Idiopathic hypersomnia is a chronic neurologic sleep disorder characterized by excessive daytime sleepiness despite adequate or prolonged nocturnal sleep, with significant functional impairment.
Additional phase 2 data showed alixorexton sustained improvements in disease severity, cognition and fatigue in narcolepsy type 1 through weeks 12-13. The oral orexin 2 receptor agonist was generally well tolerated, with no serious treatment-emergent adverse events reported.
The FDA accepted Takeda's NDA for oveporexton (TAK-861), an oral orexin receptor 2 agonist for narcolepsy type 1, and granted Priority Review with a PDUFA goal date in Q3 2026. The drug could become the first approved orexin agonist.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06752668 |
A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia |
RECRUITING | PHASE2 |
| NCT06525077 |
Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ) |
COMPLETED | PHASE3 |
| NCT05837091 |
Low Sodium Oxybate in Patients With Idiopathic Hypersomnia |
RECRUITING | PHASE4 |
