Skip to content

Loteprednol Etabonate

FDA-approved product (suspension/drops, ophthalmic), marketed as Alrex, Eysuvis, Inveltys and 3 more.

Registered studies
50+
Lab records
0
Pathogens at ≥40%
1 of 4

Chemical structure

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

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Allergic conjunctivitis
  • Anterior uveitis
  • Dry eye syndrome
  • Eye inflammation
  • Inflammation

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

WHO therapeutic group
Corticosteroids, plain
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
  • MRSA53.2% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli39.0% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae23.5% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis34.6% 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

50+registered studies name this medicine, for any condition. The registry search keeps the first 50, so there may be more. 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)

-6.1 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-6.4 kcal/mol

0better fit →-12

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

-8.0 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 Loteprednol Etabonate 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.

  • Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease

    NCT02819284 · start 2016-06

    Registered record
    Registry ID
    NCT02819284
    Conditions
    Dry Eye Syndromes; Keratoconjunctivitis Sicca
    Interventions
    KPI-121 0.25% Ophthalmic Suspension; Vehicle of KPI-121 0.25% Ophthalmic Suspension
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2016-06
    Completion
    2017-09
    Enrolment
    909

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

    ConditionDry Eye Syndromes; Keratoconjunctivitis Sicca
    InterventionKPI-121 0.25% Ophthalmic Suspension; Vehicle of KPI-121 0.25% Ophthalmic Suspension
    PhasePhase 3
    Registry statusCompleted
  • Topical 0.2% Loteprednol Etabonate vs. Topical 0.1% Dexamethasone in Impending Recurrent Pterygium

    NCT04075227 · start 2015-10-16

    Registered record
    Registry ID
    NCT04075227
    Conditions
    Recurrent Pterygium of Eye; Steroid-Induced Glaucoma
    Interventions
    0.2% loteprednol etabonate; 0.1% dexamethasone
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2015-10-16
    Completion
    2019-03-02
    Enrolment
    108

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

    ConditionRecurrent Pterygium of Eye; Steroid-Induced Glaucoma
    Intervention0.2% loteprednol etabonate; 0.1% dexamethasone
    PhasePhase 4
    Registry statusCompleted
  • Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability

    NCT03063489 · start 2015-02

    Registered record
    Registry ID
    NCT03063489
    Conditions
    Eye Pain
    Interventions
    Loteprednol Etabonate Ophthalmic Gel
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2015-02
    Completion
    2015-07
    Enrolment
    15

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

    ConditionEye Pain
    InterventionLoteprednol Etabonate Ophthalmic Gel
    PhasePhase 1
    Registry statusCompleted
  • Loteprednol vs. Prednisolone and Fluorometholone

    NCT03123614 · start 2014-09-19

    Registered record
    Registry ID
    NCT03123614
    Conditions
    Intraocular Pressure; Corneal Opacity
    Interventions
    Loteprednol Etabonate 0.5% Oph Gel; Prednisolone Acetate 1% Oph Susp
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2014-09-19
    Completion
    2018-07
    Enrolment
    131

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

    ConditionIntraocular Pressure; Corneal Opacity
    InterventionLoteprednol Etabonate 0.5% Oph Gel; Prednisolone Acetate 1% Oph Susp
    PhasePhase 4
    Registry statusCompleted
  • Loteprednol Etabonate Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

    NCT02208297 · start 2014-09

    Registered record
    Registry ID
    NCT02208297
    Conditions
    Inflammation; Pain; Cataract
    Interventions
    Loteprednol Etabonate Gel (BID); Vehicle Gel (BID)
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2014-09
    Completion
    2015-03
    Enrolment
    326

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

    ConditionInflammation; Pain; Cataract
    InterventionLoteprednol Etabonate Gel (BID); Vehicle Gel (BID)
    PhasePhase 3
    Registry statusCompleted
  • Topical Steroid Treatment For Dry Eye

    NCT02218827 · start 2014-09

    Registered record
    Registry ID
    NCT02218827
    Conditions
    Dry Eye
    Interventions
    Loteprednol Etabonate (FML)
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Unknown
    Start
    2014-09
    Completion
    2015-09
    Enrolment
    30

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

    ConditionDry Eye
    InterventionLoteprednol Etabonate (FML)
    PhaseNot applicable
    Registry statusUnknown
  • Safety and Efficacy of KPI-121 in Subjects With Inflammatory Meibomian Gland Disease

    NCT02218489 · start 2014-07

    Registered record
    Registry ID
    NCT02218489
    Conditions
    Blepharitis
    Interventions
    KPI-121; Vehicle
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2014-07
    Completion
    2016-06
    Enrolment
    206

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

    ConditionBlepharitis
    InterventionKPI-121; Vehicle
    PhasePhase 2
    Registry statusCompleted
  • Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease

    NCT02188160 · start 2014-06

    Registered record
    Registry ID
    NCT02188160
    Conditions
    Dry Eye Syndromes; Keratoconjunctivitis Sicca
    Interventions
    KPI-121; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2014-06
    Completion
    2015-03
    Enrolment
    150

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

    ConditionDry Eye Syndromes; Keratoconjunctivitis Sicca
    InterventionKPI-121; Placebo
    PhasePhase 2
    Registry statusCompleted
  • Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation

    NCT02163824 · start 2014-05

    Registered record
    Registry ID
    NCT02163824
    Conditions
    Ocular Infections, Irritations and Inflammations
    Interventions
    KPI-121 0.25%; KPI-121 1.0%; Vehicle of KPI-121 0.25%; Vehicle of KPI-121 1.0%
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2014-05
    Completion
    2014-12
    Enrolment
    380

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

    ConditionOcular Infections, Irritations and Inflammations
    InterventionKPI-121 0.25%; KPI-121 1.0%; Vehicle of KPI-121 0.25%; Vehicle of KPI-121 1.0%
    PhasePhase 3
    Registry statusCompleted
  • A Phase IV, Randomized, Parallel Group, Investigator-Masked Evaluation of the Effect of Loteprednol Etabonate Ophthalmic Gel 0.5% on the Initiation of Dry Eye Treatment With Restasis®

    NCT02028312 · start 2014-01

    Registered record
    Registry ID
    NCT02028312
    Conditions
    Dry Eye Disease
    Interventions
    Loteprednol etabonate; Artificial Tears; Restasis
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Withdrawn
    Start
    2014-01
    Completion
    2016-06
    Enrolment
    0

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

    ConditionDry Eye Disease
    InterventionLoteprednol etabonate; Artificial Tears; Restasis
    PhasePhase 4
    Registry statusWithdrawn
  • Loteprednol Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

    NCT01996839 · start 2013-12

    Registered record
    Registry ID
    NCT01996839
    Conditions
    Inflammation; Pain; Cataract
    Interventions
    Loteprednol Etabonate Gel (BID); Loteprednol Etabonate Gel (TID); Vehicle (BID); Vehicle (TID)
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2013-12
    Completion
    2014-07
    Enrolment
    514

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

    ConditionInflammation; Pain; Cataract
    InterventionLoteprednol Etabonate Gel (BID); Loteprednol Etabonate Gel (TID); Vehicle (BID); Vehicle (TID)
    PhasePhase 3
    Registry statusCompleted
  • Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children.

    NCT01475643 · start 2013-06

    Registered record
    Registry ID
    NCT01475643
    Conditions
    Cataract
    Interventions
    Loteprednol etabonate; Prednisolones acetate
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2013-06
    Completion
    2017-07
    Enrolment
    107

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

    ConditionCataract
    InterventionLoteprednol etabonate; Prednisolones acetate
    PhasePhase 3
    Registry statusCompleted
  • Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease)

    NCT01817582 · start 2013-05-17

    Registered record
    Registry ID
    NCT01817582
    Conditions
    Keratoconjunctivitis Sicca
    Interventions
    Lotemax; Restasis; Soothe® Lubricant Eye Drops
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2013-05-17
    Completion
    2014-01-10
    Enrolment
    102

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

    ConditionKeratoconjunctivitis Sicca
    InterventionLotemax; Restasis; Soothe® Lubricant Eye Drops
    PhasePhase 2
    Registry statusCompleted
  • Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty

    NCT01853696 · start 2013-03

    Registered record
    Registry ID
    NCT01853696
    Conditions
    Fuchs' Dystrophy; Corneal Edema
    Interventions
    loteprednol etabonate; prednisolone acetate 1%
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2013-03
    Completion
    2015-01
    Enrolment
    167

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

    ConditionFuchs' Dystrophy; Corneal Edema
    Interventionloteprednol etabonate; prednisolone acetate 1%
    PhasePhase 4
    Registry statusCompleted
  • Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% Following a Single Instillation

    NCT01736527 · start 2013-01

    Registered record
    Registry ID
    NCT01736527
    Conditions
    Pharmacokinetics
    Interventions
    LE Gel
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2013-01
    Completion
    2013-04
    Enrolment
    12

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

    ConditionPharmacokinetics
    InterventionLE Gel
    PhasePhase 1
    Registry statusCompleted