FDA greenlight for Takeda's narcolepsy drug Orzeyful

6 August 2026

The US Food and Drug Administration has approved Japanese pharma major Takeda’s (TYO: 4502) Orzeyful (oveporexton) tablets for the treatment of narcolepsy type 1 in adults. The company’s shares rose 3% to 5,425 yen on the news.

Orzeyful is the first medicine approved for narcolepsy type 1 as a complete disorder - addressing the full range of symptoms that define the condition - and the first to work by directly targeting the loss of orexin signaling that causes the disease.

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