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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 Among Chronic HBV Patients with Hepatic Steatosis : Clinical and Portal Doppler Outcomes

    NCT06691412 · start 2024-11-15

    Registered record
    Registry ID
    NCT06691412
    Conditions
    Hepatitis B Virus; Steatosis
    Interventions
    Obeticholic Acid 5 mg
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Not yet recruiting
    Start
    2024-11-15
    Completion
    2026-03-01
    Enrolment
    100

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

    ConditionHepatitis B Virus; Steatosis
    InterventionObeticholic Acid 5 mg
    PhasePhase 3
    Registry statusNot yet recruiting

  • Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Obeticholic Acid (OCA) Compared to Placebo in Pediatric Participants With Biliary Atresia, Post-hepatoportoenterostomy

    NCT06121375 · start 2024-09-02

    Registered record
    Registry ID
    NCT06121375
    Conditions
    Biliary Atresia
    Interventions
    OCA; Matching Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2 / Phase 3
    Registry status
    Terminated
    Start
    2024-09-02
    Completion
    2025-10-21
    Enrolment
    28

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

    ConditionBiliary Atresia
    InterventionOCA; Matching Placebo
    PhasePhase 2 / Phase 3
    Registry statusTerminated

  • To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate

    NCT06488911 · start 2024-07-01

    Registered record
    Registry ID
    NCT06488911
    Conditions
    Primary Biliary Cholangitis
    Interventions
    FDC tablet (OCA 5 mg + BZF 400 mg SR)
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Terminated
    Start
    2024-07-01
    Completion
    2025-10-21
    Enrolment
    62

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

    ConditionPrimary Biliary Cholangitis
    InterventionFDC tablet (OCA 5 mg + BZF 400 mg SR)
    PhasePhase 3
    Registry statusTerminated

  • Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment.

    NCT06247735 · start 2024-02-07

    Registered record
    Registry ID
    NCT06247735
    Conditions
    Primary Biliary Cholangitis
    Interventions
    K-808 (Dose A); K-808 (Dose B); Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2024-02-07
    Completion
    2026-07-22
    Enrolment
    46

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

    ConditionPrimary Biliary Cholangitis
    InterventionK-808 (Dose A); K-808 (Dose B); Placebo
    PhasePhase 2
    Registry statusCompleted

  • Obeticholic Acid for Prevention in Barrett's Esophagus

    NCT04939051 · start 2024-01-03

    Registered record
    Registry ID
    NCT04939051
    Conditions
    Barrett Esophagus; Esophageal Adenocarcinoma
    Interventions
    Biospecimen Collection; Esophageal Biopsy; Esophagogastroduodenoscopy; Liver Ultrasonographic Elastography; Obeticholic Acid; Placebo Administration; Questionnaire Administration
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2024-01-03
    Completion
    2027-09-01
    Enrolment
    30

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

    ConditionBarrett Esophagus; Esophageal Adenocarcinoma
    InterventionBiospecimen Collection; Esophageal Biopsy; Esophagogastroduodenoscopy; Liver Ultrasonographic Elastography +3 more
    PhasePhase 2
    Registry statusRecruiting

  • Comparison of Effectiveness of Obeticholic Acid With Vitamin E in Patients of Non-alcoholic Fatty Liver Disease

    NCT07104786 · start 2023-08-24

    Registered record
    Registry ID
    NCT07104786
    Conditions
    Non Alcoholic Fatty Liver Disease
    Interventions
    Obeticholic Acid 10 MG; Vitamin E 400mg
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2023-08-24
    Completion
    2024-05-23
    Enrolment
    90

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

    ConditionNon Alcoholic Fatty Liver Disease
    InterventionObeticholic Acid 10 MG; Vitamin E 400mg
    PhasePhase 2
    Registry statusCompleted

  • Testing Obeticholic Acid for Familial Adenomatous Polyposis

    NCT05223036 · start 2023-01-19

    Registered record
    Registry ID
    NCT05223036
    Conditions
    Attenuated Familial Adenomatous Polyposis; Colorectal Carcinoma; Duodenal Carcinoma; Familial Adenomatous Polyposis
    Interventions
    Biopsy Procedure; Biospecimen Collection; Gastrointestinal Endoscopy; Obeticholic Acid; Placebo Administration; Questionnaire Administration
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2023-01-19
    Completion
    2026-04-17
    Enrolment
    15

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

    ConditionAttenuated Familial Adenomatous Polyposis; Colorectal Carcinoma; Duodenal Carcinoma; Familial Adenomatous Polyposis
    InterventionBiopsy Procedure; Biospecimen Collection; Gastrointestinal Endoscopy; Obeticholic Acid +2 more
    PhasePhase 2
    Registry statusTerminated

  • The Effect of Obeticholic Acid in Healthy Volunteers

    NCT05740631 · start 2022-08-22

    Registered record
    Registry ID
    NCT05740631
    Conditions
    Healthy
    Interventions
    Ocaliva; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Unknown
    Start
    2022-08-22
    Completion
    2023-07-22
    Enrolment
    12

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

    ConditionHealthy
    InterventionOcaliva; Placebo
    PhaseNot applicable
    Registry statusUnknown

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

    NCT05293938 · start 2022-03-28

    Registered record
    Registry ID
    NCT05293938
    Conditions
    Primary Biliary Cholangitis
    Interventions
    Obeticholic Acid 5 MG; Obeticholic Acid 10 MG; Standard of Care: UDCA
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Withdrawn
    Start
    2022-03-28
    Completion
    2023-07
    Enrolment
    0

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

    ConditionPrimary Biliary Cholangitis
    InterventionObeticholic Acid 5 MG; Obeticholic Acid 10 MG; Standard of Care: UDCA
    PhaseNot recorded
    Registry statusWithdrawn

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

    NCT05239468 · start 2022-03-21

    Registered record
    Registry ID
    NCT05239468
    Conditions
    Primary Biliary Cholangitis
    Interventions
    Bezafibrate 100 mg; Bezafibrate 200 mg; Obeticholic Acid 5 mg; Obeticholic Acid placebo; Bezafibrate Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2022-03-21
    Completion
    2025-09-01
    Enrolment
    72

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

    ConditionPrimary Biliary Cholangitis
    InterventionBezafibrate 100 mg; Bezafibrate 200 mg; Obeticholic Acid 5 mg; Obeticholic Acid placebo +1 more
    PhasePhase 2
    Registry statusCompleted

  • Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Adult Participants

    NCT05133830 · start 2021-11-23

    Registered record
    Registry ID
    NCT05133830
    Conditions
    Pruritus
    Interventions
    Obeticholic acid; Linerixibat
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2021-11-23
    Completion
    2022-05-31
    Enrolment
    52

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

    ConditionPruritus
    InterventionObeticholic acid; Linerixibat
    PhasePhase 1
    Registry statusCompleted

  • Obeticholic Acid Versus Placebo, in Combination with Ursodeoxycholic Acid in Patients with Primary Biliary Cirrhosis

    NCT06715319 · start 2021-10-09

    Registered record
    Registry ID
    NCT06715319
    Conditions
    PBC
    Interventions
    OCA; UDCA; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2021-10-09
    Completion
    2024-04-29
    Enrolment
    100

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

    ConditionPBC
    InterventionOCA; UDCA; Placebo
    PhasePhase 3
    Registry statusCompleted

  • Efficacy and Safety of Obeticholic Acid in the Treatment of Primary Biliary Cholangitis

    NCT05450887 · start 2021-09-23

    Registered record
    Registry ID
    NCT05450887
    Conditions
    Primary Biliary Cholangitis
    Interventions
    Obeticholic Acid Tablets（OCA）; UDCA; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2021-09-23
    Completion
    2024-04-09
    Enrolment
    108

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

    ConditionPrimary Biliary Cholangitis
    InterventionObeticholic Acid Tablets（OCA）; UDCA; Placebo
    PhasePhase 3
    Registry statusCompleted

  • Comparative Study Between Obeticholic Acid Versus Vitamin E in Patients with Non-alcoholic Steatohepatitis

    NCT05573204 · start 2021-09-01

    Registered record
    Registry ID
    NCT05573204
    Conditions
    Non-alcoholic Steatohepatitis
    Interventions
    Obeticholic Acid Oral Tablet; Vit E
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2021-09-01
    Completion
    2026-12-30
    Enrolment
    59

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

    ConditionNon-alcoholic Steatohepatitis
    InterventionObeticholic Acid Oral Tablet; Vit E
    PhasePhase 2
    Registry statusActive not recruiting

  • 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