Takeda’s novel orexin receptor 2 selective agonist, oveporexton, achieved all primary and secondary endpoints in two pivotal Phase 3 narcolepsy studies. The oral drug demonstrated clinically meaningful improvements in wakefulness and symptom control with a consistent safety profile. Takeda plans regulatory submissions in the U.S. and other markets within its 2025 fiscal year. This marks the first late-stage success for a drug stimulating orexin receptors, a target long sought in sleep disorder R&D. The findings position oveporexton to capture a lucrative and unmet clinical niche in narcolepsy treatment.