Sanbexin (edaravone dexborneol) / Simcere - LARVOL DELTA

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

Meta-Analysis of Edaravone Dexborneol for Acute Ischemic Stroke: Efficacy and Safety Based on Four Randomized Controlled Trials (ISC 2026) - "Available on Wednesday, February 04, 2026 at 12:30pm CST."

Late-breaking abstract • Retrospective data • Cardiovascular • 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

A Novel Mutation in Exon 10 of the NOTCH3 Gene in Human Cerebral Microvascular Endothelial Cells Induces CADASIL-Like Pathology and the Therapeutic Effect of Edaravone Dexborneol on Hereditary and Non-hereditary Cerebral Small Vessel Disease. (PubMed, Neurochem Res) - "The progression of CADASIL is intensified by a cascade of interactions between compromised hCMEC and surrounding neurons and glial cells. EDB may offer a promising therapeutic approach for cerebral small vessel disease including CADASIL and non-hereditary one."

Journal • Cardiovascular • CNS Disorders • Inflammation • Ischemic stroke • Solid Tumor • ASS1 • NOTCH3

Edaravone Dexborneol Attenuates Cerebral Ischemia-Reperfusion Injury via cGAS-STING Inhibition, STX17-Mediated Autophagic Flux Restoration, and NLRP3 Inflammasome Suppression. (PubMed, Eur J Pharmacol) - "In conclusion, this study identifies a novel mechanism whereby EDB alleviates CI/RI through dual regulation of autophagy and inflammation via inhibition of cGAS-STING signaling. These findings not only provide new mechanistic insights but also support the clinical potential of EDB as an adjunctive therapy for AIS reperfusion injury."

Journal • Cardiovascular • Inflammation • Ischemic stroke • Reperfusion Injury • CGAS • NLRP3 • STING

Edaravone dexborneol attenuates neuroinflammation in acute cerebral ischemia-reperfusion injury through the CXCL13/CXCR5/NF-κB pathway. (PubMed, Immunopharmacol Immunotoxicol) - "Our results validate the protective efficacy of Edaravone dexborneol in OGD/R-induced microglia and MCAO rats. This effect may be attributed to its ability to mitigate neuroinflammation by modulating microglial M1/M2 polarization in vitro and inhibiting the CXCL13/CXCR5 axis and its associated NF-κB signaling pathway in vivo."

Journal • Cardiovascular • Inflammation • Ischemic stroke • Reperfusion Injury • CXCL13 • CXCR5 • IL1B • TNFA

Edaravone Dexborneol in acute ischemic stroke patients treated with combined intravenous thrombolysis and mechanical thrombectomy for large vessel occlusion. (PubMed, Front Neurol) - "Patients treated with Edaravone Dexborneol were associated with better functional outcomes three months after stroke onset compared to those who did not receive the treatment. These findings may be related to the drug's anti-inflammatory properties; however, randomized controlled trials are needed to confirm efficacy in patients undergoing MT combined with IVT."

Journal • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke • IL10 • IL1B • IL6 • TGFB1 • TNFA

Efficacy and safety of edaravone dexborneol in acute ischemic stroke: systematic review and meta-analysis. (PubMed, Front Neurol) - "The promising efficacy of this compound underscores the necessity for further comprehensive global studies aimed at optimizing its application and enhancing its relevance across diverse populations. https://www.crd.york.ac.uk/prospero/, identifier CRD42024626320."

Journal • Retrospective data • Review • Cardiovascular • CNS Disorders • Depression • Hematological Disorders • Inflammation • Ischemic stroke • Psychiatry

Clinical efficacy of edaravone dexborneol in the treatment of acute ischemic stroke: meta-analysis. (PubMed, Front Neurol) - "The results showed that the funnel plot of the NIHSS scores and hs-CRP were basically symmetrical. While ED demonstrates short-term efficacy in improving neurological outcomes, its clinical applicability remains uncertain due to unresolved questions about drug diffusion and delivery in human brain tissue, which may fundamentally limit its long-term benefits."

Journal • Retrospective data • Review • Cardiovascular • Ischemic stroke

Clinical and Safety Outcomes of Edaravone Dexborneol in Acute Ischemic Stroke: A Multicenter, Prospective, Cohort Study. (PubMed, Neurology) - P=N/A | "In this observational cohort study involving Chinese patients with AIS, edaravone dexborneol was associated with significantly better functional outcome at 90 days. Verification of our findings is warranted in other populations."

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

S100A11 mediates the protective effects of edaravone dexborneol on docetaxel-induced cognitive impairment in rats by inhibiting the MAPK signaling pathway. (PubMed, Toxicol Appl Pharmacol) - "Further rescue experiments showed that S100A11 knockdown reversed the defensive role of ED in DTX-induced neuronal damage. In conclusion, ED ameliorates cognitive dysfunction caused by DTX by upregulating the S100A11 expression and subsequently inactivating the MAPK signaling pathway."

Journal • Preclinical • Alzheimer's Disease • Cognitive Disorders • S100A11

PRECISE AM: A Prospective, Multicentre, Randomized Controlled 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

New P4 trial • Cardiovascular • Ischemic stroke • Oncology

Edaravone dexborneol compared to edaravone in the treatment of acute cerebral infarction: A meta-analysis. (PubMed, Front Pharmacol) - "Fourteen days after treatment, the edaravone dexborneol group showed significantly better scores than the edaravone group in the NIHSS (MD = -2.13, 95% CI [-2.90, -1.35], p < 0.00001), Barthel Index (MD = 12.13, 95% CI [7.68, 16.58], p < 0.00001), and modified Rankin Scale (MD = -1.16, 95% CI [-1.75, -0.56], p = 0.0001). Edaravone dexborneol demonstrates superior clinical efficacy and safety compared to edaravone in the treatment of acute cerebral infarction, suggesting it may be a more effective therapeutic option."

Journal • Retrospective data • Review • CNS Disorders

Efficacy and Safety of Butylphthalide Combined with Edaravone Dexborneol in Acute Ischemic Stroke Patients Undergoing Thrombectomy (ChiCTR) - P4 | N=702 | Recruiting | Sponsor: Drum Tower Hospital; Drum Tower Hospital

New P4 trial • Cardiovascular • Ischemic stroke

EFFECTIVENESS OF EDARAVONE DEXBORNEOL IN REAL-WORLD PATIENTS WITH MODERATE AND SEVERE ACUTE ISCHEMIC STROKE (ESOC 2025) - P=N/A | "Edaravone dexborneol is associated with higher odds of excellent functional outcomes among patients with moderate to severe AIS compared to those not receiving the treatment."

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

TREATMENT OF ACUTE ISCHEMIC STROKE WITH EDARAVONE DEXBORNEOL IN SMALL VESSEL DISEASE (TASTE-SVD) (ESOC 2025) - P3 | "TASTE-SVD seeks to establish edaravone dexborneol sublingual tablets as a treatment option for acute ischemic SVD, targeting specific pathological mechanisms in SVD to slow disease progression and improve cognitive and functional outcomes"

Cardiovascular • Ischemic stroke

EDARAVONE DEXBORNEOL FOR ACUTE ISCHEMIC STROKE: A SYSTEMATIC REVIEW AND META-ANALYSIS (ESOC 2025) - "Edaravone Dexborneol significantly improves functional and neurological recovery in AIS with a favorable safety profile. Figure 1: Forest plot showing NIHSS Figure 2: Forest plot showing mRS available data"

Retrospective data • Review • Cardiovascular • Ischemic stroke

EFFICACY AND SAFETY OF EDARAVONE DEXBORNEOL IN ACUTE ISCHEMIC STROKE: A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS (ESOC 2025) - "The neuroprotective clinical benefits of Edaravone Dexborneol in AIS are encouraging, improving functional outcomes and reducing hemorrhagic transformation risk. Further large-scale RCTs are needed to confirm these findings and confirm its efficacy and safety."

Retrospective data • Review • Cardiovascular • Ischemic stroke

EDARAVONE DEXBORNEOL IN LARGE ISCHEMIC STROKE: REAL-WORLD EXPERIENCE FROM MULTICENTER IN CHINA (ESOC 2025) - "In AIS patients with large infarction, edaravone dexborneol improved the likelihood of achieving favorable functional outcomes at 90 days."

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