The FDA approved Takeda’s Orzeyful (oveporexton), an oral orexin receptor 2 agonist, as the first therapy designed to address the underlying biology of narcolepsy type 1 in adults. The approval follows two large trials showing Orzeyful improved wakefulness and reduced the sudden muscle weakness characteristic of the condition versus placebo. Regulators also acknowledged a regulatory pathway typical for first-in-class neurology drugs, including a subsequent Drug Enforcement Administration scheduling review that could affect launch timing. Takeda separately has an approval pathway already cleared abroad, with China’s NMPA decision reported earlier. With a new mechanism that targets orexin signaling rather than symptom management, the drug is positioned to open a “next chapter” for narcolepsy type 1 treatment choices and monitoring in the U.S. market.