Takeda’s oral orexin receptor 2 agonist oveporexton (Orzeyful) gained FDA approval as the first therapy designed to address underlying biology in narcolepsy type 1. The approval follows Phase 3 results showing improvements in wakefulness and reductions in cataplexy versus placebo, with Takeda positioning the program as a potential category entry beyond symptom management. Regulators also flagged post-marketing follow-up given the nature of evidence generation in the registration program. After approval, Drug Enforcement Administration review on scheduling classification becomes a gating step before broad launch. For biotech and pharma, the approval underscores ongoing interest in neuropeptide pathway targeting and provides a new commercial benchmark for orexin-focused sleep therapeutics.