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Niclosamide

FDA-approved product (tablet, chewable, oral), marketed as Niclocide.

Registered studies
35
Lab records
4
Pathogens at ≥40%
2 of 4

Chemical structure

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

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Helminthiasis

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

WHO therapeutic group
Salicylic acid derivatives
Anti-infective classification
Classified as another kind of anti-infective (for example an antifungal, antiviral or antiparasitic medicine).WHO ATC P02DA01

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
  • MRSA48.7% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli20.1% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae6.4% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis47.9% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates. This medicine was in the model's training data, so this is recall, not a new prediction.

A model’s estimate of laboratory activity against each pathogen species. It is not clinical effectiveness.

Evidence

Clinical and experimental

Documented evidence

Clinical

35registered studies name this medicine, for any condition. See them below.

Experimental

  • M. tuberculosis: measured active in 4 of 4 lab records
Show the 4 laboratory records, with sources

Loading records…

“Active” means the measured value reached this project’s laboratory cutoff (10 µM or stronger). A laboratory result does not show an effect in patients.

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

-7.6 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-7.7 kcal/mol

0better fit →-12

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

Not yet docked: queued in the docking rundetails

Dihydrofolate reductase ↗ (MRSA)

-7.7 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 Niclosamide 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, and Efficacy of CP-PCA07 in Combination With Enzalutamide in Patients With Castration-Resistant Prostate Cancer

    NCT07683013 · start 2026-07

    Registered record
    Registry ID
    NCT07683013
    Conditions
    Castration-Resistant Prostate Cancer (CRPC)
    Interventions
    CP-PCA07; Enzalutamide 40 mg capsule
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Not yet recruiting
    Start
    2026-07
    Completion
    2027-12
    Enrolment
    18

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

    ConditionCastration-Resistant Prostate Cancer (CRPC)
    InterventionCP-PCA07; Enzalutamide 40 mg capsule
    PhasePhase 1
    Registry statusNot yet recruiting
  • Niclosamide in Pediatric Patients With Relapsed and Refractory AML

    NCT05188170 · start 2022-11-21

    Registered record
    Registry ID
    NCT05188170
    Conditions
    Acute Myeloid Leukemia (AML)
    Interventions
    Niclosamide
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Recruiting
    Start
    2022-11-21
    Completion
    2026-12
    Enrolment
    16

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

    ConditionAcute Myeloid Leukemia (AML)
    InterventionNiclosamide
    PhasePhase 1
    Registry statusRecruiting
  • Clinical Trials to Assess Safety and Efficacy of DWRX2003 Combination With Remdesivir in Moderate to Severe COVID-19 Patients.

    NCT05226533 · start 2022-03-31

    Registered record
    Registry ID
    NCT05226533
    Conditions
    COVID-19
    Interventions
    DWRX2003; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2022-03-31
    Completion
    2022-12-21
    Enrolment
    1

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

    ConditionCOVID-19
    InterventionDWRX2003; Placebo
    PhasePhase 2
    Registry statusTerminated
  • Niclosamide In Moderate COVID-19

    NCT04436458 · start 2022-01-20

    Registered record
    Registry ID
    NCT04436458
    Conditions
    COVID
    Interventions
    Niclosamide Oral Tablet; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Withdrawn
    Start
    2022-01-20
    Completion
    2022-01-20
    Enrolment
    0

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

    ConditionCOVID
    InterventionNiclosamide Oral Tablet; Placebo
    PhasePhase 2
    Registry statusWithdrawn
  • Niclosamide in COVID-19

    NCT04542434 · start 2022-01-20

    Registered record
    Registry ID
    NCT04542434
    Conditions
    Covid19
    Interventions
    Niclosamide Oral Tablet; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Withdrawn
    Start
    2022-01-20
    Completion
    2022-01-20
    Enrolment
    0

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

    ConditionCovid19
    InterventionNiclosamide Oral Tablet; Placebo
    PhasePhase 2
    Registry statusWithdrawn
  • Single Ascending Dose and Multiple Ascending Dose Study of Niclosamide Inhalation Powder in Healthy Adult Subjects

    NCT05168644 · start 2021-11-14

    Registered record
    Registry ID
    NCT05168644
    Conditions
    Healthy
    Interventions
    Niclosamide Inhalation Powder; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2021-11-14
    Completion
    2022-01-26
    Enrolment
    40

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

    ConditionHealthy
    InterventionNiclosamide Inhalation Powder; Placebo
    PhasePhase 1
    Registry statusCompleted
  • Randomized-controlled Trial of the Effectiveness of COVID-19 Early Treatment in Community

    NCT05087381 · start 2021-10-01

    Registered record
    Registry ID
    NCT05087381
    Conditions
    Treatment Efficacy
    Interventions
    FluvoxaMINE Maleate 50 MG; Fluvoxamine, Bromhexine; Fluvoxamine, Cyproheptadine; Niclosamide Pill; Niclosamide, Bromhexine
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2021-10-01
    Completion
    2022-06-21
    Enrolment
    1,200

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

    ConditionTreatment Efficacy
    InterventionFluvoxaMINE Maleate 50 MG; Fluvoxamine, Bromhexine; Fluvoxamine, Cyproheptadine; Niclosamide Pill +1 more
    PhasePhase 4
    Registry statusCompleted
  • Safety and Efficacy of Intranasal Administration of Niclosamide (UNI91103) in Adults With Asymptomatic or Mild COVID-19

    NCT04932915 · start 2021-09-03

    Registered record
    Registry ID
    NCT04932915
    Conditions
    Covid19
    Interventions
    Niclosamide; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2021-09-03
    Completion
    2022-01-10
    Enrolment
    4

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

    ConditionCovid19
    InterventionNiclosamide; Placebo
    PhasePhase 2
    Registry statusTerminated
  • Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection

    NCT04858425 · start 2021-04-30

    Registered record
    Registry ID
    NCT04858425
    Conditions
    Covid19
    Interventions
    Niclosamide; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2021-04-30
    Completion
    2023-09-10
    Enrolment
    166

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

    ConditionCovid19
    InterventionNiclosamide; Placebo
    PhasePhase 2
    Registry statusTerminated
  • PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V

    NCT04870333 · start 2021-02-19

    Registered record
    Registry ID
    NCT04870333
    Conditions
    Covid19
    Interventions
    Niclosamide; Placebo; Ciclesonide; Placebo; Sotrovimab; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2 / Phase 3
    Registry status
    Completed
    Start
    2021-02-19
    Completion
    2025-04-16
    Enrolment
    2,240

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

    ConditionCovid19
    InterventionNiclosamide; Placebo; Ciclesonide; Placebo +2 more
    PhasePhase 2 / Phase 3
    Registry statusCompleted
  • Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat

    NCT04750759 · start 2021-02-03

    Registered record
    Registry ID
    NCT04750759
    Conditions
    Covid19
    Interventions
    Niclosamide + Camostat; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2021-02-03
    Completion
    2021-10-29
    Enrolment
    4

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

    ConditionCovid19
    InterventionNiclosamide + Camostat; Placebo
    PhasePhase 2
    Registry statusTerminated
  • Effectiveness of Niclosamide as Add-on Therapy to the Standard of Care Measures in COVID-19 Management

    NCT04753619 · start 2021-01-03

    Registered record
    Registry ID
    NCT04753619
    Conditions
    Covid-19; SARS Pneumonia
    Interventions
    Niclosamide Oral Tablet
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Unknown
    Start
    2021-01-03
    Completion
    2021-12-03
    Enrolment
    150

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

    ConditionCovid-19; SARS Pneumonia
    InterventionNiclosamide Oral Tablet
    PhasePhase 2
    Registry statusUnknown
  • To Evaluate Safety, Tolerability and Pharmacodynamics of DWRX2003 Against COVID-19 (in Philippines)

    NCT04541485 · start 2020-12-04

    Registered record
    Registry ID
    NCT04541485
    Conditions
    COVID-19 Patients
    Interventions
    DWRX2003; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Terminated
    Start
    2020-12-04
    Completion
    2021-03-23
    Enrolment
    2

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

    ConditionCOVID-19 Patients
    InterventionDWRX2003; Placebo
    PhasePhase 1
    Registry statusTerminated
  • To Assess the Safety, Tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) Which is the Treatment of COVID-19 in Healthy Volunteers.

    NCT04749173 · start 2020-11-21

    Registered record
    Registry ID
    NCT04749173
    Conditions
    Covid19
    Interventions
    DWRX2003, 96mg; DWRX2003, 432mg; DWRX2003, 144mg; DWRX2003, 144mg
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2020-11-21
    Completion
    2021-06-18
    Enrolment
    24

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

    ConditionCovid19
    InterventionDWRX2003, 96mg; DWRX2003, 432mg; DWRX2003, 144mg; DWRX2003, 144mg
    PhasePhase 1
    Registry statusCompleted
  • A Single and Multiple Ascending Dose Study of Niclosamide in Healthy Volunteers

    NCT04705415 · start 2020-11-17

    Registered record
    Registry ID
    NCT04705415
    Conditions
    Healthy
    Interventions
    Niclosamide; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2020-11-17
    Completion
    2022-10-28
    Enrolment
    54

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

    ConditionHealthy
    InterventionNiclosamide; Placebo
    PhasePhase 1
    Registry statusCompleted