{"id":"bf2-649-add-on-modafinil","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":"BF2.649 blocks histamine H3 receptors, which are inhibitory autoreceptors on histaminergic neurons in the brain. This blockade increases histamine release and promotes wakefulness and alertness. When used as an add-on to modafinil, it provides complementary mechanisms to enhance arousal, vigilance, and cognitive performance through multiple neurotransmitter systems.","oneSentence":"BF2.649 is a histamine H3 receptor antagonist that enhances wakefulness and cognitive function when combined with modafinil's dopamine/norepinephrine reuptake inhibition.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:04:13.066Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Excessive daytime sleepiness in narcolepsy (as add-on to modafinil)"},{"name":"Cognitive impairment and fatigue in neurological conditions"}]},"trialDetails":[{"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}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Pitolisant","Modiodal"],"phase":"phase_3","status":"active","brandName":"BF2.649 add on Modafinil","genericName":"BF2.649 add on Modafinil","companyName":"Bioprojet","companyId":"bioprojet","modality":"Small molecule","firstApprovalDate":"","aiSummary":"BF2.649 is a medication studied for the treatment of narcolepsy, cataplexy, and excessive daytime sleepiness. In a clinical trial, BF2.649 was tested both as a standalone treatment and in combination with modafinil for its efficacy in reducing cataplexy in patients with narcolepsy.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}