{"id":"act-129968","safety":{"commonSideEffects":[{"rate":null,"effect":"Somnolence"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Fatigue"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The drug selectively antagonizes the orexin 2 receptor, which is involved in regulating the sleep-wake cycle. By blocking orexin signaling, ACT-129968 reduces wakefulness and facilitates sleep onset and maintenance. This mechanism is distinct from traditional sedative-hypnotics and targets the underlying neurobiological drivers of insomnia.","oneSentence":"ACT-129968 is a selective orexin 2 receptor antagonist that promotes sleep by blocking wake-promoting signals in the brain.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:44:08.020Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Insomnia disorder"}]},"trialDetails":[{"nctId":"NCT01241214","phase":"PHASE2","title":"Study of ACT-129968 in Adult Patients With Seasonal Allergic Rhinitis","status":"COMPLETED","sponsor":"Idorsia Pharmaceuticals Ltd.","startDate":"2010-11","conditions":"Seasonal Allergic Rhinitis","enrollment":579},{"nctId":"NCT01484119","phase":"PHASE3","title":"Efficacy, Safety, and Tolerability Study of ACT-129968 in Patients With Seasonal Allergic Rhinitis","status":"COMPLETED","sponsor":"Idorsia Pharmaceuticals Ltd.","startDate":"2011-12","conditions":"Seasonal Allergic Rhinitis","enrollment":630},{"nctId":"NCT02381496","phase":"PHASE1","title":"A Study to Assess the Tolerability, Safety, Pharmacodynamics, and Pharmacokinetics of Ascending Single Doses (Including Food Interaction) and Ascending Multiple Doses of ACT-453859, and Multiple Doses of Setipiprant (ACT-129968)","status":"COMPLETED","sponsor":"Idorsia Pharmaceuticals Ltd.","startDate":"2011-12","conditions":"Healthy","enrollment":88},{"nctId":"NCT01877629","phase":"PHASE1","title":"Clinical Study to Assess the Pharmacokinetics, Safety, and Tolerability of ACT-129968 in Healthy Subjects","status":"COMPLETED","sponsor":"Idorsia Pharmaceuticals Ltd.","startDate":"2011-07-01","conditions":"Healthy Subjects","enrollment":20},{"nctId":"NCT01225315","phase":"PHASE2","title":"Clinical Study to Explore the Efficacy of ACT-129968 in Patients With Partly Controlled Asthma","status":"COMPLETED","sponsor":"Idorsia Pharmaceuticals Ltd.","startDate":"2010-11-01","conditions":"Asthma","enrollment":438}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":4,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Setipiprant"],"phase":"phase_3","status":"active","brandName":"ACT-129968","genericName":"ACT-129968","companyName":"Idorsia Pharmaceuticals Ltd.","companyId":"idorsia-pharmaceuticals-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"ACT-129968 is a selective orexin 2 receptor antagonist that promotes sleep by blocking wake-promoting signals in the brain. Used for Insomnia disorder.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}