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AUG 10 2026
UPCOMING · 10 DAYS TO PDUFA

Takeda Pharmaceuticals oveporexton $TAK

for narcolepsy type 1

NDA · Priority Review · Breakthrough

Accepted FEB 10 2026.

About

Narcolepsy type 1 is a chronic neurological disorder that impairs the brain's ability to regulate sleep-wake cycles, leading to severe daytime sleepiness and sudden episodes of muscle weakness called cataplexy. Oveporexton is an oral drug designed to selectively activate the orexin receptor 2, a key signaling pathway in the brain that promotes stable wakefulness. By mimicking this natural wake-promoting signal, the drug may help reduce excessive daytime sleepiness and cataplexy attacks for people with this condition.

Pivotal trial

NCT06505031 Phase 3 completed NCT06505031

The main aim of this study is to learn how effective TAK-861 is in improving excessive sleepiness during the day (called excessive daytime sleepiness or EDS) after 3 months of treatment. Other aims are to learn how effective TAK-861 is in lowering the number of sudden, unexpected attacks of muscle weakness while staying conscious (cataplexy) in a week; to learn the effect TAK-861 has on participants' ability to maintain attention, participant's overall quality of life, the spectrum of narcole...

Source: ClinicalTrials.gov