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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.

  • RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)

    NCT04620733 · start 2021-04-21

    Registered record
    Registry ID
    NCT04620733
    Conditions
    Primary Biliary Cholangitis
    Interventions
    Seladelpar 10 mg; Placebo; Seladelpar 5 mg
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2021-04-21
    Completion
    2023-08-11
    Enrolment
    193

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

    ConditionPrimary Biliary Cholangitis
    InterventionSeladelpar 10 mg; Placebo; Seladelpar 5 mg
    PhasePhase 3
    Registry statusCompleted
  • Efficacy of 24 Month of Bezafibrate in Primary Sclerosing Cholangitis With Persistent Cholestasis Despite Ursodeoxycholic Acid Therapy

    NCT04309773 · start 2021-04-06

    Registered record
    Registry ID
    NCT04309773
    Conditions
    Primary Sclerosing Cholangitis; Cholestasis
    Interventions
    Bezafibrate (400mg) in addition to standard 15-20 mg/kg/jour UDCA therapy; Placebo of Bezafibrate in addition to standard UDCA therapy
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Unknown
    Start
    2021-04-06
    Completion
    2025-03
    Enrolment
    104

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

    ConditionPrimary Sclerosing Cholangitis; Cholestasis
    InterventionBezafibrate (400mg) in addition to standard 15-20 mg/kg/jour UDCA therapy; Placebo of Bezafibrate in addition to standard UDCA therapy
    PhasePhase 3
    Registry statusUnknown
  • Effect of UDCA on the New Onset Diabetes and Glucose Intolerance Induced by Statin

    NCT05500937 · start 2021-03-01

    Registered record
    Registry ID
    NCT05500937
    Conditions
    Diabetes Mellitus
    Interventions
    UDCA
    Study type
    INTERVENTIONAL
    Phase
    Phase 2 / Phase 3
    Registry status
    Unknown
    Start
    2021-03-01
    Completion
    2024-12-31
    Enrolment
    1,000

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

    ConditionDiabetes Mellitus
    InterventionUDCA
    PhasePhase 2 / Phase 3
    Registry statusUnknown
  • Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II

    NCT04617561 · start 2020-11-01

    Registered record
    Registry ID
    NCT04617561
    Conditions
    Hepatitis, Autoimmune; Primary Biliary Cholangitis
    Interventions
    Ursodeoxycholic acid; Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone)
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Unknown
    Start
    2020-11-01
    Completion
    2022-11-01
    Enrolment
    90

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

    ConditionHepatitis, Autoimmune; Primary Biliary Cholangitis
    InterventionUrsodeoxycholic acid; Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone)
    PhasePhase 4
    Registry statusUnknown
  • Effectiveness and Safety in Administrating CNU® Capsule to Refractory Functional Dyspepsia Patients

    NCT03844100 · start 2019-11-01

    Registered record
    Registry ID
    NCT03844100
    Conditions
    Dyspepsia; Biliary Dysplasia
    Interventions
    efficacy and safety of CNU® Capsule
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Completed
    Start
    2019-11-01
    Completion
    2021-08-04
    Enrolment
    37

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

    ConditionDyspepsia; Biliary Dysplasia
    Interventionefficacy and safety of CNU® Capsule
    PhasePhase 1 / Phase 2
    Registry statusCompleted
  • Trial of Ursodeoxycholic Acid (UDCA) for Parkinson's Disease: The "UP" Study

    NCT03840005 · start 2018-12-18

    Registered record
    Registry ID
    NCT03840005
    Conditions
    Parkinson's Disease
    Interventions
    Ursonorm
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2018-12-18
    Completion
    2021-05-13
    Enrolment
    31

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

    ConditionParkinson's Disease
    InterventionUrsonorm
    PhasePhase 2
    Registry statusCompleted
  • ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

    NCT03602560 · start 2018-10-01

    Registered record
    Registry ID
    NCT03602560
    Conditions
    Primary Biliary Cholangitis
    Interventions
    seladelpar 5-10 mg; seladelpar 10 mg; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2018-10-01
    Completion
    2020-02-16
    Enrolment
    265

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

    ConditionPrimary Biliary Cholangitis
    Interventionseladelpar 5-10 mg; seladelpar 10 mg; Placebo
    PhasePhase 3
    Registry statusCompleted
  • Ursodeoxycholic Acid (UDCA) for Hepatic Sarcoidosis

    NCT03602976 · start 2018-08-20

    Registered record
    Registry ID
    NCT03602976
    Conditions
    Hepatic Sarcoidosis, Elevated Alkaline Phosphatase
    Interventions
    Ursodeoxycholic Acid
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2018-08-20
    Completion
    2022-01-12
    Enrolment
    7

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

    ConditionHepatic Sarcoidosis, Elevated Alkaline Phosphatase
    InterventionUrsodeoxycholic Acid
    PhasePhase 2
    Registry statusTerminated
  • Genetic Polymorphisms of ABCB11 and ABCB4 in Women With Intrahepatic Cholestasis of Pregnancy (ICP) and in Their First Degree Relatives

    NCT04281082 · start 2018-01-01

    Registered record
    Registry ID
    NCT04281082
    Conditions
    Cholestasis of Pregnancy
    Interventions
    ursofalk
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Unknown
    Start
    2018-01-01
    Completion
    2022-01-31
    Enrolment
    50

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

    ConditionCholestasis of Pregnancy
    Interventionursofalk
    PhaseNot recorded
    Registry statusUnknown
  • Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol.

    NCT03226067 · start 2017-06-26

    Registered record
    Registry ID
    NCT03226067
    Conditions
    Primary Biliary Cirrhosis
    Interventions
    GKT137831; Placebo oral capsule
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2017-06-26
    Completion
    2019-04-11
    Enrolment
    111

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

    ConditionPrimary Biliary Cirrhosis
    InterventionGKT137831; Placebo oral capsule
    PhasePhase 2
    Registry statusCompleted
  • Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid

    NCT03124108 · start 2017-04-05

    Registered record
    Registry ID
    NCT03124108
    Conditions
    Primary Biliary Cholangitis (PBC)
    Interventions
    Elafibranor 80 mg; Elafibranor 120 mg; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2017-04-05
    Completion
    2018-10-31
    Enrolment
    45

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

    ConditionPrimary Biliary Cholangitis (PBC)
    InterventionElafibranor 80 mg; Elafibranor 120 mg; Placebo
    PhasePhase 2
    Registry statusCompleted
  • Ursodeoxycholic Acid for Rhegmatogenous Retinal Detachment

    NCT02841306 · start 2016-07

    Registered record
    Registry ID
    NCT02841306
    Conditions
    Rhegmatogenous Retinal Detachment
    Interventions
    Ursodeoxycholic Acid
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2016-07
    Completion
    2017-09
    Enrolment
    26

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

    ConditionRhegmatogenous Retinal Detachment
    InterventionUrsodeoxycholic Acid
    PhasePhase 1
    Registry statusCompleted
  • Impact of Ursodeoxycholic Acid, Silymarin, Antioxidants and Colchicine on Fibrosis Regression in HCV After SVR

    NCT03659058 · start 2016-03-02

    Registered record
    Registry ID
    NCT03659058
    Conditions
    Fibrosis, Liver
    Interventions
    silymarin; Ursodeoxycholic Acid; Antioxidants; Colchicine; FOLLOW UP
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Completed
    Start
    2016-03-02
    Completion
    2018-08-01
    Enrolment
    400

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

    ConditionFibrosis, Liver
    Interventionsilymarin; Ursodeoxycholic Acid; Antioxidants; Colchicine +1 more
    PhaseNot applicable
    Registry statusCompleted
  • Probiotics for Gallstones in Post-bariatric Surgery Patients:A Prospective Randomized Trial

    NCT03247101 · start 2016-02

    Registered record
    Registry ID
    NCT03247101
    Conditions
    Clostridium Butyricum Miyairi; Gallstones; Gastrointestinal Quality of Life Index
    Interventions
    Miyarisan-BM (Clostridium Butyricum Miyairi); Urso group; Biotase group
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Unknown
    Start
    2016-02
    Completion
    2017-12
    Enrolment
    180

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

    ConditionClostridium Butyricum Miyairi; Gallstones; Gastrointestinal Quality of Life Index
    InterventionMiyarisan-BM (Clostridium Butyricum Miyairi); Urso group; Biotase group
    PhaseNot applicable
    Registry statusUnknown
  • Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid

    NCT02823366 · start 2016-01

    Registered record
    Registry ID
    NCT02823366
    Conditions
    Primary Biliary Cirrhosis
    Interventions
    Fenofibrate; UDCA
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Unknown
    Start
    2016-01
    Completion
    2023-12
    Enrolment
    104

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

    ConditionPrimary Biliary Cirrhosis
    InterventionFenofibrate; UDCA
    PhasePhase 3
    Registry statusUnknown