{"id":"distigmine","rwe":[],"tags":[{"label":"distigmine","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Acetylcholinesterase","category":"target"},{"label":"ACHE","category":"gene"},{"label":"N07AA03","category":"atc"},{"label":"Active","category":"status"},{"label":"Acute cystitis","category":"indication"},{"label":"Difficulty passing urine","category":"indication"},{"label":"Myasthenia gravis","category":"indication"},{"label":"Torii Pharmaceuticals","category":"company"},{"label":"Cholinergic Agents","category":"pharmacology"},{"label":"Cholinesterase Inhibitors","category":"pharmacology"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":665.69,"date":"","count":134,"signal":"Appendicolith","source":"DrugCentral FAERS","actionTaken":"Reported 134 times (LLR=666)"},{"llr":531.62,"date":"","count":134,"signal":"Appendicitis","source":"DrugCentral FAERS","actionTaken":"Reported 134 times (LLR=532)"},{"llr":451.749,"date":"","count":135,"signal":"Cardiogenic shock","source":"DrugCentral FAERS","actionTaken":"Reported 135 times (LLR=452)"},{"llr":398.546,"date":"","count":116,"signal":"Ventricular fibrillation","source":"DrugCentral FAERS","actionTaken":"Reported 116 times (LLR=399)"},{"llr":361.619,"date":"","count":136,"signal":"Ascites","source":"DrugCentral FAERS","actionTaken":"Reported 136 times (LLR=362)"},{"llr":351.887,"date":"","count":136,"signal":"Stress","source":"DrugCentral FAERS","actionTaken":"Reported 136 times (LLR=352)"},{"llr":346.398,"date":"","count":82,"signal":"Blood phosphorus increased","source":"DrugCentral FAERS","actionTaken":"Reported 82 times (LLR=346)"},{"llr":309.519,"date":"","count":136,"signal":"Multiple organ dysfunction syndrome","source":"DrugCentral FAERS","actionTaken":"Reported 136 times (LLR=310)"},{"llr":296.809,"date":"","count":135,"signal":"Abdominal distension","source":"DrugCentral FAERS","actionTaken":"Reported 135 times (LLR=297)"},{"llr":278.794,"date":"","count":142,"signal":"Hyponatraemia","source":"DrugCentral FAERS","actionTaken":"Reported 142 times (LLR=279)"},{"llr":220.169,"date":"","count":152,"signal":"Constipation","source":"DrugCentral FAERS","actionTaken":"Reported 152 times (LLR=220)"},{"llr":213.985,"date":"","count":144,"signal":"Sepsis","source":"DrugCentral FAERS","actionTaken":"Reported 144 times (LLR=214)"},{"llr":203.135,"date":"","count":139,"signal":"General physical health deterioration","source":"DrugCentral FAERS","actionTaken":"Reported 139 times (LLR=203)"},{"llr":153.039,"date":"","count":135,"signal":"Abdominal pain","source":"DrugCentral FAERS","actionTaken":"Reported 135 times (LLR=153)"},{"llr":152.26,"date":"","count":46,"signal":"Blood uric acid increased","source":"DrugCentral FAERS","actionTaken":"Reported 46 times (LLR=152)"}],"commonSideEffects":[]},"trials":[],"aliases":[],"company":"Torii Pharmaceuticals","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=DISTIGMINE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:19:38.432004+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:19:44.294568+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DISTIGMINE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:19:44.598749+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Acetylcholinesterase inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:19:45.660974+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1199307/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:19:45.307842+00:00"}},"allNames":"ubretid","offLabel":[],"synonyms":["BC-51","hexamarium","distigmine","distigmine bromide","ubretid"],"timeline":[{"date":"1967-09-05","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Torii Pharmaceuticals)"}],"approvals":[{"date":"1967-09-05","orphan":false,"company":"Torii Pharmaceuticals","regulator":"PMDA"}],"brandName":"Ubretid","ecosystem":[{"indication":"Acute cystitis","otherDrugs":[],"globalPrevalence":null},{"indication":"Difficulty passing urine","otherDrugs":[],"globalPrevalence":null},{"indication":"Myasthenia gravis","otherDrugs":[{"name":"ambenonium","slug":"ambenonium","company":"Sanofi Aventis Us"},{"name":"azathioprine","slug":"azathioprine","company":"Prometheus Labs"},{"name":"efgartigimod alfa","slug":"efgartigimod-alfa","company":"Argenx Bv"},{"name":"neostigmine","slug":"neostigmine","company":"Eclat Pharms Llc"}],"globalPrevalence":621600}],"mechanism":{"target":"Acetylcholinesterase","targets":[{"gene":"ACHE","source":"DrugCentral","target":"Acetylcholinesterase","protein":"Acetylcholinesterase"}],"modality":"Small Molecule","drugClass":"distigmine","explanation":"","oneSentence":"","technicalDetail":"Ubretid competitively inhibits acetylcholinesterase, preventing the breakdown of acetylcholine and increasing its concentration in the synaptic cleft, thereby enhancing cholinergic transmission."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/927","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DISTIGMINE","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T10:43:29.739558","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:19:46.952640+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"neostigmine","drugSlug":"neostigmine","fdaApproval":"2013-05-31","genericCount":16,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"pyridostigmine","drugSlug":"pyridostigmine","fdaApproval":"1955-04-06","patentExpiry":"Jun 18, 2038","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"ambenonium","drugSlug":"ambenonium","fdaApproval":"1956-05-01","patentStatus":"Unknown","relationship":"same-class"}],"genericName":"distigmine","indications":{"approved":[{"name":"Acute cystitis","source":"DrugCentral","snomedId":68226007,"regulator":"FDA"},{"name":"Difficulty passing urine","source":"DrugCentral","snomedId":102835006,"regulator":"FDA"},{"name":"Myasthenia gravis","source":"DrugCentral","snomedId":91637004,"regulator":"FDA","prevalenceClass":"1-9 / 100 000","globalPrevalence":621600,"prevalenceMethod":"orphanet","prevalenceSource":"Orphanet (20565885[PMID])"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"neostigmine","brandName":"neostigmine","genericName":"neostigmine","approvalYear":"2013","relationship":"same-class"},{"drugId":"pyridostigmine","brandName":"pyridostigmine","genericName":"pyridostigmine","approvalYear":"1955","relationship":"same-class"},{"drugId":"ambenonium","brandName":"ambenonium","genericName":"ambenonium","approvalYear":"1956","relationship":"same-class"}],"trialDetails":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"NDDF":"003959","UNII":"T940307O7B","CHEBI":"CHEBI:31512","INN_ID":"764","RXNORM":"154982","UMLSCUI":"C0012757","chemblId":"CHEMBL1199307","ChEMBL_ID":"CHEMBL1199307","KEGG_DRUG":"D01228","DRUGBANK_ID":"DB13694","PUBCHEM_CID":"3116","SNOMEDCT_US":"349943004","SECONDARY_CAS_RN":"15876-67-2","MESH_SUPPLEMENTAL_RECORD_UI":"C084645"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"present","companyName":"Torii Pharmaceuticals","relationship":"Current Owner"}],"pharmacokinetics":{"source":"DrugCentral","halfLife":"59.8 hours","clearance":"0.2 mL/min/kg","bioavailability":"8%","volumeOfDistribution":"1.0 L/kg"},"publicationCount":100,"therapeuticAreas":["Neuroscience"],"atcClassification":{"source":"DrugCentral","atcCode":"N07AA03","allCodes":["N07AA03"]},"biosimilarFilings":[],"recentPublications":[],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"Torii Pharmaceuticals","companyId":"torii-pharmaceuticals","modality":"Small molecule","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"JP","regulator":"PMDA","status":"approved","approval_date":"1967-09-05T00:00:00.000Z","mah":"Torii Pharmaceuticals","brand_name_local":null,"application_number":""},{"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":"2026-04-20T00:19:46.952640+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"enriching","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":false,"score":1}}