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AMR Drug RepurposingSmart Screeningresearch prototype

Odevixibat

FDA-approved product (capsule, pellets, oral), marketed as Bylvay.

Registered studies
13
Lab records
0
Pathogens at ≥40%
3 of 4

Chemical structure

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

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Intrahepatic cholestasis

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

WHO therapeutic group
Other drugs for bile therapy
FDA pharmacologic class
Ileal Bile Acid Transporter Inhibitor 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 E. coli, MRSA and M. tuberculosis. It was surfaced computationally for further investigation; it is not an established treatment for these infections.

AI-predicted activity

AI prediction · nothing measured
  • MRSA54.4% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli53.7% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae33.5% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis52.9% AI-predicted activityAt or above 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

13registered 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 Odevixibat in ChEMBL Registered studies below

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

Not yet docked: queued in the docking rundetails

KPC-2 carbapenemase ↗ (K. pneumoniae)

Not yet docked: queued in the docking rundetails

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

Not yet docked: queued in the docking rundetails

Dihydrofolate reductase ↗ (MRSA)

Not yet docked: queued in the docking rundetails

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 Odevixibat 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.

  • A Study to Observe the Long-term Safety of Odevixibat in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment

    NCT07585097 · start 2026-07-10

    Registered record
    Registry ID
    NCT07585097
    Conditions
    Alagille Syndrome
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2026-07-10
    Completion
    2031-09-30
    Enrolment
    30

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

    ConditionAlagille Syndrome
    InterventionNot recorded
    PhaseNot recorded
    Registry statusRecruiting

  • Odevixibat Outcomes in Patients With PFIC Versus an External Control Cohort (OvEC-PFIC)

    NCT07497724 · start 2026-04-26

    Registered record
    Registry ID
    NCT07497724
    Conditions
    PFIC - Progressive Familial Intrahepatic Cholestasis
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Active not recruiting
    Start
    2026-04-26
    Completion
    2026-09-30
    Enrolment
    200

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

    ConditionPFIC - Progressive Familial Intrahepatic Cholestasis
    InterventionNot recorded
    PhaseNot recorded
    Registry statusActive not recruiting

  • A Study of the Effectiveness, Safety and the Long-term Outcomes of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay) in China

    NCT07588880 · start 2026-04-16

    Registered record
    Registry ID
    NCT07588880
    Conditions
    Progressive Familial Intrahepatic Cholestasis
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2026-04-16
    Completion
    2031-04-30
    Enrolment
    20

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

    ConditionProgressive Familial Intrahepatic Cholestasis
    InterventionNot recorded
    PhaseNot recorded
    Registry statusRecruiting

  • A Study of the Effectiveness, Safety and the Long-term Outcomes of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay) in South Korea

    NCT07185919 · start 2025-10-30

    Registered record
    Registry ID
    NCT07185919
    Conditions
    Progressive Familial Intrahepatic Cholestasis
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2025-10-30
    Completion
    2032-09-30
    Enrolment
    10

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

    ConditionProgressive Familial Intrahepatic Cholestasis
    InterventionNot recorded
    PhaseNot recorded
    Registry statusRecruiting

  • A Study Observing the Long-term, Effectiveness and Safety of Odevixibat (Bylvay) in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment

    NCT06850038 · start 2025-04-22

    Registered record
    Registry ID
    NCT06850038
    Conditions
    Alagille Syndrome
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2025-04-22
    Completion
    2030-11-30
    Enrolment
    30

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

    ConditionAlagille Syndrome
    InterventionNot recorded
    PhaseNot recorded
    Registry statusRecruiting

  • Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation

    NCT06258902 · start 2023-09-28

    Registered record
    Registry ID
    NCT06258902
    Conditions
    Pregnancy Related
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2023-09-28
    Completion
    2032-05-31
    Enrolment
    20

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

    ConditionPregnancy Related
    InterventionNot recorded
    PhaseNot recorded
    Registry statusRecruiting

  • An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia

    NCT05426733 · start 2022-07-05

    Registered record
    Registry ID
    NCT05426733
    Conditions
    Biliary Atresia
    Interventions
    Odevixibat
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Active not recruiting
    Start
    2022-07-05
    Completion
    2026-10-28
    Enrolment
    180

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

    ConditionBiliary Atresia
    InterventionOdevixibat
    PhasePhase 3
    Registry statusActive not recruiting

  • Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome

    NCT05035030 · start 2021-09-03

    Registered record
    Registry ID
    NCT05035030
    Conditions
    Alagille Syndrome
    Interventions
    Odevixibat
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Active not recruiting
    Start
    2021-09-03
    Completion
    2026-12-31
    Enrolment
    62

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

    ConditionAlagille Syndrome
    InterventionOdevixibat
    PhasePhase 3
    Registry statusActive not recruiting

  • Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome

    NCT04674761 · start 2021-03-19

    Registered record
    Registry ID
    NCT04674761
    Conditions
    Alagille Syndrome
    Interventions
    Odevixibat; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2021-03-19
    Completion
    2022-09-09
    Enrolment
    52

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

    ConditionAlagille Syndrome
    InterventionOdevixibat; Placebo
    PhasePhase 3
    Registry statusCompleted

  • Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)

    NCT04336722 · start 2020-07-08

    Registered record
    Registry ID
    NCT04336722
    Conditions
    Biliary Atresia
    Interventions
    Odevixibat; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2020-07-08
    Completion
    2026-06-22
    Enrolment
    254

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

    ConditionBiliary Atresia
    InterventionOdevixibat; Placebo
    PhasePhase 3
    Registry statusCompleted

  • Long Term Safety & Efficacy Study Evaluating The Effect of A4250 in Children With PFIC

    NCT03659916 · start 2018-09-28

    Registered record
    Registry ID
    NCT03659916
    Conditions
    Progressive Familial Intrahepatic Cholestasis
    Interventions
    A4250 (odevixibat)
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2018-09-28
    Completion
    2025-12-02
    Enrolment
    116

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

    ConditionProgressive Familial Intrahepatic Cholestasis
    InterventionA4250 (odevixibat)
    PhasePhase 3
    Registry statusCompleted

  • This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2

    NCT03566238 · start 2018-05-16

    Registered record
    Registry ID
    NCT03566238
    Conditions
    PFIC1; PFIC2
    Interventions
    A4250 (odevixibat); Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2018-05-16
    Completion
    2020-07-28
    Enrolment
    62

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

    ConditionPFIC1; PFIC2
    InterventionA4250 (odevixibat); Placebo
    PhasePhase 3
    Registry statusCompleted

  • Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis

    NCT04483531

    Registered record
    Registry ID
    NCT04483531
    Conditions
    Progressive Familial Intrahepatic Cholestasis
    Interventions
    Odevixibat
    Study type
    EXPANDED_ACCESS
    Phase
    Not recorded
    Registry status
    No longer available
    Start
    Not recorded
    Completion
    Not recorded
    Enrolment
    Not recorded

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

    ConditionProgressive Familial Intrahepatic Cholestasis
    InterventionOdevixibat
    PhaseNot recorded
    Registry statusNo longer available