Niclosamide

Generic Name: Niclosamide

Drug Type: Small Molecule

Chemical Formula: C_₁₃H_₈Cl_₂N_₂O_₄

CAS Number: 50-65-7

Unique Ingredient Identifier: 8KK8CQ2K8G

Background: Niclosamide is an antihelminthic used for the treatment of tapeworm infections. Helminths (worms) are multicellular organisms that infect very large numbers of humans and cause a broad range of diseases. Over 1 billion people are infected with intestinal nematodes, and many millions are infected with filarial nematodes, flukes, and tapeworms. They are an even greater problem in domestic animals.

Niclosamide, once marketed in the US under the brand name Niclocide, was voluntarily withdrawn from market by Bayer in 1996.

Indication: For the treatment of tapeworm and intestinal fluke infections: Taenia saginata (Beef Tapeworm), Taenia solium (Pork Tapeworm), Diphyllobothrium latum (Fish Tapeworm), Fasciolopsis buski (large intestinal fluke). Niclosamide is also used as a molluscicide in the control of schistosomiasis.

Associated Conditions: Helminthic infection, Tapeworm infestation

Clinical Trials

Clinical Trials to Assess Safety and Efficacy of DWRX2003 Combination With Remdesivir in Moderate to Severe COVID-19 Patients.

Phase 2

Terminated

Conditions: COVID-19

Interventions: Drug: DWRX2003
Drug: Placebo

First Posted Date: 2022-02-07

Last Posted Date: 2023-02-10

Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Target Recruit Count: 1

Registration Number: NCT05226533

Locations: 🇮🇩
RSUPN Cipto Mangunkusumo, Jakarta, DKI Jakarta, Indonesia
🇮🇩
RS. Hasan Sadikin, Bandung, Jawa Barat, Indonesia
🇮🇩
RSUP Fatmawati, Jakarta, DKI Jakarta, Indonesia

Niclosamide in Pediatric Patients With Relapsed and Refractory AML

Phase 1

Recruiting

Conditions: Acute Myeloid Leukemia (AML)

Interventions: Drug: Niclosamide

First Posted Date: 2022-01-12

Last Posted Date: 2025-01-28

Lead Sponsor: Stanford University

Target Recruit Count: 16

Registration Number: NCT05188170

Locations: 🇺🇸
Stanford University, Palo Alto, California, United States

Single Ascending Dose and Multiple Ascending Dose Study of Niclosamide Inhalation Powder in Healthy Adult Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Niclosamide Inhalation Powder
Drug: Placebo

First Posted Date: 2021-12-23

Last Posted Date: 2022-02-02

Lead Sponsor: TFF Pharmaceuticals, Inc.

Target Recruit Count: 40

Registration Number: NCT05168644

Locations: 🇨🇦
Altasciences, Mount Royal, Quebec, Canada

Randomized-controlled Trial of the Effectiveness of COVID-19 Early Treatment in Community

Phase 4

Completed

Conditions: Treatment Efficacy

Interventions: Combination Product: Niclosamide, Bromhexine
Combination Product: Fluvoxamine, Bromhexine
Combination Product: Fluvoxamine, Cyproheptadine
Drug: FluvoxaMINE Maleate 50 MG
Drug: Niclosamide Pill

First Posted Date: 2021-10-21

Last Posted Date: 2022-11-04

Lead Sponsor: Chulalongkorn University

Target Recruit Count: 1200

Registration Number: NCT05087381

Locations: 🇹🇭
Chiangmai Neurological Hospital, Chiangmai, Thailand
🇹🇭
Rajvithi Hospital, Ratchathewi, Bangkok, Thailand
🇹🇭
Vibhavadi Hospital, Bangkok, Thailand

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

Phase 2

Terminated

Conditions: Covid19

Interventions: Drug: Placebo
Drug: Niclosamide

First Posted Date: 2021-06-21

Last Posted Date: 2022-02-21

Lead Sponsor: UNION therapeutics

Target Recruit Count: 4

Registration Number: NCT04932915

Locations: 🇩🇪
Klinische Forschung Dresden GmbH, Dresden, Germany
🇩🇪
Klinische Forschung Berlin-Mitte GmbH, Berlin, Germany
🇩🇪
Klinische Forschung Hamburg GmbH, Hamburg, Germany

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

Phase 2

Recruiting

Conditions: Covid19

Interventions: Drug: Placebo
Drug: Niclosamide
Drug: Ciclesonide
Drug: Sotrovimab

First Posted Date: 2021-05-03

Last Posted Date: 2024-03-22

Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Target Recruit Count: 5000

Registration Number: NCT04870333

Locations: 🇬🇧
Queen Elizabeth Hospital, King's Lynn, NHS Foundation Trust, King's Lynn, United Kingdom
🇬🇧
University Hospitals of Leicester NHS Trust, Leicester, United Kingdom
🇬🇧
Imperial College Healthcare NHS Trust, London, United Kingdom

and more 42 locations

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

Phase 2

Terminated

Conditions: Covid19

Interventions: Drug: Placebo
Drug: Niclosamide

First Posted Date: 2021-04-26

Last Posted Date: 2024-10-08

Lead Sponsor: Entero Therapeutics

Target Recruit Count: 166

Registration Number: NCT04858425

Locations: 🇮🇳
Yashoda Hospital, Secunderabad, Andhra Pradesh, India
🇮🇳
SSG Hospital and Medical Institute, Vadodara, Gujarat, India
🇺🇦
Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council, Dnipro, Ukraine

and more 22 locations