{"id":"er-oros-paliperidone-and-olanzapine","safety":{"commonSideEffects":[{"rate":null,"effect":"Weight gain"},{"rate":null,"effect":"Metabolic syndrome"},{"rate":null,"effect":"Extrapyramidal symptoms"},{"rate":null,"effect":"Sedation"},{"rate":null,"effect":"Prolactin elevation"},{"rate":null,"effect":"Orthostatic hypotension"}]},"_chembl":{"chemblId":"CHEMBL2107360","moleculeType":"Small molecule","molecularWeight":"664.91"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Paliperidone is a dopamine D2 and serotonin 5-HT2A receptor antagonist formulated as an extended-release OROS (osmotic-controlled release oral delivery system) for sustained therapeutic levels. Olanzapine similarly antagonizes dopamine D2 and serotonin 5-HT2A receptors. The combination targets multiple neurotransmitter pathways implicated in schizophrenia and bipolar disorder to provide enhanced antipsychotic and mood-stabilizing effects.","oneSentence":"This combination of an extended-release atypical antipsychotic (paliperidone) and another atypical antipsychotic (olanzapine) works by blocking dopamine and serotonin receptors in the brain to reduce psychotic symptoms and mood disturbances.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:11:19.275Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Schizophrenia"},{"name":"Bipolar disorder"}]},"trialDetails":[{"nctId":"NCT00396565","phase":"PHASE3","title":"A Study to Evaluate Effectiveness and Safety of ER OROS Paliperidone in Patients With Schizophrenia","status":"COMPLETED","sponsor":"Janssen Pharmaceutical K.K.","startDate":"2006-07","conditions":"Schizophrenia","enrollment":394},{"nctId":"NCT00650793","phase":"PHASE3","title":"A 52-week, Open-label Extension Study Following a 6-week, Double-blind, Placebo- and Active- Controlled Study (R076477-SCH-303) to Evaluate the Safety and Tolerability of Paliperidone ER in Subjects With Schizophrenia","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2004-03","conditions":"Schizophrenia","enrollment":473},{"nctId":"NCT00350467","phase":"PHASE3","title":"A Randomized, Active-controlled, Double-blind, Parallel-Goup Study of the Efficacy and Safety of Extended Release(ER) Paliperidone in the Treatment of Schizophrenia","status":"COMPLETED","sponsor":"Xian-Janssen Pharmaceutical Ltd.","startDate":"2006-06","conditions":"Acute Schizophrenia","enrollment":288},{"nctId":"NCT00210769","phase":"PHASE3","title":"A Study of the Long-term Safety and Tolerability and the Long-term Effectiveness of Extended-release Oral Paliperidone in Patients Diagnosed With Schizophrenia","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2004-01","conditions":"Schizophrenia","enrollment":203}],"_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":"ER OROS paliperidone and Olanzapine","genericName":"ER OROS paliperidone and Olanzapine","companyName":"Xian-Janssen Pharmaceutical Ltd.","companyId":"xian-janssen-pharmaceutical-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This combination of an extended-release atypical antipsychotic (paliperidone) and another atypical antipsychotic (olanzapine) works by blocking dopamine and serotonin receptors in the brain to reduce psychotic symptoms and mood disturbances. Used for Schizophrenia, Bipolar disorder.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}