ArticleBrain and behavior2026
Prospective Open-Label Safety Study of Edaravone Dexborneol in Filipino Patients With Acute Ischemic Stroke.
Article in Brain and behavior, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundEdaravone dexborneol is a neuroprotective agent combining the free-radical scavenging properties of edaravone and the anti-inflammatory, blood-brain barrier-modulating effects of dexborneol. While international trials have demonstrated favorable safety and potential clinical benefit, data in Filipino patients remain lacking. This study evaluated the real-world safety and tolerability of edaravone dexborneol among Filipino patients with acute ischemic stroke.
methodsThis was a single-center, open-label, single-arm, prospective study conducted under a compassionate-use program. Patients aged 18-80 years with clinically confirmed acute ischemic stroke within 48 h of onset received edaravone dexborneol (30 mg edaravone + 7.5 mg dexborneol) twice daily for 14 days. Safety monitoring continued until Day 20. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) were classified using the International Council for Harmonisation (ICH E2A) criteria, and causality was assessed using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) categories.
resultsTwenty-seven of 29 enrolled patients completed the 14-day regimen. Mean age was 55.7 ± 12.8 years; 66.7% were male. Overall, 15 patients (55.6%) experienced at least one TEAE, most commonly headache (29.6%), which occurred on Day 0 and resolved within 0.7 ± 1.2 days. Elevated liver enzymes were observed in 25.9% for aspartate transaminase (AST) as well as for alanine aminotransferase (ALT), generally mild and self-limited. One patient developed both moderate transaminitis and acute kidney injury, attributed to concurrent antituberculosis therapy rather than the study drug. No treatment discontinuations, life-threatening reactions, or deaths occurred.
conclusionEdaravone dexborneol demonstrated a favorable safety profile in Filipino patients with acute ischemic stroke, with adverse events (AE) predominantly mild, transient, and reversible. These real-world findings align with international data and support their potential incorporation into acute stroke management pathways in the Philippines.
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