Novel Neuroprotective Drug Loberamisal Improves Stroke Recovery in Phase III Trial

A phase III clinical trial found that stroke patients treated with loberamisal within 48 hours of symptom onset had significantly better functional outcomes at 90 days compared to placebo, with 69% achieving excellent recovery versus 56% in the control group.

Dallas Metrowire Staff
Healthcare
Novel Neuroprotective Drug Loberamisal Improves Stroke Recovery in Phase III Trial

Stroke patients treated with a novel neuroprotective medication, loberamisal, within 48 hours of symptom onset showed significantly better recovery outcomes than those receiving a placebo, according to preliminary findings presented at the American Stroke Association's International Stroke Conference 2026 in New Orleans.

The phase III clinical trial, conducted at 32 centers in China, enrolled 998 adults aged 18 to 80 who had experienced a moderate to severe ischemic stroke caused by a blocked vessel. Participants received daily intravenous infusions of either 40 mg of loberamisal or a placebo for 10 days, starting within 48 hours of stroke symptoms. The study, published as an abstract, found that 69% of those treated with loberamisal achieved excellent functional recovery—defined as little to no disability—at 90 days, compared to about 56% in the placebo group.

“Neuroprotective agents may help improve patient outcomes since they are aimed at preserving the function of neurovascular units. However, trials for most of these agents have not been successful,” said study author Shuya Li, M.D., director of the Clinical Trial Center at Beijing Tiantan Hospital. “In this trial, we tested loberamisal, a small-molecule, dual-acting neuroprotective agent that was an effective neuroprotectant in rodent studies.”

The treatment was considered safe, with no increased risk of serious side effects or death compared to the placebo group. The findings are significant because neuroprotection has garnered renewed interest, as noted in the American Heart Association's 2026 Guideline for the Early Management of Patients With Acute Ischemic Stroke, which highlights current knowledge gaps that need to be addressed in future research.

Study limitations include that the trial was conducted only in China, so results may not be directly applicable to other populations. Additionally, only about 17% of participants received standard IV clot-busting medication, limiting assessment of combined effects, and patients who underwent mechanical thrombectomy were excluded. No blood or imaging biomarkers were assessed, which limits understanding of how loberamisal works in the body.

“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,” Li said. The researchers plan to study biomarkers in multiple population groups.

The trial, which took place from July 2024 to April 2025, was a multicenter, randomized, double-blind, parallel, placebo-controlled study. Functional outcomes were measured using the modified Rankin Scale, a standard tool for assessing disability after stroke. Patients with moderate to severe stroke, as indicated by National Institutes of Health Stroke Scale scores between 7 and 20, were included.

According to the American Heart Association's 2026 Heart Disease and Stroke Statistics, stroke is now the fourth leading cause of death in the U.S. The findings from this trial offer hope for a new treatment option that could reduce disability after stroke.

More information about stroke types and treatment is available at www.stroke.org.

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