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AMR Drug RepurposingSmart Screeningresearch prototype

Omaveloxolone

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

Registered studies
25
Lab records
0
Pathogens at ≥40%
2 of 4

Chemical structure

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

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Friedreich ataxia

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

WHO therapeutic group
Other nervous system drugs
Anti-infective classification
Not classified as an anti-infective.

Repurposing investigation

This medicine is being investigated here for AI-predicted antimicrobial activity against MRSA and E. coli. It was surfaced computationally for further investigation; it is not an established treatment for these infections.

AI-predicted activity

AI prediction · nothing measured
  • MRSA53.6% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli46.4% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae35.4% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis37.2% 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

25registered 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 Omaveloxolone 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)

-7.1 kcal/mol

0better fit →-12

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

-7.7 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-8.4 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 Omaveloxolone 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 Pharmacokinetic Study of Omaveloxolone in Healthy Volunteers

    NCT03664453 · start 2018-10-29

    Registered record
    Registry ID
    NCT03664453
    Conditions
    Healthy
    Interventions
    omaveloxolone
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2018-10-29
    Completion
    2018-11-20
    Enrolment
    32

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

    ConditionHealthy
    Interventionomaveloxolone
    PhasePhase 1
    Registry statusCompleted

  • RTA 408 Capsules in Patients With Mitochondrial Myopathy - MOTOR

    NCT02255422 · start 2015-05-05

    Registered record
    Registry ID
    NCT02255422
    Conditions
    MItochondrial Myopathies
    Interventions
    Omaveloxolone capsules, 2.5 mg; omaveloxolone capsules, 5 mg; omaveloxolone capsules, 10 mg; Placebo capsules; omaveloxolone capsules, 20 mg; omaveloxolone capsules, 40 mg; omaveloxolone capsules, 80 mg; omaveloxolone capsules, 160 mg
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2015-05-05
    Completion
    2017-11-30
    Enrolment
    53

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

    ConditionMItochondrial Myopathies
    InterventionOmaveloxolone capsules, 2.5 mg; omaveloxolone capsules, 5 mg; omaveloxolone capsules, 10 mg; Placebo capsules +4 more
    PhasePhase 2
    Registry statusCompleted

  • A Study to Learn About the Effects and Safety of RTA 408 (Omaveloxolone) in People Aged 16 to 40 With Friedreich's Ataxia

    NCT02255435 · start 2015-01-31

    Registered record
    Registry ID
    NCT02255435
    Conditions
    Friedreich Ataxia
    Interventions
    Omaveloxolone Capsules, 2.5 mg; Omaveloxolone Capsules, 5 mg; Omaveloxolone Capsules, 10 mg; Placebo; Omaveloxolone Capsules, 20 mg; Omaveloxolone Capsules, 40 mg; Omaveloxolone Capsules, 80 mg; Omaveloxolone Capsules, 160 mg; Omaveloxolone Capsules, 300 mg; Omaveloxolone Capsules, 150 mg
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2015-01-31
    Completion
    2025-12-19
    Enrolment
    172

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

    ConditionFriedreich Ataxia
    InterventionOmaveloxolone Capsules, 2.5 mg; Omaveloxolone Capsules, 5 mg; Omaveloxolone Capsules, 10 mg; Placebo +6 more
    PhasePhase 2
    Registry statusCompleted

  • RTA 408 Capsules in Patients With Melanoma - REVEAL

    NCT02259231 · start 2014-10-31

    Registered record
    Registry ID
    NCT02259231
    Conditions
    Melanoma; Unresectable (Stage III) Melanoma; Metastatic (Stage IV) Melanoma
    Interventions
    Omaveloxolone Capsules (2.5 mg/capsule); Ipilimumab (3 mg/kg); Nivolumab (240 mg); Omaveloxolone Capsules (10 mg/capsule); Omaveloxolone Capsules (50 mg/capsule)
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Completed
    Start
    2014-10-31
    Completion
    2018-07-23
    Enrolment
    41

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

    ConditionMelanoma; Unresectable (Stage III) Melanoma; Metastatic (Stage IV) Melanoma
    InterventionOmaveloxolone Capsules (2.5 mg/capsule); Ipilimumab (3 mg/kg); Nivolumab (240 mg); Omaveloxolone Capsules (10 mg/capsule) +1 more
    PhasePhase 1 / Phase 2
    Registry statusCompleted

  • RTA 408 Lotion in Patients at Risk for Radiation Dermatitis - PRIMROSE

    NCT02142959 · start 2014-06-30

    Registered record
    Registry ID
    NCT02142959
    Conditions
    Breast Cancer
    Interventions
    Omaveloxolone Lotion 0.5%; Omaveloxolone Lotion 3%; Vehicle Lotion; 3D conformal radiation therapy
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2014-06-30
    Completion
    2015-04-30
    Enrolment
    187

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

    ConditionBreast Cancer
    InterventionOmaveloxolone Lotion 0.5%; Omaveloxolone Lotion 3%; Vehicle Lotion; 3D conformal radiation therapy
    PhasePhase 2
    Registry statusCompleted

  • RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARD

    NCT02128113 · start 2014-05-31

    Registered record
    Registry ID
    NCT02128113
    Conditions
    Corneal Endothelial Cell Loss; Ocular Pain; Ocular Inflammation; Cataract Surgery
    Interventions
    Vehicle Ophthalmic Solution; Omaveloxolone Ophthalmic Suspension 0.5%; Omaveloxolone Ophthalmic Suspension 1%
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2014-05-31
    Completion
    2015-04-30
    Enrolment
    307

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

    ConditionCorneal Endothelial Cell Loss; Ocular Pain; Ocular Inflammation; Cataract Surgery
    InterventionVehicle Ophthalmic Solution; Omaveloxolone Ophthalmic Suspension 0.5%; Omaveloxolone Ophthalmic Suspension 1%
    PhasePhase 2
    Registry statusCompleted

  • RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery

    NCT02065375 · start 2014-02-28

    Registered record
    Registry ID
    NCT02065375
    Conditions
    Inflammation and Pain Following Ocular Surgery
    Interventions
    Omaveloxolone Ophthalmic Suspension 1.0%; Omaveloxolone Opthalmic Suspension 0.5%; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2014-02-28
    Completion
    2014-09-30
    Enrolment
    109

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

    ConditionInflammation and Pain Following Ocular Surgery
    InterventionOmaveloxolone Ophthalmic Suspension 1.0%; Omaveloxolone Opthalmic Suspension 0.5%; Placebo
    PhasePhase 2
    Registry statusCompleted

  • RTA 408 Lotion in Healthy Volunteers

    NCT02029716 · start 2013-12-31

    Registered record
    Registry ID
    NCT02029716
    Conditions
    Healthy
    Interventions
    RTA 408 Lotion 0.5%, 1%, 3%; Lotion vehicle/placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2013-12-31
    Completion
    2014-04-01
    Enrolment
    109

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

    ConditionHealthy
    InterventionRTA 408 Lotion 0.5%, 1%, 3%; Lotion vehicle/placebo
    PhasePhase 1
    Registry statusCompleted

  • RTA 408 in the Treatment of Advanced Solid Tumors (NSCLC & Melanoma) - DISCOVER

    NCT02029729 · start 2013-12-31

    Registered record
    Registry ID
    NCT02029729
    Conditions
    Metastatic or Incurable Non-small Cell Lung Cancer; Relapsed, Refractory Melanoma
    Interventions
    omaveloxolone
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2013-12-31
    Completion
    2015-10-01
    Enrolment
    11

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

    ConditionMetastatic or Incurable Non-small Cell Lung Cancer; Relapsed, Refractory Melanoma
    Interventionomaveloxolone
    PhasePhase 1
    Registry statusCompleted

  • Expanded Access to Omaveloxolone for Melanoma for Patients Previously Enrolled in 408-C-1401

    NCT03593499

    Registered record
    Registry ID
    NCT03593499
    Conditions
    Melanoma
    Interventions
    omaveloxolone
    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.

    ConditionMelanoma
    Interventionomaveloxolone
    PhaseNot recorded
    Registry statusNo longer available