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Drug

Ursodoxicoltaurine

In clinical development
Emerging researchLate-stage development
Also known as Relyvrio, TAURURSODIOL, TUDCA, Tauroursodeoxycholic acid+2 more

Relyvrio, TAURURSODIOL, TUDCA, Tauroursodeoxycholic acid, Tauroursodesoxycholic acid, Ursodeoxycholyltaurine.

RxNorm2613950ChEMBLCHEMBL272427ATCA05AA05UNII60EUX8MN5X
2
Research papers
3
Active clinical trials
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Maternal Oral TUDCA in High-Risk Lactating Mother-Infant Dyads Identified by Early Postpartum Breast Milk Bile Acid Hydrophobicity Index

Clinical trial2026-05-30Primary completion · ClinicalTrials.gov

Tauroursodeoxycholic Acid (TUDCA) Plus Camrelizumab and Regorafenib in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab: A Randomized, Phase 2 Study.

Clinical trial2025-08-17Results expected Q3 2027 · ClinicalTrials.gov

Clinical Investigation of Efficacy of Tauroursodeoxycholic Acid (TUDCA) to Enhance Pancreatic Beta Cell Survival In Type 1 Diabetes by Reducing Endoplasmic Reticulum Stress

Clinical trial2025-06-05Results posted · ClinicalTrials.gov

Open Label Extension Study to Investigate Long Term Safety, Tolerability and Efficacy of Tauroursodeoxycholic Acid in Patients With ALS Who Completed the TUDCA-ALS Study

Clinical trial2025-03-31Primary completion · ClinicalTrials.gov

Targeting Endoplasmic Reticulum Stress in Human Hypertension

Clinical trial2025-03-28Results expected Q4 2028 · ClinicalTrials.gov

Safety and Efficacy of Tauroursodeoxycholic (TUDCA) as add-on Treatment in Patients Affected by Amyotrophic Lateral Sclerosis (ALS)

Clinical trial2023-12-31Primary completion · ClinicalTrials.gov

A Phase 1/2 Trial of Tauroursodeoxycholic Acid Supplementation in Progressive MS Patients

Clinical trial2023-05-03Results posted · ClinicalTrials.gov

The Clinical Application of Tauroursodeoxycholic Acid in Patients With Liver Fibrosis.

Clinical trial2021-07-30Primary completion · ClinicalTrials.gov

Gut microbiota mediates intermittent-fasting alleviation of diabetes-induced cognitive impairment.

Research2020-02-18Nature communications

Tauroursodeoxycholic Acid for Protease-inhibitor Associated Insulin Resistance

Clinical trial2020-01-27Results posted · ClinicalTrials.gov

Tauroursodeoxycholate-Bile Acid with Chaperoning Activity: Molecular and Cellular Effects and Therapeutic Perspectives.

Research2019-11-20Cells

Trial of Tauroursodeoxycholic Acid (TUDCA) in Asthma

Clinical trial2019-09-11Terminated · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Ursodoxicoltaurine
Aliases & brands
RelyvrioTAURURSODIOLTUDCATauroursodeoxycholic acidTauroursodesoxycholic acidUrsodeoxycholyltaurine
RxNorm CUI
2613950
ChEMBL ID
CHEMBL272427
ATC codes
A05AA05
UNII
60EUX8MN5X

Clinical trials

16 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
16
registered trials across all phases
LATEST COMPLETION 2022
3
Active studies
3
Recruiting
8
Late-stage (III+)
8
Completed
5
Discontinued
PHASE DISTRIBUTIONn = 16
Early Phase 11Phase 11Phase 1 / 22Phase 24Phase 33Phase 41Phase N / A4

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

The Discovery of the Double Sphincter in Gallbladder

Unknown statusPH IVThe First Affiliated Hospital of Guangzhou Medical Universityn=1502018

Open Label Extension Study to Investigate Long Term Safety, Tolerability and Efficacy of Tauroursodeoxycholic Acid in Patients With ALS Who Completed the TUDCA-ALS Study

Unknown statusPH IIIHumanitas Mirasole SpAn=1842025

Safety and Efficacy of Tauroursodeoxycholic (TUDCA) as add-on Treatment in Patients Affected by Amyotrophic Lateral Sclerosis (ALS)

Unknown statusPH IIIHumanitas Mirasole SpAn=3372023

A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical Trial to Investigate Safety and Efficacy of Tauroursodeoxycholic Acid Capsules in Treatment of Adult Primary Biliary Cirrhosis

CompletedPH IIIBeijing Friendship Hospitaln=2162013

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 1/2 Trial of Tauroursodeoxycholic Acid Supplementation in Progressive MS Patients

CompletedPH I/IIJohns Hopkins Universityn=592022

Clinical Investigation of Efficacy of Tauroursodeoxycholic Acid (TUDCA) to Enhance Pancreatic Beta Cell Survival In Type 1 Diabetes by Reducing Endoplasmic Reticulum Stress

CompletedPH IIRobin Goland, MDn=202019

Tauroursodeoxycholic Acid for Protease-inhibitor Associated Insulin Resistance

CompletedN/AWashington University School of Medicinen=272018

Effect of Endoplasmic Reticulum Stress on Metabolic Function

CompletedN/AWashington University School of Medicinen=1012014

A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical Trial to Investigate Safety and Efficacy of Tauroursodeoxycholic Acid Capsules in Treatment of Adult Primary Biliary Cirrhosis

CompletedPH IIIBeijing Friendship Hospitaln=2162013

A Randomized, Double-blind Multicenter Pilot Study vs. Placebo for the Evaluation of Efficacy and Tolerability of Tauroursodeoxycholic Acid Administered by Oral Route as Add on Treatment in Patients Affected by Amyotrophic Lateral Sclerosis

CompletedPH IIFondazione I.R.C.C.S. Istituto Neurologico Carlo Bestan=342012

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20192020
Major research themes1
Fasting1
Journals, researchers & institutions
Top journals
  • Cells1
  • Nature communications1
Leading researchers
  • Cadenas E1
  • Chu C1
  • Dai X1
  • Hui Y1
  • Jin X1
  • Kusaczuk M1
  • Lan L1
  • Liu X1
Leading institutions
free-text, unnormalised
  • BGI Institute of Applied Agriculture1
  • Center for Innovation in Brain Science and Department of Pharmacology1
  • Chalmers University of Technology1
  • College of Food Science and Engineering1
  • Medical University of Białystok1
  • School of Pharmacy1

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Indolepropionic acid

Studied across 4 of the same disease areas as Ursodoxicoltaurine in the shared literature.

4 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials