{"id":"lumateperone-high-dose","safety":{"commonSideEffects":[{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Somnolence"},{"rate":null,"effect":"Akathisia"},{"rate":null,"effect":"Weight gain"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Lumateperone works through dual mechanisms: antagonism of 5-HT7 receptors and inhibition of PDE10, which together reduce excessive glutamate signaling and normalize dopamine neurotransmission. This combination is thought to address both positive and negative symptoms of psychosis while potentially improving cognitive function. The high-dose formulation is being evaluated to optimize therapeutic efficacy in treatment-resistant conditions.","oneSentence":"Lumateperone is a serotonin 5-HT7 receptor antagonist and phosphodiesterase 10 (PDE10) inhibitor that modulates dopamine and glutamate signaling in the brain.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:19:45.305Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Schizophrenia (phase 3)"},{"name":"Bipolar depression (phase 3)"}]},"trialDetails":[{"nctId":"NCT01499563","phase":"PHASE2","title":"Study of a Novel Antipsychotic ITI-007 in Schizophrenia","status":"COMPLETED","sponsor":"Intra-Cellular Therapies, Inc.","startDate":"2011-12","conditions":"Schizophrenia","enrollment":335},{"nctId":"NCT06706674","phase":"PHASE3","title":"Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients","status":"RECRUITING","sponsor":"Intra-Cellular Therapies, Inc.","startDate":"2024-12-06","conditions":"Irritability Associated With Autism Spectrum Disorder","enrollment":174},{"nctId":"NCT06690398","phase":"PHASE3","title":"Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients","status":"RECRUITING","sponsor":"Intra-Cellular Therapies, Inc.","startDate":"2024-11-22","conditions":"Irritability Associated With Autism Spectrum Disorder","enrollment":174}],"_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":[],"phase":"phase_3","status":"active","brandName":"Lumateperone high dose","genericName":"Lumateperone high dose","companyName":"Intra-Cellular Therapies, Inc.","companyId":"intra-cellular-therapies-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Lumateperone is a small molecule serotonin 2a (5-HT2a) receptor antagonist used to treat conditions such as schizophrenia and irritability associated with autism spectrum disorder. It is administered in high and low doses as part of clinical trials.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}