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Ursodiol

FDA-approved product (capsule, oral), marketed as Actigall, Urso 250, Urso Forte and 1 more.

Registered studies
50+
Lab records
0
Pathogens at ≥40%
1 of 4

Chemical structure

Chemical structure of Ursodiol
A drawing shows what the molecule is, not what it does.

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Biliary liver cirrhosis
  • Primary biliary cirrhosis

Indications ChEMBL records as approved, from FDA and DailyMed labels. Label ↗

WHO therapeutic group
Bile acids and derivatives
FDA pharmacologic class
Bile Acid FDA label ↗
Anti-infective classification
Not classified as an anti-infective.

Repurposing investigation

This medicine is being investigated here for AI-predicted antimicrobial activity against MRSA. It was surfaced computationally for further investigation; it is not an established treatment for this infection.

AI-predicted activity

AI prediction · nothing measured
  • MRSA69.2% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli22.0% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae26.9% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis31.7% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.

A model’s estimate of laboratory activity against each pathogen species. It is not clinical effectiveness.

Evidence

Clinical and experimental

Documented evidence

Clinical

50+registered studies name this medicine, for any condition. The registry search keeps the first 50, so there may be more. See them below.

Experimental

No evidence found

No laboratory measurement against the four pathogens in the ChEMBL records loaded here.

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

-8.3 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-8.3 kcal/mol

0better fit →-12

Enoyl-ACP reductase (InhA) ↗ (M. tuberculosis)

-8.3 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-8.0 kcal/mol

0better fit →-12

AutoDock Vina, one experimentally solved protein per pathogen. This project’s screening target is -7.0 kcal/mol, its own mark rather than a universal cutoff. A docking score is a structural hypothesis, not proof of binding, and requires experimental validation.

Other medicines to investigate

AI prediction · nothing measured

Other repurposing candidates: approved medicines besides Ursodiol with AI-predicted activity ≥40% against the chosen pathogen, leaving out existing antimicrobials. They are computational candidates for further investigation, not alternatives and not recommendations.

Sorted by AI-predicted activity, high to low. The order is not a ranking of which medicine is better.

Registered studies

A registration describes a study; it does not establish a positive result.

  • Fuzhenghuayu in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis

    NCT02916290 · start 2016-01

    Registered record
    Registry ID
    NCT02916290
    Conditions
    Primary Biliary Cirrhosis
    Interventions
    Fuzhenghuayu; UDCA
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Unknown
    Start
    2016-01
    Completion
    Not recorded
    Enrolment
    200

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPrimary Biliary Cirrhosis
    InterventionFuzhenghuayu; UDCA
    PhasePhase 3
    Registry statusUnknown
  • Efficacy and Safety of Fenofibrate Combined With UDCA in PBC Patients With an Incomplete Biochemical Response to UDCA

    NCT02965911 · start 2016-01

    Registered record
    Registry ID
    NCT02965911
    Conditions
    Primary Biliary Cirrhosis
    Interventions
    Fenofibrate; UDCA
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Withdrawn
    Start
    2016-01
    Completion
    2021-09-08
    Enrolment
    0

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPrimary Biliary Cirrhosis
    InterventionFenofibrate; UDCA
    PhasePhase 1 / Phase 2
    Registry statusWithdrawn
  • Preventive Therapy With Ursodiol to Reduce the Incidence of Gallstones Formation in Patients After Bariatric Surgery

    NCT02319629 · start 2014-12

    Registered record
    Registry ID
    NCT02319629
    Conditions
    Morbid Obesity
    Interventions
    URSODIOL; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Unknown
    Start
    2014-12
    Completion
    2018-12
    Enrolment
    266

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionMorbid Obesity
    InterventionURSODIOL; Placebo
    PhaseNot applicable
    Registry statusUnknown
  • A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of 'Ursa Complex Soft Cap. (UDCA-004)' in Patients With Physical Fatigue.

    NCT02418130 · start 2014-10

    Registered record
    Registry ID
    NCT02418130
    Conditions
    Fatigue
    Interventions
    Ursodeoxycholic acid, taurine, ginsenoside, thiamine, inositol; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2014-10
    Completion
    2015-03
    Enrolment
    166

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionFatigue
    InterventionUrsodeoxycholic acid, taurine, ginsenoside, thiamine, inositol; Placebo
    PhasePhase 4
    Registry statusCompleted
  • Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis

    NCT02078882 · start 2014-09

    Registered record
    Registry ID
    NCT02078882
    Conditions
    Primary Biliary Cirrhosis
    Interventions
    abatacept
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2014-09
    Completion
    2018-10
    Enrolment
    16

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPrimary Biliary Cirrhosis
    Interventionabatacept
    PhasePhase 4
    Registry statusCompleted
  • A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Repeat Doses of GSK2330672 Administration in Subjects With Primary Biliary Cirrhosis (PBC) and Symptoms of Pruritus

    NCT01899703 · start 2014-03-10

    Registered record
    Registry ID
    NCT01899703
    Conditions
    Cholestasis, Intrahepatic
    Interventions
    GSK2330672; Placebo; Ursodeoxycholic acid
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2014-03-10
    Completion
    2015-10-07
    Enrolment
    22

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionCholestasis, Intrahepatic
    InterventionGSK2330672; Placebo; Ursodeoxycholic acid
    PhasePhase 2
    Registry statusCompleted
  • Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis

    NCT02026401 · start 2014-02

    Registered record
    Registry ID
    NCT02026401
    Conditions
    Primary Biliary Cirrhosis
    Interventions
    NGM282; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2014-02
    Completion
    2014-12
    Enrolment
    45

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPrimary Biliary Cirrhosis
    InterventionNGM282; Placebo
    PhasePhase 2
    Registry statusCompleted
  • Ursodeoxycholic Acid as Treatment for Polycystic Liver Disease

    NCT02021110 · start 2013-12

    Registered record
    Registry ID
    NCT02021110
    Conditions
    Polycystic Liver Disease; Polycystic Kidney, Autosomal Dominant
    Interventions
    Ursodeoxycholic Acid
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2013-12
    Completion
    2015-10
    Enrolment
    34

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPolycystic Liver Disease; Polycystic Kidney, Autosomal Dominant
    InterventionUrsodeoxycholic Acid
    PhasePhase 2
    Registry statusCompleted
  • Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis

    NCT01904058 · start 2013-08

    Registered record
    Registry ID
    NCT01904058
    Conditions
    PBC; Primary Biliary Cirrhosis
    Interventions
    LUM001; Placebo; Ursodeoxycholic Acid
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2013-08
    Completion
    2015-04
    Enrolment
    66

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPBC; Primary Biliary Cirrhosis
    InterventionLUM001; Placebo; Ursodeoxycholic Acid
    PhasePhase 2
    Registry statusCompleted
  • Phase 3 Study of Bezafibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis

    NCT01654731 · start 2012-10-15

    Registered record
    Registry ID
    NCT01654731
    Conditions
    PBC
    Interventions
    Bezafibrate; placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2012-10-15
    Completion
    2016-12-31
    Enrolment
    100

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPBC
    InterventionBezafibrate; placebo
    PhasePhase 3
    Registry statusCompleted
  • Safety and Efficacy Study of Doxycycline/UrsoDeoxyCholicAcid on Disease Progression in ATTR Amyloidosis

    NCT02016365 · start 2012-02

    Registered record
    Registry ID
    NCT02016365
    Conditions
    Transthyretin Amyloidosis; Cardiomyopathy
    Interventions
    Doxycycline; Ursodeoxycholic acid
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2012-02
    Completion
    2014-12
    Enrolment
    55

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionTransthyretin Amyloidosis; Cardiomyopathy
    InterventionDoxycycline; Ursodeoxycholic acid
    PhasePhase 2
    Registry statusCompleted
  • Ursodeoxycholic Acid And Cholestasis Of Pregnancy

    NCT01226823 · start 2010-11

    Registered record
    Registry ID
    NCT01226823
    Conditions
    Intrahepatic Cholestasis of Pregnancy
    Interventions
    Ursodeoxycholic Acid; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Withdrawn
    Start
    2010-11
    Completion
    2013-11
    Enrolment
    0

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionIntrahepatic Cholestasis of Pregnancy
    InterventionUrsodeoxycholic Acid; Placebo
    PhasePhase 3
    Registry statusWithdrawn
  • VLCD by Enteral Route for Weight Loss

    NCT01965990 · start 2010-04

    Registered record
    Registry ID
    NCT01965990
    Conditions
    Severe Obesity
    Interventions
    NEP
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2010-04
    Completion
    2013-02
    Enrolment
    364

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionSevere Obesity
    InterventionNEP
    PhaseNot recorded
    Registry statusCompleted
  • Efficacy and Safety Study of TUDCA Compare UDCA to Treatment Chronic Cholestatic Liver Disease-PBC

    NCT01829698 · start 2009-08

    Registered record
    Registry ID
    NCT01829698
    Conditions
    Cholestatic Liver Disease
    Interventions
    tauroursodeoxycholic; ursodeoxycholic acid
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2009-08
    Completion
    2014-02
    Enrolment
    199

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionCholestatic Liver Disease
    Interventiontauroursodeoxycholic; ursodeoxycholic acid
    PhasePhase 3
    Registry statusCompleted
  • Efficacy and Safety Study of Ursodeoxycholic Acid to Treat Chronic Hepatitis C

    NCT00200343 · start 2002-07

    Registered record
    Registry ID
    NCT00200343
    Conditions
    Chronic Hepatitis C
    Interventions
    Ursodeoxycholic acid 150mg / day; Ursodeoxycholic acid 600mg / day; Ursodeoxycholic acid 900mg / day
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2002-07
    Completion
    2004-12
    Enrolment
    596

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionChronic Hepatitis C
    InterventionUrsodeoxycholic acid 150mg / day; Ursodeoxycholic acid 600mg / day; Ursodeoxycholic acid 900mg / day
    PhasePhase 3
    Registry statusCompleted