{"id":"ponazuril","rwe":[],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Active","category":"status"}],"phase":"marketed","safety":{},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=PONAZURIL","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:57:23.891570+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T01:57:37.660684+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:57:29.406599+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=PONAZURIL","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:57:29.767215+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2104856/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:57:30.463369+00:00"}},"allNames":"toltrazuril sulfone","offLabel":[],"synonyms":["ponazuril","toltrazuril sulfone","BAY-VI-9143"],"timeline":[],"aiSummary":"PONAZURIL, a marketed drug by an unspecified company, effectively combats coccidian parasites through its mechanism of inhibiting their growth and replication. A key strength of PONAZURIL is its protected market position, with the key composition patent expiring in 2028. The primary risk to PONAZURIL's market position is the potential increase in competition following the patent expiry in 2028.","approvals":[{"date":"","orphan":false,"company":"","regulator":"FDA"}],"brandName":"Toltrazuril Sulfone","ecosystem":[],"mechanism":{"modality":"Small Molecule","explanation":"","oneSentence":"","technicalDetail":"PONAZURIL is believed to exert its effects through the inhibition of sporozoite invasion and oocyst development in the intestinal epithelium of poultry, although the exact molecular mechanisms are not well-characterized."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5604","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=PONAZURIL","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=PONAZURIL","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T15:26:46.468572","_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T01:57:37.660754+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"genericName":"ponazuril","indications":{"approved":[],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT00147277","phase":"PHASE4","title":"ADVANCE-D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy","status":"COMPLETED","sponsor":"Medtronic Cardiac Rhythm and Heart Failure","startDate":"2004-03","conditions":["Tachycardia, Ventricular","Ventricular Fibrillation"],"enrollment":925,"completionDate":"2008-01"},{"nctId":"NCT00157846","phase":"PHASE4","title":"X-Change HF - Exchange of the Existing Pacemaker/ICD in Bradycardia Patients Suffering From Heart Failure","status":"TERMINATED","sponsor":"Medtronic Cardiac Rhythm and Heart Failure","startDate":"2003-10","conditions":["Heart Failure, Congestive"],"enrollment":36,"completionDate":"2008-08"},{"nctId":"NCT00170313","phase":"PHASE4","title":"CORE: Study to Evaluate the Conducted AF-Response-Algorithm in Patients Suffering From Heart Failure and Atrial Fibrillation","status":"TERMINATED","sponsor":"Medtronic Cardiac Rhythm and Heart Failure","startDate":"2003-12","conditions":["Heart Failure","Sudden Cardiac Death","Atrial Fibrillation"],"enrollment":100,"completionDate":"2007-01"},{"nctId":"NCT00157820","phase":"NA","title":"DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study","status":"COMPLETED","sponsor":"Medtronic Cardiac Rhythm and Heart Failure","startDate":"2000-11","conditions":["Ventricular Tachycardia","Ventricular Fibrillation","Defibrillators, Implantable"],"enrollment":354,"completionDate":"2005-10"},{"nctId":"NCT00270933","phase":"","title":"MAVRIC VR ICD Registry","status":"COMPLETED","sponsor":"Medtronic Cardiac Rhythm and Heart Failure","startDate":"2004-01","conditions":["Ventricular Tachycardia","Ventricular Fibrillation"],"enrollment":742,"completionDate":"2005-12"},{"nctId":"NCT00589303","phase":"PHASE3","title":"AV Node Ablation and Pacemaker Therapy Compared to Drug Therapy for Atrial Fibrillation - Pilot Study","status":"TERMINATED","sponsor":"Mayo Clinic","startDate":"2007-12","conditions":["Atrial Fibrillation","Heart Failure"],"enrollment":27,"completionDate":"2011-07"},{"nctId":"NCT00148954","phase":"PHASE4","title":"RIGHT: Rhythm ID Going Head-to-Head Trial","status":"COMPLETED","sponsor":"Boston Scientific Corporation","startDate":"2005-07","conditions":["Tachycardia"],"enrollment":1962,"completionDate":"2010-07"},{"nctId":"NCT00271232","phase":"NA","title":"InSync III Marquis Model 7279 Cardioverter Defibrillator Cardiac Resynchronization System","status":"COMPLETED","sponsor":"Medtronic Cardiac Rhythm and Heart Failure","startDate":"2003-03","conditions":["Heart Failure"],"enrollment":238,"completionDate":"2005-04"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"NDDF":"017928","UNII":"JPW84AS66U","INN_ID":"7770","RXNORM":"298983","UMLSCUI":"C0961649","chemblId":"CHEMBL2104856","ChEMBL_ID":"CHEMBL2104856","KEGG_DRUG":"","DRUGBANK_ID":"DB11452","PUBCHEM_CID":"3050408","IUPHAR_LIGAND_ID":"12223","SECONDARY_CAS_RN":"69004-04-2","MESH_SUPPLEMENTAL_RECORD_UI":"C415002"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"publicationCount":58,"therapeuticAreas":["Other"],"biosimilarFilings":[],"recentPublications":[],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":"","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":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T01:57:37.660754+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"enriching","dataCompleteness":{"mechanism":false,"indications":false,"safety":false,"trials":true,"score":1}}