Back to discover
Drug

Ursodeoxycholic Acid

In clinical development
ClassBile acid receptor FXR agonistEmerging researchLate-stage development
Also known as 3 alpha, 7 beta dihydroxy-5 beta cholanic acid, 3alpha,7beta-Dihydroxy-5beta-cholan-24-oic acid, Acide ursodesoxycholique, Acido ursodeossicolico+10 more

3 alpha, 7 beta dihydroxy-5 beta cholanic acid, 3alpha,7beta-Dihydroxy-5beta-cholan-24-oic acid, Acide ursodesoxycholique, Acido ursodeossicolico, Acido ursodeoxicolico, Acidum ursodeoxycholicum, Actigall, Reltone, UDCA, UDCA - ursodeoxycholic acid, URSODIOL, Urso, Urso Forte, (3alpha,5beta,7beta)-3,7-dihydroxycholan-24-oic acid.

RxNorm11065ChEMBLCHEMBL1551ATCA05AA02UNII724L30Y2QR
2
Research papers
23
Active clinical trials
Bile acid receptor
Primary target
Latest activity
beta

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

Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance: A Randomized Controlled Clinical Trial

Clinical trial2026-06-30Results expected Q4 2026 · ClinicalTrials.gov

Protective Effect of Perioperative Ursodeoxycholic Acid Intervention Against Ischemia-Reperfusion Injury During Partial Nephrectomy: A Single-Center, Prospective, Double-Blind, Randomized Controlled Trial (PURIFY Trial)

Clinical trial2026-06-29Results expected Q4 2026 · ClinicalTrials.gov

Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration in Adult Living Donor Liver Transplant (LDLT) Recipients : A Placebo Controlled Randomised Trial

Clinical trial2026-06-23Results expected Q4 2027 · ClinicalTrials.gov

Efficacy of Ursodeoxycholic Acid Versus Corticosteroids for the Treatment of Cholestatic Hepatitis Secondary to Immunotherapy: A Multicenter, Controlled, Randomized, Open Trial

Clinical trial2026-06-18Results expected Q3 2028 · ClinicalTrials.gov

Efficacy and Safety of Oral Zinc Sulphate and Ursodeoxycholic Acid as Adjuvants to Phototherapy in Management of Neonatal Non-Hemolytic Unconjugated Hyperbilirubinemia

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

PREVENTION OF RECURRENCE OF CLOSTRIDIOIDES DIFFICILE COLITIS WITH URSODEOXYCHOLIC ACID (UCDA) AS A SUPPLEMENT TO STANDARD THERAPY

Clinical trial2026-04-29Results expected Q2 2027 · ClinicalTrials.gov

A Prospective Open-label Randomized Controlled Trial , Evaluating the Efficacy of Ursodeoxycholic Acid (UDCA) as an Adjuvant to Phototherapy in Neonates With Indirect Hyperbilirubinemia

Clinical trial2026-04-21Results expected Q1 2027 · ClinicalTrials.gov

Comparative Evaluation of Oral Ursodeoxycholic Acid in Reducing Bilirubin Levels Among Patients With Acute Viral Hepatitis

Clinical trial2026-04-13Results expected Q4 2026 · ClinicalTrials.gov

The Role of Secondary Bile Acids in Intestinal Inflammation

Clinical trial2026-03-02Terminated · ClinicalTrials.gov

A dysregulated bile acid-gut microbiota axis contributes to obesity susceptibility.

Research2020-05-11EBioMedicine

Diversification of host bile acids by members of the gut microbiota.

Research2019-10-09Gut microbes

Profile

Identifiers & mechanism

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

Canonical name
Ursodeoxycholic Acid
Aliases & brands
3 alpha, 7 beta dihydroxy-5 beta cholanic acid3alpha,7beta-Dihydroxy-5beta-cholan-24-oic acidAcide ursodesoxycholiqueAcido ursodeossicolicoAcido ursodeoxicolicoAcidum ursodeoxycholicumActigallReltoneUDCAUDCA - ursodeoxycholic acidURSODIOLUrsoUrso Forte(3alpha,5beta,7beta)-3,7-dihydroxycholan-24-oic acid
RxNorm CUI
11065
ChEMBL ID
CHEMBL1551
ATC codes
A05AA02
UNII
724L30Y2QR
Primary mechanism
Bile acid receptor FXR agonist

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Bile acid receptor
NR1H4 · Q96RI1
AGONISTBile acid receptor FXR agonist

Clinical trials

120 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
120
registered trials across all phases
LATEST COMPLETION 2025
23
Active studies
20
Recruiting
76
Late-stage (III+)
51
Completed
46
Discontinued
PHASE DISTRIBUTIONn = 120
Early Phase 12Phase 117Phase 1 / 23Phase 222Phase 2 / 313Phase 320Phase 420Phase N / A23

Late-stage studies

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

Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia: A Multicenter, Randomized, Placebo-Controlled Trial

RecruitingPH IVYongquan Shin=1962026

Efficacy and Safety of Oral Zinc Sulphate and Ursodeoxycholic Acid as Adjuvants to Phototherapy in Management of Neonatal Non-Hemolytic Unconjugated Hyperbilirubinemia

RecruitingPH IVAmira Adel Foulyn=802026

Prophylactic Effect of Nirmatrelvir/Ritonavir and Ursodeoxycholic Acid on Reducing Complications After Cardiac Surgery During COVID-19 Pandemics: A Prospective, Randomized Controlled, Multicenter Trial

Unknown statusPH IVChina National Center for Cardiovascular Diseasesn=4912026

Hepatoprotective Measures for Children at High Risk of Non Alcoholic Fatty Liver Disease

Active, not recruitingPH IVAin Shams Universityn=2002025

Randomised Controlled Trial of Gestational Treatment With Ursodeoxycholic Acid Compared to Metformin to Reduce Effects of Diabetes Mellitus

Active, not recruitingPH IVKing's College Londonn=642025

Recent completions

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

A Single Center, Randomized Controlled, Pilot Study of Fenofibrate and Ursodeoxycholic Acid in the Treatment of Newly Diagnosed Primary Biliary Cholangitis

CompletedPH IHan Yingn=302025

Phase I Study of Ursodeoxycholic Acid (Ursodiol)in Combination With 5-Fluorouracil, Leucovorin, Oxaliplatin and Bevacizumab in Patients With Metastatic Colorectal Cancer

CompletedPH ICity of Hope Medical Centern=112025

Effect of Ursodeoxycholic Acid Supplementation on Liver Regeneration on Right Lobe Donor Hepatectomy: An Open Label Randomised Trial

CompletedN/AInstitute of Liver and Biliary Sciences, Indian=902024

Evaluating the Effect of Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis in Egypt

CompletedPH IITanta Universityn=602024

A Double-blind, Randomized Phase 3 Trial Evaluating the Efficacy and Safety of Obecholic Acid Versus Placebo, in Combination with Ursodeoxycholic Acid in Primary Biliary Cirrhosis Patients with an Inadequate Response to Ursodeoxycholic Acid

CompletedPH IIIShanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.n=1002024

A Randomized, Double-blind, Multicenter, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of Obeticholic Acid in Patients With Primary Biliary Cholangitis

CompletedPH IIINanjing Chia-tai Tianqing Pharmaceuticaln=1082024

Research activity

2 papers

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

Major research themes2
Gastrointestinal Microbiome2Bile Acids and Salts1
Journals, researchers & institutions
Top journals
  • EBioMedicine1
  • Gut microbes1
Leading researchers
  • Bian Z1
  • Ge K1
  • Han X1
  • Huang F1
  • Jia W1
  • Li M1
  • Qu C1
  • Rajani C1
Leading institutions
free-text, unnormalised
  • College of Veterinary Medicine1
  • School of Chinese Medicine1
  • Shanghai Key Laboratory of Diabetes Mellitus and Centre for Translational Medicine1
  • University of Hawaii Cancer Centre1

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).

Chenodeoxycholic Acid

Acts on the same molecular target as Ursodeoxycholic Acid, with 3 overlapping disease areas.

Shared target3 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