{"id":"xywav","rwe":[],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Active","category":"status"},{"label":"Leiden University Medical Center","category":"company"}],"phase":"marketed","safety":{"boxedWarnings":["WARNING: CENTRAL NERVOUS SYSTEM DEPRESSION and ABUSE AND MISUSE. • Central Nervous System Depression XYWAV is a CNS depressant. Clinically significant respiratory depression and obtundation may occur in patients treated with XYWAV at recommended doses [see Warnings and Precautions ( 5.1 , 5.4 )]. Many patients who received XYWAV during clinical trials in narcolepsy and idiopathic hypersomnia were receiving central nervous system stimulants [see Clinical Studies ( 14.1 , 14.2 , 14.3 )]. • Abuse a"],"commonSideEffects":[{"effect":"Headache","drugRate":"20%","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"13%","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"10%","severity":"common","organSystem":""},{"effect":"Decreased appetite","drugRate":"8%","severity":"common","organSystem":""},{"effect":"Parasomnia","drugRate":"6%","severity":"common","organSystem":""},{"effect":"Diarrhea","drugRate":"6%","severity":"common","organSystem":""},{"effect":"Hyperhidrosis","drugRate":"6%","severity":"common","organSystem":""},{"effect":"Anxiety","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Fatigue","drugRate":"4%","severity":"common","organSystem":""},{"effect":"Dry mouth","drugRate":"4%","severity":"common","organSystem":""},{"effect":"Depressed mood","drugRate":"4%","severity":"common","organSystem":""},{"effect":"Enuresis","drugRate":"4%","severity":"common","organSystem":""},{"effect":"Irritability","drugRate":"3%","severity":"common","organSystem":""},{"effect":"Paresthesia","drugRate":"3%","severity":"common","organSystem":""},{"effect":"Depression","drugRate":"3%","severity":"common","organSystem":""},{"effect":"Tremor","drugRate":"3%","severity":"common","organSystem":""},{"effect":"Somnolence","drugRate":"2%","severity":"common","organSystem":""},{"effect":"Muscle spasms","drugRate":"2%","severity":"common","organSystem":""}],"seriousAdverseEvents":[]},"trials":[],"aliases":[],"company":"Leiden University Medical Center","patents":[],"pricing":[],"allNames":["xywav"],"offLabel":[],"synonyms":[],"timeline":[],"approvals":[],"ecosystem":[],"mechanism":{"modality":"Small Molecule","explanation":"Imagine your body's cells have locks on them, and Xywav has a key that fits into one of those locks. When the key fits, it allows the cell to do its job in a different way, which can help treat a medical condition. This is a simplified explanation of how Xywav works at a molecular level.","oneSentence":"Xywav works by interacting with a specific target in the body to produce a desired effect.","technicalDetail":"Xywav's mechanism of action is not well understood, but it is believed to involve the modulation of a specific protein or receptor in the body, leading to changes in cellular function and potentially therapeutic effects."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Xywav","title":"Xywav","extract":"Xywav is a fixed-dose combination medication used to treat cataplexy or excessive daytime sleepiness. It contains a mixture of the oxybate salts calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate. It is a central nervous system (CNS) depressant and it is taken by mouth.","wiki_society_and_culture":"== Society and culture ==\n=== Legal status ===\nXywav was granted orphan drug designation by the US Food and Drug Administration.\n\nXywav is a prescription drug and a Schedule III controlled substance in the United States.\n\nCalcium, magnesium, potassium, and sodium oxybate are salts of gamma hydroxybutyrate (GHB)."},"commercial":{},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=xywav","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=xywav","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://en.wikipedia.org/wiki/Xywav","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-31T10:26:20.720951","biosimilars":[],"competitors":[],"dataSources":[],"genericName":"xywav","indications":{"approved":[],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06421532","phase":"PHASE2","title":"Stimulating Amyloid Clearance in Cerebral Amyloid Angiopathy","status":"ENROLLING_BY_INVITATION","sponsor":"Leiden University Medical Center","startDate":"2025-03-27","conditions":["Cerebral Amyloid Angiopathy"],"enrollment":60,"completionDate":"2027-09-27"},{"nctId":"NCT06950281","phase":"PHASE2","title":"Efficacy, Safety and Tolerability of Low Sodium Oxybate for Nocturnal Cluster Headache Attacks","status":"NOT_YET_RECRUITING","sponsor":"Leiden University Medical Center","startDate":"2026-01","conditions":["Chronic Cluster Headache"],"enrollment":52,"completionDate":"2028-05"},{"nctId":"NCT06809803","phase":"PHASE2","title":"Extended-release Sodium Oxybate in Children","status":"RECRUITING","sponsor":"Stanford University","startDate":"2025-10-27","conditions":["Narcolepsy Type 1 (NT 1)"],"enrollment":36,"completionDate":"2027-07"},{"nctId":"NCT05875974","phase":"PHASE4","title":"A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy","status":"COMPLETED","sponsor":"Jazz Pharmaceuticals","startDate":"2023-07-27","conditions":["Idiopathic Hypersomnia","Narcolepsy"],"enrollment":207,"completionDate":"2025-03-13"},{"nctId":"NCT05837091","phase":"PHASE4","title":"Low Sodium Oxybate in Patients With Idiopathic Hypersomnia","status":"RECRUITING","sponsor":"Mayo Clinic","startDate":"2024-02-14","conditions":["Idiopathic Hypersomnia"],"enrollment":30,"completionDate":"2026-06"},{"nctId":"NCT05869773","phase":"PHASE4","title":"A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy","status":"COMPLETED","sponsor":"Jazz Pharmaceuticals","startDate":"2023-06-26","conditions":["Narcolepsy"],"enrollment":160,"completionDate":"2025-03-10"},{"nctId":"NCT04794491","phase":"PHASE4","title":"An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy","status":"COMPLETED","sponsor":"Jazz Pharmaceuticals","startDate":"2021-03-22","conditions":["Narcolepsy"],"enrollment":62,"completionDate":"2022-11-15"},{"nctId":"NCT04803786","phase":"","title":"A Patient-Centric, Prospective, Observational, Non-Interventional Switch Study of XYWAV in Narcolepsy","status":"COMPLETED","sponsor":"Jazz Pharmaceuticals","startDate":"2021-04-09","conditions":["Narcolepsy"],"enrollment":110,"completionDate":"2022-02-24"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{},"formularyStatus":[],"_enricherVersion":"v2-openfda","developmentCodes":[],"ownershipHistory":[{"period":"","companyName":"Leiden University Medical Center","relationship":"Original Developer"}],"publicationCount":16,"therapeuticAreas":["Other"],"_revenueScrapedAt":"2026-03-31 13:14:04.390947+00","biosimilarFilings":[],"originalDeveloper":"Leiden University Medical Center","recentPublications":[],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","brandName":"XYWAV","companyName":"Leiden University Medical Center","companyId":"leiden-university-medical-center","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Xywav is a small molecule developed by Leiden University Medical Center, but its target, drug class, and approved indications are unknown. As a small molecule, it is a type of pharmaceutical compound that can be taken orally. The commercial status of Xywav is unclear, and it is owned by Leiden University Medical Center. Further information on its safety and efficacy is not available. More research is needed to understand its potential benefits and risks.","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":false,"safety":true,"trials":true,"score":3}}