15 completed, 4 unknown, 3 not yet recruiting, 3 recruiting. 13 Phase 2, 7 Not applicable, 5 Phase 3, 4 Phase 1, 1 Early Phase 1.
Follow ursodoxicoltaurine: new trials by email Literature Review of ursodoxicoltaurine trials Research Report on ursodoxicoltaurine
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Integrative Liver-Targeted Therapy for Diabetic Macular Edema: Using "Tauroursodeoxycholate" or Traditional Chinese Medicine. Tauroursodeoxycholate (TUDCA), Traditional Chinese Medicine (mQJDHW), placebo capsule - Diabetic Macular Edema (DME) | Phase 2 | Withdrawn | University of Alabama at Birmingham | 2026-10-01 | 2026-10-09 | |
| TUDCA in High-Risk Lactating Mothers Identified by Early Postpartum Milk Hydrophobicity Index tauroursodeoxycholic acid (TUDCA), Placebo - Metabolic Dysfunction-Associated Steatotic Liver Disease Infant Development | Phase 2 | Not yet recruiting | Peking University First Hospital | 80 | 2026-04-02 | 2026-04-08 |
| A Platform Trial for Personalized and Adaptive Therapies in Hepatocellular Carcinoma Lenvatinib, Regorafenib (BAY 73-4506), Tislelizumab+TKI - Hepato Cellular Carcinoma (HCC) | Phase 2 | Recruiting | Fudan University | 350 | 2026-01-19 | 2026-04-21 |
| Tauroursodeoxycholic Acid (TUDCA) Plus Camrelizumab and Regorafenib in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab tauroursodeoxycholic acid (TUDCA), Camrelizumab, Regorafenib - Hepatocellular Carcinoma (HCC) | Phase 2 | Recruiting | Fudan University | 141 | 2025-08-14 | 2025-08-17 |
| Tauroursodeoxycholic Acid Combined With PD-1/PD-L1 Immunotherapy in Advanced Hepatocellular Carcinoma: A Prospective Study TUDCA (Tauroursodeoxycholic Acid) Supplementation, Immune checkpoint inhibitor (ICI) - Hepatocellular Carcinoma | Phase 2 | Not yet recruiting | Tongji Hospital | 300 | 2025-07-30 | 2025-07-15 |
| Effect of Oral Supplements for Influenza Vaccine Response ARA (Arachidonic Acid) Supplementation, TUDCA (Tauroursodeoxycholic Acid) Supplementation, Placebo Supplementation - Influenza Vaccine Response | Not applicable | Not yet recruiting | Tsinghua University | 45 | 2025-02-01 | 2025-02-14 |
| Targeting Endoplasmic Reticulum Stress in Human Hypertension TUDCA, Placebo - Hypertension | Phase 1 / Phase 2 | Recruiting | University of North Texas Health Science Center | 70 | 2023-08-15 | 2025-03-28 |
| Open Label Extension of TUDCA-ALS Study Tauroursodeoxycholic Acid - Amyotrophic Lateral Sclerosis | Phase 3 | Unknown | Humanitas Mirasole SpA | 184 | 2021-10-25 | 2023-03-03 |
| The Clinical Application of Tauroursodeoxycholic Acid in Patients With Liver Fibrosis. Tauroursodeoxycholic acid, Placebo - Liver Cirrhosis | Early Phase 1 | Unknown | The First Affiliated Hospital with Nanjing Medical University | 60 | 2021-03-05 | 2021-03-09 |
| Safety and Efficacy of TUDCA as add-on Treatment in Patients Affected by ALS Tauroursodeoxycholic Acid, Placebo - Amyotrophic Lateral Sclerosis (ALS) | Phase 3 | Unknown | Humanitas Mirasole SpA | 337 | 2019-02-22 | 2023-07-10 |
| Trial of Tauroursodeoxycholic Acid (TUDCA) in Asthma Tauroursodeoxycholic Acid - Asthma | Phase 1 | Terminated | University of Vermont | 11 | 2019-01-10 | 2019-09-16 |
| Study to Assess the Safety and Biological Activity of AMX0035 for the Treatment of Alzheimer's Disease AMX0035, Placebo - Alzheimer Disease | Phase 2 | Completed | Amylyx Pharmaceuticals Inc. | 95 | 2018-09-14 | 2025-03-07 |
| A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis Tauroursodeoxycholic Acid, Placebo oral capsule - Progressive Multiple Sclerosis | Phase 1 / Phase 2 | Completed | Johns Hopkins University | 59 | 2018-06-19 | 2023-05-03 |
| A Study of Doxycycline and Tauroursodeoxycholic Acid (Doxy/TUDCA) Plus Standard Supportive Therapy Versus Standard Supportive Therapy Alone in Cardiac Amyloidosis Caused by Transthyretin Doxycycline and tauroursodeoxycholic acid, Standard of care - TTR Cardiac Amyloidosis | Phase 3 | Completed | Fondazione IRCCS Policlinico San Matteo di Pavia | 102 | 2018-04-11 | 2024-07-11 |
| Effects of TUDCA on Endothelial Function in Type 2 DM Tauroursodeoxycholic acid - Diabetes Mellitus, Type 2, Insulin Response | Not applicable | Terminated | Boston University | 2 | 2018-04-02 | 2021-03-24 |
| Open Label Extension Study of AMX0035 in Patients With ALS AMX0035 - Amyotrophic Lateral Sclerosis, ALS | Phase 2 | Completed | Amylyx Pharmaceuticals Inc. | 90 | 2018-03-29 | 2025-08-13 |
| Effects of Dietary Supplement Tauroursodeoxycholic Acid on Vascular Function Tauroursodeoxycholic acid, Placebo - Type 2 Diabetes Mellitus | Not applicable | Completed | University of Missouri-Columbia | 8 | 2015-10-28 | 2018-02-19 |
| Tauroursodeoxycholic Acid (TUDCA) in New-Onset Type 1 Diabetes Tauroursodeoxycholic Acid (TUDCA), Sugar Pill (placebo) - Type 1 Diabetes | Phase 2 | Completed | Robin Goland, MD | 20 | 2015-08-01 | 2025-06-05 |
| Tauroursodeoxycholic Acid for Protease-inhibitor Associated Insulin Resistance Tauroursodeoxycholic acid, Placebo tablet - HIV Related Insulin Resistance, Protease Inhibitor Related Insulin Resistance | Not applicable | Completed | Washington University School of Medicine | 27 | 2013-09-01 | 2020-01-27 |
| Doxycycline and TUDCA in Patients With Transthyretin Amyloid Cardiomyopathy Tauroursodeoxycholic Acid and Doxycycline - Amyloidosis; Heart (Manifestation), Senile Cardiac Amyloidosis | Phase 1 / Phase 2 | Completed | Brigham and Women's Hospital | 40 | 2013-06-01 | 2020-12-04 |
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Amyotrophic Lateral Sclerosis (4) · Diabetes Mellitus, Type 2 (3) · Alzheimer Disease (2) · Amyloidosis (2) · Amyloidosis, Hereditary, Transthyretin-Related (2) · Carcinoma, Hepatocellular (2) · Insulin Resistance (2) · Rare Diseases (2) · Amyloid Neuropathies, Familial (1) · Amyloidosis, Familial (1) · Asthma (1) · Cholestasis (1) · Cystic Fibrosis (1) · Diabetes Mellitus (1) · Diabetes Mellitus, Type 1 (1)
Amylyx Pharmaceuticals Inc. (2) · Children's Hospital Medical Center, Cincinnati (2) · Fondazione IRCCS Policlinico San Matteo di Pavia (2) · Fudan University (2) · Humanitas Mirasole SpA (2) · Washington University School of Medicine (2) · Beijing Friendship Hospital (1) · Beijing Trendful Kangjian Medical Information Consulting Limited Company (1) · Boston University (1) · Brigham and Women's Hospital (1) · Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta (1) · Johns Hopkins University (1) · Peking University First Hospital (1) · Robin Goland, MD (1) · The First Affiliated Hospital of Guangzhou Medical University (1)
United States (13) · China (7) · Italy (6) · Belgium (2) · France (2) · Germany (2) · Ireland (2) · Netherlands (2) · United Kingdom (2)
Alberto Albanese, MD (2) · Cheng Wei Chen, Doctor (1) · Chengyi Sun, M.D. (1) · David Kaminsky, MD (1) · Dominic N. Reeds, M.D. (1) · Dong Ji Jia, Doctor (1) · Giampaolo Merlini, MD (1) · Guang Feng Shi, Doctor (1) · Gui Qiang Wang, Doctor (1) · Guo Feng Chen, Doctor (1) · He Ping Hu, Doctor (1) · Hong Tang, Doctor (1) · Hui Ping Yan, Doctor (1) · James Heubi (1) · Jaume Padilla, PhD (1)
PMID 20522594, PMID 25664595, PMID 31757001, PMID 33063909, PMID 34071550, PMID 34547326, PMID 34585527, PMID 35365570, PMID 35508892, PMID 35577511, PMID 35928688, PMID 35996998, PMID 36633259, PMID 37941072, PMID 38053196, PMID 38058259, PMID 38664391, PMID 39131742, PMID 39340066, PMID 39447576, PMID 39915447
2018 (1), R01DK096982 (1)