New research presented at the American Stroke Association’s International Stroke Conference 2026 suggests a potential breakthrough in stroke recovery. A novel neuroprotective medication, loberamisal, demonstrated improved functional outcomes in patients treated within 48 hours of experiencing a stroke, according to preliminary findings from a Phase III clinical trial.
The study, conducted at 32 centers in China, involved nearly 1,000 adults (998 total) between the ages of 18 and 80 who had suffered a moderate to severe stroke caused by a blocked blood vessel. Participants received either a daily intravenous infusion of 40 mg of loberamisal or a placebo for 10 days, beginning within 48 hours of the onset of stroke symptoms. The goal was to assess whether loberamisal, designed to protect brain cells, could improve recovery.
“Neuroprotective agents may help improve patient outcomes since they are aimed at preserving the function of neurovascular units,” explained Dr. Shuya Li, study author and director of the Clinical Trial Center at Beijing Tiantan Hospital in Beijing. “However, trials for most of these agents have not been successful. In this trial, we tested loberamisal, a small-molecule, dual-acting neuroprotective agent that was an effective neuroprotectant in 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.”
At 90 days following treatment, the analysis revealed a significant difference in functional recovery between the two groups. Approximately 69% of patients treated with loberamisal experienced excellent functional recovery – defined as little to no disability – compared to about 56% in the placebo group. Importantly, the treatment appeared to be safe, with no increased risk of serious side effects or death observed in the loberamisal group compared to the placebo group.
The study utilized the National Institutes of Health Stroke Scale (NIHSS) to assess stroke severity, with participants having scores between 7 and 20, indicating moderate to severe impairment. Functional outcomes were then measured using the modified Rankin Scale (mRS), where a score of 0-1 signifies little to no disability. Assessments were conducted by trained and certified researchers through face-to-face interviews or standardized telephone questionnaires.
While the results are promising, researchers emphasize several limitations. The trial was conducted exclusively in China, raising questions about the generalizability of the findings to other populations. Dr. Li noted the need for further research, stating, “We want to confirm our findings with larger groups of people, including people from different racial and ethnic backgrounds, patients with more severe strokes and those who also have had vascular surgery. We need to better understand how loberamisal works by studying biomarkers in multiple population groups.”
the study excluded patients who received surgical treatment to remove the blockage (mechanical thrombectomy) and those who received standard clot-busting medication (alteplase), limiting the ability to assess the combined effects of loberamisal with these existing treatments. Only about 17% of participants received alteplase. The majority of patients included in the study had moderate to severe strokes, potentially affecting the applicability of the findings to individuals with less severe impairments. The study also did not assess blood or imaging biomarkers, which could have provided further insight into the mechanisms by which loberamisal exerts its effects.
The trial was a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial conducted over a nine-month period, from July 2024 to April 2025. While 20 participants did not complete the 90-day follow-up, they were still included in the final statistical analysis. Randomization to either loberamisal or placebo was computer-generated, ensuring that neither the investigators nor the participants were aware of the treatment assignment.
The American Stroke Association’s 2026 guideline for the early management of patients with acute ischemic stroke acknowledges a renewed interest in neuroprotection, highlighting the need for further research to address existing knowledge gaps. This study represents a step forward in that direction, offering a potential new avenue for improving outcomes for stroke patients.
The findings suggest that loberamisal, if validated in larger and more diverse populations, could become a valuable addition to the toolkit for stroke care, potentially reducing long-term disability and improving the quality of life for millions affected by this devastating condition.
