Narcolepsy type 2 is a central hypersomnolence disorder with persistent excessive daytime sleepiness but without cataplexy. It involves abnormal sleep-wake regulation and may be underdiagnosed.
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.
GSK agreed to license linerixibat to Alfasigma in a deal worth up to $690 million, while Eisai received orphan drug designation in Japan for E2086, a novel selective orexin 2 receptor agonist for narcolepsy.
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 |
|---|---|---|---|
| NCT07598708 |
A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence |
NOT_YET_RECRUITING | PHASE2/PHASE3 |
| NCT07502443 |
A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2 |
RECRUITING | PHASE3 |
| NCT07299097 |
Epidemiology of Narcolepsy Type 1 and Type 2 in Spain |
RECRUITING | |
| NCT07096674 |
A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia |
RECRUITING | PHASE2 |
| NCT06952699 |
A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2) |
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 |
| NCT06555783 |
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2 |
COMPLETED | PHASE2 |
| NCT06251063 |
Improving Social Relationships for Adolescents With Central Disorders of Hypersomnolence |
COMPLETED | NA |
| NCT05709873 |
Narcolepsy Nightmare Study |
COMPLETED | NA |
