--- title: "FDA Approves First Drug To Treat Narcolepsy Type 1 Symptoms" type: "News" locale: "en" url: "https://longbridge.com/en/news/295106426.md" description: "The FDA has approved Orzeyful (oveporexton) tablets, developed by Takeda Pharmaceuticals, for treating narcolepsy type 1 in adults. It is the first drug to address the full range of symptoms by targeting the underlying loss of orexin signaling, rather than just masking symptoms. Clinical trials showed improved daytime wakefulness with common side effects including insomnia and urinary issues." datetime: "2026-08-06T12:15:47.000Z" locales: - [zh-CN](https://longbridge.com/zh-CN/news/295106426.md) - [en](https://longbridge.com/en/news/295106426.md) - [zh-HK](https://longbridge.com/zh-HK/news/295106426.md) generator: "portal-rs" --- # FDA Approves First Drug To Treat Narcolepsy Type 1 Symptoms Add as your preferred news source on Google Add Now The U.S. Food and Drug Administration has approved Orzeyful (oveporexton) tablets for the treatment of narcolepsy type 1 in adults. 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. "For too long, people with narcolepsy type 1 have had to manage a complex, lifelong neuropsychiatric condition with treatments that only address pieces of it," said Tiffany R. Farchione, Director of the Division of Psychiatry within the FDA's Center for Drug Evaluation and Research. "This new drug is the first medicine that impacts the underlying biology of the disease, treating narcolepsy type 1 as a whole." Narcolepsy type 1 is a rare, lifelong neuropsychiatric sleep disorder affecting an estimated 1 in 2,000 people in the United States. It is caused by the loss of brain cells that produce orexin, a chemical messenger that regulates wakefulness, sleep, and muscle tone. Without orexin, the brain struggles to maintain alertness or to control the boundary between sleep and waking. The result is a cluster of disabling symptoms, including excessive daytime sleepiness, cataplexy (sudden muscle weakness triggered by strong emotions such as laughter), sleep paralysis, hallucinations at the edge of sleep or waking, and disrupted nighttime sleep. Until today, no medicine had been approved for narcolepsy type 1 as a unified disorder, and none acted on the orexin system. Rather than masking symptoms with stimulants or sedatives, Orzeyful directly activates the same brain receptor that the body's own orexin would normally stimulate, restoring the missing signal. The medicine is taken as an oral tablet twice daily. The effectiveness and safety of Orzeyful were evaluated in two randomized, double-blind, placebo-controlled 12-week studies enrolling 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. The most common side effects were insomnia, increased urinary frequency, urgency to urinate, and increased saliva production. The approval of Orzeyful for the treatment of narcolepsy type 1 was granted to Takeda Pharmaceuticals America, Inc. For comments and feedback contact: editorial@rttnews.com Business News ### Related Stocks - [TAK.US](https://longbridge.com/en/quote/TAK.US.md) - [4502.JP](https://longbridge.com/en/quote/4502.JP.md) ## Related News & Research - [Takeda Achieves Major Milestone With Holistic Narcolepsy Drug Approval](https://longbridge.com/en/news/295123994.md) - [Takeda CHRO Nicola D. Greenway sells 12,980 ADS for $235,173.42](https://longbridge.com/en/news/296395853.md) - [CMI adopts orphan drug field with dedicated center of excellence](https://longbridge.com/en/news/296242891.md) - [Royalty Pharma Locks in $100M Zealand Pharma Funding Pact for Blood Disorder Drug](https://longbridge.com/en/news/295829552.md) - [Regeneron Stock (REGN) Buckling as Shareholders Sue Over Cancer Drug Claims](https://longbridge.com/en/news/296616209.md) --- > **Disclaimer: This article is for reference only and does not constitute any investment advice.**