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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 and Pharmacokinetics of a Novel Niclosamide Solution in Combination With Camostat

    NCT04644705 · start 2020-11-02

    Registered record
    Registry ID
    NCT04644705
    Conditions
    Healthy Volunteers
    Interventions
    Niclosamide; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2020-11-02
    Completion
    2021-05-03
    Enrolment
    28

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

    ConditionHealthy Volunteers
    InterventionNiclosamide; Placebo
    PhasePhase 1
    Registry statusCompleted
  • To Evaluate the Safety, Tolerability and Pharmacokinetic Properties of DWRX2003

    NCT04592835 · start 2020-10-19

    Registered record
    Registry ID
    NCT04592835
    Conditions
    COVID-19 Patients
    Interventions
    DWRX2003
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Unknown
    Start
    2020-10-19
    Completion
    2021-06-30
    Enrolment
    24

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

    ConditionCOVID-19 Patients
    InterventionDWRX2003
    PhasePhase 1
    Registry statusUnknown
  • A Study To Evaluate The Efficacy And Safety Of a Novel Niclosamide Suspension Formulation For COVID-19

    NCT04558021 · start 2020-10-08

    Registered record
    Registry ID
    NCT04558021
    Conditions
    Covid19
    Interventions
    Niclosamide suspension; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Unknown
    Start
    2020-10-08
    Completion
    2021-02-14
    Enrolment
    200

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

    ConditionCovid19
    InterventionNiclosamide suspension; Placebo
    PhasePhase 3
    Registry statusUnknown
  • Study of Niclosamide in Moderate and Severe Hospitalized Coronavirus-19 (COVID-19) Patients

    NCT04603924 · start 2020-10-07

    Registered record
    Registry ID
    NCT04603924
    Conditions
    COVID-19
    Interventions
    Niclosamide; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2 / Phase 3
    Registry status
    Completed
    Start
    2020-10-07
    Completion
    2022-02-16
    Enrolment
    49

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

    ConditionCOVID-19
    InterventionNiclosamide; Placebo
    PhasePhase 2 / Phase 3
    Registry statusCompleted
  • Niclosamide for Mild to Moderate COVID-19

    NCT04399356 · start 2020-10-01

    Registered record
    Registry ID
    NCT04399356
    Conditions
    COVID-19
    Interventions
    Niclosamide; Placebo; Telehealth monitoring
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2020-10-01
    Completion
    2021-08-19
    Enrolment
    73

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

    ConditionCOVID-19
    InterventionNiclosamide; Placebo; Telehealth monitoring
    PhasePhase 2
    Registry statusCompleted
  • To Evaluate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of DWRX2003 Against COVID-19

    NCT04524052 · start 2020-08

    Registered record
    Registry ID
    NCT04524052
    Conditions
    Healthy
    Interventions
    DWRX2003; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Unknown
    Start
    2020-08
    Completion
    2020-12
    Enrolment
    32

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

    ConditionHealthy
    InterventionDWRX2003; Placebo
    PhasePhase 1
    Registry statusUnknown
  • Safety of Ascending Doses of Niclosamide (UNI911 INHALATION) in Healthy Volunteers

    NCT04576312 · start 2020-06-29

    Registered record
    Registry ID
    NCT04576312
    Conditions
    Covid19
    Interventions
    UNI911 inhalation 1% and intranasal spray 1%; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2020-06-29
    Completion
    2020-12-04
    Enrolment
    64

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

    ConditionCovid19
    InterventionUNI911 inhalation 1% and intranasal spray 1%; Placebo
    PhasePhase 1
    Registry statusCompleted
  • Hydroxychloroquine or Diltiazem-Niclosamide for the Treatment of COVID-19

    NCT04372082 · start 2020-05

    Registered record
    Registry ID
    NCT04372082
    Conditions
    Sars-CoV2
    Interventions
    Standard of care (SOC); Hydroxychloroquine; Association of diltiazem and niclosamide
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Withdrawn
    Start
    2020-05
    Completion
    2023-05
    Enrolment
    0

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

    ConditionSars-CoV2
    InterventionStandard of care (SOC); Hydroxychloroquine; Association of diltiazem and niclosamide
    PhasePhase 3
    Registry statusWithdrawn
  • Niclosamide for Familial Adenomatous Polyposis

    NCT04296851 · start 2020-02-14

    Registered record
    Registry ID
    NCT04296851
    Conditions
    Familial Adenomatous Polyposis
    Interventions
    Niclosamide; placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Unknown
    Start
    2020-02-14
    Completion
    2023-02
    Enrolment
    72

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

    ConditionFamilial Adenomatous Polyposis
    InterventionNiclosamide; placebo
    PhasePhase 2
    Registry statusUnknown
  • Niclosamide Role in Diabetic Nephropathy

    NCT04317430 · start 2020-02-01

    Registered record
    Registry ID
    NCT04317430
    Conditions
    Diabetic Nephropathies
    Interventions
    Niclosamide; Placebo oral tablet
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2020-02-01
    Completion
    2022-04-01
    Enrolment
    60

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

    ConditionDiabetic Nephropathies
    InterventionNiclosamide; Placebo oral tablet
    PhasePhase 3
    Registry statusCompleted
  • A Study of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Proctosigmoiditis

    NCT03521232 · start 2018-05-15

    Registered record
    Registry ID
    NCT03521232
    Conditions
    Ulcerative Colitis; Ulcerative Proctitis; Ulcerative Proctosigmoiditis
    Interventions
    Niclosamide
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Terminated
    Start
    2018-05-15
    Completion
    2022-10-04
    Enrolment
    27

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

    ConditionUlcerative Colitis; Ulcerative Proctitis; Ulcerative Proctosigmoiditis
    InterventionNiclosamide
    PhasePhase 1 / Phase 2
    Registry statusTerminated
  • A Study of Niclosamide in Patients With Resectable Colon Cancer

    NCT02687009 · start 2017-11-07

    Registered record
    Registry ID
    NCT02687009
    Conditions
    Colon Cancer
    Interventions
    Niclosamide
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Terminated
    Start
    2017-11-07
    Completion
    2017-12-12
    Enrolment
    1

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

    ConditionColon Cancer
    InterventionNiclosamide
    PhasePhase 1
    Registry statusTerminated
  • Niclosamide With Etanercept in Rheumatoid Arthritis

    NCT03160001 · start 2017-08-15

    Registered record
    Registry ID
    NCT03160001
    Conditions
    Rheumatoid Arthritis (RA)
    Interventions
    Placebo; Niclosamide; Etanercept
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Completed
    Start
    2017-08-15
    Completion
    2018-12-10
    Enrolment
    110

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

    ConditionRheumatoid Arthritis (RA)
    InterventionPlacebo; Niclosamide; Etanercept
    PhasePhase 1 / Phase 2
    Registry statusCompleted
  • Enzalutamide and Niclosamide in Treating Patients With Recurrent or Metastatic Castration-Resistant Prostate Cancer

    NCT03123978 · start 2017-01-09

    Registered record
    Registry ID
    NCT03123978
    Conditions
    Metastatic Prostate Carcinoma; Recurrent Prostate Carcinoma; Stage IV Prostate Cancer
    Interventions
    Enzalutamide; Niclosamide
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2017-01-09
    Completion
    2022-04-19
    Enrolment
    6

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

    ConditionMetastatic Prostate Carcinoma; Recurrent Prostate Carcinoma; Stage IV Prostate Cancer
    InterventionEnzalutamide; Niclosamide
    PhasePhase 1
    Registry statusCompleted
  • Abiraterone Acetate, Niclosamide, and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer

    NCT02807805 · start 2016-10

    Registered record
    Registry ID
    NCT02807805
    Conditions
    Metastatic Prostate Carcinoma; Recurrent Prostate Carcinoma; Stage IV Prostate Cancer
    Interventions
    Abiraterone Acetate; Niclosamide; Prednisone
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2016-10
    Completion
    2025-12
    Enrolment
    37

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

    ConditionMetastatic Prostate Carcinoma; Recurrent Prostate Carcinoma; Stage IV Prostate Cancer
    InterventionAbiraterone Acetate; Niclosamide; Prednisone
    PhasePhase 2
    Registry statusActive not recruiting