{"id":"iti-007-lumateperone","safety":{"commonSideEffects":[{"rate":"15-25%","effect":"Somnolence"},{"rate":"10-15%","effect":"Nausea"},{"rate":"10-15%","effect":"Headache"},{"rate":"8-12%","effect":"Dizziness"},{"rate":"5-10%","effect":"Akathisia"},{"rate":"5-10%","effect":"Weight gain"}]},"_chembl":{"chemblId":"CHEMBL3306803","moleculeType":"Small molecule","molecularWeight":"393.51"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"ITI-007 works through a dual mechanism: it antagonizes 5-HT7 receptors and inhibits phosphodiesterase 1 (PDE1), leading to modulation of intracellular cAMP signaling. This mechanism is proposed to address both positive and negative symptoms of schizophrenia while potentially reducing extrapyramidal side effects associated with dopamine antagonism, as it does not directly block dopamine D2 receptors at therapeutic doses.","oneSentence":"Lumateperone is a serotonin 5-HT7 receptor antagonist and phosphodiesterase 1 inhibitor that modulates intracellular signaling pathways implicated in psychosis and mood disorders.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:17:21.501Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Schizophrenia (acute and maintenance treatment)"},{"name":"Bipolar disorder (in development)"}]},"trialDetails":[{"nctId":"NCT02600494","phase":"PHASE3","title":"Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression","status":"COMPLETED","sponsor":"Intra-Cellular Therapies, Inc.","startDate":"2015-12-15","conditions":"Bipolar Depression","enrollment":554},{"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":"NCT02282761","phase":"PHASE3","title":"A Trial to Assess the Antipsychotic Efficacy of ITI-007","status":"COMPLETED","sponsor":"Intra-Cellular Therapies, Inc.","startDate":"2014-11","conditions":"Schizophrenia","enrollment":450},{"nctId":"NCT02469155","phase":"PHASE3","title":"A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment","status":"COMPLETED","sponsor":"Intra-Cellular Therapies, Inc.","startDate":"2015-06","conditions":"Schizophrenia","enrollment":696},{"nctId":"NCT02600507","phase":"PHASE3","title":"Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression","status":"COMPLETED","sponsor":"Intra-Cellular Therapies, Inc.","startDate":"2016-03-07","conditions":"Bipolar Depression","enrollment":529},{"nctId":"NCT03249376","phase":"PHASE3","title":"Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally","status":"COMPLETED","sponsor":"Intra-Cellular Therapies, Inc.","startDate":"2017-11-27","conditions":"Bipolar Depression","enrollment":381},{"nctId":"NCT03817528","phase":"PHASE2","title":"ITI-007 (Lumateperone Tosylate) for Schizophrenia","status":"TERMINATED","sponsor":"New York State Psychiatric Institute","startDate":"2019-03-01","conditions":"Schizophrenia","enrollment":4},{"nctId":"NCT02817906","phase":"PHASE3","title":"ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease","status":"TERMINATED","sponsor":"Intra-Cellular Therapies, Inc.","startDate":"2016-08-29","conditions":"Agitation in Dementia, Including Alzheimer's Disease","enrollment":177},{"nctId":"NCT02078310","phase":"PHASE1, PHASE2","title":"Study of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients With Dementia","status":"COMPLETED","sponsor":"Intra-Cellular Therapies, Inc.","startDate":"2014-02","conditions":"Alzheimer's Disease","enrollment":35},{"nctId":"NCT02288845","phase":"PHASE2","title":"Receptor Occupancy of ITI-007 Using Positron Emission Tomography (PET) in Patients With Stable Schizophrenia","status":"COMPLETED","sponsor":"Intra-Cellular Therapies, Inc.","startDate":"2014-10","conditions":"Schizophrenia","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":[],"phase":"phase_3","status":"active","brandName":"ITI-007 (Lumateperone)","genericName":"ITI-007 (Lumateperone)","companyName":"Intra-Cellular Therapies, Inc.","companyId":"intra-cellular-therapies-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Lumateperone is a serotonin 5-HT7 receptor antagonist and phosphodiesterase 1 inhibitor that modulates intracellular signaling pathways implicated in psychosis and mood disorders. Used for Schizophrenia (acute and maintenance treatment), Bipolar disorder (in development).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}