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narcolepsy - Clinical Profile, Treatments & Trials | Kisho | Kisho

Rare Disease

narcolepsy

MONDO:0021107

Also known as:narcolepsy with or without cataplexyparoxysmal sleepnarcolepsy, without cataplexy

Find Clinical TrialsTrials

Overview

A sleep disorder characterized by a tendency for excessive sleepiness during the day which occurs even after adequate sleep in the nighttime. The persons who suffer from this condition experience fatigue and may fall asleep at inappropriate times during the day.

Treatments7 FDA approved

Clinical Trials49 registered · 33 recruiting

Patient Orgs4 organizations · Narcolepsy Network, Wake Up Narcolepsy, Inc. + 2 more

Diagnosis

Biomarker and diagnostic research for narcolepsy has been reported in the published literature.

Treatment

Compiled from FDA-approved drug records, orphan drug designations, and FDA Adverse Event Reporting System (FAERS) safety data. GeneReviews management guidance is included where available.

6 FDA-approved treatments are available for narcolepsy, including SODIUM OXYBATE (LUMRYZ, approved 2023), PITOLISANT HYDROCHLORIDE (WAKIX, approved 2020), and SOLRIAMFETOL (SUNOSI, approved 2019). An additional 6 compounds hold orphan drug designation.

Approved Therapies

Brand Name	Generic Name	Mechanism	Approved

Research Landscape

Sourced from ClinicalTrials.gov and PubMed. Publication types are classified using NLM-curated article metadata; research type breakdowns reflect the nature of published work for this disease.

49 clinical trials registered, 33 recruiting. Interventions under study include drug therapy, other interventions, medical devices, and gene therapy. Pipeline includes 8 PHASE3, 10 PHASE2, 3 PHASE1. Research is sponsored by a mix of industry and academic institutions.

NCT ID	Title	Phase	Sponsor	Status
[NCT06336057](https://clinicaltrials.gov/study/NCT06336057)

Data assembled from 5 of 12 sources · Last updated Sep 20, 2026, 12:59 AM UTC

MONDOHPOClinicalTrials.govFDAPubMedHGNCClinVarClinGenGeneReviewsOrphanetOMIMRUSP

Patient Support

Patient Advocacy Groups

View all PAGs →

Narcolepsy NetworkPrimary Focus

USWebsite ↗

Wake Up Narcolepsy, Inc.Primary Focus

USWebsite ↗

NICER FoundationPrimary Focus

USWebsite ↗

PWN4PWN CorpPrimary Focus

USWebsite ↗

Patient Advocacy Groups (PAGs) provide support, resources, and community for patients and caregivers.

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Medical References

External Resources

Orphanet

European rare disease database

Orphanet:619284

GARD

Genetic and Rare Diseases Info Center

GARD:22460

Questions for Your Care Team

→What are the benefits and potential side effects of LUMRYZ for managing narcolepsy?
→Are any of the 49 active clinical trials a good fit for my situation?
→Are there specialists or centers of excellence for this condition in my area?
→How can I connect with Narcolepsy Network and other patient organizations for support?

← Back to All Diseases

Brand Name	Generic Name	Sponsor	Designated	Exclusivity End	Designation Status
4-((L-valyl)oxy)butanoic acid	4-((L-valyl)oxy)butanoic acid	Avadel CNS Pharmaceuticals, LLC	2019	—	Designated
reboxetine	reboxetine	Axsome Therapeutics, Inc.	2018	—	Designated
methyl (2R,3S)-3-[(methylsulfonyl)amino]-2-{[(cis-4-phenylcyclohexyl)oxy]methyl}piperidine-1-carboxylate	methyl (2R,3S)-3-[(methylsulfonyl)amino]-2-{[(cis-4-phenylcyclohexyl)oxy]methyl}piperidine-1-carboxylate	Takeda Development Center Americas, Inc.	2017	—	Withdrawn
pentetrazol	pentetrazol	Balance Therapeutics, Inc.	2017	—	Designated
fixed dose combination of modafinil and flecainide	fixed dose combination of modafinil and flecainide	Theranexus S.A	2016	—	Withdrawn
mazindol	mazindol	NLS-0 Pharma AG	2016	—	Designated

Research Type	Count	% of Total
Research summaries	45	33%
Disease patterns and progression	33	24%
Laboratory research	31	22%
Clinical study results	12	9%
Testing and diagnosis research	6	4%
New treatment approaches	5	4%
Other research	4	3%
Patient case studies	2	1%

Kisho

narcolepsy

Overview

Diagnosis

Treatment

Approved Therapies

Research Landscape

Patient Support

Patient Advocacy Groups

Medical References

External Resources

Orphanet

GARD

Questions for Your Care Team

Questions for Your Care Team

Orphan Drug Designations

Clinical Trials

Recent Publications

Latest News & Developments

Takeda leads wave of orexin drugs with potential to upend narcolepsy market

Takeda’s narcolepsy nod opens orexin doors

Therapeutic potential of targeting the orexin (hypocretin) system in sleep disorders.

Lundbeck secures FDA Fast Track for narcolepsy drug

Alkermes’ Richard Pops to step down after three-decade run as CEO

narcolepsy

Overview

Diagnosis

Treatment

Approved Therapies

Research Landscape

Patient Support

Patient Advocacy Groups

Medical References

External Resources

Orphanet

GARD

Subtypes

Related Diseases

Questions for Your Care Team

Questions for Your Care Team

Orphan Drug Designations

Clinical Trials

Recent Publications

Latest News & Developments

Takeda leads wave of orexin drugs with potential to upend narcolepsy market

Takeda’s narcolepsy nod opens orexin doors

Therapeutic potential of targeting the orexin (hypocretin) system in sleep disorders.

Lundbeck secures FDA Fast Track for narcolepsy drug

Alkermes’ Richard Pops to step down after three-decade run as CEO