Sanbexin sublingual (edaravone dexborneol sublingual) / Yantai YenePharma, Simcere, NeuroDawn - LARVOL DELTA

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

Effect of Early Emergency Department Administration of Sublingual Edaravone Dexborneol on Neurological Function Improvement in Acute Ischemic Stroke Patients Undergoing Reperfusion Therapy: the EARLY-AID trial (ChiCTR) - P4 | N=645 | Not yet recruiting | Sponsor: Zigong Fourth People's Hospital; Zigong Fourth People's Hospital

New P4 trial • 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

Exploratory Study on Sublingual Edaravone Dexborneol in Improving the Effective Reperfusion Rate of Large Vessel Occlusion in Acute Ischemic Stroke (ChiCTR) - P=N/A | N=100 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Chengdu Medical College; The First Affiliated Hospital of Chengdu Medical College

New trial • Cardiovascular • Ischemic stroke

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

TASTE-SVD: Treatment of Acute Ischemic Stroke With Edaravone Dexborneol Sublingual Tablets in Small Vessel Disease (clinicaltrials.gov) - P3 | N=600 | Recruiting | Sponsor: Peking Union Medical College Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • 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

TASTE-SVD: Treatment of Acute Ischemic Stroke with Edaravone Dexborneol Sublingual Tablets in Small Vessel Disease (clinicaltrials.gov) - P3 | N=600 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital | Initiation date: Mar 2025 ➔ Jun 2025

Trial initiation date • Alzheimer's Disease • Cardiovascular • Ischemic stroke

Edaravone Dexborneol Sublingual Tablet for the PSCI in Acute Ischemic Stroke Patients (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Simcere Pharmaceutical Co., Ltd | N=80 ➔ 200 | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Enrollment change • Trial completion date • Trial primary completion date • Alzheimer's Disease • Cardiovascular • Cognitive Disorders • Ischemic stroke

TASTE-SVD: Treatment of Acute Ischemic Stroke With Sublingual Edaravone Dexborneol in Small Vessel Disease (clinicaltrials.gov) - P3 | N=600 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital

New P3 trial • Cardiovascular • Ischemic stroke

Edaravone Dexborneol Sublingual Tablet for the PSCI in Acute Ischemic Stroke Patients (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Simcere Pharmaceutical Co., Ltd | Trial completion date: May 2025 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Alzheimer's Disease • Cardiovascular • Cognitive Disorders • Ischemic stroke

Edaravone Dexborneol Sublingual Tablet for the PSCI in Acute Ischemic Stroke Patients (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Simcere Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • Cardiovascular • Cognitive Disorders • Ischemic stroke

EDARAVONE DEXBORNEOL IN TREATMENT OF LARGE ARTERY ATHEROSCLEROSIS STROKE (ESOC 2024) - "This analysis demonstrated that both injectional and sublingual edaravone dexborneol showed more favorable functional outcomes without increase in AEs in LAA stroke."

Atherosclerosis • Cardiovascular • Dyslipidemia • Ischemic stroke

Edaravone Dexborneol Sublingual Tablet for the PSCI in Acute Ischemic Stroke Patients (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Simcere Pharmaceutical Co., Ltd

New P2 trial • Alzheimer's Disease • Cardiovascular • Cognitive Disorders • Ischemic stroke

Sublingual Edaravone Dexborneol for the Treatment of Acute Ischemic Stroke: The TASTE-SL Randomized Clinical Trial. (PubMed, JAMA Neurol) - P3 | "Among patients with AIS within 48 hours, sublingual edaravone dexborneol could improve the proportion of those achieving a favorable functional outcome at 90 days compared with placebo. ClinicalTrials.gov Identifier: NCT04950920."

Clinical • Journal • Cardiovascular • Ischemic stroke

Longitudinal evaluation of major salivary gland functioning in Sjögren's disease patients in a prospective standard-of-care cohort. (PubMed, Clin Exp Rheumatol) - "Overall, major salivary gland functioning assessed with SGUS, sialometry and PROMs did not change significantly up to 5 years of follow-up in a standard-of-care cohort of SjD patients from daily clinical practice."

Journal • Dental Disorders • Immunology • Sjogren's Syndrome • Xerostomia

A Study to Evaluate the Pharmacokinetics,Safety and Tolerability of Y-2 Sublingual Tablet in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: Simcere Pharmaceutical Co., Ltd | Not yet recruiting ➔ Completed

Trial completion

A Study to Evaluate the Pharmacokinetics,Safety and Tolerability of Y-2 Sublingual Tablet in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Simcere Pharmaceutical Co., Ltd

New P1 trial

Efficacy and safety of Y-2 sublingual tablet for patients with acute ischaemic stroke: protocol of a phase III randomised double-blind placebo-controlled multicentre trial. (PubMed, Stroke Vasc Neurol) - P3 | "This trial will provide valuable evidence for the efficacy and safety of Y-2 sublingual table for improving 90 days the functional outcomes in patients with AIS."

Journal • P3 data • Cardiovascular • Ischemic stroke