{"id":"tauroursodeoxycholic-acid","safety":{"commonSideEffects":[{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Abdominal discomfort"},{"rate":null,"effect":"Nausea"}]},"_chembl":{"chemblId":"CHEMBL272427","moleculeType":"Small molecule","molecularWeight":"499.71"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"TUDCA is a conjugated bile acid that acts as a chemical chaperone, helping to restore proper protein folding in the endoplasmic reticulum and reducing ER stress-induced cell death. It also has anti-inflammatory and antioxidant properties, protecting cells from mitochondrial dysfunction and apoptosis. These mechanisms make it potentially beneficial in neurodegenerative diseases and other conditions characterized by cellular stress and protein misfolding.","oneSentence":"Tauroursodeoxycholic acid (TUDCA) is a bile acid that reduces endoplasmic reticulum stress and promotes cell survival by stabilizing mitochondrial function and inhibiting apoptosis pathways.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:11:15.509Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Progressive familial intrahepatic cholestasis (PFIC)"},{"name":"Cerebrotendinous xanthomatosis (CTX)"},{"name":"Neurodegenerative diseases (investigational)"}]},"trialDetails":[{"nctId":"NCT03431896","phase":"","title":"Monitoring of Early Disease Progression in Hereditary Transthyretin Amyloidosis","status":"COMPLETED","sponsor":"The Cleveland Clinic","startDate":"2018-02-01","conditions":"Amyloidosis, Amyloid, Amyloid Neuropathies, Familial","enrollment":37},{"nctId":"NCT04114292","phase":"PHASE1","title":"TUDCA as a Therapy for Ulcerative Colitis (UC)","status":"COMPLETED","sponsor":"Washington University School of Medicine","startDate":"2019-01-17","conditions":"Ulcerative Colitis","enrollment":14},{"nctId":"NCT07457632","phase":"PHASE2","title":"Integrative Liver-Targeted Therapy for Diabetic Macular Edema: Combining Tauroursodeoxycholate and Traditional Chinese Medicine.","status":"NOT_YET_RECRUITING","sponsor":"University of Alabama at Birmingham","startDate":"2026-04-01","conditions":"Diabetic Macular Edema (DME)","enrollment":69},{"nctId":"NCT07357467","phase":"","title":"Effect of Oral Supplement on Influenza Vaccine Long-term Response","status":"NOT_YET_RECRUITING","sponsor":"Tsinghua University","startDate":"2026-03","conditions":"Influenza, Immunosenescence","enrollment":30},{"nctId":"NCT07328009","phase":"PHASE2","title":"A Platform Trial for Personalized and Adaptive Therapies in Hepatocellular Carcinoma","status":"NOT_YET_RECRUITING","sponsor":"Fudan University","startDate":"2026-01-25","conditions":"Hepato Cellular Carcinoma (HCC)","enrollment":350},{"nctId":"NCT04244630","phase":"PHASE2","title":"Mitochondrial Capacity Boost in ALS (MICABO-ALS) Trial","status":"RECRUITING","sponsor":"Dallas VA Medical Center","startDate":"2023-11-02","conditions":"Amyotrophic Lateral Sclerosis (ALS)","enrollment":60},{"nctId":"NCT07100392","phase":"PHASE2","title":"Tauroursodeoxycholic Acid (TUDCA) Plus Camrelizumab and Regorafenib in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab","status":"RECRUITING","sponsor":"Fudan University","startDate":"2025-08-14","conditions":"Hepatocellular Carcinoma (HCC)","enrollment":141},{"nctId":"NCT03488524","phase":"PHASE2","title":"Open Label Extension Study of AMX0035 in Patients With ALS","status":"COMPLETED","sponsor":"Amylyx Pharmaceuticals Inc.","startDate":"2018-03-29","conditions":"Amyotrophic Lateral Sclerosis, ALS","enrollment":90},{"nctId":"NCT07064668","phase":"PHASE2","title":"Tauroursodeoxycholic Acid Combined With PD-1/PD-L1 Immunotherapy in Advanced Hepatocellular Carcinoma: A Prospective Study","status":"NOT_YET_RECRUITING","sponsor":"Tongji Hospital","startDate":"2025-07-30","conditions":"Hepatocellular Carcinoma","enrollment":300},{"nctId":"NCT02218619","phase":"PHASE2","title":"Tauroursodeoxycholic Acid (TUDCA) in New-Onset Type 1 Diabetes","status":"COMPLETED","sponsor":"Robin Goland, MD","startDate":"2015-08","conditions":"Type 1 Diabetes","enrollment":20},{"nctId":"NCT04001647","phase":"EARLY_PHASE1","title":"Targeting ER Stress in Vascular Dysfunction","status":"TERMINATED","sponsor":"Colorado State University","startDate":"2019-06-01","conditions":"Vasodilation, Arterial Stiffness","enrollment":17},{"nctId":"NCT05676034","phase":"PHASE2","title":"AMX0035 in Adult Patients With Wolfram Syndrome","status":"ACTIVE_NOT_RECRUITING","sponsor":"Amylyx Pharmaceuticals Inc.","startDate":"2023-03-03","conditions":"Wolfram Syndrome","enrollment":12},{"nctId":"NCT06025630","phase":"PHASE1, PHASE2","title":"Targeting Endoplasmic Reticulum Stress in Human Hypertension","status":"RECRUITING","sponsor":"University of North Texas Health Science Center","startDate":"2023-08-15","conditions":"Hypertension","enrollment":70},{"nctId":"NCT03533257","phase":"PHASE2","title":"Study to Assess the Safety and Biological Activity of AMX0035 for the Treatment of Alzheimer's Disease","status":"COMPLETED","sponsor":"Amylyx Pharmaceuticals Inc.","startDate":"2018-09-14","conditions":"Alzheimer Disease","enrollment":95},{"nctId":"NCT06827873","phase":"NA","title":"Effect of Oral Supplements for Influenza Vaccine Response","status":"NOT_YET_RECRUITING","sponsor":"Tsinghua University","startDate":"2025-02","conditions":"Influenza Vaccine Response","enrollment":45},{"nctId":"NCT05619783","phase":"PHASE3","title":"Extension Study Evaluating The Safety And Tolerability of AMX0035","status":"COMPLETED","sponsor":"Amylyx Pharmaceuticals Inc.","startDate":"2022-12-29","conditions":"Amyotrophic Lateral Sclerosis","enrollment":352},{"nctId":"NCT06122662","phase":"PHASE2, PHASE3","title":"AMX0035 and Progressive Supranuclear Palsy","status":"ACTIVE_NOT_RECRUITING","sponsor":"Amylyx Pharmaceuticals Inc.","startDate":"2023-12-21","conditions":"Progressive Supranuclear Palsy, PSP, Neurodegenerative Diseases","enrollment":110},{"nctId":"NCT05021536","phase":"PHASE3","title":"Phase III Trial of AMX0035 for Amyotrophic Lateral Sclerosis Treatment","status":"ACTIVE_NOT_RECRUITING","sponsor":"Amylyx Pharmaceuticals Inc.","startDate":"2021-10-28","conditions":"Amyotrophic Lateral Sclerosis","enrollment":664},{"nctId":"NCT03481972","phase":"PHASE3","title":"A Study of Doxycycline and Tauroursodeoxycholic Acid (Doxy/TUDCA) Plus Standard Supportive Therapy Versus Standard Supportive Therapy Alone in Cardiac Amyloidosis Caused by Transthyretin","status":"COMPLETED","sponsor":"Fondazione IRCCS Policlinico San Matteo di Pavia","startDate":"2018-04-11","conditions":"TTR Cardiac Amyloidosis","enrollment":102},{"nctId":"NCT03127514","phase":"PHASE2","title":"AMX0035 in Patients With Amyotrophic Lateral Sclerosis (ALS)","status":"COMPLETED","sponsor":"Amylyx Pharmaceuticals Inc.","startDate":"2017-06-22","conditions":"Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Neuromuscular Diseases","enrollment":137},{"nctId":"NCT04987671","phase":"PHASE1, PHASE2","title":"Pharmacokinetic and Pharmacodynamic Study of AMX0035 in Patients With ALS","status":"UNKNOWN","sponsor":"Amylyx Pharmaceuticals Inc.","startDate":"2021-08-05","conditions":"ALS","enrollment":14},{"nctId":"NCT03800524","phase":"PHASE3","title":"Safety and Efficacy of TUDCA as add-on Treatment in Patients Affected by ALS","status":"UNKNOWN","sponsor":"Humanitas Mirasole SpA","startDate":"2019-02-22","conditions":"Amyotrophic Lateral Sclerosis (ALS)","enrollment":337},{"nctId":"NCT03423121","phase":"PHASE1, PHASE2","title":"A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis","status":"COMPLETED","sponsor":"Johns Hopkins University","startDate":"2018-06-19","conditions":"Progressive Multiple Sclerosis","enrollment":59},{"nctId":"NCT04516096","phase":"PHASE2, PHASE3","title":"A Compassionate Use Protocol of AMX0035 for Treatment of Patients With Amyotrophic Lateral Sclerosis (ALS)","status":"COMPLETED","sponsor":"Amylyx Pharmaceuticals Inc.","startDate":"2020-11-22","conditions":"Amyotrophic Lateral Sclerosis","enrollment":28},{"nctId":"NCT05753852","phase":"PHASE3","title":"Open Label Extension of TUDCA-ALS Study","status":"UNKNOWN","sponsor":"Humanitas Mirasole SpA","startDate":"2021-10-25","conditions":"Amyotrophic Lateral Sclerosis","enrollment":184},{"nctId":"NCT05286372","phase":"","title":"An Intermediate Size Expanded Access Protocol of AMX0035 for ALS","status":"APPROVED_FOR_MARKETING","sponsor":"Amylyx Pharmaceuticals Inc.","startDate":"","conditions":"Amyotrophic Lateral Sclerosis","enrollment":""},{"nctId":"NCT03462940","phase":"NA","title":"Effects of TUDCA on Endothelial Function in Type 2 DM","status":"TERMINATED","sponsor":"Boston University","startDate":"2018-04-02","conditions":"Diabetes Mellitus, Type 2, Insulin Response, Endothelial Dysfunction","enrollment":2},{"nctId":"NCT04727320","phase":"EARLY_PHASE1","title":"The Clinical Application of Tauroursodeoxycholic Acid in Patients With Liver Fibrosis.","status":"UNKNOWN","sponsor":"The First Affiliated Hospital with Nanjing Medical University","startDate":"2021-03-05","conditions":"Liver Cirrhosis","enrollment":60},{"nctId":"NCT01855360","phase":"PHASE1, PHASE2","title":"Doxycycline and TUDCA in Patients With Transthyretin Amyloid Cardiomyopathy","status":"COMPLETED","sponsor":"Brigham and Women's Hospital","startDate":"2013-06","conditions":"Amyloidosis; Heart (Manifestation), Senile Cardiac Amyloidosis","enrollment":40},{"nctId":"NCT01877551","phase":"NA","title":"Tauroursodeoxycholic Acid for Protease-inhibitor Associated Insulin Resistance","status":"COMPLETED","sponsor":"Washington University School of Medicine","startDate":"2013-09","conditions":"HIV Related Insulin Resistance, Protease Inhibitor Related Insulin Resistance, Endoplasmic Reticulum Stress","enrollment":27},{"nctId":"NCT03878654","phase":"PHASE1","title":"Trial of Tauroursodeoxycholic Acid (TUDCA) in Asthma","status":"TERMINATED","sponsor":"University of Vermont","startDate":"2019-01-10","conditions":"Asthma","enrollment":11},{"nctId":"NCT00771901","phase":"NA","title":"Effect of Endoplasmic Reticulum Stress on Metabolic Function","status":"COMPLETED","sponsor":"Washington University School of Medicine","startDate":"2008-02","conditions":"Insulin Resistance, Diabetes, Obesity","enrollment":101},{"nctId":"NCT03331432","phase":"NA","title":"Effects of Dietary Supplement Tauroursodeoxycholic Acid on Vascular Function","status":"COMPLETED","sponsor":"University of Missouri-Columbia","startDate":"2015-10-28","conditions":"Type 2 Diabetes Mellitus","enrollment":8},{"nctId":"NCT01998451","phase":"PHASE4","title":"The Discovery of the Double Sphincter in Gallbladder","status":"UNKNOWN","sponsor":"The First Affiliated Hospital of Guangzhou Medical University","startDate":"2012-12","conditions":"Gallstone","enrollment":150},{"nctId":"NCT01171859","phase":"PHASE2","title":"Safety, Efficacy and Pharmacokinetics of Doxycycline Plus Tauroursodeoxycholic Acid in Transthyretin Amyloidosis","status":"COMPLETED","sponsor":"Fondazione IRCCS Policlinico San Matteo di Pavia","startDate":"2010-07","conditions":"Transthyretin Amyloidosis","enrollment":40},{"nctId":"NCT00004410","phase":"NA","title":"Randomized Study of Tauroursodeoxycholic Acid in Prophylactic Therapy of Total Parenteral Nutrition Associated Cholestasis in Infants","status":"COMPLETED","sponsor":"Children's Hospital Medical Center, Cincinnati","startDate":"1998-06","conditions":"Cholestasis","enrollment":50},{"nctId":"NCT00004441","phase":"NA","title":"Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis","status":"COMPLETED","sponsor":"Children's Hospital Medical Center, Cincinnati","startDate":"1997-09","conditions":"Cystic Fibrosis","enrollment":39},{"nctId":"NCT00877604","phase":"PHASE2","title":"Efficacy and Tolerability of Tauroursodeoxycholic Acid in Amyotrophic Lateral Sclerosis","status":"COMPLETED","sponsor":"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta","startDate":"2008-06","conditions":"Amyotrophic Lateral Sclerosis","enrollment":34},{"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":"NCT00514774","phase":"PHASE1","title":"Ursodiol in Huntington's Disease","status":"UNKNOWN","sponsor":"Oregon Health and Science University","startDate":"2007-08","conditions":"Huntington Disease","enrollment":21}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1057,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Taurolite","TUDCA","Tudcabil","TUDCA,Tudcabil, Taurolite","taurolite"],"phase":"marketed","status":"active","brandName":"Tauroursodeoxycholic Acid","genericName":"Tauroursodeoxycholic Acid","companyName":"Johns Hopkins University","companyId":"johns-hopkins-university","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Tauroursodeoxycholic acid (TUDCA) is a bile acid that reduces endoplasmic reticulum stress and promotes cell survival by stabilizing mitochondrial function and inhibiting apoptosis pathways. Used for Progressive familial intrahepatic cholestasis (PFIC), Cerebrotendinous xanthomatosis (CTX), Neurodegenerative diseases (investigational).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":3,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}