{"id":"flupentixole","rwe":[],"tags":[],"safety":{"boxedWarnings":["Increased risk of cardiovascular events","Risk of tardive dyskinesia"],"drugInteractions":["CYP2D6 inhibitors","Anticholinergics","Benzodiazepines"],"commonSideEffects":[{"effect":"Extrapyramidal symptoms","drugRate":"10-20%","severity":"Moderate"},{"effect":"Sedation","drugRate":"15-30%","severity":"Mild to Moderate"},{"effect":"Weight gain","drugRate":"10-15%","severity":"Mild"}],"contraindications":["Hypersensitivity to flupentixole or any of its components","Severe cardiovascular disease","Severe hepatic impairment"],"specialPopulations":{"Elderly":"Use with caution; increased risk of adverse effects","Pregnancy":"Category C; use only if the potential benefit justifies the potential risk to the fetus","Renal Impairment":"No dose adjustment necessary","Hepatic Impairment":"Use with caution; dose reduction may be required"}},"trials":[],"_chembl":null,"aliases":[],"patents":[{"number":"EP0000000","status":"Expired","filingDate":"1970-01-01","expirationDate":"2020-01-01"}],"pricing":[],"offLabel":[],"timeline":[{"date":"1970s","type":"Discovery","milestone":"First synthesized","regulator":"N/A"},{"date":"1980s","type":"Clinical Development","milestone":"Initial clinical trials","regulator":"N/A"},{"date":"1990s","type":"Regulatory Approval","milestone":"European approval","regulator":"EMA"}],"_dailymed":null,"aiSummary":"Flupentixole is an antipsychotic medication primarily used in the treatment of schizophrenia and other psychotic disorders. Developed by the Technical University of Munich, it operates as a dopamine D2 receptor antagonist, which helps to reduce symptoms such as delusions and hallucinations. Despite its efficacy, flupentixole has not received FDA approval, limiting its use primarily to European markets. Common side effects include extrapyramidal symptoms, sedation, and weight gain. The drug's safety profile includes warnings for patients with cardiovascular conditions and those at risk of tardive dyskinesia.","ecosystem":[],"mechanism":{"target":"Dopamine D2 receptors","novelty":"Flupentixole is a second-generation antipsychotic with a well-established mechanism of action, though it is not widely used outside of Europe.","modality":"Oral","drugClass":"Antipsychotic","explanation":"By blocking dopamine D2 receptors, flupentixole decreases the activity of dopaminergic pathways, which are overactive in conditions like schizophrenia.","oneSentence":"Flupentixole is a dopamine D2 receptor antagonist that reduces psychotic symptoms by blocking dopamine receptors in the brain.","technicalDetail":"Flupentixole binds to dopamine D2 receptors with high affinity, leading to a reduction in the release of dopamine and subsequent neurotransmission in the mesolimbic and mesocortical pathways."},"_scrapedAt":"2026-03-27T23:46:41.736Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":"N/A","launchDate":"N/A","annualCostUS":"N/A","currentRevenue":"N/A","patientPopulation":"N/A","peakSalesEstimate":"N/A"},"references":[],"biosimilars":[],"competitors":["Risperidone","Olanzapine","Aripiprazole","Quetiapine"],"indications":{"approved":["Schizophrenia","Psychotic Disorders"],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT02435095","phase":"PHASE4","title":"Antipsychotic Induced Structural and Functional Brain Changes","status":"TERMINATED","sponsor":"RWTH Aachen University","startDate":"2015-05","conditions":"Schizophrenia","enrollment":174},{"nctId":"NCT02307396","phase":"PHASE4","title":"Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic Patients","status":"COMPLETED","sponsor":"Technical University of Munich","startDate":"2015-02-01","conditions":"Schizophrenia, Schizophrenia and Disorders With Psychotic Features, Schizoaffective Disorders","enrollment":21}],"_emaApprovals":[],"_faersSignals":[{"count":1,"reaction":"PATHOLOGICAL GAMBLING"}],"genericFilers":["Generic Company A","Generic Company B","Generic Company C"],"latestUpdates":[],"manufacturing":[],"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":3,"therapeuticAreas":["Neuroscience"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Flupentixole","genericName":"Flupentixole","companyName":"Technical University of Munich","companyId":"technical-university-of-munich","modality":"Small molecule","firstApprovalDate":"N/A","enrichmentLevel":3,"visitCount":0,"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":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}