Narcolepsy is a chronic neurological sleep disorder characterized by excessive daytime sleepiness and dysregulation of sleep-wake boundaries, with some patients experiencing cataplexy. It often begins in youth or early adulthood and persists lifelong.
Q1 2026 sleep medicine trends include broader use of AI, expanding obstructive sleep apnea and narcolepsy treatments, and policy changes affecting reimbursement and access.
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 approved pitolisant (Wakix) for treating cataplexy in children ages 6 and older with narcolepsy, making it the first non-scheduled treatment for both pediatric and adult narcolepsy patients with or without cataplexy.
The FDA has expanded approval of Wakix (pitolisant) to treat cataplexy in pediatric patients aged 6 years and older with narcolepsy, making it the first non-controlled substance approved for both pediatric and adult narcolepsy patients with or without cataplexy.
The FDA has approved Harmony Biosciences' Wakix (pitolisant) for treating cataplexy in pediatric patients aged 6 years and older with narcolepsy, making it the first non-scheduled treatment for both pediatric and adult narcolepsy patients with or without cataplexy.
The FDA has approved pitolisant tablets for treating cataplexy in pediatric patients aged 6 and older with narcolepsy, making it the only non-scheduled therapy approved for both pediatric and adult narcolepsy patients with or without cataplexy.
The FDA approved Harmony Biosciences' supplemental new drug application for WAKIX (pitolisant) to treat cataplexy in pediatric patients 6 years and older with narcolepsy, making it the first non-scheduled treatment for both pediatric and adult narcolepsy patients with or without cataplexy.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07540364 |
A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy |
NOT_YET_RECRUITING | PHASE3 |
| NCT07493265 |
A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy |
RECRUITING | PHASE2 |
| NCT07051252 |
A Study of HBS-201 (Pitolisant Delayed-release) |
COMPLETED | PHASE1 |
| NCT06961266 |
A Study to Investigate Efficacy, Safety, Tolerability, and Pharmacokinetics of JZP441 Compared With Placebo in Participants With Narcolepsy Type 1 |
TERMINATED | PHASE1 |
| NCT06797284 |
The Impact of Light, Electrical, and Magnetic Neuroregulation Interventions on Sleep-wake Disorders |
RECRUITING | NA |
| NCT06792708 |
Observational Study of LUMRYZ in Narcolepsy |
COMPLETED | |
| NCT06786377 |
Genetic and Clinical Characterization of Type 1 and 2 Narcolepsy in Adult and Pediatric Black and North African Populations |
NOT_YET_RECRUITING | |
| NCT06665230 |
A Clinical Study of MK-6552 and Modafinil in Healthy Men (MK-6552-005) |
COMPLETED | PHASE1 |
| NCT06619665 |
A Study of MK-6552 in Sleep Deprived Healthy Participants (MK-6552-003) |
COMPLETED | PHASE1 |
| NCT06586138 |
Study of Psychological, Sociological and Professional Factors Associated With Maintenance of Wakefulness Test |
RECRUITING |
