Takeda Secures FDA Approval for ORZEYFUL in Narcolepsy Type 1
Takeda has secured US Food and Drug Administration (FDA) approval for ORZEYFUL™ (oveporexton), an oral orexin receptor 2 (OX2R) agonist for treating narcolepsy type 1 (NT1) in adults.
NT1 is a rare neurological disorder caused by orexin deficiency and is characterised by excessive daytime sleepiness, cataplexy, disrupted night-time sleep and cognitive symptoms.
The condition affects an estimated 120,000 people in the US.
ORZEYFUL is the first approved orexin-based therapy designed to address the broader range of NT1 symptoms rather than individual symptoms.
The medicine selectively activates OX2R to restore orexin signalling, supporting wakefulness and reducing abnormal REM-sleep-related symptoms such as cataplexy.
The FDA approval was supported by Takeda’s Phase 3 FirstLight and RadiantLight studies, which demonstrated statistically significant improvements in excessive daytime sleepiness, cataplexy and health-related quality of life.
Oveporexton was generally well tolerated across clinical studies.
The most common adverse reactions included insomnia, urinary frequency, urinary urgency and increased saliva production.
ORZEYFUL is contraindicated in patients taking strong CYP3A inhibitors.
The US Drug Enforcement Administration (DEA) is currently reviewing ORZEYFUL’s controlled substance classification.
Takeda expects the decision within 90 days, after which the medicine will become available through a specialty pharmacy in the US.
