FDA Grants Priority Review To Takeda’s Oveporexton NDA For Narcolepsy Type 1 Treatment

Takeda has announced that the U.S. FDA has accepted its New Drug Application for oveporexton (TAK-861) to treat narcolepsy type 1 and has granted the filing Priority Review, with a PDUFA decision expected in the third quarter of the year. The oral therapy is designed to restore orexin signaling by selectively activating the orexin receptor 2, potentially making it the first approved medicine to directly target the biological cause of the disease.

Narcolepsy type 1 is a rare, chronic neurological disorder driven by orexin loss and marked by excessive daytime sleepiness and sudden muscle weakness known as cataplexy. These symptoms can significantly disrupt daily functioning, work, and social life, and many patients continue to struggle despite available treatments. Takeda’s application is supported by extensive clinical data from the global Phase 3 FirstLight and RadiantLight studies.

“The FDA’s acceptance of our NDA is a milestone for people living with narcolepsy type 1,” said Andy Plump, M.D., Ph.D., president of R&D at Takeda. “Considering the high unmet need, this community deserves a new and different treatment approach that aims to address the underlying orexin deficiency that causes NT1 by restoring orexin signaling. We are one step closer to potentially transforming the current treatment paradigm and intend to deliver through our leading work in orexin science.”

Across these trials, oveporexton delivered statistically significant and clinically meaningful improvements in both objective and patient-reported outcomes, including wakefulness, daytime sleepiness, cataplexy frequency, attention, quality of life, and daily activities—often approaching near-normal levels. The drug was generally well tolerated, with insomnia, urinary urgency, and urinary frequency reported most often.

Oveporexton has previously received Breakthrough Therapy designation from regulators in the U.S. and China, as well as Sakigake status in Japan, highlighting its potential importance in addressing unmet medical need. Takeda added that the NDA submission is not expected to materially affect its financial outlook for the fiscal year ending March 31, 2026.