Prospective Open-Label Safety Study of Edaravone Dexborneol in Filipino Patients With Acute Ischemic Stroke.

BACKGROUND: Edaravone 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. METHODS: This 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. RESULTS: Twenty-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. CONCLUSION: Edaravone 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.