The U.S. FDA approved Takeda’s oral orexin receptor 2 agonist Orzeyful (oveporexton) for adults with narcolepsy type 1, positioning the drug as the first therapy designed to address the underlying cause of the sleep disorder. The approval follows Takeda’s July 22 clearance in China, where the product received NMPA authorization earlier. Orzeyful adds to a growing orexin-modulating pipeline as companies shift from symptomatic narcolepsy management toward disease-mechanism targeting. For prescribers, the move expands adult treatment options beyond older wake-promoting approaches. Takeda’s label also underscores a dual regulatory milestone strategy—sequencing major filings across geographies to accelerate availability—highlighting how quickly global CNS programs are now moving when pivotal data support mechanism-driven claims.