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Vamorolone

FDA-approved product (suspension, oral), marketed as Agamree.

Registered studies
12
Lab records
0
Pathogens at ≥40%
1 of 4

Chemical structure

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

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Becker muscular dystrophy
  • Duchenne muscular dystrophy

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

WHO therapeutic group
Glucocorticoids
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
  • MRSA51.7% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli33.3% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae37.5% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis26.5% 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

12registered 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.

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

-7.5 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-8.9 kcal/mol

0better fit →-12

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

-8.8 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-7.0 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 Vamorolone 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 on Safety and Effectiveness of Long-term Treatment With Vamorolone in Boys With Duchenne Muscular Dystrophy

    NCT06713135 · start 2024-11-10

    Registered record
    Registry ID
    NCT06713135
    Conditions
    Duchenne Muscular Dystrophy
    Interventions
    vamorolone 40 mg/mL oral suspension
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Active not recruiting
    Start
    2024-11-10
    Completion
    2028-09
    Enrolment
    80

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

    ConditionDuchenne Muscular Dystrophy
    Interventionvamorolone 40 mg/mL oral suspension
    PhasePhase 4
    Registry statusActive not recruiting
  • Registry Study to Observe Long-term Safety of Vamorolone (AGAMREE®) in Patients With Duchenne Muscular Dystrophy-SUMMIT

    NCT06564974 · start 2024-09-25

    Registered record
    Registry ID
    NCT06564974
    Conditions
    Duchenne Muscular Dystrophy
    Interventions
    Vamorolone
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2024-09-25
    Completion
    2032-02
    Enrolment
    250

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

    ConditionDuchenne Muscular Dystrophy
    InterventionVamorolone
    PhaseNot recorded
    Registry statusRecruiting
  • Evaluation of Vamorolone CYP3A4 Induction on Midazolam (a Sensitive CYP 3A4 Substrate) Pharmacokinetics

    NCT06689527 · start 2024-08-13

    Registered record
    Registry ID
    NCT06689527
    Conditions
    Drug Interaction
    Interventions
    Vamorolone; Midazolam
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2024-08-13
    Completion
    2024-10-16
    Enrolment
    18

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

    ConditionDrug Interaction
    InterventionVamorolone; Midazolam
    PhasePhase 1
    Registry statusCompleted
  • Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects

    NCT06649409 · start 2024-06-05

    Registered record
    Registry ID
    NCT06649409
    Conditions
    Pharmacodynamic
    Interventions
    Vamorolone; Eplerenone; Fludrocortisone
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2024-06-05
    Completion
    2024-07-06
    Enrolment
    30

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

    ConditionPharmacodynamic
    InterventionVamorolone; Eplerenone; Fludrocortisone
    PhasePhase 1
    Registry statusCompleted
  • A Study to Assess Vamorolone in Becker Muscular Dystrophy (BMD)

    NCT05166109 · start 2022-07-07

    Registered record
    Registry ID
    NCT05166109
    Conditions
    Becker Muscular Dystrophy
    Interventions
    Vamorolone; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2022-07-07
    Completion
    2025-08-18
    Enrolment
    46

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

    ConditionBecker Muscular Dystrophy
    InterventionVamorolone; Placebo
    PhasePhase 2
    Registry statusCompleted
  • A Study to Assess Vamorolone in Boys Ages 2 to <4 Years and 7 to <18 Years With Duchenne Muscular Dystrophy (DMD)

    NCT05185622 · start 2022-03-21

    Registered record
    Registry ID
    NCT05185622
    Conditions
    Duchenne Muscular Dystrophy
    Interventions
    Vamorolone
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2022-03-21
    Completion
    2024-07-16
    Enrolment
    54

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

    ConditionDuchenne Muscular Dystrophy
    InterventionVamorolone
    PhasePhase 2
    Registry statusCompleted
  • Proof of Concept Trial of Vamorolone in Pediatric Ulcerative Colitis

    NCT04348890 · start 2020-09-01

    Registered record
    Registry ID
    NCT04348890
    Conditions
    Pediatric Ulcerative Colitis
    Interventions
    Vamorolone 4% suspension for oral dosing
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Withdrawn
    Start
    2020-09-01
    Completion
    2022-09-01
    Enrolment
    0

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

    ConditionPediatric Ulcerative Colitis
    InterventionVamorolone 4% suspension for oral dosing
    PhasePhase 1 / Phase 2
    Registry statusWithdrawn
  • A Study to Assess the Efficacy and Safety of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)

    NCT03439670 · start 2018-06-29

    Registered record
    Registry ID
    NCT03439670
    Conditions
    Duchenne Muscular Dystrophy
    Interventions
    Vamorolone; Prednisone; Placebo; Vamorolone; Prednisone; Placebo; Vamorolone; Vamorolone
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2018-06-29
    Completion
    2021-08-19
    Enrolment
    121

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

    ConditionDuchenne Muscular Dystrophy
    InterventionVamorolone; Prednisone; Placebo; Vamorolone +4 more
    PhasePhase 2
    Registry statusCompleted
  • Long-term Extension Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)

    NCT03038399 · start 2017-02-02

    Registered record
    Registry ID
    NCT03038399
    Conditions
    Duchenne Muscular Dystrophy
    Interventions
    Vamorolone 0.25 mg/day/day; Vamorolone 0.75 mg/day/day; Vamorolone 2.0 mg/day/day; Vamorolone 6.0 mg/day/day
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2017-02-02
    Completion
    2020-04-30
    Enrolment
    46

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

    ConditionDuchenne Muscular Dystrophy
    InterventionVamorolone 0.25 mg/day/day; Vamorolone 0.75 mg/day/day; Vamorolone 2.0 mg/day/day; Vamorolone 6.0 mg/day/day
    PhasePhase 2
    Registry statusCompleted
  • An Extension Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)

    NCT02760277 · start 2016-07-28

    Registered record
    Registry ID
    NCT02760277
    Conditions
    Duchenne Muscular Dystrophy
    Interventions
    Vamorolone 0.25 mg/day/day; Vamorolone 0.75 mg/day/day; Vamorolone 2.0 mg/day/day; Vamorolone 6.0 mg/day/day
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2016-07-28
    Completion
    2018-04-26
    Enrolment
    48

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

    ConditionDuchenne Muscular Dystrophy
    InterventionVamorolone 0.25 mg/day/day; Vamorolone 0.75 mg/day/day; Vamorolone 2.0 mg/day/day; Vamorolone 6.0 mg/day/day
    PhasePhase 2
    Registry statusCompleted
  • A Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)

    NCT02760264 · start 2016-06

    Registered record
    Registry ID
    NCT02760264
    Conditions
    Duchenne Muscular Dystrophy
    Interventions
    Vamorolone 0.25 mg/kg/day; Vamorolone 0.75 mg/kg/day; Vamorolone 2.0 mg/kg/day; Vamorolone 6.0 mg/kg/day
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2016-06
    Completion
    2018-05-01
    Enrolment
    48

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

    ConditionDuchenne Muscular Dystrophy
    InterventionVamorolone 0.25 mg/kg/day; Vamorolone 0.75 mg/kg/day; Vamorolone 2.0 mg/kg/day; Vamorolone 6.0 mg/kg/day
    PhasePhase 2
    Registry statusCompleted
  • Expanded Access Protocol for Boys With Duchenne Muscular Dystrophy

    NCT03863119

    Registered record
    Registry ID
    NCT03863119
    Conditions
    Duchenne Muscular Dystrophy
    Interventions
    Vamorolone
    Study type
    EXPANDED_ACCESS
    Phase
    Not recorded
    Registry status
    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.

    ConditionDuchenne Muscular Dystrophy
    InterventionVamorolone
    PhaseNot recorded
    Registry statusAvailable