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AMR Drug RepurposingSmart Screeningresearch prototype

Lotilaner

FDA-approved product (solution/drops, ophthalmic), marketed as Xdemvy.

Registered studies
14
Lab records
0
Pathogens at ≥40%
2 of 4

Chemical structure

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

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Eye infection

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

WHO therapeutic group
Other antiinfectives
FDA pharmacologic class
Ectoparasiticide FDA label ↗
Anti-infective classification
Classified as another kind of anti-infective (for example an antifungal, antiviral or antiparasitic medicine).WHO ATC S01AX25

Repurposing investigation

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

AI-predicted activity

AI prediction · nothing measured
  • MRSA51.4% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli39.2% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae27.2% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis44.6% 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

14registered 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 Lotilaner in ChEMBL Registered studies below

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

-8.2 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-7.5 kcal/mol

0better fit →-12

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

-9.0 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-8.0 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 Lotilaner 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, Tolerability, Pharmacokinetics, and Mosquitocidal Activity of Lotilaner in Healthy Participants in Mali.

    NCT07758985 · start 2026-08

    Registered record
    Registry ID
    NCT07758985
    Conditions
    Malaria
    Interventions
    Cohort 1 low dose lotilaner with a high-fat meal; Cohort 1 low dose placebo with a high-fat meal; Cohort 2 high dose lotilaner in fasted state; Cohort 2 high dose placebo in fasted state; Cohort 3 high dose lotilaner with a high-fat meal; Cohort 3 high dose placebo with a high-fat meal
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Not yet recruiting
    Start
    2026-08
    Completion
    2027-08
    Enrolment
    75

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

    ConditionMalaria
    InterventionCohort 1 low dose lotilaner with a high-fat meal; Cohort 1 low dose placebo with a high-fat meal; Cohort 2 high dose lotilaner in fasted state; Cohort 2 high dose placebo in fasted state +2 more
    PhasePhase 1
    Registry statusNot yet recruiting

  • A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure

    NCT07562087 · start 2026-03-09

    Registered record
    Registry ID
    NCT07562087
    Conditions
    Lyme Disease
    Interventions
    TP-05 (lotilaner) Low Dose; TP-05 (lotilaner) High Dose; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2026-03-09
    Completion
    2027-12
    Enrolment
    722

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

    ConditionLyme Disease
    InterventionTP-05 (lotilaner) Low Dose; TP-05 (lotilaner) High Dose; Placebo
    PhasePhase 2
    Registry statusActive not recruiting

  • Study of Lotilaner Ophthalmic Gel in Patients With Ocular Rosacea (KORE)

    NCT07443202 · start 2025-12-05

    Registered record
    Registry ID
    NCT07443202
    Conditions
    Ocular Rosacea
    Interventions
    lotilaner; Vehicle
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Enrolling by invitation
    Start
    2025-12-05
    Completion
    2027-12-31
    Enrolment
    155

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

    ConditionOcular Rosacea
    Interventionlotilaner; Vehicle
    PhasePhase 2
    Registry statusEnrolling by invitation

  • Impact of XDEMVY® on Demodex Blepharitis in Soft Contact Lens Wearers

    NCT06182358 · start 2023-12-27

    Registered record
    Registry ID
    NCT06182358
    Conditions
    Demodex Blepharitis
    Interventions
    Lotilaner ophthalmic solution, 0.25%; Vehicle control
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2023-12-27
    Completion
    2025-01-27
    Enrolment
    145

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

    ConditionDemodex Blepharitis
    InterventionLotilaner ophthalmic solution, 0.25%; Vehicle control
    PhasePhase 4
    Registry statusCompleted

  • Effect of an Exploratory Vehicle on Meibomian Gland Dysfunction in Patients With Demodex

    NCT06054217 · start 2023-08-01

    Registered record
    Registry ID
    NCT06054217
    Conditions
    Meibomian Gland Dysfunction; Demodex Infestation of Eyelid; Blepharitis; Demodectic Blepharitis
    Interventions
    Vehicle of TP-03
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Unknown
    Start
    2023-08-01
    Completion
    2024-06-15
    Enrolment
    36

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

    ConditionMeibomian Gland Dysfunction; Demodex Infestation of Eyelid; Blepharitis; Demodectic Blepharitis
    InterventionVehicle of TP-03
    PhasePhase 2
    Registry statusUnknown

  • Study of TP-04 in Participants With Papulopustular Rosacea

    NCT05838170 · start 2023-03-01

    Registered record
    Registry ID
    NCT05838170
    Conditions
    Papulopustular Rosacea
    Interventions
    Lotilaner Gel, 2.0%; Vehicle control gel
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2023-03-01
    Completion
    2023-11-13
    Enrolment
    37

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

    ConditionPapulopustular Rosacea
    InterventionLotilaner Gel, 2.0%; Vehicle control gel
    PhasePhase 2
    Registry statusCompleted

  • Study to Evaluate the Food Effect of TP-05 in Healthy Participants

    NCT05720364 · start 2023-01-19

    Registered record
    Registry ID
    NCT05720364
    Conditions
    Healthy
    Interventions
    TP-05 (lotilaner oral), fasted group; TP-05 (lotilaner oral), high-fat group; TP-05 (lotilaner oral), low-fat group
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2023-01-19
    Completion
    2023-05-30
    Enrolment
    42

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

    ConditionHealthy
    InterventionTP-05 (lotilaner oral), fasted group; TP-05 (lotilaner oral), high-fat group; TP-05 (lotilaner oral), low-fat group
    PhasePhase 1
    Registry statusCompleted

  • A Human Tick Kill Study to Investigate the Safety, Tolerability, and Whole Blood Concentration of TP-05

    NCT05387083 · start 2022-12-12

    Registered record
    Registry ID
    NCT05387083
    Conditions
    Healthy Volunteer
    Interventions
    Low Dose TP-05; High Dose TP-05; Placebo Comparator
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2022-12-12
    Completion
    2024-06-26
    Enrolment
    30

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

    ConditionHealthy Volunteer
    InterventionLow Dose TP-05; High Dose TP-05; Placebo Comparator
    PhasePhase 2
    Registry statusCompleted

  • Trial to Evaluate the Efficacy and Safety of TP-03, LIBRA Study

    NCT05629390 · start 2022-10-23

    Registered record
    Registry ID
    NCT05629390
    Conditions
    Blepharitis
    Interventions
    Lotilaner; Vehicle Control
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2022-10-23
    Completion
    2024-04-02
    Enrolment
    163

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

    ConditionBlepharitis
    InterventionLotilaner; Vehicle Control
    PhasePhase 3
    Registry statusCompleted

  • Pilot Study Comparing the Safety and Efficacy of Two Dosing Regimens of TP-03 for the Treatment of MGD

    NCT05454956 · start 2022-08-03

    Registered record
    Registry ID
    NCT05454956
    Conditions
    Meibomian Gland Dysfunction; Blepharitis; Demodex Infestation
    Interventions
    TP-03; TP-03 Vehicle
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2022-08-03
    Completion
    2023-05-18
    Enrolment
    39

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

    ConditionMeibomian Gland Dysfunction; Blepharitis; Demodex Infestation
    InterventionTP-03; TP-03 Vehicle
    PhasePhase 2
    Registry statusCompleted

  • A Pharmacokinetic Study of TP-05 in Healthy Subjects

    NCT05138796 · start 2021-05-06

    Registered record
    Registry ID
    NCT05138796
    Conditions
    Healthy
    Interventions
    TP-05 (lotilaner oral capsules); Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2021-05-06
    Completion
    2022-07-25
    Enrolment
    67

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

    ConditionHealthy
    InterventionTP-05 (lotilaner oral capsules); Placebo
    PhasePhase 1
    Registry statusCompleted

  • Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis

    NCT04784091 · start 2021-04-29

    Registered record
    Registry ID
    NCT04784091
    Conditions
    Blepharitis
    Interventions
    TP-03; TP-03 Vehicle
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2021-04-29
    Completion
    2022-05-09
    Enrolment
    412

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

    ConditionBlepharitis
    InterventionTP-03; TP-03 Vehicle
    PhasePhase 3
    Registry statusCompleted

  • A Six Week Pharmacokinetic Study of TP-03 in Healthy Subjects

    NCT05138861 · start 2021-02-09

    Registered record
    Registry ID
    NCT05138861
    Conditions
    Healthy
    Interventions
    TP-03 (Lotilaner Ophthalmic Solution), 0.25%
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2021-02-09
    Completion
    2021-09-03
    Enrolment
    24

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

    ConditionHealthy
    InterventionTP-03 (Lotilaner Ophthalmic Solution), 0.25%
    PhasePhase 1
    Registry statusCompleted

  • Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis

    NCT04475432 · start 2020-09-09

    Registered record
    Registry ID
    NCT04475432
    Conditions
    Blepharitis
    Interventions
    TP-03, 0.25%; TP-03 Vehicle
    Study type
    INTERVENTIONAL
    Phase
    Phase 2 / Phase 3
    Registry status
    Completed
    Start
    2020-09-09
    Completion
    2021-05-04
    Enrolment
    421

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

    ConditionBlepharitis
    InterventionTP-03, 0.25%; TP-03 Vehicle
    PhasePhase 2 / Phase 3
    Registry statusCompleted