Phase III Trial Shows Neuroprotective Drug Loberamisal Improves Stroke Recovery When Administered Early

Stroke patients treated with a novel neuroprotective medication called loberamisal within 48 hours of symptom onset showed significantly better functional recovery at 90 days compared to those receiving a placebo, according to preliminary findings from a Phase III clinical trial presented at the American Stroke Association’s International Stroke Conference 2026. The study, which involved 998 adults in China, represents a notable step in the long-challenged field of neuroprotection for acute stroke care.

In the trial, patients aged 18 to 80 with moderate to severe ischemic strokes received a daily 40 mg intravenous infusion of loberamisal or a matched placebo for 10 days, starting within 48 hours of symptom onset. At the 90-day follow-up, 69% of participants treated with loberamisal achieved an excellent functional outcome, defined as little to no disability on the modified Rankin Scale, compared to about 56% in the placebo group. The treatment was considered safe, with no increased risk of serious side effects or death observed compared to the placebo. Study author Shuya Li, M.D., of Beijing Tiantan Hospital, noted that while most prior neuroprotective agent trials have not been successful, loberamisal—a small-molecule, dual-acting agent—showed promise as an effective neuroprotectant in earlier rodent studies. ‘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 findings align with renewed interest in neuroprotection highlighted in the American Stroke Association’s 2026 Guideline for the Early Management of Patients With Acute Ischemic Stroke, which notes current knowledge gaps need addressing. However, the study has several limitations. It was conducted only in China, so results may not directly translate to other populations. Most participants had moderate to severe strokes, and only about 17% received standard IV clot-busting medication like alteplase, limiting assessment of combined effects. Patients who underwent mechanical thrombectomy were excluded. Additionally, 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, and to study biomarkers in multiple populations. The research was a multicenter, randomized, double-blind, placebo-controlled trial conducted from July 2024 to April 2025. Functional outcomes were assessed via face-to-face interviews or standardized telephone questionnaires using a structured form. The study abstract is available in the American Stroke Association International Stroke Conference 2026 Online Program Planner.

It is important to note that the findings are preliminary, as abstracts presented at the association’s scientific meetings are not peer-reviewed. The results are considered preliminary until published as a full manuscript in a peer-reviewed scientific journal. 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. The trial suggests that early administration of a neuroprotective agent like loberamisal could improve recovery outcomes, though further research is required to validate these results across broader demographics and understand the drug’s biological effects.

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