Skip to content

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.

  • Phase I/II Trial of Human Umbilical Cord Mesenchymal Stromal Cells for UDCA-Refractory Primary Biliary Cholangitis

    NCT07795151 · start 2026-08-31

    Registered record
    Registry ID
    NCT07795151
    Conditions
    Primary Biliary Cholangitis
    Interventions
    Standard background therapy; Placebo; hUC-MSC Dose Level 1; hUC-MSC Dose Level 2
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Not yet recruiting
    Start
    2026-08-31
    Completion
    2030-08-31
    Enrolment
    68

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

    ConditionPrimary Biliary Cholangitis
    InterventionStandard background therapy; Placebo; hUC-MSC Dose Level 1; hUC-MSC Dose Level 2
    PhasePhase 1 / Phase 2
    Registry statusNot yet recruiting
  • Comparing UDCA and Corticosteroids in Immunotherapy Induced Cholestatic Hepatitis

    NCT07378761 · start 2026-06-25

    Registered record
    Registry ID
    NCT07378761
    Conditions
    Immune-Mediated Cholestasis
    Interventions
    UDCA (Ursodeoxycholic acid); Corticosteroids (Reference Treatment)
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2026-06-25
    Completion
    2028-12
    Enrolment
    94

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

    ConditionImmune-Mediated Cholestasis
    InterventionUDCA (Ursodeoxycholic acid); Corticosteroids (Reference Treatment)
    PhasePhase 2
    Registry statusRecruiting
  • Prevention of Recurrence of Clostridioides Difficile Colitis With Ursodeoxycholic Acid (UCDA) as a Supplement to Standard Therapy

    NCT06884748 · start 2026-05-01

    Registered record
    Registry ID
    NCT06884748
    Conditions
    Clostridioides Difficile Infection
    Interventions
    Ursodiol 500 MG
    Study type
    INTERVENTIONAL
    Phase
    Early phase 1
    Registry status
    Not yet recruiting
    Start
    2026-05-01
    Completion
    2028-05-01
    Enrolment
    30

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

    ConditionClostridioides Difficile Infection
    InterventionUrsodiol 500 MG
    PhaseEarly phase 1
    Registry statusNot yet recruiting
  • Fecal Microbiota Transplantation for Primary Sclerosing Cholangitis - Randomized Study Versus Sham Transplantation

    NCT07477782 · start 2026-05

    Registered record
    Registry ID
    NCT07477782
    Conditions
    Primary Sclerosing Cholangitis (PSC); Inflammatory Bowel Disease (IBD)
    Interventions
    Fecal microbiota transplantation (FMT); Sham-transplantation (placebo)
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Not yet recruiting
    Start
    2026-05
    Completion
    2030-05
    Enrolment
    72

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

    ConditionPrimary Sclerosing Cholangitis (PSC); Inflammatory Bowel Disease (IBD)
    InterventionFecal microbiota transplantation (FMT); Sham-transplantation (placebo)
    PhasePhase 2
    Registry statusNot yet recruiting
  • UDCA to Prevent Post-TIPS Hepatic Encephalopathy

    NCT07273734 · start 2026-01-01

    Registered record
    Registry ID
    NCT07273734
    Conditions
    Hepatic Encephalopathy (HE); TIPS
    Interventions
    Ursodeoxycholic Acid (UDCA); Lactulose
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Not yet recruiting
    Start
    2026-01-01
    Completion
    2027-12-31
    Enrolment
    270

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

    ConditionHepatic Encephalopathy (HE); TIPS
    InterventionUrsodeoxycholic Acid (UDCA); Lactulose
    PhaseNot applicable
    Registry statusNot yet recruiting
  • Monitoring the Response of Combination Ursodiol and Seladelpar Treatment

    NCT07122206 · start 2025-08

    Registered record
    Registry ID
    NCT07122206
    Conditions
    Primary Biliary Cholangitis
    Interventions
    Blood Draws
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Not yet recruiting
    Start
    2025-08
    Completion
    2027-08
    Enrolment
    100

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

    ConditionPrimary Biliary Cholangitis
    InterventionBlood Draws
    PhaseNot recorded
    Registry statusNot yet recruiting
  • A Study to Evaluate the Efficacy and Safety of CnU Capsule 750 mg in Patients With Cholesterol Gallstones(GB Stones).

    NCT07005752 · start 2025-07-28

    Registered record
    Registry ID
    NCT07005752
    Conditions
    Cholesterol Cholelithiasis
    Interventions
    CnU cap. 250mg & Ursa placebo tab. 200mg; Ursa tab. 200mg & CnU placebo cap. 250mg
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Recruiting
    Start
    2025-07-28
    Completion
    2028-06-13
    Enrolment
    484

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

    ConditionCholesterol Cholelithiasis
    InterventionCnU cap. 250mg & Ursa placebo tab. 200mg; Ursa tab. 200mg & CnU placebo cap. 250mg
    PhasePhase 4
    Registry statusRecruiting
  • Gepaktiv vs UDCA and Ademetionine in MAFLD With Hepatomegaly

    NCT07068191 · start 2025-06-19

    Registered record
    Registry ID
    NCT07068191
    Conditions
    Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD); Hepatomegaly; Nonalcoholic Fatty Liver (NAFL); Nonalcoholic Fatty Liver Disease (NAFLD); Fatty Liver; Fatty Liver, Alcoholic; Fatty Liver, Nonalcoholic; Fatty Liver Disease
    Interventions
    Dietary supplement "Gepaktiv"; UDCA (Ursodeoxycholic acid); Ademetionine
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Recruiting
    Start
    2025-06-19
    Completion
    2025-08
    Enrolment
    90

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

    ConditionMetabolic Dysfunction-associated Fatty Liver Disease (MAFLD); Hepatomegaly; Nonalcoholic Fatty Liver (NAFL); Nonalcoholic Fatty Liver Disease (NAFLD) +4 more
    InterventionDietary supplement "Gepaktiv"; UDCA (Ursodeoxycholic acid); Ademetionine
    PhaseNot applicable
    Registry statusRecruiting
  • Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance

    NCT06684106 · start 2024-11-25

    Registered record
    Registry ID
    NCT06684106
    Conditions
    Hyperlipidemia; Ursodeoxycholic Acid; Statin Therapy; Glucose Intolerance
    Interventions
    Ursodeoxycholic acid (UDCA) 500 mg; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Recruiting
    Start
    2024-11-25
    Completion
    2027-06-01
    Enrolment
    128

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

    ConditionHyperlipidemia; Ursodeoxycholic Acid; Statin Therapy; Glucose Intolerance
    InterventionUrsodeoxycholic acid (UDCA) 500 mg; Placebo
    PhaseNot applicable
    Registry statusRecruiting
  • A Pilot Study of Fenofibrate and Ursodeoxycholic Acid in the Treatment of Newly Diagnosed Primary Biliary Cholangitis

    NCT06591455 · start 2024-09-14

    Registered record
    Registry ID
    NCT06591455
    Conditions
    Primary Biliary Cholangitis (PBC)
    Interventions
    Fenofibrate; UDCA (Ursodeoxycholic acid)
    Study type
    INTERVENTIONAL
    Phase
    Early phase 1
    Registry status
    Completed
    Start
    2024-09-14
    Completion
    2025-08-18
    Enrolment
    30

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

    ConditionPrimary Biliary Cholangitis (PBC)
    InterventionFenofibrate; UDCA (Ursodeoxycholic acid)
    PhaseEarly phase 1
    Registry statusCompleted
  • Ursodeoxycholic Acid as add-on Therapy in Type 2 Diabetes Mellitus

    NCT05902468 · start 2023-06-28

    Registered record
    Registry ID
    NCT05902468
    Conditions
    Diabetes Mellitus, Type 2
    Interventions
    Ursodeoxycholic acid
    Study type
    INTERVENTIONAL
    Phase
    Phase 2 / Phase 3
    Registry status
    Unknown
    Start
    2023-06-28
    Completion
    2024-11-28
    Enrolment
    88

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

    ConditionDiabetes Mellitus, Type 2
    InterventionUrsodeoxycholic acid
    PhasePhase 2 / Phase 3
    Registry statusUnknown
  • BSEP Function Rescue During Childhood Inhereditary Cholestatic Diseases

    NCT04531878 · start 2023-02-08

    Registered record
    Registry ID
    NCT04531878
    Conditions
    Hereditary Diseases; Cholestasis, Intrahepatic
    Interventions
    4-Phenylbutyrate
    Study type
    INTERVENTIONAL
    Phase
    Phase 2 / Phase 3
    Registry status
    Withdrawn
    Start
    2023-02-08
    Completion
    2023-02-08
    Enrolment
    0

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

    ConditionHereditary Diseases; Cholestasis, Intrahepatic
    Intervention4-Phenylbutyrate
    PhasePhase 2 / Phase 3
    Registry statusWithdrawn
  • A Phase 2 Study of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Diet and Exercise

    NCT06411275 · start 2022-03-31

    Registered record
    Registry ID
    NCT06411275
    Conditions
    Type 2 Diabetes Mellitus
    Interventions
    HTD1801; Placebo; HTD1801
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2022-03-31
    Completion
    2023-01-17
    Enrolment
    113

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

    ConditionType 2 Diabetes Mellitus
    InterventionHTD1801; Placebo; HTD1801
    PhasePhase 2
    Registry statusCompleted
  • Study of Obeticholic Acid(OCA) Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC)

    NCT04956328 · start 2021-07-22

    Registered record
    Registry ID
    NCT04956328
    Conditions
    Primary Biliary Cirrhosis
    Interventions
    Obeticholic Acid Tablets; UDCA; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Unknown
    Start
    2021-07-22
    Completion
    2023-09-20
    Enrolment
    120

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

    ConditionPrimary Biliary Cirrhosis
    InterventionObeticholic Acid Tablets; UDCA; Placebo
    PhasePhase 3
    Registry statusUnknown
  • Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Due to Nonresponse to Standard Therapy

    NCT04376528 · start 2021-06-16

    Registered record
    Registry ID
    NCT04376528
    Conditions
    Hepatitis, Autoimmune; Primary Biliary Cholangitis; Immunosuppression
    Interventions
    Cyclosporin A; Mycophenolate Mofetil
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Unknown
    Start
    2021-06-16
    Completion
    2021-12-30
    Enrolment
    89

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

    ConditionHepatitis, Autoimmune; Primary Biliary Cholangitis; Immunosuppression
    InterventionCyclosporin A; Mycophenolate Mofetil
    PhasePhase 4
    Registry statusUnknown