AUG 5 2026
Takeda Pharmaceuticals — Orzeyful (oveporexton) $TAK
for narcolepsy type 1
About
Narcolepsy type 1 is a chronic brain disorder that disrupts the body's sleep–wake switch, causing overwhelming daytime sleepiness, sudden muscle weakness while awake, and poor sleep at night. Orzeyful (oveporexton) is an oral medicine that mimics orexin, the brain signal that keeps people awake and alert, by binding to and activating the OX2R receptor. Because narcolepsy type 1 involves a loss of orexin-producing cells, replacing that signal could help restore normal wakefulness and may reduce daytime sleepiness and muscle-weakness attacks.
Pivotal trial
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
Also in development
Drug Watch — recent news on Orzeyful
- FDA approves Takeda's ORZEYFUL as first drug to treat narcolepsy type 1 cause - scanx.trade
- Takeda secures Japan approval for ORZEYFUL, first holistic NT1 treatment - scanx.trade
- ORZEYFUL Approval Might Change The Case For Investing In Takeda Stock - simplywall.st
- New England Journal of Medicine Publishes Data from Phase 3 Studies Demonstrating Oveporexton (ORZEYFUL) Improved the Full Range of Narcolepsy Type 1 Symptoms and Quality of Life - Business Wire
- Takeda’s Orzeyful Gets Japan Approval for Narcolepsy - Voice of Healthcare