FDA approves Takeda’s orexin-2 drug Orzeyful for narcolepsy type 1

The U.S. Food and Drug Administration has approved Takeda Pharmaceutical's new sleep medication, Orzeyful, marking the first product in the emerging orexin‑2 drug class.

Orzeyful works by amplifying the orexin‑2 protein, which helps regulate appetite, arousal and alertness. Two large clinical trials showed the drug significantly improved wakefulness and reduced the sudden muscle weakness characteristic of type 1 narcolepsy, and it was generally well tolerated.

Analysts estimate the annual price could range from $142,000 to over $250,000 per patient, comparable to the existing therapy Xywav. Based on the lower end of that range, peak annual sales are projected to approach $2 billion.

The approval opens a potentially multibillion‑dollar market for orexin‑targeting sleep therapies.