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AMR Drug RepurposingSmart Screeningresearch prototype

Obeticholic Acid

FDA-approved product (tablet, oral), marketed as Obeticholic Acid, Ocaliva.

Registered studies
44
Lab records
0
Pathogens at ≥40%
1 of 4

Chemical structure

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

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Biliary liver cirrhosis
  • Cholangitis
  • Primary biliary cirrhosis

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

WHO therapeutic group
Bile acids and derivatives
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
  • MRSA60.9% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli31.2% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae29.6% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis35.2% 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

44registered studies name this medicine, for any condition. See them below.

Experimental

No evidence found

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

Open Obeticholic Acid in ChEMBL Registered studies below

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

-7.1 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-8.7 kcal/mol

0better fit →-12

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

-8.5 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-7.5 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 Obeticholic Acid 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.

  • Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC)

    NCT02177136 · start 2015-02-09

    Registered record
    Registry ID
    NCT02177136
    Conditions
    Primary Sclerosing Cholangitis (PSC)
    Interventions
    Obeticholic Acid (OCA); Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2015-02-09
    Completion
    2018-03-22
    Enrolment
    77

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

    ConditionPrimary Sclerosing Cholangitis (PSC)
    InterventionObeticholic Acid (OCA); Placebo
    PhasePhase 2
    Registry statusCompleted

  • Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis

    NCT02308111 · start 2014-12-26

    Registered record
    Registry ID
    NCT02308111
    Conditions
    Liver Cirrhosis, Biliary
    Interventions
    Obeticholic Acid (OCA); Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Terminated
    Start
    2014-12-26
    Completion
    2021-12-23
    Enrolment
    334

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

    ConditionLiver Cirrhosis, Biliary
    InterventionObeticholic Acid (OCA); Placebo
    PhasePhase 4
    Registry statusTerminated

  • Trial of Obeticholic Acid in Patients With Moderately Severe Alcoholic Hepatitis (AH)

    NCT02039219 · start 2014-11-03

    Registered record
    Registry ID
    NCT02039219
    Conditions
    Alcoholic Hepatitis
    Interventions
    Placebo; 10 mg Obeticholic Acid (OCA)
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2014-11-03
    Completion
    2018-01-29
    Enrolment
    19

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

    ConditionAlcoholic Hepatitis
    InterventionPlacebo; 10 mg Obeticholic Acid (OCA)
    PhasePhase 2
    Registry statusTerminated

  • Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis

    NCT01865812 · start 2013-12-03

    Registered record
    Registry ID
    NCT01865812
    Conditions
    Primary Biliary Cirrhosis
    Interventions
    Obeticholic Acid
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2013-12-03
    Completion
    2016-09-12
    Enrolment
    27

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

    ConditionPrimary Biliary Cirrhosis
    InterventionObeticholic Acid
    PhasePhase 2
    Registry statusCompleted

  • Single Dose and Multiple Dose Trial to Assess Pharmacokinetics of Obeticholic Acid (OCA)

    NCT01933503 · start 2013-10

    Registered record
    Registry ID
    NCT01933503
    Conditions
    Healthy
    Interventions
    OCA 5 mg; OCA 10 mg; OCA 25 mg
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2013-10
    Completion
    2013-11
    Enrolment
    24

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

    ConditionHealthy
    InterventionOCA 5 mg; OCA 10 mg; OCA 25 mg
    PhasePhase 1
    Registry statusCompleted

  • Obeticholic Acid in Bariatric and Gallstone Disease

    NCT01625026 · start 2013-09

    Registered record
    Registry ID
    NCT01625026
    Conditions
    Obesity; Gallstones
    Interventions
    Obeticholic acid; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2013-09
    Completion
    2016-04
    Enrolment
    40

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

    ConditionObesity; Gallstones
    InterventionObeticholic acid; Placebo
    PhasePhase 2
    Registry statusCompleted

  • Effect of Food on Pharmacokinetics of Obeticholic Acid (OCA)

    NCT01914562 · start 2013-08

    Registered record
    Registry ID
    NCT01914562
    Conditions
    Healthy
    Interventions
    OCA 10 mg; OCA 25 mg
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2013-08
    Completion
    2013-11
    Enrolment
    32

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

    ConditionHealthy
    InterventionOCA 10 mg; OCA 25 mg
    PhasePhase 1
    Registry statusCompleted

  • Hepatic Impairment Trial of Obeticholic Acid

    NCT01904539 · start 2013-06

    Registered record
    Registry ID
    NCT01904539
    Conditions
    Hepatic Impairment
    Interventions
    obeticholic acid 10 mg
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2013-06
    Completion
    2013-10
    Enrolment
    32

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

    ConditionHepatic Impairment
    Interventionobeticholic acid 10 mg
    PhasePhase 1
    Registry statusCompleted

  • Obeticholic Acid in Bile Acid Diarrhoea

    NCT01585025 · start 2012-04

    Registered record
    Registry ID
    NCT01585025
    Conditions
    Primary Bile Acid Malabsorption; Secondary Bile Acid Malabsorption; Chronic Diarrhoea
    Interventions
    Obeticholic acid
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2012-04
    Completion
    2014-02
    Enrolment
    35

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

    ConditionPrimary Bile Acid Malabsorption; Secondary Bile Acid Malabsorption; Chronic Diarrhoea
    InterventionObeticholic acid
    PhasePhase 2
    Registry statusCompleted

  • Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis

    NCT01473524 · start 2012-01

    Registered record
    Registry ID
    NCT01473524
    Conditions
    Primary Biliary Cirrhosis
    Interventions
    Obeticholic Acid (OCA); Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2012-01
    Completion
    2018-12-17
    Enrolment
    217

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

    ConditionPrimary Biliary Cirrhosis
    InterventionObeticholic Acid (OCA); Placebo
    PhasePhase 3
    Registry statusCompleted

  • The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in NASH Treatment Trial(FLINT)

    NCT01265498 · start 2011-03

    Registered record
    Registry ID
    NCT01265498
    Conditions
    Nonalcoholic Fatty Liver Disease (NAFLD); Nonalcoholic Steatohepatitis (NASH)
    Interventions
    obeticholic acid; placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2011-03
    Completion
    2014-09
    Enrolment
    283

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

    ConditionNonalcoholic Fatty Liver Disease (NAFLD); Nonalcoholic Steatohepatitis (NASH)
    Interventionobeticholic acid; placebo
    PhasePhase 2
    Registry statusCompleted

  • Study of INT-747 as Monotherapy in Participants With Primary Biliary Cirrhosis (PBC)

    NCT00570765 · start 2008-01-17

    Registered record
    Registry ID
    NCT00570765
    Conditions
    Liver Cirrhosis, Biliary
    Interventions
    Placebo; Obeticholic Acid (OCA)
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2008-01-17
    Completion
    2017-09-25
    Enrolment
    60

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

    ConditionLiver Cirrhosis, Biliary
    InterventionPlacebo; Obeticholic Acid (OCA)
    PhasePhase 2
    Registry statusCompleted

  • Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)

    NCT00550862 · start 2007-10

    Registered record
    Registry ID
    NCT00550862
    Conditions
    Liver Cirrhosis, Biliary
    Interventions
    INT-747; Ursodeoxycholic Acid (URSO); Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2007-10
    Completion
    2010-12
    Enrolment
    165

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

    ConditionLiver Cirrhosis, Biliary
    InterventionINT-747; Ursodeoxycholic Acid (URSO); Placebo
    PhasePhase 2
    Registry statusTerminated

  • Study of INT-747 in Patients With Diabetes and Presumed NAFLD

    NCT00501592 · start 2007-07

    Registered record
    Registry ID
    NCT00501592
    Conditions
    Diabetes Mellitus, Type II; Fatty Liver
    Interventions
    INT-747; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2007-07
    Completion
    2009-04
    Enrolment
    64

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

    ConditionDiabetes Mellitus, Type II; Fatty Liver
    InterventionINT-747; Placebo
    PhasePhase 2
    Registry statusCompleted