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A type of narcolepsy characterized by excessive day-time sleepiness associated with uncontrollable sleep urges and cataplexy (loss of muscle tone often triggered by pleasant emotions).
Biomarker and diagnostic research for narcolepsy-cataplexy syndrome has been reported in the published literature.
Estimated prevalence: 1-5 in 10,000 (Uncommon).
35 clinical trials registered, 23 recruiting. Interventions under study include other interventions, drug therapy, medical devices, and gene therapy. Pipeline includes 5 PHASE3, 6 PHASE2, 2 PHASE1. Research is sponsored by a mix of industry and academic institutions.
NCT ID | Title | Phase | Sponsor | Status |
|---|---|---|---|---|
[NCT06279247](https://clinicaltrials.gov/study/NCT06279247) |
Data assembled from 4 of 12 sources · Last updated Sep 18, 2026, 6:00 AM UTC
European rare disease database
Genetic and Rare Diseases Info Center
Proteomics and Metabolomics of Body Fluid in Patients With Narcolepsy |
— |
Qilu Hospital of Shandong University |
RECRUITING |
[NCT05536011](https://clinicaltrials.gov/study/NCT05536011) | WAKIX® (Pitolisant) Pregnancy Registry | — | Harmony Biosciences Management, Inc. | RECRUITING |
[NCT06484348](https://clinicaltrials.gov/study/NCT06484348) | Deciphering the Interactions Between Food Intake, Sleepiness, and Nighttime Sleep Quality in Patients With Type 1 Narcolepsy and Idiopathic Hypersomnia | NA | Hospices Civils de Lyon | RECRUITING |
[NCT06767683](https://clinicaltrials.gov/study/NCT06767683) | A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia | PHASE2 | Alkermes, Inc. | RECRUITING |
[NCT05816382](https://clinicaltrials.gov/study/NCT05816382) | A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions | PHASE2 | Takeda | RECRUITING |
11 publications have been identified in PubMed for narcolepsy-cataplexy syndrome. Research spans Epidemiology / Natural History (36%), Basic Science / Preclinical (27%), and Clinical Trial Publication (18%).
Research Type | Count | % of Total |
|---|---|---|
Disease patterns and progression | 4 | 36% |
Laboratory research | 3 | 27% |
Clinical study results | 2 | 18% |
Testing and diagnosis research | 1 | 9% |
Research summaries | 1 | 9% |
Gelineau A (2026). [PMID: 41644767](https://pubmed.ncbi.nlm.nih.gov/41644767/). *Nature immunology*. [Review / Meta-Analysis]
Michel A (2026). [PMID: 42033338](https://pubmed.ncbi.nlm.nih.gov/42033338/). *Med Mycol*. [Epidemiology / Natural History]
Cavalli RG (2026). [PMID: 40810502](https://pubmed.ncbi.nlm.nih.gov/40810502/). *Sleep*. [Epidemiology / Natural History]
van Halteren AGS (2025). [PMID: 40453139](https://pubmed.ncbi.nlm.nih.gov/40453139/). *Blood neoplasia*. [Clinical Trial Publication]
Gelineau NU (2025). [PMID: 40753395](https://pubmed.ncbi.nlm.nih.gov/40753395/). *Journal of experimental & clinical cancer research : CR*. [Diagnostic / Biomarker]
Gelineau NU (2025). [PMID: 41411610](https://pubmed.ncbi.nlm.nih.gov/41411610/). *JCO Precis Oncol*. [Clinical Trial Publication]
van Zogchel LMJ (2024). [PMID: 39722049](https://pubmed.ncbi.nlm.nih.gov/39722049/). *Journal of experimental & clinical cancer research : CR*. [Basic Science / Preclinical]
Yu J (2024). [PMID: 38873239](https://pubmed.ncbi.nlm.nih.gov/38873239/). *Nature and science of sleep*. [Epidemiology / Natural History]
Haubjerg Østerby NC (2024). [PMID: 39430232](https://pubmed.ncbi.nlm.nih.gov/39430232/). *Sleep advances : a journal of the Sleep Research Society*. [Epidemiology / Natural History]
Fima R (2024). [PMID: 39333539](https://pubmed.ncbi.nlm.nih.gov/39333539/). *Nature communications*. [Basic Science / Preclinical]
AI-curated news mentioning narcolepsy-cataplexy syndrome
Updated Aug 19, 2026
Takeda's Orzeyful receives FDA approval for treating all narcolepsy symptoms, marking a significant advancement in the sleep disorder market. This approval positions Takeda as a leader in the emerging orexin drug segment.
FDA approves Orzeyful, the first orexin agonist for narcolepsy, addressing all disease symptoms. This approval is expected to significantly change the treatment landscape for narcolepsy.
Recent research highlights the therapeutic potential of targeting the orexin (hypocretin) system in treating sleep disorders. This study opens avenues for novel interventions in conditions like narcolepsy and insomnia.
Lundbeck receives FDA Fast Track designation for its novel orexin therapy aimed at treating narcolepsy. This designation will expedite the development process, enhancing the potential for timely access to this innovative treatment.
Richard Pops, CEO of Alkermes, will step down after a 30-year tenure, during which he led the company through multiple transformations, including its current focus on a new narcolepsy drug. His leadership has positioned Alkermes as a key player in the biotech sector.