Idiopathic hypersomnia is a chronic neurologic sleep disorder characterized by excessive daytime sleepiness despite adequate or prolonged nocturnal sleep, with significant functional impairment.
The FDA has approved WAKIX for cataplexy in pediatric narcolepsy patients, making it the first non-scheduled treatment for all ages. Harmony Biosciences reported 2025 WAKIX revenue of $868.5 million and projects 2026 sales over $1 billion, nearing blockbuster status.
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 |
|---|---|---|---|
| NCT07766343 |
Hypersomnia in the Paediatric Population |
NOT_YET_RECRUITING | NA |
| NCT07646678 |
A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia |
RECRUITING | PHASE2/PHASE3 |
| NCT07625280 |
A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH |
RECRUITING | PHASE3 |
| NCT07500090 |
A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH) |
RECRUITING | PHASE3 |
| NCT06843590 |
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia |
RECRUITING | PHASE2 |
| NCT06812078 |
A Study of TAK-360 in Adults With Idiopathic Hypersomnia |
RECRUITING | PHASE2 |
| NCT06767683 |
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia |
RECRUITING | PHASE2/PHASE3 |
| 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 |
| NCT06484348 |
Deciphering the Interactions Between Food Intake, Sleepiness, and Nighttime Sleep Quality in Patients With Type 1 Narcolepsy and Idiopathic Hypersomnia |
RECRUITING | NA |
