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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 Topical Infliximab in Autoimmune Dry Eye Disease

    NCT07671222 · start 2026-12

    Registered record
    Registry ID
    NCT07671222
    Conditions
    Sjogren Syndrome; Sjogren Syndrome With Keratoconjunctivitis; Dry Eye Disease (DED)
    Interventions
    Infliximab 0.1%; Loteprednol
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Not yet recruiting
    Start
    2026-12
    Completion
    2028-03
    Enrolment
    38

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

    ConditionSjogren Syndrome; Sjogren Syndrome With Keratoconjunctivitis; Dry Eye Disease (DED)
    InterventionInfliximab 0.1%; Loteprednol
    PhasePhase 2
    Registry statusNot yet recruiting
  • Autologous Plasma Rich in Growth Factors for Severe Dry Eye Disease

    NCT07773740 · start 2026-08-25

    Registered record
    Registry ID
    NCT07773740
    Conditions
    Dry Eye Disease With Severe Keratitis
    Interventions
    PRGF; Balanced Salt Solution (BSS®)
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Not yet recruiting
    Start
    2026-08-25
    Completion
    2027-08
    Enrolment
    100

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

    ConditionDry Eye Disease With Severe Keratitis
    InterventionPRGF; Balanced Salt Solution (BSS®)
    PhaseNot applicable
    Registry statusNot yet recruiting
  • Loteprednol Etabonate Versus Prednisolone Acetate for Anterior Chamber Granulomas

    NCT07496060 · start 2025-08-10

    Registered record
    Registry ID
    NCT07496060
    Conditions
    Anterior Chamber Granulomatous Uveitis
    Interventions
    loteprednol etabonate 1% arm 1; prednisolone acete 1%
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2025-08-10
    Completion
    2026-01-13
    Enrolment
    66

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

    ConditionAnterior Chamber Granulomatous Uveitis
    Interventionloteprednol etabonate 1% arm 1; prednisolone acete 1%
    PhasePhase 4
    Registry statusCompleted
  • The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain

    NCT05542381 · start 2022-12-22

    Registered record
    Registry ID
    NCT05542381
    Conditions
    Age-Related Macular Degeneration
    Interventions
    Loteprednol Etabonate Ophthalmic Gel [Lotemax]; Refresh Lubricant Eye Drops [Artificial Tears]
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Completed
    Start
    2022-12-22
    Completion
    2025-05-01
    Enrolment
    64

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

    ConditionAge-Related Macular Degeneration
    InterventionLoteprednol Etabonate Ophthalmic Gel [Lotemax]; Refresh Lubricant Eye Drops [Artificial Tears]
    PhaseNot applicable
    Registry statusCompleted
  • Comparing Post-intravitreal Injection Pain Scores Using Loteprednol, Bromfenac Sodium, and Artificial Tears Over a 24-hour Period

    NCT07090044 · start 2021-08-20

    Registered record
    Registry ID
    NCT07090044
    Conditions
    Vein Occlusion; Macular Degeneration Choroidal Neovascularization; Macular Edema; Diabetic Retinopathy
    Interventions
    Bromfenac Sodium 0.07%; Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly; Propylene Glycol Preservative-free Artificial Tears
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2021-08-20
    Completion
    2022-12-08
    Enrolment
    77

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

    ConditionVein Occlusion; Macular Degeneration Choroidal Neovascularization; Macular Edema; Diabetic Retinopathy
    InterventionBromfenac Sodium 0.07%; Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly; Propylene Glycol Preservative-free Artificial Tears
    PhasePhase 4
    Registry statusCompleted
  • The DEPOT Study (Dry Eye Prescription Options for Therapy)

    NCT04911361 · start 2021-08-10

    Registered record
    Registry ID
    NCT04911361
    Conditions
    Dry Eye
    Interventions
    Dexamethasone
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2021-08-10
    Completion
    2021-12-28
    Enrolment
    50

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

    ConditionDry Eye
    InterventionDexamethasone
    PhasePhase 4
    Registry statusCompleted
  • Tolerability Comparison of Flarex to Lotemax SM

    NCT07588074 · start 2021-05-01

    Registered record
    Registry ID
    NCT07588074
    Conditions
    Ocular Inflammation; Keratoconjunctivitis; Dry Eye Disease (DED); Post-operative Complications; Kerato Conjunctivitis Sicca; Dry Eye Syndromes; Postoperative Complications
    Interventions
    Fluorometholone Acetate Ophthalmic Suspension 0.1%; Loteprednol Etabonate Ophthalmic Gel 0.38%
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2021-05-01
    Completion
    2021-06-30
    Enrolment
    40

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

    ConditionOcular Inflammation; Keratoconjunctivitis; Dry Eye Disease (DED); Post-operative Complications +3 more
    InterventionFluorometholone Acetate Ophthalmic Suspension 0.1%; Loteprednol Etabonate Ophthalmic Gel 0.38%
    PhasePhase 4
    Registry statusCompleted
  • Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax

    NCT04555694 · start 2020-10-01

    Registered record
    Registry ID
    NCT04555694
    Conditions
    Dry Eye
    Interventions
    Cyclosporine; Loteprednol Etabonate; Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2020-10-01
    Completion
    2022-02-16
    Enrolment
    30

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

    ConditionDry Eye
    InterventionCyclosporine; Loteprednol Etabonate; Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert
    PhasePhase 4
    Registry statusCompleted
  • Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus

    NCT04418999 · start 2020-09-01

    Registered record
    Registry ID
    NCT04418999
    Conditions
    Keratoconus; Dry Eye; Allergy
    Interventions
    dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use; Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly
    Study type
    INTERVENTIONAL
    Phase
    Early phase 1
    Registry status
    Completed
    Start
    2020-09-01
    Completion
    2021-12-31
    Enrolment
    36

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

    ConditionKeratoconus; Dry Eye; Allergy
    Interventiondexamethasone ophthalmic insert 0.4 mg, for intracanalicular use; Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly
    PhaseEarly phase 1
    Registry statusCompleted
  • Cyclosporine 0.05% Eye Drops for Vernal Keratoconjunctivitis Trial

    NCT05353101 · start 2020-07-01

    Registered record
    Registry ID
    NCT05353101
    Conditions
    Vernal Keratoconjunctivitis; Cyclosporine 0.05% Eye Drops
    Interventions
    Cyclosporine 0.05% eye drops; Loteprednol Etabonate 0.5% and Tobramycin Eye Drops 0.3%
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2020-07-01
    Completion
    2021-06-01
    Enrolment
    48

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

    ConditionVernal Keratoconjunctivitis; Cyclosporine 0.05% Eye Drops
    InterventionCyclosporine 0.05% eye drops; Loteprednol Etabonate 0.5% and Tobramycin Eye Drops 0.3%
    PhasePhase 1
    Registry statusCompleted
  • Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery

    NCT03531697 · start 2018-04-26

    Registered record
    Registry ID
    NCT03531697
    Conditions
    Inflammation Following Ocular Surgery
    Interventions
    Generic Loteprednol Etabonate; Reference Listed Drug (RLD)
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2018-04-26
    Completion
    2019-10-07
    Enrolment
    381

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

    ConditionInflammation Following Ocular Surgery
    InterventionGeneric Loteprednol Etabonate; Reference Listed Drug (RLD)
    PhasePhase 1
    Registry statusCompleted
  • Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability of Single and Repeat Ocular Installations

    NCT03098953 · start 2017-04-10

    Registered record
    Registry ID
    NCT03098953
    Conditions
    Healthy
    Interventions
    Loteprednol Etabonate
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2017-04-10
    Completion
    2017-05-12
    Enrolment
    15

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

    ConditionHealthy
    InterventionLoteprednol Etabonate
    PhasePhase 1
    Registry statusCompleted
  • Safety and Efficacy of Lotemax Versus FML in Subjects Undergoing PRK for the Correction of Mild to Moderate Myopia, 3- Month Follow-up Study

    NCT02974387 · start 2017-04

    Registered record
    Registry ID
    NCT02974387
    Conditions
    Must be PRK Candidate
    Interventions
    Fluorometholone(FML); Loteprednol (Lotemax)
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Unknown
    Start
    2017-04
    Completion
    2017-11
    Enrolment
    200

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

    ConditionMust be PRK Candidate
    InterventionFluorometholone(FML); Loteprednol (Lotemax)
    PhasePhase 4
    Registry statusUnknown
  • Dexamethasone (Sterodex) Versus Loteprendol (Lotemax) Eye Drops Following Strabismus Surgery

    NCT02825186 · start 2016-07

    Registered record
    Registry ID
    NCT02825186
    Conditions
    Ophthalmology
    Interventions
    Loteprendol etabonate 0.5%; Dexamethasone 0.1%
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Unknown
    Start
    2016-07
    Completion
    2018-06
    Enrolment
    100

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

    ConditionOphthalmology
    InterventionLoteprendol etabonate 0.5%; Dexamethasone 0.1%
    PhaseNot applicable
    Registry statusUnknown
  • Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain

    NCT02793817 · start 2016-06

    Registered record
    Registry ID
    NCT02793817
    Conditions
    Post Surgical Ocular Inflammation and Pain
    Interventions
    KPI-121 1% Ophthalmic Suspension dosed BID; Vehicle of KPI-121 Ophthalmic Suspension dosed BID
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2016-06
    Completion
    2017-03
    Enrolment
    520

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

    ConditionPost Surgical Ocular Inflammation and Pain
    InterventionKPI-121 1% Ophthalmic Suspension dosed BID; Vehicle of KPI-121 Ophthalmic Suspension dosed BID
    PhasePhase 3
    Registry statusCompleted