{"id":"bf2-649","safety":{"commonSideEffects":[{"rate":null,"effect":"Insomnia"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Anxiety"},{"rate":null,"effect":"Tremor"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"By blocking H3 receptors on histaminergic neurons, BF2.649 prevents negative feedback inhibition and enhances histamine release in the central nervous system. This mechanism promotes wakefulness, improves alertness, and may enhance cognitive performance. The drug is being developed primarily for narcolepsy and other sleep-wake disorders.","oneSentence":"BF2.649 is a histamine H3 receptor antagonist that increases histamine signaling in the brain to promote wakefulness and cognitive function.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:04:14.076Z","_scrapedBy":"cloudflare-swarm","_wikipedia":{"url":"https://en.wikipedia.org/wiki/Pitolisant","title":"Pitolisant","extract":"Pitolisant, sold under the brand name Wakix among others, is a medication used for the treatment of excessive daytime sleepiness in adults with narcolepsy. It is an inverse agonist of the histamine H3 receptor. It represents the first commercially available medication in its class, so that the U.S. Food and Drug Administration (FDA) declares it a first-in-class medication. Pitolisant enhances the activity of histaminergic neurons in the brain that function to improve a person's wakefulness.\nIt was approved by the European Medicines Agency (EMA) in March 2016 for narcolepsy with or without cataplexy, and for excessive daytime sleepiness by the FDA in August 2019. The most common side effects include difficulty sleeping, nausea, and feeling worried."},"indications":{"approved":[{"name":"Narcolepsy type 1"},{"name":"Excessive daytime sleepiness"}]},"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":20,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["pitolisant","Pitolisant","Study medication"],"phase":"phase_3","status":"active","brandName":"BF2.649","genericName":"BF2.649","companyName":"Bioprojet","companyId":"bioprojet","modality":"Small molecule","firstApprovalDate":"","aiSummary":"BF2.649 is a histamine H3 receptor antagonist that increases histamine signaling in the brain to promote wakefulness and cognitive function. Used for Narcolepsy type 1, Excessive daytime sleepiness.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}