{"id":"bf2-649-pitolisant","safety":{"commonSideEffects":[{"rate":null,"effect":"Insomnia"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Anxiety"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Irritability"}]},"_chembl":{"chemblId":"CHEMBL4164059","moleculeType":"Small molecule","molecularWeight":"332.31"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"By blocking H3 autoreceptors on histaminergic neurons in the hypothalamus, pitolisant removes negative feedback inhibition and enhances histamine neurotransmission. This increased histaminergic signaling promotes arousal and wakefulness, making it effective for narcolepsy and other hypersomnias. The drug crosses the blood-brain barrier and acts centrally without significant peripheral effects.","oneSentence":"Pitolisant is a selective histamine H3 receptor antagonist that increases histamine release in the brain to promote wakefulness.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:04:09.890Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Narcolepsy type 1 and type 2"},{"name":"Idiopathic hypersomnia"}]},"trialDetails":[{"nctId":"NCT05953389","phase":"PHASE2","title":"Proof of Concept Study on Pitolisant Effect on Autism Spectrum Disorders in Children and Adolescents","status":"ACTIVE_NOT_RECRUITING","sponsor":"Bioprojet","startDate":"2023-12-20","conditions":"Autism Spectrum Disorder","enrollment":62},{"nctId":"NCT02611687","phase":"PHASE3","title":"Efficacy and Safety of Pitolisant in Pediatric Narcoleptic Patients With or Without Cataplexy, Double-blind Study Followed by a Prolonged Open-label Period","status":"COMPLETED","sponsor":"Bioprojet","startDate":"2016-06-06","conditions":"Narcolepsy With Cataplexy, Narcolepsy Without Cataplexy","enrollment":110},{"nctId":"NCT02739568","phase":"PHASE3","title":"Pitolisant (BF2.649) in the Treatment of EDS in Patients With OSA","status":"COMPLETED","sponsor":"Bioprojet","startDate":"2016-04","conditions":"Excessive Daytime Sleepiness, Obstructive Sleep Apnea","enrollment":389},{"nctId":"NCT00690274","phase":"PHASE2","title":"Study to Demonstrate Cognitive Enhancing Effects of BF2.649","status":"COMPLETED","sponsor":"University of Texas Southwestern Medical Center","startDate":"2008-06","conditions":"Schizophrenia","enrollment":52},{"nctId":"NCT02978651","phase":"PHASE3","title":"Pitolisant (BF2.649) in the Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnoea Syndrome, Treated or Not by Nasal Continuous Positive Airway Pressure, But Still Complaining of Excessive Daytime Sleepiness","status":"WITHDRAWN","sponsor":"Bioprojet","startDate":"","conditions":"Excessive Daytime Sleepiness, Obstructive Sleep Apnea","enrollment":""},{"nctId":"NCT03152123","phase":"PHASE1","title":"Determination the Abuse Potential of Pitolisant in Healthy, Non-Dependent Recreational Stimulant Users","status":"COMPLETED","sponsor":"Bioprojet","startDate":"2017-03-15","conditions":"Healthy, Drug Abuse","enrollment":43},{"nctId":"NCT01638403","phase":"PHASE3","title":"Effects of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy.","status":"COMPLETED","sponsor":"Bioprojet","startDate":"2010-11","conditions":"Treatment of Excessive Daytime Sleepiness in Narcolepsy","enrollment":180},{"nctId":"NCT01399606","phase":"PHASE3","title":"Long Term Open Label Study in Narcolepsy With BF2.649 (Pitolisant)","status":"COMPLETED","sponsor":"Bioprojet","startDate":"2011-05","conditions":"Narcolepsy, Cataplexy","enrollment":102},{"nctId":"NCT02800083","phase":"PHASE2","title":"A Trial Evaluating Pitolisant (BF2.649) in Alcohol Use Disorder Treatment","status":"WITHDRAWN","sponsor":"Bioprojet","startDate":"2016-10","conditions":"Alcohol Abuse, Nervous System","enrollment":""},{"nctId":"NCT01800045","phase":"PHASE3","title":"Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic Patients (HARMONY CTP)","status":"COMPLETED","sponsor":"Bioprojet","startDate":"2013-04","conditions":"Narcolepsy With Cataplexy, Excessive Daytime Sleepiness","enrollment":103},{"nctId":"NCT01789398","phase":"PHASE3","title":"Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV)","status":"COMPLETED","sponsor":"Bioprojet","startDate":"2012-09","conditions":"Narcolepsy","enrollment":51},{"nctId":"NCT01072968","phase":"PHASE3","title":"BF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP.","status":"COMPLETED","sponsor":"Bioprojet","startDate":"2011-10","conditions":"Obstructive Sleep Apnea, Excessive Daytime Sleepiness","enrollment":268},{"nctId":"NCT01071876","phase":"PHASE3","title":"BF2.649 in Patients With OSA and Treated by CPAP But Still Complaining of EDS","status":"COMPLETED","sponsor":"Bioprojet","startDate":"2011-08","conditions":"Obstructive Sleep Apnea, Excessive Daytime Sleepiness","enrollment":244},{"nctId":"NCT01066442","phase":"PHASE3","title":"Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease","status":"COMPLETED","sponsor":"Bioprojet","startDate":"2010-03","conditions":"Parkinson's Disease","enrollment":273},{"nctId":"NCT01036139","phase":"PHASE3","title":"Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease","status":"COMPLETED","sponsor":"Bioprojet","startDate":"2009-12","conditions":"Parkinson's Disease","enrollment":268},{"nctId":"NCT01619033","phase":"PHASE1","title":"Pharmacokinetics of BF2.649 in Renal Impairment","status":"COMPLETED","sponsor":"Bioprojet","startDate":"2011-07","conditions":"Renal Impairment","enrollment":25},{"nctId":"NCT01067235","phase":"PHASE3","title":"Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy","status":"COMPLETED","sponsor":"Bioprojet","startDate":"2009-10","conditions":"Narcolepsy, Cataplexy, Excessive Daytime Sleepiness","enrollment":14},{"nctId":"NCT01620554","phase":"PHASE2","title":"Dose-range Finding Study of BF2.649 Effect on Patients With Obstructive Sleep Apnea (OSA)","status":"COMPLETED","sponsor":"Bioprojet","startDate":"2010-10","conditions":"Obstructive Sleep Apnoea, Excessive Daytime Sleepiness","enrollment":110},{"nctId":"NCT01067222","phase":"PHASE3","title":"Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy","status":"COMPLETED","sponsor":"Bioprojet","startDate":"2009-05","conditions":"Narcolepsy, Excessive Daytime Sleepiness, Cataplexy","enrollment":110},{"nctId":"NCT00642928","phase":"PHASE2","title":"Dose Range Finding Study of BF2.649 Versus Placebo to Treat Excessive Daytime Sleepiness in Parkinson's Disease Patients","status":"COMPLETED","sponsor":"Bioprojet","startDate":"2007-10","conditions":"Excessive Daytime Sleepiness, Parkinson's Disease","enrollment":108}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":235,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Pitolisant"],"phase":"phase_3","status":"active","brandName":"BF2.649 (pitolisant)","genericName":"BF2.649 (pitolisant)","companyName":"Bioprojet","companyId":"bioprojet","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Pitolisant is a selective histamine H3 receptor antagonist that increases histamine release in the brain to promote wakefulness. Used for Narcolepsy type 1 and type 2, Idiopathic hypersomnia.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}