Sanbexin (edaravone dexborneol) / Simcere - LARVOL DELTA

Efficacy and Safety of Butylphthalide Combined with Edaravone Dexborneol in Acute Ischemic Stroke Patients Undergoing Thrombectomy (ChiCTR) - P4 | N=702 | Completed | Sponsor: Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University; Nanjing Drum Tower Hospital, Affiliated Hospital of Medical Sc | Recruiting ➔ Completed

Trial completion • Cardiovascular • Ischemic stroke

Efficacy and safety of edaravone dexborneol for acute ischemic stroke: a meta-analysis. (PubMed, Front Neurol) - "Patients with higher baseline NIHSS scores may derive greater prognostic benefit from edaravone dexborneol therapy. Future multicenter, large-sample clinical studies are still needed to further validate the efficacy and safety of Edaravone Dexborneol."

Clinical • Journal • Retrospective data • Review • Cardiovascular • CNS Disorders • Ischemic stroke

Edaravone dexborneol alleviates neuronal senescence injury by mitigating the innate immune response. (PubMed, Tissue Cell) - "Mechanistic studies revealed that EDB not only alleviated oxidative stress but also inhibited the cGAS-STING-mediated innate immune signaling pathway. This study is the first to demonstrate that EDB mitigates mitochondrial damage to exert anti-neuronal senescence effects, offering a novel intervention strategy for aging-related neurodegenerative diseases."

Journal • Alzheimer's Disease • CNS Disorders • Movement Disorders • Parkinson's Disease • CDKN1A • STING

Beyond Anterior Circulation: Clinical Outcomes of Edaravone Dexborneol in Posterior Circulation Stroke. (PubMed, J Stroke Cerebrovasc Dis) - "In this study, edaravone dexborneol demonstrated a potential signal for improved functional outcomes in the primary analysis, but sensitivity analyses did not confirm a definitive benefit. The results are exploratory and should be interpreted cautiously and require validation in adequately powered randomized controlled trials."

Clinical data • Journal • Cardiovascular • Ischemic stroke

Edaravone Dexborneol regulates the endothelial PPARγ-PON1 axis to inhibit high-cholesterol-induced atherosclerosis. (PubMed, Clin Sci (Lond)) - "Furthermore, the combination of Edaravone Dexborneol with Rosuvastatin exhibited synergistic anti-atherogenic effects superior to Rosuvastatin alone. In conclusion, Edaravone Dexborneol attenuates atherosclerosis via the PPARγ/PON1 pathway, highlighting its potential as an antioxidant-based therapeutic strategy for atherosclerotic disease."

Journal • Atherosclerosis • Cardiovascular • Dyslipidemia • APOE • PON1 • PPARG

Immune interventions in stroke: current progress and perspectives. (PubMed, Sci China Life Sci) - "Subsequently, we systematically summarize the clinical research progress on promising therapeutic strategies, encompassing traditional and novel agents such as tirofiban, methylprednisolone, natalizumab, fingolimod combined with alteplase, edaravone dexborneol, butylphthalide, JAK/STAT pathway inhibitors, ApTOLL, anakinra, and tocilizumab, as well as cell transplantation therapies. Finally, we discuss the existing challenges in clinical translation-such as suboptimal targeting efficiency, individual variability in treatment response, and unresolved safety concerns-and prospect future directions for precision immune therapy in AIS. This review offers a comprehensive and up-to-date overview of the neuroimmune landscape in AIS, providing valuable insights for researchers and clinicians engaged in stroke treatment and drug development."

Journal • Review • Cardiovascular • CNS Disorders • Inflammation • Ischemic stroke • Transplantation • Vascular Neurology

Edaravone dexborneol in acute ischemic stroke: a systematic review and meta-analysis of randomized trials with clinical and thrombectomy-specific subgroup analyses. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "ED appears to improve functional outcomes and reduce hemorrhagic complications in AIS, with a favorable safety profile. However, findings should be interpreted cautiously due to population and trial limitations, and further multicentre studies are needed to confirm efficacy, particularly in EVT and high-risk subgroups."

Journal • Retrospective data • Review • Cardiovascular • Cognitive Disorders • Hematological Disorders • Ischemic stroke

Retraction: Observations on the efficacy of edaravone dexborneol in preventing post-stroke depression and its inflammatory mechanism: a prospective, randomized, control trial. (PubMed, Front Neurosci) - "[This retracts the article DOI: 10.3389/fnins.2024.1451060.]."

Journal • Cardiovascular • CNS Disorders • Depression • Mood Disorders • Psychiatry

PRECISE AM: A Trial of Edaravone Dexborneol in Acute Ischemic Stroke With Active Malignancy (clinicaltrials.gov) - P4 | N=144 | Not yet recruiting | Sponsor: Nanfang Hospital, Southern Medical University | Initiation date: Aug 2025 ➔ Aug 2026

Trial initiation date • Cardiovascular • Ischemic stroke • Oncology

Evaluate the Efficacy and Safety of Different Doses of Edaravone Dexborneol Concentrated Solution for Injection Combined With Conventional Medical Therapy in the Treatment of Patients With Cerebral Hemorrhage (clinicaltrials.gov) - P2 | N=80 | Terminated | Sponsor: Simcere Pharmaceutical Co., Ltd | N=380 ➔ 80 | Recruiting ➔ Terminated; This study was terminated after completing the first dose level of Sanbenxin 37.5 mg due to the decision made by the sponsor that a new clinical development program for the new form of sublingual tablets would replace the existing plan.

Enrollment change • Trial termination • Cerebral Hemorrhage • Hematological Disorders

Study on the improvement of electroencephalogram signal characteristics in stroke patients by edaravone dexborneol. (PubMed, Front Neurosci) - "Treatment with edaravone dexborneol can effectively improve abnormal EEG patterns in patients with cerebral infarction, characterized by reduced slow-wave activity and increased fast-wave activity and EEG complexity/orderliness. These beneficial changes in EEG characteristics are synchronized with clinical neurological recovery, suggesting that the drug may promote the reshaping and functional reorganization of neural networks by reducing oxidative stress, neuroinflammation, improving cerebral microcirculation, and enhancing neuronal metabolism."

Journal • Cardiovascular • CNS Disorders • Inflammation • Ischemic stroke

Effects of acupuncture on ferroptosis and ferritinophagy in cerebral ischemia-reperfusion rats based on KAT3B/ACSL4 pathway (PubMed, Zhen Ci Yan Jiu) - "Acupuncture can improve cerebral injury in CIRI rats and reduce ferroptosis and ferritinophagy, potentially through inactivation of the KAT3B/ACSL4 pathway."

Journal • Preclinical • Cardiovascular • CNS Disorders • Reperfusion Injury • ACSL4 • EP300 • GPX4 • NCOA4 • SLC7A11 • TFRC

Prospective Open-Label Safety Study of Edaravone Dexborneol in Filipino Patients With Acute Ischemic Stroke. (PubMed, Brain Behav) - "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."

Journal • Acute Kidney Injury • Cardiovascular • Infectious Disease • Ischemic stroke • Nephrology • Pain • Renal Disease • Respiratory Diseases • Tuberculosis

An integrated approach elucidates Xiongzhi Tongluo formula against ischemic stroke. (PubMed, Phytomedicine) - "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."

Journal • Cardiovascular • Inflammation • Ischemic stroke • BCL2L1 • CDKN2A • IL6 • MAPK1 • MMP2 • STAT1 • TNFA

Edaravone Dexborneol Promotes Oligodendrocyte Precursor Cell Proliferation and Differentiation to Repair White Matter and Improve Long-Term Outcomes after Ischemic Stroke. (PubMed, Brain Res Bull) - "EDB treatment was associated with improved local tract integrity and global network connectivity in stroke patients. In experimental models, EDB promoted OPC proliferation and differentiation via Akt/mTOR signaling, potentially contributing to remyelination and white matter repair, accompanied by improved long-term functional outcomes. These findings suggest that EDB may represent a promising strategy for post-stroke white matter repair."

Journal • Cardiovascular • Ischemic stroke • Solid Tumor

Meta-Analysis of Edaravone Dexborneol for Acute Ischemic Stroke: Efficacy and Safety Based on Four Randomized Controlled Trials (ISC 2026) - "In the prespecified subgroup of patients who underwent endovascular therapy, ED was associated with a higher rate of favorable outcome (1.11, 1.01–1.22, P = 0.03); however, the difference in the excellent outcome was not statistically significant (1.06, 0.93–1.19, P = 0.38).Conclusion This meta-analysis indicates that edaravone dexborneol improves the likelihood of both excellent and favorable outcomes at 90 days in AIS patients. The benefit of achieving favorable outcomes was also observed in patients receiving endovascular therapy, suggesting a potential role for ED as an adjunctive treatment in this population."

Late-breaking abstract • Retrospective data • Cardiovascular • Ischemic stroke

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. (PubMed, J Invest Surg) - "The study group had a lower incidence of adverse outcomes (4.00% vs. 13.33%, p < 0.05). 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."

Journal • CNS Disorders • Oncology • Vascular Neurology • IL6 • TNFA

Evaluating the Efficacy and Safety of Edaravone-Dexborneol in Acute Ischemic Stroke: An Updated Systematic Review and Meta-Analysis of 7,846 Chinese Patients. (PubMed, Int J Neurosci) - "However, careful dosing is necessary to minimize AEs. Future research should focus on large-scale trials, long-term outcomes, and mechanistic studies to optimize treatment protocols."

Journal • Retrospective data • Review • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke • Metabolic Disorders

Intervention of Edaravone Dexborneol on Iron Metabolism in Perihematomal Brain Tissue of Rats with Intracerebral Hemorrhage and its Neuroprotective Mechanism. (PubMed, Neurol India) - "Edaravone dexborneol may play a cerebral protective role by regulating the expression of iron metabolism-related proteins in rats with cerebral hemorrhage and inhibiting iron death in neuronal cells."

Journal • Preclinical • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders • Ischemic stroke

Effect of edaravone dexborneol on clinical outcomes in patients with acute posterior circulation ischemic stroke undergoing endovascular therapy: A retrospective single-center study. (PubMed, Medicine (Baltimore)) - "EdaBorneol can protect vascular endothelial integrity and reduce reperfusion injury. This study provides evidence-based support for the use of EdaBorneol in posterior circulation stroke management."

Clinical data • Journal • Observational data • Retrospective data • Cardiovascular • Hematological Disorders • Ischemic stroke • Reperfusion Injury

Pharmacological characterization and neuroprotective efficacy of ZHB103, a novel long-acting rhKLK1. (PubMed, Neurotherapeutics) - "Compared with rKLK1 (the proprotein of ZHB103, a short-acting non-PEGylated recombinant KLK1), Sanbexin (Edaravone and Dexborneol concentrated solution for injection) or HUK (human urinary kallidinogenase, a form of tissue kallikrein 1 from urine), ZHB103 promoted cell proliferation, inhibited apoptosis, reduced inflammatory factor levels in the acute stage of stroke models and improved cognitive function recovery during the later recovery stage via a significantly prolonged duration of B2 receptor (B2R)-mediated signaling pathway (eNOS-Akt-ERK1/2-CREB-Bcl-2) activation. The introduction of B2R inhibitor HOE-140 further confirmed, both in vitro and in vivo that ZHB103 exerts its efficacy in stroke treatment through upregulation of B2R and activation of its downstream eNOS signaling pathway. These results suggest that the administration frequency of ZHB103 may be reduced to once weekly, demonstrating the advantages of PEG-conjugation strategy in improving patient..."

Journal • Cardiovascular • Ischemic stroke • BCL2 • NOS3

Edaravone dexborneol versus placebo on functional outcomes in patients with acute ischaemic stroke undergoing endovascular thrombectomy (TASTE-2): randomised controlled trial. (PubMed, BMJ) - P3 | "Among patients with acute ischaemic stroke within 24 hours of symptom onset who underwent endovascular thrombectomy, those treated with edaravone dexborneol, compared with placebo, were more likely to achieve functional independence at 90 days without increased safety concerns. This effect seemed to be primarily driven by the subgroup with mismatch present at admission, suggesting that dedicated trials in this population may be warranted."

Clinical • Journal • Cardiovascular • Ischemic stroke

Edaravone Dexborneol in Large Ischemic Stroke: Real-World Experience from a Multicenter Study in China. (PubMed, J Am Heart Assoc) - P=N/A | "In patients with acute ischemic stroke with large infarct core, edaravone dexborneol improved the likelihood of achieving favorable functional outcomes at 90 days."

Clinical • Journal • Real-world evidence • Cardiovascular • Ischemic stroke

Cost-effectiveness of edaravone dexborneol sublingual tablet versus concentrated solution for injection for the treatment of acute ischemic stroke in China. (PubMed, Front Pharmacol) - "EDSL represents a more cost-effective therapy for AIS patients compared to EDCSI, offering comparable efficacy at a lower drug cost. A full 14-day treatment course may help maximize patient benefits."

HEOR • Journal • Cardiovascular • Ischemic stroke

Efficacy and safety of Edaravone Dexborneol in acute large vessel occlusion patients with successful recanalization after endovascular treatment. (PubMed, J Stroke Cerebrovasc Dis) - "Among AIS-LVO patients with successful recanalization after EVT, ED may be associated with an improved functional outcome without an increased risk of sICH and mortality."

Journal • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke