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Disease

Narcolepsy

Late-stage therapeutic development

Also known as narcolepsy with or without cataplexy, paroxysmal sleep, narcolepsy, without cataplexy.

19
Clinical trials
12
Associated genes
3
Related proteins
Current focus
Catalase biologyHistamine h3 biologyTherapeutic development
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this disease.

Approval: Sunosi (EMA)

Regulatory2020-01-16EMA

Approval: Wakix (EMA)

Regulatory2016-03-31EMA

Approval: Xyrem (EMA)

Regulatory2005-10-13EMA

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Moderate
Key developments
  • 6 clinical trials expected to report results, the earliest in Q4 2026.
  • 5 industry developments reported.
Upcoming Milestones
Clinical Milestones8View
Results posted 1
Results expected 5
Other updates 1
Industry & Market5View
Activity timeline13

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies
Solriamfetol hydrochlorideapproved

Approval — Sunosi is indicated to improve wakefulness and reduce excessive daytime sleepiness in adu… (2020)

Pitolisantapproved

Approval — Wakix is indicated in adults, adolescents and children from the age of 6 years for the tr… (2016)

Sodium oxybateapproved

Approval — Treatment of narcolepsy with cataplexy in adult patients. (2005)

Clinical trials

10 sponsors · 3 new · 0 completed in the last 12 months (net +2)

The current development programme across all trial phases.

Clinical programme
19
All trials
6
Active
11
Late-stage
6
Completed
Late-stage studies

An Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Durability of Treatment Effect of ALKS 2680 in Subjects With Narcolepsy Type 1 and Type 2 and Idiopathic Hypersomnia

Phase 2/3 · Recruiting · Alkermes, Inc.

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy Followed by an Open-label Extension

Phase 3 · Recruiting · Harmony Biosciences Management, Inc.

A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions

Phase 2/3 · Recruiting · Takeda

A Randomized, Double-blind, 3-Arm Parallel Design Study to Investigate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Cleminorexton Compared With Placebo in Participants With Central Disorders of Hypersomnolence

Phase 2/3 · Recruiting · Centessa Pharmaceuticals (UK) Limited

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 Study 304)

Phase 3 · Recruiting · Alkermes, Inc.

A Prospective, Open-Label, Single-Arm, Multicenter Study to Evaluate the Effect of Low-Sodium Oxybate Oral Solution (XYWAV) on Sleepiness, Polysomnography, and Functional Outcomes in Adult Participants Aged 18 to 75 Years With Idiopathic Hypersomnia or Narcolepsy

Phase 4 · Completed · Jazz Pharmaceuticals
Recruiting

An Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Durability of Treatment Effect of ALKS 2680 in Subjects With Narcolepsy Type 1 and Type 2 and Idiopathic Hypersomnia

Phase 2/3 · Recruiting · Alkermes, Inc.

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy Followed by an Open-label Extension

Phase 3 · Recruiting · Harmony Biosciences Management, Inc.

A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions

Phase 2/3 · Recruiting · Takeda

A Randomized, Double-blind, 3-Arm Parallel Design Study to Investigate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Cleminorexton Compared With Placebo in Participants With Central Disorders of Hypersomnolence

Phase 2/3 · Recruiting · Centessa Pharmaceuticals (UK) Limited

A Phase 2a, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ORX750 in Subjects With Narcolepsy and Idiopathic Hypersomnia (CRYSTAL-1)

Phase 2 · Recruiting · Centessa Pharmaceuticals (UK) Limited

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 Study 304)

Phase 3 · Recruiting · Alkermes, Inc.
Recently completed

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)

Phase 3 · Completed · Takeda

A Prospective, Open-Label, Single-Arm, Multicenter Study to Evaluate the Effect of Low-Sodium Oxybate Oral Solution (XYWAV) on Sleepiness, Polysomnography, and Functional Outcomes in Adult Participants Aged 18 to 75 Years With Idiopathic Hypersomnia or Narcolepsy

Phase 4 · Completed · Jazz Pharmaceuticals

An Open-Label, Multicenter Switch Study Evaluating Changes in Blood Pressure in Participants With Narcolepsy Switching From High-Sodium Oxybate to Xywav

Phase 4 · Completed · Jazz Pharmaceuticals

Double Blind, Multicentre, Randomized, Placebo-controlled Trial to Evaluate Safety and Efficacy of Pitolisant in Children From 6 to Less Than 18 Years With Narcolepsy With/Without Cataplexy, Followed by a Prolonged Open-label Period

Phase 3 · Completed · Bioprojet

A Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects With Narcolepsy

Phase 3 · Completed · Avadel

Randomized, Double-blind, Placebo and Comparator-controlled, Parallel-group, Multi-center Trial Assessing the Effects of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy

Phase 3 · Completed · Bioprojet

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

First approvals
2020emaApproval — Solriamfetol hydrochloride· Sunosi is indicated to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy (with or without cataplexy). Sunosi is indicated to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP). source ↗
2016emaApproval — Pitolisant· Wakix is indicated in adults, adolescents and children from the age of 6 years for the treatment of narcolepsy with or without cataplexy (see also section 5.1). source ↗
2005emaApproval — Sodium oxybate· Treatment of narcolepsy with cataplexy in adult patients. source ↗

European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.

Associated genes

12 matches

Genes associated with this disease in the canonical knowledge graph (Open Targets evidence). Number shows the association score.

HRH30.51GABBR10.51TRIM550.31SLC38A110.30DSCAM0.29MBD20.29LPIN30.28GGTLC10.28GSG1L0.27CCDC390.27RGS70.27RCSD10.26

Disease biology

3 matches

Proteins whose encoding gene is associated with this disease, reached through the canonical gene→disease graph. Number shows the gene's association score.

Histamine H3 receptorvia HRH30.51Gamma-aminobutyric acid type B receptor subunit 1via GABBR10.51Catalasevia CAT0.22

Reference

Authoritative identity, definition & identifiers.

Defined in MeSH

A condition characterized by recurrent episodes of daytime somnolence and lapses in consciousness (microsomnias) that may be associated with automatic behaviors and AMNESIA. CATAPLEXY; SLEEP PARALYSIS, and hypnagogic HALLUCINATIONS frequently accompany narcolepsy. The pathophysiology of this disorder includes sleep-onset rapid eye movement (REM) sleep, which normally follows stage III or IV sleep. (From Neurology 1998 Feb;50(2 Suppl 1):S2-S7)

Synonyms

narcolepsy with or without cataplexy, paroxysmal sleep, narcolepsy, without cataplexy

References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.