Takeda’s orexin receptor 2-selective agonist, oveporexton (formerly TAK-861), achieved all primary and secondary endpoints across two Phase 3 trials targeting narcolepsy. The oral drug demonstrated statistically significant and clinically meaningful improvements in wakefulness, excessive daytime sleepiness, and cataplexy symptoms, with a safety profile consistent with earlier studies. Takeda plans regulatory filings in the US and other markets within the fiscal year and will present data at forthcoming medical conferences. This represents the first regulatory submission by any company for an orexin receptor agonist in narcolepsy, a disease characterized by sleep-wake regulation disruption, with multiple competitors developing orexin-targeted therapies.