{"id":"propantheline","rwe":[],"tags":[{"label":"Anticholinergic","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Muscarinic acetylcholine receptor M4","category":"target"},{"label":"CHRM4","category":"gene"},{"label":"CHRM3","category":"gene"},{"label":"CHRM1","category":"gene"},{"label":"A03AB05","category":"atc"},{"label":"Oral","category":"route"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Peptic ulcer","category":"indication"},{"label":"Approved 1950s","category":"decade"},{"label":"Anti-Ulcer Agents","category":"pharmacology"},{"label":"Cholinergic Agents","category":"pharmacology"},{"label":"Cholinergic Antagonists","category":"pharmacology"},{"label":"Gastrointestinal Agents","category":"pharmacology"},{"label":"Muscarinic Antagonists","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"}],"phase":"marketed","safety":{"commonSideEffects":[],"contraindications":["Achalasia of esophagus","Angle-closure glaucoma","Atony of colon","Autonomic dysreflexia","Benign prostatic hyperplasia","Bladder outflow obstruction","Bleeding","Brain damage","Chronic heart failure","Chronic lung disease","Complete trisomy 21 syndrome","Disease of liver","Disorder of coronary artery","Disturbance of salivary secretion","Drowsy","Drug AND/OR toxin-induced diarrhea","Gastric ulcer","Gastrointestinal obstruction","Hiatal hernia","Hypertensive disorder","Hyperthyroidism","Kidney disease","Myasthenia gravis","Myocardial dysfunction","Paralytic ileus"],"specialPopulations":{"Pregnancy":"Pregnancy Category C. Animal reproduction studies have not been conducted with propantheline. It is also not known whether propantheline can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Propantheline should be given to pregnant woman only if clearly needed.","Paediatric use":"Safety and effectiveness in children have not been established."}},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=PROPANTHELINE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:42:37.109986+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:42:43.822879+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=PROPANTHELINE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:42:44.664219+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1180725/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:42:45.145400+00:00"}},"allNames":"pro-banthine","offLabel":[],"synonyms":["propantheline bromide","propantheline","propanthelinium","probanthine"],"timeline":[{"date":"1953-04-02","type":"positive","source":"DrugCentral","milestone":"FDA approval"}],"aiSummary":"Pro-Banthine (Propanteline) is a small molecule anticholinergic medication that targets the muscarinic acetylcholine receptor M4. Originally developed and currently owned by Shire, it was first approved by the FDA in 1953 for the treatment of peptic ulcers. As an off-patent medication, Pro-Banthine is available as a generic product from multiple manufacturers. Key safety considerations include its potential to cause dry mouth, blurred vision, and constipation due to its anticholinergic effects. Its short half-life of 1.6 hours allows for rapid elimination from the body.","approvals":[{"date":"1953-04-02","orphan":false,"company":"","regulator":"FDA"}],"brandName":"Pro-Banthine","ecosystem":[{"indication":"Peptic ulcer","otherDrugs":[{"name":"algeldrate","slug":"algeldrate","company":"Sanofi Aventis Us"},{"name":"almasilate","slug":"almasilate","company":""},{"name":"chlordiazepoxide","slug":"chlordiazepoxide","company":"Valeant Pharm Intl"},{"name":"dexlansoprazole","slug":"dexlansoprazole","company":"Takeda Pharms Usa"}],"globalPrevalence":64000000}],"mechanism":{"target":"Muscarinic acetylcholine receptor M4","novelty":"Follow-on","targets":[{"gene":"CHRM4","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M4","protein":"Muscarinic acetylcholine receptor M4"},{"gene":"CHRM3","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M3","protein":"Muscarinic acetylcholine receptor M3"},{"gene":"CHRM1","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M1","protein":"Muscarinic acetylcholine receptor M1"},{"gene":"CHRM2","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M2","protein":"Muscarinic acetylcholine receptor M2"}],"moaClass":"Cholinergic Antagonists","modality":"Small Molecule","drugClass":"Anticholinergic","explanation":"","oneSentence":"","technicalDetail":"Pro-Banthine is a selective M4 muscarinic receptor antagonist that competes with acetylcholine for binding sites, thereby inhibiting the parasympathetic nervous system's effects on the gastrointestinal tract."},"commercial":{"launchDate":"1953","_launchSource":"DrugCentral (FDA 1953-04-02, )"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2293","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=PROPANTHELINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=PROPANTHELINE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T15:26:55.625557","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:42:47.023582+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"glycopyrronium bromide","drugSlug":"glycopyrronium-bromide","fdaApproval":"1961-08-11","relationship":"same-class"},{"drugName":"oxyphenonium","drugSlug":"oxyphenonium","fdaApproval":"","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"methanthelinium","drugSlug":"methanthelinium","fdaApproval":"1951-07-03","relationship":"same-class"},{"drugName":"tridihexethyl","drugSlug":"tridihexethyl","fdaApproval":"1954-09-15","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"isopropamide","drugSlug":"isopropamide","fdaApproval":"1957-10-09","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"hexocyclium","drugSlug":"hexocyclium","fdaApproval":"","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"mepenzolate","drugSlug":"mepenzolate","fdaApproval":"1956-11-14","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"diphemanil","drugSlug":"diphemanil","fdaApproval":"1976-05-17","patentStatus":"Unknown","relationship":"same-class"}],"genericName":"propantheline","indications":{"approved":[{"name":"Peptic ulcer","source":"DrugCentral","snomedId":13200003,"regulator":"FDA","usPrevalence":null,"globalPrevalence":64000000,"prevalenceMethod":"curated","prevalenceSource":"Aliment Pharmacol Ther, 2009 (PMID:19220208)"}],"offLabel":[{"name":"Irritable bowel syndrome","source":"DrugCentral","drugName":"PROPANTHELINE","evidenceCount":5,"evidenceLevel":"emerging"},{"name":"Urinary incontinence","source":"DrugCentral","drugName":"PROPANTHELINE","evidenceCount":58,"evidenceLevel":"strong"}],"pipeline":[]},"currentOwner":"Shire","drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"glycopyrronium-bromide","brandName":"glycopyrronium bromide","genericName":"glycopyrronium bromide","approvalYear":"1961","relationship":"same-class"},{"drugId":"oxyphenonium","brandName":"oxyphenonium","genericName":"oxyphenonium","approvalYear":"","relationship":"same-class"},{"drugId":"methanthelinium","brandName":"methanthelinium","genericName":"methanthelinium","approvalYear":"1951","relationship":"same-class"},{"drugId":"tridihexethyl","brandName":"tridihexethyl","genericName":"tridihexethyl","approvalYear":"1954","relationship":"same-class"},{"drugId":"isopropamide","brandName":"isopropamide","genericName":"isopropamide","approvalYear":"1957","relationship":"same-class"},{"drugId":"hexocyclium","brandName":"hexocyclium","genericName":"hexocyclium","approvalYear":"","relationship":"same-class"},{"drugId":"mepenzolate","brandName":"mepenzolate","genericName":"mepenzolate","approvalYear":"1956","relationship":"same-class"},{"drugId":"diphemanil","brandName":"diphemanil","genericName":"diphemanil","approvalYear":"1976","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT01640002","phase":"PHASE1","title":"A Randomized, Placebo-Controlled Study to Assess the Efficacy of Propantheline for the Treatment of Overactive Bladder","status":"UNKNOWN","sponsor":"Hospital Universitário Professor Edgard Santos","startDate":"2012-05","conditions":["Overactive Bladder Associated With HTLV-1"],"enrollment":42,"completionDate":"2013-04"},{"nctId":"NCT01010048","phase":"PHASE4","title":"Compare the Therapeutic Effect Treated With Tamsulosin and Progesterone After ESWL( Extra Corporeal Shock Wave Lithotripsy) in Urinary Calculus","status":"UNKNOWN","sponsor":"Chongqing Medical University","startDate":"2009-10","conditions":["Urinary Calculus"],"enrollment":120,"completionDate":"2010-12"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Oral","formulation":"Tablet","formulations":[{"form":"TABLET, FILM COATED","route":"ORAL","productName":"Propantheline Bromide"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000178964","MMSL":"2171","NDDF":"001732","UNII":"1306V2B0Q8","VUID":"4018122","CHEBI":"CHEBI:8481","VANDF":"4018122","INN_ID":"226","RXNORM":"224918","UMLSCUI":"C0033447","chemblId":"CHEMBL1180725","ChEMBL_ID":"CHEMBL1180725","KEGG_DRUG":"D00481","DRUGBANK_ID":"DB00782","PUBCHEM_CID":"4934","SNOMEDCT_US":"22654004","IUPHAR_LIGAND_ID":"329","SECONDARY_CAS_RN":"50-34-0","MESH_DESCRIPTOR_UI":"D011413"},"formularyStatus":[],"_enricherVersion":"v2","_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[{"period":"present","companyName":"Shire","relationship":"Current Owner"}],"pharmacokinetics":{"source":"FDA label","halfLife":"1.6 hours"},"publicationCount":408,"therapeuticAreas":["Gastroenterology"],"atcClassification":{"source":"DrugCentral","atcCode":"A03AB05","allCodes":["A03AB05","A03CA34"]},"biosimilarFilings":[],"recentPublications":[],"companionDiagnostics":[],"genericManufacturers":10,"_genericFilersChecked":true,"genericManufacturerList":["Ascot","Heather","Hikma","Impax Labs","Mylan","Par Pharm","Pvt Form","Sandoz","Tablicaps","Watson Labs"],"status":"approved","companyName":"Shire","companyId":"","modality":"Small molecule","firstApprovalDate":"1953","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1953-04-02T00:00:00.000Z","mah":"","brand_name_local":null,"application_number":""},{"country_code":"CA","regulator":"Health 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