Niclosamide

DRUG19 trials

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID), Oregon Health and Science University, Charite University, Berlin, Germany, University of Washington, Michael Morse, MD

Conditions

Acute Myeloid Leukemia (AML)COVID-19Castration Levels of TestosteroneCastration-Resistant Prostate CarcinomaColon CancerColorectal CancerCovid19Diabetic Nephropathies

Phase 1

Niclosamide and Enzalutamide in Treating Patients With Castration-Resistant, Metastatic Prostate Cancer

CompletedNCT02532114

University of WashingtonCastration Levels of Testosterone, Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma +2

Start: 2015-12-31End: 2017-11-30Updated: 2018-04-18

A Study of Niclosamide in Patients With Resectable Colon Cancer

TerminatedNCT02687009

Michael Morse, MDColon Cancer

Start: 2017-11-07End: 2017-12-12Updated: 2020-02-19

Enzalutamide and Niclosamide in Treating Patients With Recurrent or Metastatic Castration-Resistant Prostate Cancer

CompletedNCT03123978

Mamta ParikhMetastatic Prostate Carcinoma, Recurrent Prostate Carcinoma, Stage IV Prostate Cancer

Start: 2017-01-09End: 2022-04-19Updated: 2023-04-26

Niclosamide With Etanercept in Rheumatoid Arthritis

CompletedNCT03160001

Faiq GorialRheumatoid Arthritis (RA)

Start: 2017-08-15End: 2018-12-10Updated: 2018-12-12

A Study of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Proctosigmoiditis

TerminatedNCT03521232

Entero TherapeuticsUlcerative Colitis, Ulcerative Proctitis, Ulcerative Proctosigmoiditis

Start: 2018-05-15End: 2022-10-04Updated: 2022-11-29

Safety and Pharmacokinetics of a Novel Niclosamide Solution in Combination With Camostat

CompletedNCT04644705

Charité Research Organisation GmbHHealthy Volunteers

Start: 2020-11-02End: 2021-05-03Updated: 2021-11-29

A Single and Multiple Ascending Dose Study of Niclosamide in Healthy Volunteers

CompletedNCT04705415

NeuroBo Pharmaceuticals Inc.Healthy

Start: 2020-11-17End: 2022-10-28Updated: 2025-02-03

Niclosamide in Pediatric Patients With Relapsed and Refractory AML

RecruitingNCT05188170

Stanford UniversityAcute Myeloid Leukemia (AML)

Start: 2022-11-21End: 2026-12-31Target: 16Updated: 2026-01-12

Phase 2

Drug Trial to Investigate the Safety and Efficacy of Niclosamide Tablets in Patients With Metastases of a Colorectal Cancer Progressing After Therapy

Charite University, Berlin, GermanyColorectal Cancer

Start: 2015-08-31End: 2020-08-31Target: 37Updated: 2018-09-12

Abiraterone Acetate, Niclosamide, and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer

Active, not recruitingNCT02807805

Mamta ParikhMetastatic Prostate Carcinoma, Recurrent Prostate Carcinoma, Stage IV Prostate Cancer

Start: 2016-10-31End: 2025-12-31Updated: 2024-12-18

Niclosamide for Familial Adenomatous Polyposis

Yonsei UniversityFamilial Adenomatous Polyposis

Start: 2020-02-14End: 2023-02-28Target: 72Updated: 2020-03-05

Niclosamide for Mild to Moderate COVID-19

CompletedNCT04399356

Tufts Medical CenterCOVID-19

Start: 2020-10-01End: 2021-08-19Updated: 2022-04-12

Study of Niclosamide in Moderate and Severe Hospitalized Coronavirus-19 (COVID-19) Patients

CompletedNCT04603924

NeuroBo Pharmaceuticals Inc.COVID-19

Start: 2020-10-07End: 2022-02-16Updated: 2025-05-15

Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection

TerminatedNCT04858425

Entero TherapeuticsCovid19

Start: 2021-04-30End: 2023-09-10Updated: 2024-10-08

PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V

CompletedNCT04870333

Cambridge University Hospitals NHS Foundation TrustCovid19

Start: 2021-02-19End: 2025-04-16Updated: 2025-06-20

Safety and Efficacy of Intranasal Administration of Niclosamide (UNI91103) in Adults With Asymptomatic or Mild COVID-19

TerminatedNCT04932915

UNION therapeuticsCovid19

Start: 2021-09-03End: 2022-01-10Updated: 2022-02-21

Phase 3

Niclosamide Role in Diabetic Nephropathy

CompletedNCT04317430

Tanta UniversityDiabetic Nephropathies

Start: 2020-02-01End: 2022-04-01Updated: 2022-10-20

Unknown Phase

Mass Treatment T Solium Community Study

TerminatedNCT00138359

National Institute of Allergy and Infectious Diseases (NIAID)Intestinal Parasitism

Start: 2004-12-31End: 2005-01-31Target: 4200Updated: 2010-08-27

Targeted Screening for Taenia Solium Tapeworms

CompletedNCT01296958

Oregon Health and Science UniversityTaenia Solium Taeniasis

Start: 2011-05-31End: 2013-01-31Updated: 2014-10-24

Related Papers

Abstract 708: Phase I clinical trial to target oxidative phosphorylation and CREB for children and young adults with relapsed or refractory AML

Cancer Research2025-04-21

Clinical safety and pharmacokinetics of a novel oral niclosamide formulation compared with marketed niclosamide chewing tablets in healthy volunteers: A three-part randomized, double-blind, placebo-controlled trial

PLoS ONE2025-02-251 citations

Prophylaxis for renal patients at risk of COVID-19 infection: results from the intranasal niclosamide randomised, double blinded, placebo controlled arm of the PROTECT-V platform trial.

2025-02-11

497. Safety and tolerability of 2000mg intravenous sotrovimab dose in immunocompromised participants uninfected with SARS-CoV-2 in the PROTECT-V trial

Open Forum Infectious Diseases2023-11-27

PROphylaxis for vulnerable paTiEnts at risk of COVID-19 infecTion (PROTECT-V) – Sotrovimab arm

2023-09-09

PROphylaxis for paTiEnts at risk of COVID-19 infecTion (PROTECT-V).

2023-03-138 citations

Niclosamide from an anthelmintic drug to a promising adjuvant therapy for diabetic kidney disease: randomized clinical trial.

2023-02-164 citations

Efficacy of Niclosamide vs Placebo in SARS-CoV-2 Respiratory Viral Clearance, Viral Shedding, and Duration of Symptoms Among Patients With Mild to Moderate COVID-19

JAMA Network Open2022-02-0953 citations

A phase I study of niclosamide in combination with enzalutamide in men with castration-resistant prostate cancer

PLoS ONE2018-06-01134 citations

Niclosamide a new chemotherapy agent? Pharmacokinetics of the potential anticancer drug in a patient cohort of the NIKOLO trial.

Journal of Clinical Oncology2018-05-2023 citations

Combination of niclosamide to target androgen receptor variant 7 (AR-V7) and abiraterone to target androgen synthesis for the treatment of castration-resistant prostate cancer (CRPC): Initial results from a phase Ib/II trial.

Journal of Clinical Oncology2018-05-201 citations

Phase II trial to investigate the safety and efficacy of orally applied niclosamide in patients with metachronous or sychronous metastases of a colorectal cancer progressing after therapy: the NIKOLO trial.

2018-03-1586 citations

Niclosamide in combination with abiraterone and prednisone in men with castration-resistant prostate cancer (CRPC): initial results from a phase Ib/II trial.

Journal of Clinical Oncology2018-02-2012 citations

Challenges in enrolling to metastatic castration-resistant prostate cancer (mCRPC) studies that require androgen receptor splice variant (AR-V) positivity.

Journal of Clinical Oncology2017-02-20