Nitazoxanide

Generic Name: Nitazoxanide

Brand Names: Alinia, Busulfex

Drug Type: Small Molecule

Chemical Formula: C_₁₂H_₉N_₃O_₅S

CAS Number: 55981-09-4

Unique Ingredient Identifier: SOA12P041N

Background: Nitazoxanide belongs to the class of drugs known as thiazolides. Nitazoxanide (NTZ) is a broad-spectrum anti-infective drug that markedly modulates the survival, growth, and proliferation of a range of extracellular and intracellular protozoa, helminths, anaerobic and microaerophilic bacteria, in addition to viruses. This drug is effective in the treatment of gastrointestinal infections including Cryptosporidium parvum or Giardia lamblia in healthy subjects. It is generally well tolerated. Nitazoxanide is a first-line, standard treatment for illness caused by C. parvum or G. lamblia infection in healthy (not immunosuppressed) adults and children and may also be considered in the treatment of illnesses caused by other protozoa or helminths . Recently, this drug has been studied as a broad-spectrum antiviral agent due to its ability to inhibit the replication of several RNA and DNA viruses .

Indication: 用于治疗隐孢子虫、贾第鞭毛虫、阿米巴原虫引起的原虫性腹泻。

Associated Conditions: Diarrhea caused by Cryptosporidium parvum, Diarrhea caused by Giardia lamblia

Clinical Trials

Efficacy of Pegylated Interferon Plus Ribavirin Plus Nitazoxanide in HCV Genotype 4 and HIV Coinfection

Phase 2

Conditions: HIV Infection
HCV Coinfection

Interventions: Drug: Nitazoxanide

First Posted Date: 2012-02-08

Last Posted Date: 2015-01-14

Lead Sponsor: Juan Macías

Target Recruit Count: 45

Registration Number: NCT01529073

Locations: 🇪🇸
H.U. Valme, Seville, Spain

Efficacy Study of Nitazoxanide Suspension in the Treatment of Rotavirus Disease in Children

Phase 2

Completed

Conditions: Rotavirus Infection
Viral Gastroenteritis Due to Rotavirus

Interventions: Drug: Nitazoxanide

First Posted Date: 2011-04-05

Last Posted Date: 2011-04-05

Lead Sponsor: Romark Laboratories L.C.

Target Recruit Count: 100

Registration Number: NCT01328925

Locations: 🇪🇬
Cairo University Children's Hospital, Cairo, Egypt

Nitazoxanide for the Treatment of Prolonged Diarrhea in Children

Phase 3

Completed

Conditions: Diarrhea

Interventions: Drug: Nitazoxanide

First Posted Date: 2011-03-30

Last Posted Date: 2011-03-30

Lead Sponsor: Romark Laboratories L.C.

Target Recruit Count: 100

Registration Number: NCT01326338

Locations: 🇵🇪
Regional Hospital of Cajamarca, Cajamarca, Peru

Efficacy of Nitazoxanide in the Treatment of Chronic Hepatitis C Virus (HCV)

Phase 2

Completed

Conditions: Chronic Hepatitis c

Interventions: Drug: Pegylated interferon alfa-2a
Drug: Nitazoxanide
Drug: Ribavirin

First Posted Date: 2011-01-13

Last Posted Date: 2013-05-03

Lead Sponsor: Cairo University

Target Recruit Count: 100

Registration Number: NCT01276756

Locations: 🇪🇬
Cairo University, Cairo, Egypt

Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza

Phase 2

Completed

Conditions: Influenza

Interventions: Drug: Placebo
Drug: Nitazoxanide

First Posted Date: 2010-10-25

Last Posted Date: 2023-10-12

Lead Sponsor: Romark Laboratories L.C.

Target Recruit Count: 624

Registration Number: NCT01227421

Locations: 🇺🇸
Health Sciences Research Center, Elmira, New York, United States

Study of the Impact of Nitazoxanide on Chronic Hepatitis Patients

Phase 2

Completed

Conditions: Hepatitis C

Interventions: Drug: Placebo
Drug: Nitazoxanide

First Posted Date: 2010-09-09

Last Posted Date: 2014-09-30

Lead Sponsor: National Liver Institute, Egypt

Target Recruit Count: 200

Registration Number: NCT01197157

Locations: 🇪🇬
National Liver Institute, Shebin El-Kom, Menoufiya, Egypt

A Safety and Tolerability Study of Nitazoxanide in HIV-HCV Treatment Failures

Phase 1

Completed

Conditions: HIV Infection
Hepatitis C Infection

Interventions: Drug: Nitazoxanide With Pegylated Interferon And Ribavirin

First Posted Date: 2010-08-19

Last Posted Date: 2021-10-05

Lead Sponsor: National Institutes of Health Clinical Center (CC)

Target Recruit Count: 8

Registration Number: NCT01185028

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States
🇺🇸
Unity Health Care/Walker Jones, NE, Washington, District of Columbia, United States
🇺🇸
Family Medical and Counseling Services, SE, Washington, District of Columbia, United States

and more 1 locations

Hyperproteic Diet Plus Lactobacillus Reuteri and Nitazoxanide in Minimal Hepatic Encephalopathy

Not Applicable

Completed

Conditions: Minimal Hepatic Encephalopathy
Hepatic Cirrhosis

Interventions: Dietary Supplement: Hyperproteic and fiber-rich diet
Other: Auxiliary Treatment
Drug: Nitazoxanide

First Posted Date: 2010-06-03

Last Posted Date: 2014-08-20

Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Target Recruit Count: 60

Registration Number: NCT01135628

Locations: 🇲🇽
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City, Mexico

A Pilot Study to Examine the Role of Nitazoxanide to Prevent Recurrence of Hepatitis C After Transplantation

Phase 1

Completed

Conditions: Hepatitis C Recurrence

Interventions: Drug: Nitazoxanide

First Posted Date: 2010-02-24

Last Posted Date: 2012-07-31

Lead Sponsor: Mayo Clinic

Target Recruit Count: 8

Registration Number: NCT01074203

Locations: 🇺🇸
Mayo Clinic College of Medicine, Rochester, Minnesota, United States

Study of Nitazoxanide in Adults With Acute Uncomplicated Influenza

Phase 2

Terminated

Conditions: Influenza

Interventions: Drug: Placebo
Drug: Nitazoxanide

First Posted Date: 2010-01-26

Last Posted Date: 2018-04-05

Lead Sponsor: Romark Laboratories L.C.

Target Recruit Count: 79

Registration Number: NCT01056380

Locations: 🇺🇸
Health Sciences Research Center at Asthma and Allergy Associates, P.C., Elmira, New York, United States

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