Takeda’s selective OX2R agonist oveporexton (TAK-861) won FDA approval as Orzeyful, making it the first approved OX2R agonist. The approval follows Phase 3 results in narcolepsy type 1 showing improvements in wakefulness and reductions in cataplexy, alongside a safety profile Takeda said supports chronic use. The company positioned oveporexton as a potency-optimized next-generation program, noting higher potency designed to enable a low-dose regimen and potentially reduce liver toxicity risk compared with earlier OX2R agonist candidates. For the narcolepsy market, the approval adds a new mechanism-specific option distinct from existing wake-promoting and cataplexy-directed therapies, and it shifts prescriber and payer attention toward receptor selectivity and long-term tolerability.