dexborneol/cilostazol (Y-6 sublingual) / NeuroDawn - LARVOL DELTA

Y-6 Sublingual Tablets for the Treatment of Acute Perforator Artery Territory Infarction (ChiCTR) - P2/3 | N=944 | Not yet recruiting | Sponsor: Beijing Tiantan Hospital, Capital Medical University; Beijing Tiantan Hospital, Capital Medical University

New P2/3 trial

Efficacy and safety of sublingual cilostazol and dexborneol for the treatment of acute ischaemic stroke: a randomised phase 2 trial in China. (PubMed, EClinicalMedicine) - "We aimed to investigate the efficacy and safety of Y-6 sublingual tablets (cilostazol and dexborneol) in ischaemic stroke patients with endovascular treatment. Large-scale phase 3 clinical trials are warranted to further this research. The National Natural Science Foundation of China; Noncommunicable Chronic Diseases-National Science and Technology Major Project; Beijing Municipal Science & Technology Commission; Capital's Funds for Health Improvement and Research; National Key R&D Program of China."

Journal • P2 data • Cardiovascular • Cerebral Hemorrhage • Ischemic stroke

CORAL: Y-6 Sublingual Tablets for Acute Penetrating Artery Infarction (clinicaltrials.gov) - P2/3 | N=944 | Not yet recruiting | Sponsor: Neurodawn Pharmaceutical Co., Ltd.

New P2/3 trial

Sublingual Cilostazol and Dexborneol for the Treatment of Acute Ischemic Stroke:A Randomized Clinical Trial (ISC 2026) - P2 | "The symptomatic intracranial hemorrhage at 28 days occurred in 1 patient (1.8%) in Y-6 high-dose group, 3 patients (4.8%) in Y-6 low-dose group, 2 patients (3.3%) in cilostazol high-dose group, 4 patients (6.8%) cilostazol low-dose group and 2 patients (3.6%) in placebo group.Conclusions The findings suggested that for ischemic stroke patients undergoing endovascular treatment, the Y-6 sublingual tablets showed the trend of improving functional outcomes as it did not reach statistical significance; while it did not associate with the symptomatic intracranial hemorrhage events. Further research should be conducted to prove in large-scale phase 3 clinical trials."

Clinical • Late-breaking abstract • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

Phase III Clinical Trial of Y-6 Sublingual Tablets for the Treatment of Acute Ischemic Stroke - A Multicenter, Randomized, Double-Blind, Placebo-Parallel Controlled Trial (ChiCTR) - P3 | N=892 | Not yet recruiting | Sponsor: Beijing Tiantan Hospital Affiliated to Capital Medical University; NeuroDawn Pharmaceutical Co., Ltd.

New P3 trial • Cardiovascular • Ischemic stroke

Y-6 Sublingual Tablets for Patients With Acute Ischemic Stroke (clinicaltrials.gov) - P3 | N=892 | Not yet recruiting | Sponsor: Beijing Tiantan Hospital

New P3 trial • Cardiovascular • Ischemic stroke