits at specified intervals for assessments and tests, including cognitive function scales, safety evaluations, and biomarker measurements
* Be followed for a total of 52 weeks, including a 28-week follow-up period after treatment cessation
The trial will also explore additional endpoints such as changes in peripheral blood biomarkers and MRI parameters over 24 and 52 weeks, providing a comprehensive assessment of the treatment's impact on acute ischemic CSVD patients.

Start Date01 Mar 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 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 ; Wang, Yongjun ; Gu, Hong-Qiu ; Yang, Yi ; Xu, Anding ; Wang, Feng ; Wang, Ning ; Wang, Chunjuan

Background:

Edaravone 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.

Aim:

To clarify the rationale and design of the TASTE II (TASTE-2) trial.

Design:

The 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 outcomes:

The 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.

Discussion:

The 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.

01 Dec 2024·MOLECULAR BIOLOGY REPORTS

Potential of Edaravone Dexborneol in the treatment of cerebral ischemia: focus on cell death-related signaling pathways

Review

Author: Tamtaji, Omid Reza ; Nabavizadeh, Fatemeh ; Rahmati-Dehkordi, Fatemeh ; Aschner, Michael ; Mirzaei, Hamed ; Dadgostar, Ehsan ; Zare-Hoseinabadi, Alireza ; Jafarpour, Hamed ; Khanifar, Hadi

Cerebral ischemia has the highest global rate of morbidity and mortality. It occurs when a sudden occlusion develops in the arterial system, and consequently some parts of the brain are deprived from glucose and oxygen due to the cessation of blood flow. The ensuing reperfusion of the ischemic area results in a cascade of pathological alternations like neuronal apoptosis by producing excessive reactive oxygen species (ROS), oxidative stress and neuroinflammation. Edaravone Dexborneol is a novel agent, comprised of Edaravone and Dexborneol in a 4:1 ratio. It has documented neuroprotective effects against cerebral ischemia injury. Edaravone Dexborneol improves neurobehavioral and sensorimotor function, cognitive function, brain edema, and blood-brain barrier (BBB) integrity in experimental models. It at dosages ranging between 0.375 and 15 mg/kg (from immediately after ischemia until the 28th post-ischemic days) has shown neuroprotective effects in experimental models of cerebral ischemia by inhibiting cell death-signaling pathways. For example, it inhibits apoptosis by increasing Bcl2, and reducing Bax and caspase-3 expression. Edaravone Dexborneol also inhibits pyroptosis by attenuating NF-κB/NLRP3/GSDMD signaling, as well as ferroptosis by activating the Nrf-2/HO-1/GPX4 signaling pathway. It also inhibits autophagy by targeting PI3K/Akt/mTOR signaling pathway. Here, we provide a review on the impacts of Edaravone Dexborneol on cerebral ischemia.

01 Nov 2024·FREE RADICAL BIOLOGY AND MEDICINE

Edaravone Dexborneol protects against blood-brain barrier disruption following cerebral ischemia/reperfusion by upregulating pericyte coverage via vitronectin-integrin and PDGFB/PDGFR-β signaling

Article

Author: Sun, Zhiyu ; Yi, Lian ; Liu, Sihan ; Chen, Yilin ; Zhao, Hanshu ; Zhang, Zhongling ; Gao, Jiadi ; Yang, Shanshan ; Liu, Ruijia

BACKGROUND:

Recent advancements in brain cytoprotection therapies following cerebral ischemia-reperfusion (I/R) injury have become an emerging interest. Pericytes were vulnerable during the early stages of ischemia. This study aims to explore the protective effects of Edaravone dexborneol (Eda.B) on pericyte loss, as well as and the underlying mechanisms, given its potential in alleviating I/R injury.

METHODS:

The rat transient middle cerebral artery occlusion (tMCAO) model was established. Rats were randomly divided into Sham group (Sham, n = 24), tMCAO group (tMCAO, n = 24), Edaravone group (Eda, n = 24), Dexborneol group (Dexborneol, n = 24), and Eda.B group (Eda.B, n = 24). Neurological function recovery, infarct volume, and blood-brain barrier (BBB) disruption were assessed using Zea-Longa scoring, TTC staining, and Evans Blue extravasation, respectively. Alterations in Basement membrane (BM) and pericyte coverage were assessed by transmission electron microscopy (TEM). The expression levels of pericyte marker NG2 and PDGFR-β in the ischemic region, as well as BBB transcellular transport-related proteins vitronectin (VTN), α5 and PDGFB were detected by western blotting. Furthermore, a specific inhibitor of PDGFB, MOR8457, was employed (Eda.B + MOR8457, n = 8) to explore the protective effects of Eda.B on pericyte injury via PDGFB/PDGFR-β.

RESULTS:

Eda.B significantly reduced cerebral infarct volume and promoted neurological function recovery in comparison to the tMCAO, Eda and Dexborneol groups. Additionally, Eda.B significantly ameliorated BBB leakage, mitigated the decrease in pericyte coverage, and reduced vesicle density in endothelial cells and BM thickness following I/R. Mechanically, Eda.B inhibited the downregulation of NG2, PDGFB/PDGFR-β, VTN, while preventing upregulation of α5 protein expression in tMCAO rats. Blocking PDGFB with MOR8457 demonstrated that Eda.B improved pericyte loss and BBB permeability by activating PDGFB/PDGFR-β signaling.

CONCLUSIONS:

We elucidated that vitronectin-integrin and PDGFB/PDGFR-β signaling contributed to Eda.B's protective effects against pericyte loss and BBB permeability following I/R injury, unraveling new insights into mechanisms of pericyte as a promising therapeutic target.

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	CN	Nanjing Simcere Dongyuan Pharmaceutical Co. Ltd.	01 Dec 2024
Brain Infarction	CN	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
Cognitive Dysfunction	Phase 2	CN	Simcere Pharmaceutical Group Ltd.	08 Apr 2024
Cerebral Hemorrhage	Phase 2	-	Jiangsu Simcere Pharmaceutical Co., Ltd.	01 Mar 2021
Intracranial Hemorrhages	Phase 1	US	Yantai Yinuoyi Biomedical Technology Co., Ltd.	25 Oct 2018
Amyotrophic Lateral Sclerosis	IND Application	US	Neurodawn Pharmaceutical Co., Ltd.	-
Cognition Disorders	IND Application	US	Neurodawn Pharmaceutical Co., Ltd.	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ISC2025	Not Applicable	Acute Ischemic Stroke	-	Edaravone Dexborneol	lizdpukbhm(dyusbmalhn) = hlhpschmpi iekiazkiga (kwkcytrstj )	Positive	30 Jan 2025
				No Edaravone Dexborneol	lizdpukbhm(dyusbmalhn) = yclbcbysog iekiazkiga (kwkcytrstj )
ISC2025	Not Applicable	Acute Ischemic Stroke	4,684	Edaravone Dexborneol	hebvbtshyq(smzkrowgdj): 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	eugovjnrnb(vqchfnzmxt) = zgbqqdaxfp xbzcqsrpeh (wotevqpzfp ) View more	Positive	19 Feb 2024
				Placebo	eugovjnrnb(vqchfnzmxt) = smdaudzgqt xbzcqsrpeh (wotevqpzfp ) View more
CTR20210233 (Corporate Publications) Manual	Phase 3	Acute Ischemic Stroke	-	先必新	ycfwhipisd(pwqqtfjbxl) = 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 toplgmgbsy (jjdjvgsowk ) Met	Positive	01 Dec 2022
				Placebo
NEWS Manual	Not Applicable	Acute Ischemic Stroke	94	先必新	gobvmmqbhp(uzuydkchow) = qngqxjhddq rnipmwhtnn (bjmpukwytv, 4.11) View more	Positive	06 May 2022
				先必新+Alteplase	gobvmmqbhp(uzuydkchow) = qadjtgrfxq rnipmwhtnn (bjmpukwytv, 2.15) View more
NCT02430350 (TASTE, Cochrane Database Syst Rev \| Pubmed \| Stroke) Manual	Phase 3	Acute Ischemic Stroke	1,165	Edaravone+Dexborneol	cuydzdjpff(wjnlrnefbq) = jthrmuiiwy flmhefyvte (zbizozajik ) View more	Superior	01 Mar 2021
				Edaravone	cuydzdjpff(wjnlrnefbq) = iilcowqmod flmhefyvte (zbizozajik )
NCT01929096 (Pubmed) Manual	Phase 2	Acute Ischemic Stroke	385	Edaravone Dexborneol	njzpwzfkue(fbhwvnmgrg): P-Value = 0.6799 View more	Positive	22 Apr 2019
				Edaravone

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