Also known as: NT1
Narcolepsy type 1 is a central hypersomnolence disorder characterized by excessive daytime sleepiness with cataplexy and usually low cerebrospinal hypocretin levels. It reflects dysregulation of sleep-wake control with REM intrusion phenomena.
Takeda Pharmaceutical Company has announced updates on two ongoing neuroscience clinical trials: a Phase 2 study of TAK-360 for narcolepsy and a Phase 3 study of vortioxetine for major depressive disorder in Japanese teens. Both trials are randomized, triple-blind, and currently recruiting patients.
January and March 2026 drug pipeline updates included Phase 3 results, Fast Track designations and Priority Review decisions across multiple disease areas. Mavacamten, teplizumab-mzwv, anifrolumab, AXS-05, gedatolisib and AFTX-201 were among the programs with notable milestones.
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 new drug application for oveporexton, an investigational orexin 2 receptor agonist for narcolepsy type 1, and granted priority review with a PDUFA action date in Q3 2026.
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 |
|---|---|---|---|
| NCT07609537 |
Imagery Control Therapy and Lucid Dreaming for REM-Related Symptoms in Narcolepsy |
COMPLETED | NA |
| 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 |
| NCT07540897 |
A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304) |
RECRUITING | PHASE3 |
| NCT07455383 |
A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 |
RECRUITING | PHASE3 |
| NCT07365566 |
Pain Assessment in Patients With Idiopathic Rapid Eye Movement (REM) Sleep Behaviour Disorder |
RECRUITING | NA |
| 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 |
| 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 |
| NCT06531876 |
Efficacy of the Dreem 3S Ambulatory Sleep Monitoring Device for the Evaluation of Narcolepsy |
COMPLETED |
