The FDA approved Takeda’s oral orexin receptor 2 agonist Orzeyful (oveporexton/TAK-861), marking the first approved therapy designed to address the underlying biology of narcolepsy type 1 in adults. Takeda’s treatment improves wakefulness and reduces cataplexy in Phase 3 data. The approval adds a new mechanism to the narcolepsy treatment landscape by directly amplifying orexin-2 signaling, which regulates arousal and alertness. Takeda previously noted a favorable safety profile in the pivotal program. Industry observers also flagged that Orzeyful will likely face additional regulatory steps related to controlled-substance classification before full commercialization.