Takeda’s orexin receptor 2-selective agonist, oveporexton (formerly TAK-861), met all primary and secondary endpoints in two registrational Phase III trials for narcolepsy type 1. The oral therapy improved wakefulness, reduced excessive daytime sleepiness, and mitigated muscle weakness. Safety was consistent with prior studies, with insomnia and urinary urgency noted as common adverse events. More than 95% of completers enrolled in extension studies. The drug represents the first late-stage success for the orexin agonist class and positions Takeda to file for regulatory approval within the fiscal year, aiming to tap the growing market for narcolepsy therapeutics.