Takeda's ORZEYFUL Demonstrates Significant Improvement in Narcolepsy Type 1 Symptoms in Phase 3 Studies
Takeda Pharmaceutical Company Limited announced that the New England Journal of Medicine has published results from two Phase 3 studies, FirstLight and RadiantLight, evaluating oveporexton (ORZEYFUL) for narcolepsy type 1 (NT1). ORZEYFUL, an oral orexin receptor 2 (OX2R) agonist, is the first and only medicine approved to treat the underlying cause of NT1. The studies demonstrated statistically significant and clinically meaningful improvements across a full range of NT1 symptoms, including wakefulness, sleepiness, cataplexy, disease severity, and quality of life measures, compared to placebo over 12 weeks. These improvements were observed early in treatment and sustained throughout the study duration. The medication was generally well-tolerated, with common adverse events including transient insomnia, urinary urgency, urinary frequency, and excessive saliva. ORZEYFUL is now approved in the U.S., China, and Japan, with additional regulatory submissions underway.