A Phase III clinical trial presented at the American Stroke Association's International Stroke Conference 2026 indicates that the novel neuroprotective medication loberamisal, when administered intravenously within 48 hours of stroke symptoms, significantly improves functional recovery in patients. The study, conducted across 32 centers in China from July 2024 to April 2025, involved 998 adults aged 18 to 80 with moderate to severe ischemic strokes. Participants received either a daily 40 mg infusion of loberamisal or a matched placebo for 10 days.
At the 90-day follow-up, 69% of patients treated with loberamisal achieved excellent functional recovery, defined as little to no disability on the modified Rankin Scale, compared to approximately 56% in the placebo group. The treatment was deemed safe, with no increased risk of serious side effects or death observed compared to the placebo. Study author Shuya Li, M.D., director of the Clinical Trial Center at Beijing Tiantan Hospital, noted that while most neuroprotective agents have not succeeded in previous trials, loberamisal represents a new-generation dual-target strategy designed to protect brain cells. "New treatments for stroke may come from multi-target neuroprotective agents, which could lead to important advancements in reducing or preventing disability after a stroke," Li said.
The trial's design was multicenter, randomized, double-blind, and placebo-controlled. Participants had National Institutes of Health Stroke Scale scores between 7 and 20, and functional outcomes were assessed via face-to-face interviews or standardized telephone questionnaires. Notably, only about 17% of participants received standard intravenous clot-busting medication like alteplase, and those who underwent mechanical thrombectomy were excluded, limiting assessment of combined treatments. The American Stroke Association's 2026 Guideline for the Early Management of Patients With Acute Ischemic Stroke highlights renewed interest in neuroprotection, though current knowledge gaps require further research. According to the American Heart Association's 2026 Heart Disease and Stroke Statistics, stroke is the fourth leading cause of death in the U.S., underscoring the need for effective treatments.
Study limitations include its conduct solely in China, which may limit generalizability to other populations, and the focus on moderate to severe strokes, potentially affecting applicability to more severe cases. No blood or imaging biomarkers were assessed, restricting understanding of loberamisal's mechanisms. Li emphasized the need for confirmation in larger, more diverse groups, including patients with more severe strokes and those who have had vascular surgery. "We need to better understand how loberamisal works by studying biomarkers in multiple population groups," Li stated. The findings are preliminary until published in a peer-reviewed journal, as abstracts presented at the association's meetings are not peer-reviewed. Additional resources, including the abstract, are available in the American Stroke Association International Stroke Conference 2026 Online Program Planner.
The implications of this research are significant for stroke care globally. If validated, loberamisal could offer a new therapeutic option to reduce disability in stroke patients, addressing a major public health burden. The study aligns with ongoing efforts to develop neuroprotective strategies, as highlighted in prior research such as the American Heart Association news release on neuroprotectants delivered via nanoparticles. However, broader trials are necessary to assess efficacy across different ethnicities and stroke severities. This trial contributes to the evolving landscape of stroke treatment, potentially enhancing recovery outcomes and improving quality of life for survivors worldwide.
