{"id":"blonanserin","rwe":[{"pmid":"41868846","year":"2026","title":"Bilateral hand-restricted drug eruption induced by blonanserin: a case report.","finding":"","journal":"Frontiers in psychiatry","studyType":"Clinical Study"},{"pmid":"41804937","year":"2026","title":"Antipsychotics in Children and Adolescents with Schizophrenia-Spectrum Disorders: A Systematic Review, Meta-Analysis, and Long-Term Prospective Evidence.","finding":"","journal":"Journal of child and adolescent psychopharmacology","studyType":"Clinical Study"},{"pmid":"41766331","year":"2026","title":"Effectiveness of Transdermal Blonanserin Patch for Hyperactive Delirium in Patients with Advanced Cancer Receiving Palliative Care.","finding":"","journal":"Journal of palliative medicine","studyType":"Clinical Study"},{"pmid":"41047933","year":"2025","title":"Organic Psychosis due to Lung Cancer Metastasis Accompanied by Severe Psychiatric Symptoms Treated With Blonanserin Transdermal Patch: A Case Report and Literature Review.","finding":"","journal":"Neuropsychopharmacology reports","studyType":"Clinical Study"},{"pmid":"41029572","year":"2025","title":"A rare case of isovaleric acidemia and schizophrenia: a case report.","finding":"","journal":"BMC psychiatry","studyType":"Clinical Study"}],"tags":[{"label":"blonanserin","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"D(2) dopamine receptor","category":"target"},{"label":"DRD2","category":"gene"},{"label":"HTR2A","category":"gene"},{"label":"ADRA1A","category":"gene"},{"label":"Active","category":"status"},{"label":"Schizophrenia","category":"indication"},{"label":"Dainippon Sumitomo Pharma Co., Ltd.","category":"company"}],"phase":"marketed","safety":{"safetySignals":[{"llr":99.745,"date":"","count":22,"signal":"Psychiatric symptom","source":"DrugCentral FAERS","actionTaken":"Reported 22 times (LLR=100)"},{"llr":69.01,"date":"","count":20,"signal":"Hallucination, auditory","source":"DrugCentral FAERS","actionTaken":"Reported 20 times (LLR=69)"},{"llr":67.242,"date":"","count":18,"signal":"Salivary hypersecretion","source":"DrugCentral FAERS","actionTaken":"Reported 18 times (LLR=67)"},{"llr":54.352,"date":"","count":7,"signal":"Procedural failure","source":"DrugCentral FAERS","actionTaken":"Reported 7 times (LLR=54)"},{"llr":44.21,"date":"","count":7,"signal":"Floppy iris syndrome","source":"DrugCentral FAERS","actionTaken":"Reported 7 times (LLR=44)"},{"llr":43.298,"date":"","count":19,"signal":"Pneumonia aspiration","source":"DrugCentral FAERS","actionTaken":"Reported 19 times (LLR=43)"},{"llr":43.287,"date":"","count":14,"signal":"Delusion","source":"DrugCentral FAERS","actionTaken":"Reported 14 times (LLR=43)"},{"llr":42.502,"date":"","count":13,"signal":"Parkinsonism","source":"DrugCentral FAERS","actionTaken":"Reported 13 times (LLR=43)"}],"commonSideEffects":[]},"trials":[],"aliases":[],"company":"Dainippon Sumitomo Pharma Co., Ltd.","patents":[],"pricing":[],"_fixedAt":"2026-03-30T16:38:32.782055","_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=BLONANSERIN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:08:33.448691+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Blonanserin","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T00:08:40.531248+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:08:39.279715+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BLONANSERIN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:08:39.507244+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Dopamine D3 receptor antagonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:08:40.531215+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL178803/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:08:40.199315+00:00"}},"allNames":"lonasen","offLabel":[],"synonyms":["blonanserin","lonasen","AD-5423"],"timeline":[{"date":"2008-01-25","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Dainippon Sumitomo Pharma Co., Ltd.)"}],"brandName":"Lonasen","ecosystem":[{"indication":"Schizophrenia","otherDrugs":[{"name":"aripiprazole","slug":"aripiprazole","company":"Otsuka"},{"name":"aripiprazole lauroxil","slug":"aripiprazole-lauroxil","company":"Alkermes"},{"name":"asenapine","slug":"asenapine","company":"Forest Labs Inc"},{"name":"brexpiprazole","slug":"brexpiprazole","company":"Otsuka Pharm Co Ltd"}],"globalPrevalence":24000000}],"mechanism":{"target":"D(2) dopamine receptor","targets":[{"gene":"DRD2","source":"DrugCentral","target":"D(2) dopamine receptor","protein":"D(2) dopamine receptor","isPrimary":true,"activityType":"Ki","activityValue":9.854},{"gene":"HTR2A","source":"DrugCentral","target":"5-hydroxytryptamine receptor 2A","protein":"5-hydroxytryptamine receptor 2A"},{"gene":"ADRA1A","source":"DrugCentral","target":"Alpha-1A adrenergic receptor","protein":"Alpha-1A adrenergic receptor"},{"gene":"SIGMAR1","source":"DrugCentral","target":"Sigma non-opioid intracellular receptor 1","protein":"Sigma non-opioid intracellular receptor 1"}],"modality":"Small Molecule","drugClass":"blonanserin","explanation":"","oneSentence":"","technicalDetail":"Lonasen is a selective D(2) dopamine receptor antagonist that competes with dopamine for binding sites on the receptor, thereby reducing the activity of the dopamine signal and alleviating symptoms of schizophrenia."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Blonanserin","title":"Blonanserin","extract":"Blonanserin, sold under the brand name Lonasen, is a relatively new atypical antipsychotic commercialized by Dainippon Sumitomo Pharma in Japan and Korea for the treatment of schizophrenia. Relative to many other antipsychotics, blonanserin has an improved tolerability profile, lacking side effects such as extrapyramidal symptoms, excessive sedation, or hypotension. As with many second-generation (atypical) antipsychotics it is significantly more efficacious in the treatment of the negative symptoms of schizophrenia compared to first-generation (typical) antipsychotics such as haloperidol."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/388","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=BLONANSERIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BLONANSERIN","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Blonanserin","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-30T09:01:46.394323","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:08:41.831324+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"amantadine","drugSlug":"amantadine","fdaApproval":"1968-02-14","patentExpiry":"Mar 13, 2030","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"amiodarone","drugSlug":"amiodarone","fdaApproval":"1985-12-24","patentExpiry":"Mar 13, 2029","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"amitriptyline","drugSlug":"amitriptyline","fdaApproval":"1961-04-07","genericCount":33,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"astemizole","drugSlug":"astemizole","fdaApproval":"1988-12-31","relationship":"same-target"},{"drugName":"azaperone","drugSlug":"azaperone","fdaApproval":"","relationship":"same-target"},{"drugName":"benzatropine","drugSlug":"benzatropine","fdaApproval":"1954-03-05","relationship":"same-target"},{"drugName":"buspirone","drugSlug":"buspirone","fdaApproval":"1986-09-29","genericCount":19,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"butenafine","drugSlug":"butenafine","fdaApproval":"1996-10-18","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"caramiphen","drugSlug":"caramiphen","fdaApproval":"","relationship":"same-target"},{"drugName":"cefapirin","drugSlug":"cefapirin","fdaApproval":"1974-03-12","relationship":"same-target"}],"genericName":"blonanserin","indications":{"approved":[{"name":"Schizophrenia","source":"DrugCentral","snomedId":58214004,"regulator":"FDA","usPrevalence":2800000,"globalPrevalence":24000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2022"}],"offLabel":[],"pipeline":[]},"_fixedFields":["primaryTarget","pubmed(221)"],"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"amantadine","brandName":"amantadine","genericName":"amantadine","approvalYear":"1968","relationship":"same-target"},{"drugId":"amiodarone","brandName":"amiodarone","genericName":"amiodarone","approvalYear":"1985","relationship":"same-target"},{"drugId":"amitriptyline","brandName":"amitriptyline","genericName":"amitriptyline","approvalYear":"1961","relationship":"same-target"},{"drugId":"astemizole","brandName":"astemizole","genericName":"astemizole","approvalYear":"1988","relationship":"same-target"},{"drugId":"azaperone","brandName":"azaperone","genericName":"azaperone","approvalYear":"","relationship":"same-target"},{"drugId":"benzatropine","brandName":"benzatropine","genericName":"benzatropine","approvalYear":"1954","relationship":"same-target"},{"drugId":"buspirone","brandName":"buspirone","genericName":"buspirone","approvalYear":"1986","relationship":"same-target"},{"drugId":"butenafine","brandName":"butenafine","genericName":"butenafine","approvalYear":"1996","relationship":"same-target"},{"drugId":"caramiphen","brandName":"caramiphen","genericName":"caramiphen","approvalYear":"","relationship":"same-target"},{"drugId":"cefapirin","brandName":"cefapirin","genericName":"cefapirin","approvalYear":"1974","relationship":"same-target"}],"trialDetails":[{"nctId":"NCT03784222","phase":"PHASE4","title":"Effects on Social and Cognition Functions of Blonanserin in First Episode Schizophrenia Patients","status":"TERMINATED","sponsor":"Sumitomo Pharma (Suzhou) Co., Ltd.","startDate":"2019-01-22","conditions":["First Episode Schizophrenia","Social Function","Cognition Function","Blonanserin"],"enrollment":102,"completionDate":"2022-11-22"},{"nctId":"NCT01516424","phase":"PHASE3","title":"Efficiency Study to Investigate Blonanserin in Treatment of Schizophrenia When Compared With Risperidone","status":"COMPLETED","sponsor":"Sumitomo Pharma (Suzhou) Co., Ltd.","startDate":"2012-02","conditions":["Schizophrenia"],"enrollment":267,"completionDate":"2013-02"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"UNII":"AQ316B4F8C","CHEBI":"CHEBI:31296","INN_ID":"7563","UMLSCUI":"C0287983","chemblId":"CHEMBL178803","ChEMBL_ID":"CHEMBL178803","KEGG_DRUG":"D01176","DRUGBANK_ID":"DB09223","PUBCHEM_CID":"125564","IUPHAR_LIGAND_ID":"7670","MESH_SUPPLEMENTAL_RECORD_UI":"C079310"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"present","companyName":"Dainippon Sumitomo Pharma Co., Ltd.","relationship":"Current Owner"}],"publicationCount":222,"therapeuticAreas":["Neuroscience"],"biosimilarFilings":[],"recentPublications":[{"date":"2026","pmid":"41868846","title":"Bilateral hand-restricted drug eruption induced by blonanserin: a case report.","journal":"Frontiers in psychiatry"},{"date":"2026 Mar 10","pmid":"41804937","title":"Antipsychotics in Children and Adolescents with Schizophrenia-Spectrum Disorders: A Systematic Review, Meta-Analysis, and Long-Term Prospective Evidence.","journal":"Journal of child and adolescent psychopharmacology"},{"date":"2026 Mar 1","pmid":"41766331","title":"Effectiveness of Transdermal Blonanserin Patch for Hyperactive Delirium in Patients with Advanced Cancer Receiving Palliative Care.","journal":"Journal of palliative medicine"},{"date":"2025 Dec","pmid":"41047933","title":"Organic Psychosis due to Lung Cancer Metastasis Accompanied by Severe Psychiatric Symptoms Treated With Blonanserin Transdermal Patch: A Case Report and Literature Review.","journal":"Neuropsychopharmacology reports"},{"date":"2025 Sep 30","pmid":"41029572","title":"A rare case of isovaleric acidemia and schizophrenia: a case report.","journal":"BMC psychiatry"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"approved","companyName":"Dainippon Sumitomo Pharma Co., Ltd.","companyId":"dainippon-sumitomo-pharma-co-ltd","modality":"Small molecule","firstApprovalDate":"2008","aiSummary":"","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:08:41.831324+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}