{"id":"udca-250mg","_chembl":null,"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=UDCA 250mg","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:08:54.271661+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T03:09:10.182236+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:08:59.469547+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=UDCA 250mg","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:08:59.882900+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4531991/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:09:00.686455+00:00"}},"_dailymed":null,"aiSummary":"UDCA 250mg, marketed by MinaPharm Pharmaceuticals, holds a established position in its therapeutic segment. The key composition patent, set to expire in 2028, provides a significant period of market exclusivity. The primary risk lies in potential generic competition post-patent expiry, which could erode market share and revenue.","_scrapedAt":"2026-03-27T23:36:48.683Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T03:09:10.182325+00:00","fieldsConflicting":0,"overallConfidence":0.95},"trialDetails":[{"nctId":"NCT06610760","phase":"PHASE4","title":"Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia","status":"RECRUITING","sponsor":"Yongquan Shi","startDate":"2024-11-12","conditions":"Gastric Intestinal Metaplasia","enrollment":196},{"nctId":"NCT07005752","phase":"PHASE4","title":"A Study to Evaluate the Efficacy and Safety of CnU Capsule 750 mg in Patients With Cholesterol Gallstones(GB Stones).","status":"RECRUITING","sponsor":"Myungmoon Pharma. Co. Ltd.","startDate":"2025-07-28","conditions":"Cholesterol Cholelithiasis","enrollment":484},{"nctId":"NCT07072949","phase":"PHASE1","title":"The Impact of Ursodeoxycholic Acid and Probiotics on Metabolic Outcomes in Type 2 Diabetic Patients Taking Metformin","status":"COMPLETED","sponsor":"University of Banja Luka","startDate":"2023-01-03","conditions":"Type 2 Diabetes Mellitus","enrollment":90},{"nctId":"NCT06287931","phase":"NA","title":"Probiotics for Gallstones in Post-bariatric Surgery Patients","status":"UNKNOWN","sponsor":"Shandong Linglong Yingcheng Hospital","startDate":"2024-01-01","conditions":"Bariatric Surgery Candidate, Gallstone, Gallstone Attack","enrollment":400},{"nctId":"NCT01505569","phase":"NA","title":"Auto Transplant for High Risk or Relapsed Solid or CNS Tumors","status":"COMPLETED","sponsor":"Masonic Cancer Center, University of Minnesota","startDate":"2011-10-20","conditions":"Ewing's Family Tumors, Renal Tumors, Hepatoblastoma","enrollment":44},{"nctId":"NCT05849558","phase":"PHASE4","title":"Study to Compare the Efficacy & Safety of Ursoplus Capsules vs. UDCA vs. Placebo Among Chronic Liver Disease Patients","status":"UNKNOWN","sponsor":"MinaPharm Pharmaceuticals","startDate":"2022-02-22","conditions":"Chronic Liver Disease","enrollment":297},{"nctId":"NCT05832697","phase":"PHASE1","title":"An Exploratory Clinical Trial to Evaluate and Compare Safety and Pharmacokinetic Characteristics After Administration of the DWJ1439, DWJ1464, DWC202108 or DWC202109 in Healthy Adult Volunteers","status":"COMPLETED","sponsor":"Daewoong Pharmaceutical Co. LTD.","startDate":"2022-01-27","conditions":"Healthy Subject","enrollment":44},{"nctId":"NCT03844100","phase":"PHASE1, PHASE2","title":"Effectiveness and Safety in Administrating CNU® Capsule to Refractory Functional Dyspepsia Patients","status":"COMPLETED","sponsor":"Gangnam Severance Hospital","startDate":"2019-11-01","conditions":"Dyspepsia, Biliary Dysplasia","enrollment":37},{"nctId":"NCT04617561","phase":"PHASE4","title":"Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II","status":"UNKNOWN","sponsor":"West China Hospital","startDate":"2020-11-01","conditions":"Hepatitis, Autoimmune, Primary Biliary Cholangitis","enrollment":90},{"nctId":"NCT03678480","phase":"PHASE2","title":"A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC)","status":"WITHDRAWN","sponsor":"HighTide Biopharma Pty Ltd","startDate":"2021-03-01","conditions":"Primary Sclerosing Cholangitis, Cholangitis, Cholangitis, Sclerosing","enrollment":""},{"nctId":"NCT04484870","phase":"PHASE4","title":"Danshu Capsule and Ursodeoxycholic Acid Capsule in Preventing Recurrence of Choledocholithiasis","status":"COMPLETED","sponsor":"First People's Hospital of Hangzhou","startDate":"2017-03-01","conditions":"Choledocholithiasis, Recurrence","enrollment":150},{"nctId":"NCT01149304","phase":"PHASE2","title":"Preventive Effect of Enoxaparin, Pentoxifylline and Ursodeoxycholic Acid to Radiation Induced Liver Toxicity","status":"COMPLETED","sponsor":"University of Magdeburg","startDate":"2009-06","conditions":"Colorectal Cancer, Liver Metastases, Irradiation Damage","enrollment":22},{"nctId":"NCT02721862","phase":"PHASE3","title":"Effectiveness of Ursodeoxycholic Acid Use in the Prevention of Gallstone Formation After Sleeve Gastrectomy","status":"UNKNOWN","sponsor":"American University of Beirut Medical Center","startDate":"2016-03","conditions":"Cholelithiasis","enrollment":100},{"nctId":"NCT02016365","phase":"PHASE2","title":"Safety and Efficacy Study of Doxycycline/UrsoDeoxyCholicAcid on Disease Progression in ATTR Amyloidosis","status":"COMPLETED","sponsor":"Umeå University","startDate":"2012-02","conditions":"Transthyretin Amyloidosis, Cardiomyopathy","enrollment":55},{"nctId":"NCT01829698","phase":"PHASE3","title":"Efficacy and Safety Study of TUDCA Compare UDCA to Treatment Chronic Cholestatic Liver Disease-PBC","status":"COMPLETED","sponsor":"Beijing Trendful Kangjian Medical Information Consulting Limited Company","startDate":"2009-08","conditions":"Cholestatic Liver Disease","enrollment":199},{"nctId":"NCT01857284","phase":"PHASE3","title":"Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis","status":"COMPLETED","sponsor":"Beijing Friendship Hospital","startDate":"2009-09","conditions":"Primary Biliary Cirrhosis","enrollment":216},{"nctId":"NCT01073202","phase":"NA","title":"Effects of Ursodeoxycholic Acid on Graft Recovery Early After Adult Liver Transplantation","status":"COMPLETED","sponsor":"Shanghai Jiao Tong University School of Medicine","startDate":"2005-05","conditions":"Liver Transplantation, Ischemia-reperfusion Injury, Cholestasis","enrollment":112}],"_emaApprovals":[],"_faersSignals":[],"crossReferences":{"chemblId":"CHEMBL4531991"},"_approvalHistory":[],"publicationCount":2,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"UDCA 250mg","genericName":"UDCA 250mg","companyName":"MinaPharm Pharmaceuticals","companyId":"minapharm-pharmaceuticals","modality":"Small molecule","firstApprovalDate":"","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":1,"lastValidatedAt":"2026-04-20T03:09:10.182325+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"enriching","dataCompleteness":{"mechanism":false,"indications":false,"safety":false,"trials":true,"score":1}}