Takeda Pharmaceutical’s oral orexin receptor 2-selective agonist, oveporexton (TAK-861), achieved all primary and secondary endpoints in two Phase 3 trials for narcolepsy type 1. The compound demonstrated clinically meaningful improvements in measures of wakefulness, excessive daytime sleepiness, and cataplexy-related symptoms within 12 weeks, with a consistent safety profile and no serious treatment-related adverse events. With over 95% of participants enrolling in an extension study, Takeda plans to file regulatory approvals in the US and other markets within fiscal 2025. The trials validate orexin receptor agonism as a novel mechanism for treating narcolepsy, potentially opening a sizable market opportunity.