The U.S. Food and Drug Administration has granted approval to Takeda for its new drug, oveporexton. This medication is now the first-in-class oral selective orexin receptor 2 agonist authorized to treat narcolepsy type 1 in adults.
Narcolepsy type 1 is a chronic condition rooted in the loss of orexin neurons, which play a central role in sleep regulation. For years, patients have relied on treatments that manage individual symptoms, such as excessive daytime sleepiness or cataplexy, without addressing the core biological cause of the disorder. Oveporexton changes this by directly targeting the lack of orexin signaling in the brain.
The approval follows results from two phase 3 clinical trials, known as FirstLight and RadiantLight. In these studies, 273 participants showed significant improvement across a range of symptoms, including sleep paralysis, hallucinations, and disrupted nighttime sleep. Data also indicated improvements in cognitive measures like memory and attention.
Oveporexton is taken twice daily. While the drug was well-tolerated in trials, common side effects include increased saliva production, urinary urgency, and insomnia. The medication is not yet approved for use in patients under 18 years of age. Takeda expects final scheduling from the Drug Enforcement Administration within 90 days, at which point the drug will reach the market.