On Aug. 5, 2026, Takeda announced that the U.S. Food and Drug Administration approved Orzeyful (oveporexton) tablets for the treatment of narcolepsy type 1 in adults. Orzeyful is the first medicine approved to treat narcolepsy type 1 as a complete disorder, addressing the full range of symptoms that define the condition.
About Orzeyful
Orzeyful is an oral orexin receptor 2 agonist that selectively stimulates orexin receptor 2 to help restore orexin signaling. Narcolepsy type 1 is driven by orexin deficiency, and Orzeyful is the first approved medicine to directly target the loss of orexin signaling that causes the disease. The medicine is taken as an oral tablet twice daily.
The FDA approval was supported by two randomized, double-blind, placebo-controlled 12-week studies involving 273 adults with narcolepsy type 1. Across both studies, patients taking Orzeyful 2 mg showed improvements in their ability to stay awake during the day compared with those receiving placebo. Patients also reported less daytime sleepiness, a significant reduction in cataplexy episodes, and improvement across symptoms including sleep paralysis, hallucinations, and disrupted nighttime sleep.
The most common side effects reported were insomnia, increased urinary frequency, urgency to urinate, and increased saliva production. Orzeyful should not be used at the same time as strong CYP3A inhibitors, and its safety and effectiveness have not been established in patients younger than 18 years. The drug has been recommended for scheduling under the Controlled Substances Act and will be lawful to market after the Drug Enforcement Administration issues a scheduling decision.
About narcolepsy
Narcolepsy is a lifelong neurologic disorder that disrupts the normal sleep-wake cycle. Common symptoms include excessive daytime sleepiness and, in some patients, episodes of sudden muscle weakness known as cataplexy. Affecting an estimated one in 2,000 people, narcolepsy is frequently underdiagnosed and can significantly interfere with daily activities such as eating, walking, and driving, highlighting the importance of timely recognition and appropriate management.
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