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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.

  • Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC

    NCT04594694 · start 2019-10-02

    Registered record
    Registry ID
    NCT04594694
    Conditions
    Primary Biliary Cholangitis
    Interventions
    Obeticholic acid; Bezafibrate 200 MG; OCA Placebo; Bezafibrate 200 mg Placebo; Bezafibrate 400 MG; Bezafibrate 400 mg Placebo; OCA; Bezafibrate
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2019-10-02
    Completion
    2025-10-14
    Enrolment
    75

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

    ConditionPrimary Biliary Cholangitis
    InterventionObeticholic acid; Bezafibrate 200 MG; OCA Placebo; Bezafibrate 200 mg Placebo +4 more
    PhasePhase 2
    Registry statusTerminated

  • Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis

    NCT04076527 · start 2019-09-19

    Registered record
    Registry ID
    NCT04076527
    Conditions
    PBC; Primary Biliary Cholangitis
    Interventions
    UDCA; Ocaliva
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Unknown
    Start
    2019-09-19
    Completion
    2024-03
    Enrolment
    1,200

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

    ConditionPBC; Primary Biliary Cholangitis
    InterventionUDCA; Ocaliva
    PhaseNot recorded
    Registry statusUnknown

  • Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Subjects

    NCT04053023 · start 2019-08-27

    Registered record
    Registry ID
    NCT04053023
    Conditions
    Cholestasis
    Interventions
    GSK2330672 (linerixibat); Obeticholic acid
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2019-08-27
    Completion
    2019-11-25
    Enrolment
    19

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

    ConditionCholestasis
    InterventionGSK2330672 (linerixibat); Obeticholic acid
    PhasePhase 1
    Registry statusCompleted

  • Role of Obeticholic Acid in the Patients of NAFLD With Raised ALT

    NCT03836937 · start 2019-03-05

    Registered record
    Registry ID
    NCT03836937
    Conditions
    Non-Alcoholic Fatty Liver Disease
    Interventions
    Obeticholic acid
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Completed
    Start
    2019-03-05
    Completion
    2021-12-31
    Enrolment
    70

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

    ConditionNon-Alcoholic Fatty Liver Disease
    InterventionObeticholic acid
    PhaseNot applicable
    Registry statusCompleted

  • Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment

    NCT03633227 · start 2018-06-22

    Registered record
    Registry ID
    NCT03633227
    Conditions
    Liver Cirrhosis, Biliary
    Interventions
    Obeticholic Acid (OCA); Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Terminated
    Start
    2018-06-22
    Completion
    2021-07-09
    Enrolment
    22

    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

  • A Post-Authorisation Non-Interventional Observational of Patients in France With Primary Biliary Cholangitis Treated With Obeticholic Acid in Real Life

    NCT03703076 · start 2018-04-10

    Registered record
    Registry ID
    NCT03703076
    Conditions
    Primary Biliary Cholangitis
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Unknown
    Start
    2018-04-10
    Completion
    2019-04
    Enrolment
    150

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

    ConditionPrimary Biliary Cholangitis
    InterventionNot recorded
    PhaseNot recorded
    Registry statusUnknown

  • Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis

    NCT03439254 · start 2017-08-30

    Registered record
    Registry ID
    NCT03439254
    Conditions
    Compensated Cirrhosis; Nonalcoholic Steatohepatitis
    Interventions
    Obeticholic acid (10 mg); Obeticholic acid (10 mg to 25 mg); Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2017-08-30
    Completion
    2022-09-08
    Enrolment
    919

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

    ConditionCompensated Cirrhosis; Nonalcoholic Steatohepatitis
    InterventionObeticholic acid (10 mg); Obeticholic acid (10 mg to 25 mg); Placebo
    PhasePhase 3
    Registry statusCompleted

  • Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients

    NCT02430077 · start 2016-06

    Registered record
    Registry ID
    NCT02430077
    Conditions
    Familial Partial Lipodystrophy
    Interventions
    Obeticholic Acid; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2016-06
    Completion
    2022-12
    Enrolment
    10

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

    ConditionFamilial Partial Lipodystrophy
    InterventionObeticholic Acid; Placebo
    PhasePhase 2
    Registry statusCompleted

  • Effect of Obeticholic Acid on Transport of Bile Acids in PBC Examined by 11C-cholyl-sarcosine PET/CT

    NCT03253276 · start 2016-05-19

    Registered record
    Registry ID
    NCT03253276
    Conditions
    Primary Biliary Cirrhosis
    Interventions
    Obeticholic acid; Placebos
    Study type
    INTERVENTIONAL
    Phase
    Early phase 1
    Registry status
    Completed
    Start
    2016-05-19
    Completion
    2018-09-20
    Enrolment
    8

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

    ConditionPrimary Biliary Cirrhosis
    InterventionObeticholic acid; Placebos
    PhaseEarly phase 1
    Registry statusCompleted

  • Effect of Heavy Alcohol Consumption on Farnesoid X Receptor (FXR) Signaling

    NCT02654236 · start 2016-04

    Registered record
    Registry ID
    NCT02654236
    Conditions
    Alcohol Consumption
    Interventions
    Placebo; 10 mg Obeticholic Acid (OCA)
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Completed
    Start
    2016-04
    Completion
    2019-09
    Enrolment
    30

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

    ConditionAlcohol Consumption
    InterventionPlacebo; 10 mg Obeticholic Acid (OCA)
    PhaseNot applicable
    Registry statusCompleted

  • Combination Obeticholic Acid (OCA) and Statins for Monitoring of Lipids (CONTROL)

    NCT02633956 · start 2015-12-04

    Registered record
    Registry ID
    NCT02633956
    Conditions
    Nonalcoholic Steatohepatitis
    Interventions
    Obeticholic Acid; Atorvastatin; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2015-12-04
    Completion
    2018-03-12
    Enrolment
    84

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

    ConditionNonalcoholic Steatohepatitis
    InterventionObeticholic Acid; Atorvastatin; Placebo
    PhasePhase 2
    Registry statusCompleted

  • Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment

    NCT02548351 · start 2015-09-22

    Registered record
    Registry ID
    NCT02548351
    Conditions
    Non Alcoholic Steatohepatitis (NASH)
    Interventions
    Obeticholic Acid; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Terminated
    Start
    2015-09-22
    Completion
    2023-09-15
    Enrolment
    2,477

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

    ConditionNon Alcoholic Steatohepatitis (NASH)
    InterventionObeticholic Acid; Placebo
    PhasePhase 3
    Registry statusTerminated

  • Obeticholic Acid in Morbidly Obese Patients and Healthy Volunteers

    NCT02532335 · start 2015-08

    Registered record
    Registry ID
    NCT02532335
    Conditions
    Obesity
    Interventions
    Obeticholic acid; Obeticholic acid placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Unknown
    Start
    2015-08
    Completion
    2021-06
    Enrolment
    40

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

    ConditionObesity
    InterventionObeticholic acid; Obeticholic acid placebo
    PhasePhase 1
    Registry statusUnknown

  • Obeticholic Acid in Pediatric Subjects With Biliary Atresia

    NCT05321524 · start 2015-07-01

    Registered record
    Registry ID
    NCT05321524
    Conditions
    Biliary Atresia
    Interventions
    OCA 0.1mg; OCA 1.5mg; OCA 5mg
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2015-07-01
    Completion
    2023-03-09
    Enrolment
    7

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

    ConditionBiliary Atresia
    InterventionOCA 0.1mg; OCA 1.5mg; OCA 5mg
    PhasePhase 2
    Registry statusTerminated

  • Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients

    NCT05292872 · start 2015-06-01

    Registered record
    Registry ID
    NCT05292872
    Conditions
    Primary Biliary Cholangitis
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2015-06-01
    Completion
    2021-12-31
    Enrolment
    4,577

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

    ConditionPrimary Biliary Cholangitis
    InterventionNot recorded
    PhaseNot recorded
    Registry statusCompleted