{"id":"open-label-pitolisant","safety":{"commonSideEffects":[{"rate":null,"effect":"Insomnia"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Anxiety"},{"rate":null,"effect":"Irritability"},{"rate":null,"effect":"Nausea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Pitolisant antagonizes histamine H3 receptors, which are autoreceptors and heteroreceptors that normally suppress histamine neuron activity and wakefulness. By blocking these receptors, pitolisant enhances histaminergic neurotransmission, promoting arousal and reducing excessive daytime sleepiness. This mechanism is distinct from stimulants and addresses the underlying neurobiological deficit in narcolepsy.","oneSentence":"Pitolisant is a selective histamine H3 receptor antagonist that increases wakefulness by blocking inhibitory histamine signaling in the brain.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:50:43.016Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Narcolepsy type 1 and type 2"},{"name":"Idiopathic hypersomnia"}]},"trialDetails":[{"nctId":"NCT06366464","phase":"PHASE3","title":"A Study of Pitolisant in Patients With Prader-Willi Syndrome","status":"RECRUITING","sponsor":"Harmony Biosciences Management, Inc.","startDate":"2024-05-28","conditions":"Prader-Willi Syndrome","enrollment":134},{"nctId":"NCT07219485","phase":"PHASE3","title":"A Study of Pitolisant in Participants With Prader-Willi Syndrome","status":"ENROLLING_BY_INVITATION","sponsor":"Harmony Biosciences Management, 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Disease","enrollment":268}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":8,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Open-label pitolisant","genericName":"Open-label pitolisant","companyName":"Harmony Biosciences Management, Inc.","companyId":"harmony-biosciences-management-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Pitolisant is a selective histamine H3 receptor antagonist that increases wakefulness by blocking inhibitory histamine signaling in the brain. Used for Narcolepsy type 1 and type 2, Idiopathic hypersomnia.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}