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. Investigators 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 2026

Sponsor / Collaborator

Nanfang Hospital

NCT07682922

/ Not yet recruitingPhase 4IIT

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

This is a multicenter, randomized, double-blind, placebo-controlled clinical trial (SLEDAIS) involving 1,040 patients with acute ischemic stroke (AIS) who require inter-hospital transfer for potential endovascular therapy. The study aims to evaluate the efficacy and safety of sublingual Edaravone Dexborneol tablets administered in the ultra-early stage (within 6 hours of symptom onset) during the critical inter-hospital transfer window.
Patients will be randomly assigned in a 1:1 ratio to receive either sublingual Edaravone Dexborneol (a loading dose of 4 tablets initially, followed by 1 tablet twice daily for 13 days) or a matching placebo. The primary efficacy endpoint is the functional outcome assessed by the modified Rankin Scale (mRS) score at 90 days. The primary safety endpoint is the mortality rate at 90 days. This study seeks to provide high-quality evidence for neuroprotection during the transfer period, potentially improving functional recovery for stroke patients.

Start Date01 Jul 2026

Sponsor / Collaborator

Xinqiao Hospital

[+1]

NCT07454473

/ RecruitingPhase 4IIT

Edaravone and Dexborneol Sublingual Tablet for Treating Chemotherapy- Induced Cognitive Impairment Study

Chemotherapy-induced cognitive impairment (CICI), also known as "chemobrain," is a range of neurocognitive deficits experienced during and after cancer chemotherapy. It is also one of the significant factors affecting the quality of life of cancer patients. Due to patients' subjective feelings, the definition of cognitive impairment, the variety of testing scales, and the lack of pre-chemotherapy cognitive function measurements, it is difficult to determine its incidence rate. Consequently, the diagnosis and treatment of this condition are delayed. Existing studies report a high incidence of CICI, affecting 17% to 78% of survivors, and it may persist for years after chemotherapy cessation, leading to more severe progressive manifestations. Its main clinical presentations include deficits in attention, memory, reasoning, multi-tasking ability, decision-making ability, as well as learning and language impairments. These significantly affect patients' functional independence, imposing a heavy burden on families and society. Numerous studies have proposed several potential mechanisms and etiologies for CICI, including direct neurotoxicity of chemotherapeutic drugs, blood-brain barrier disruption, reduced hippocampal neurogenesis, white matter abnormalities, secondary neuroinflammatory responses, and increased oxidative stress. However, the exact underlying mechanisms remain unclear. Currently, there is no clear and effective diagnosis or treatment method for CICI. How to effectively diagnose and treat cognitive impairment caused by chemobrain remains a key focus and challenge in current research.
Previous studies indicate that in the treatment of ischemic stroke, Edaravone exerts its effects by scavenging oxygen free radicals, reducing inflammatory responses, mitigating neuronal and endothelial cell damage, and inhibiting excitatory neurotoxicity. It also inhibits neuronal lipid peroxidation and alleviates brain tissue damage and cerebral edema caused by cerebral ischemia and hypoxia. Dexborneol, as a bicyclic monoterpenoid compound, can also inhibit inflammatory responses, protect blood-brain barrier permeability, and reduce cell apoptosis. The combination of these two active ingredients can exert multiple mechanisms of action, including free radical scavenging, anti-inflammation, and blood-brain barrier protection, significantly reducing neuronal damage caused by acute ischemic stroke and exerting neuroprotective effects. Clinically, it effectively reduces infarct volume and improves neurological function.
The aforementioned pathogenesis of CICI precisely involves increased neuroinflammation and oxidative stress, as well as damage to the blood-brain barrier. Furthermore, the sublingual tablet dosage form offers advantages in convenience compared to injections. Based on this, we hypothesize that Edaravone Borneol sublingual tablets may also have considerable efficacy in treating chemotherapy-related cognitive impairment.
This study addresses a clinical cross-disciplinary event in neurology and oncology. It aims to evaluate the efficacy of Edaravone Dexborneol sublingual tablets for CICI and conduct preliminary exploration of early diagnostic biomarkers for CICI by collecting clinical patient imaging data, blood samples, and neuropsychological scale results. This will ultimately help optimize chemotherapy regimens to the greatest extent.

Start Date02 Mar 2026

Sponsor / Collaborator

The First Hospital Of China Medical 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

31 Dec 2026·JOURNAL OF INVESTIGATIVE SURGERY

The Effect of Edaravone Dexborneol Treatment After Intracranial Vascular Intervention on Inflammatory Factors and Oxidative Stress Level in Elderly Patients with Acute Ischemic Cerebrovascular Disease

Article

Author: Wang, Zezhao ; Dai, Xiaoyan ; Yu, Xueji ; Zhang, Liyuan ; Wang, Xi ; Qiu, Tao ; Tang, Jie

OBJECTIVE:

We aimed to explore the effects of applying edaravone dexborneol after intracranial vascular intervention on the levels of neuron-specific enolase (NSE), homocysteine (Hcy) and neurological function in elderly patients with acute ischemic cerebrovascular disease (AICVD).

METHODS:

The control group and study group were established. Serum levels of NSE, Hcy, interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), malondialdehyde (MDA), and superoxide dismutase (SOD) activity were measured. Neurological function and hemorheological indices [plasma viscosity (PV), high-shear viscosity (HSV), low-shear viscosity (LSV)] were assessed. Adverse reactions and 6-month adverse outcomes were recorded.

RESULTS:

At 14 days postoperatively, the study group exhibited lower NSE, Hcy, IL-6, TNF-α, and MDA levels and higher SOD activity than the control group (all p < 0.05). NIHSS scores, PV, HSV, and LSV decreased in both groups at 7 and 14 days postoperatively (p < 0.05), with greater improvements in the study group (p < 0.05). The study group had a lower incidence of adverse outcomes (4.00% vs. 13.33%, p < 0.05).

CONCLUSION:

Edaravone dexborneol after intracranial vascular intervention significantly reduces NSE and Hcy levels, mitigates inflammation and oxidative stress, improves neurological function and hemorheology, and lowers adverse outcome rates in elderly AICVD patients without increasing adverse reactions.

01 May 2026·PHYTOMEDICINE

An integrated approach elucidates Xiongzhi Tongluo formula against ischemic stroke

Article

Author: Chang, Ze ; Liu, Longtao ; Miao, Lina ; Wei, Jingjing ; Niu, Qikai ; Liang, Xiao ; Liu, Yue ; Zhang, Yunling ; Liu, Hongxi ; Qu, Hua ; Zhao, Di ; Cao, Weiyi ; Wang, Liuding ; Zhang, Yunfan ; Zhang, Qi ; Yao, Mingjiang

BACKGROUND:

Ischemic stroke (IS) remains a critical challenge in stroke management. Xiongzhi Tongluo formula (XZTLF), a traditional Chinese herbal prescription, has shown potential in treating ischemic stroke, yet its mechanisms remain elusive.

METHODS:

This integrated study combined clinical and in vivo approaches to investigate XZTLF. We first employed network node similarity algorithms, ultra-high performance liquid chromatography quadrupole-time-of-flight mass spectrometry (UPLC-Q-TOF/MS)-based phytochemical profiling, and network pharmacology to identify potential molecular targets for ischemic stroke (IS) intervention. The predicted hub genes were then validated through molecular docking and a multicenter randomized controlled trial in patients with acute IS. For in vivo validation, a middle cerebral artery occlusion (MCAO) rat model was used. Rats were treated with XZTLF via oral gavage at doses of 2.97 or 11.88 g/kg/day for 7 days, using edaravone dexborneol (10 mg/kg, i.p.) as a positive control. Key targets and mechanisms of action were further assessed through biochemical and histological analyses of rat brain tissue.

RESULTS:

XZTLF demonstrated significantly closer network-based proximity to IS targets compared to control prescriptions. Chemical systematic pharmacology analysis identified 173 bioactive constituents in XZTLF. Network pharmacology screening revealed eight core targets (NFKB1, BCL2L1, MAPK1, STAT1, CDKN2A, AR, RAF1, and MMP2), which were subsequently validated in IS patients through ELISA quantification. In MCAO rat models, XZTLF administration significantly reduced cerebral infarct volume and improved neurological function. Mechanistically, XZTLF attenuated neuroinflammation by downregulating pro-inflammatory mediators (including IL-6, TNF-α, and NF-κB), mitigated oxidative damage (MDA, SOD, CAT), and suppressed hyperactivation of the PI3K/AKT signaling pathway.

CONCLUSION:

XZTLF shows potential for treating IS through multimodal regulation of neuroinflammatory cascades, redox homeostasis, and autophagy pathways, based on integrated preclinical and preliminary clinical findings.

01 Mar 2026·Brain and Behavior

Prospective Open‐Label Safety Study of Edaravone Dexborneol in Filipino Patients With Acute Ischemic Stroke

Article

Author: Sabellano, Zenyros Faith ; Batino, Laurence Kristoffer ; Pedregosa, Bonifacio ; Navarro, Jose

ABSTRACT:

Background:

Edaravone dexborneol is a neuroprotective agent combining the free‐radical scavenging properties of edaravone and the anti‐inflammatory, blood–brain barrier–modulating effects of dexborneol. While international trials have demonstrated favorable safety and potential clinical benefit, data in Filipino patients remain lacking. This study evaluated the real‐world safety and tolerability of edaravone dexborneol among Filipino patients with acute ischemic stroke.

Methods:

This was a single‐center, open‐label, single‐arm, prospective study conducted under a compassionate‐use program. Patients aged 18–80 years with clinically confirmed acute ischemic stroke within 48 h of onset received edaravone dexborneol (30 mg edaravone + 7.5 mg dexborneol) twice daily for 14 days. Safety monitoring continued until Day 20. Treatment‐emergent adverse events (TEAEs) and serious adverse events (SAEs) were classified using the International Council for Harmonisation (ICH E2A) criteria, and causality was assessed using the World Health Organization–Uppsala Monitoring Centre (WHO–UMC) categories.

Results:

Twenty‐seven of 29 enrolled patients completed the 14‐day regimen. Mean age was 55.7 ± 12.8 years; 66.7% were male. Overall, 15 patients (55.6%) experienced at least one TEAE, most commonly headache (29.6%), which occurred on Day 0 and resolved within 0.7 ± 1.2 days. Elevated liver enzymes were observed in 25.9% for aspartate transaminase (AST) as well as for alanine aminotransferase (ALT), generally mild and self‐limited. One patient developed both moderate transaminitis and acute kidney injury, attributed to concurrent antituberculosis therapy rather than the study drug. No treatment discontinuations, life‐threatening reactions, or deaths occurred.

Conclusion:

Edaravone dexborneol demonstrated a favorable safety profile in Filipino patients with acute ischemic stroke, with adverse events (AE) predominantly mild, transient, and reversible. These real‐world findings align with international data and support their potential incorporation into acute stroke management pathways in the Philippines.

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
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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	Simcere Pharmaceutical Co., Ltd.	01 Dec 2024
Brain Infarction	China	Simcere 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
Blood brain barrier defect	Phase 2	China	Jiangsu Simcere Pharmaceutical Co., Ltd.	01 Jul 2026
Cadasil	Phase 2	China	Jiangsu Simcere Pharmaceutical Co., Ltd.	01 Jul 2026
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

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04667637 (Pubmed \| Nat Commun)	Phase 2	Ischemic stroke	-	Edaravone dexborneol	fdmqalovkn(fwqfbvjoyl): 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	eqmsuqivnt(rxmynbufhr) = slledaqqhf vfccpfjxbo (qukghogzby )	Positive	30 Jan 2025
				No Edaravone Dexborneol	eqmsuqivnt(rxmynbufhr) = ungdsgxrfy vfccpfjxbo (qukghogzby )
ISC2025	Not Applicable	Acute Ischemic Stroke	4,684	Edaravone Dexborneol	zudjshefyx(ywqlzrzrgs): 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	kgcsaxestx(jqeiylgvej) = yvemephxqs pcqisfgwqg (wyrfaxedqu ) View more	Positive	19 Feb 2024
				Placebo	kgcsaxestx(jqeiylgvej) = vdhqkzmqpg pcqisfgwqg (wyrfaxedqu ) View more
CTR20210233 (Corporate Publications) Manual	Phase 3	Acute Ischemic Stroke	-	先必新	qiuoovpzfe(tezwuupykj) = 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 sitvrjlbdk (qvhasbxsnc ) Met	Positive	01 Dec 2022
				Placebo
NEWS Manual	Not Applicable	Acute Ischemic Stroke	94	先必新	omiwygczrx(kvpljqnisp) = nyenkpvnns tlegzvcukm (kzenmqhkbm, 4.11) View more	Positive	06 May 2022
				先必新+Alteplase	omiwygczrx(kvpljqnisp) = qypumppyit tlegzvcukm (kzenmqhkbm, 2.15) View more
NCT02430350 (Cochrane Database Syst Rev \| Pubmed \| Stroke) Manual	Phase 3	Acute Ischemic Stroke	1,165	Edaravone+Dexborneol	uylzhqkdcm(icfmsqpqtd) = ttytuhfblj kepepswwge (lkpprxrtwm ) View more	Superior	01 Mar 2021
				Edaravone	uylzhqkdcm(icfmsqpqtd) = ufhgitvtnp kepepswwge (lkpprxrtwm )
NCT01929096 (Pubmed) Manual	Phase 2	Acute Ischemic Stroke	385	Edaravone Dexborneol	soctqwggvy(vhchxmzxtm): P-Value = 0.6799 View more	Positive	22 Apr 2019
				Edaravone

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