Clinical Trials

Numerous clinical trials spanning phases 1 through 4 have evaluated nitazoxanide across diverse infectious, metabolic, and oncological indications, including metastatic colorectal cancer, tuberculosis, non-alcoholic steatohepatitis, hepatic and renal impairment, cryptosporidiosis, and Clostridium colitis. Sponsored by academic institutions, medical research centers, and pharmaceutical companies such as Genfit, Biogen, and Romark Laboratories, these studies present varying recruitment statuses ranging from actively recruiting and completed to terminated and withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04382846 RECRUITING
COVID; Corona Virus Infection
Tanta University
 2020-05-08 PHASE3
NCT04415983 RECRUITING
Helicobacter Pylori Infection
Tanta University
 2020-06-01 PHASE3
NCT06600711 NOT_YET_RECRUITING
Cryptosporidiosis
Johns Hopkins Bloomberg School of Public Health
 2026-09-30 PHASE3
NCT04161053 RECRUITING
Hepatic Encephalopathy
Tanta University
 2018-11-01 PHASE3
NCT07756255 NOT_YET_RECRUITING
ADHD; ADHD - Attention Deficit Disorder With Hyperactivity; ADHD - Combined Type
University of Calgary
 2026-08-31 PHASE2
NCT04746183 RECRUITING
Covid19
University of Liverpool
 2020-07-03 PHASE1; PHASE2
NCT05041907 RECRUITING
COVID-19
University of Oxford
 2021-09-30 PHASE2
NCT06817096 NOT_YET_RECRUITING
Covid 19; Influenza
Azidus Brasil
 2025-02 PHASE3
NCT06993974 RECRUITING
Ulcerative Colitis
Alexandria University
 2025-05-30 PHASE2
NCT03441893 UNKNOWN
Ulcerative Colitis; Ulcerative Colitis Exacerbation; Protozoan Infections; Helminth Infection
Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
 2015-01-01 PHASE1; PHASE2
NCT07086937 COMPLETED
Helicobacter Pylori Infection
Muhammad Aamir Latif
 2025-01-01
NCT05157243 WITHDRAWN
COVID-19
Romark Laboratories L.C.
 2024-08 PHASE3
NCT07790926 COMPLETED
Entamoeba Histolytica Diarrhea
University of Child Health Sciences and Children's Hospital, Lahore
 2024-04-02 PHASE2
NCT05157269 WITHDRAWN
COVID-19
Romark Laboratories L.C.
 2024-08 PHASE3
NCT06049901 UNKNOWN
Metastatic Colorectal Cancer
Tanta University
 2023-03-01 PHASE3
NCT06010992 UNKNOWN
Diabetes Mellitus, Type 2
Tanta University
 2023-10-01 PHASE2
NCT05453916 WITHDRAWN
Irritable Bowel Syndrome With Diarrhea
Sadat City University
 2022-07-01 PHASE1; PHASE2
NCT05897034 NOT_YET_RECRUITING
Sexually Transmitted Diseases
Tanta University
 2023-06-20 PHASE2; PHASE3
NCT04920838 UNKNOWN
Covid19; Covid19 Drug Treatment; Severe Acute Respiratory Syndrome Coronavirus 2; SARS-CoV2 Infection
ANRS, Emerging Infectious Diseases
 2021-04-12 PHASE2; PHASE3
NCT05480878 COMPLETED
Rheumatoid Arthritis
Tanta University
 2022-12-02 PHASE3
NCT04918927 COMPLETED
Covid19
Coordinación de Investigación en Salud, Mexico
 2021-10-12 PHASE2
NCT04423861 UNKNOWN
covid19
Azidus Brasil
 2022-06-22 PHASE3
NCT06049901 Recruiting
Metastatic Colorectal Cancer
Tanta University
 2023-03-01 Phase 3
NCT05701423 Recruiting
Multiple Sclerosis
Biogen
 2023-02-08 --
NCT05680792 COMPLETED
Drug Interaction
Obafemi Awolowo University
 2020-09-10
NCT04103216 COMPLETED
Cryptosporidiosis
International Centre for Diarrhoeal Disease Research, Bangladesh
 2020-02-01
NCT02621359 UNKNOWN
Dyspepsia
Tanta University
 2015-01 PHASE3
NCT04959786 UNKNOWN
COVID-19 Pneumonia
Mansoura University
 2021-04-01 PHASE2; PHASE3
NCT05368935 COMPLETED
Renal Impairment; Renal Disease; Kidney Disease
Genfit
 2022-04-25 PHASE1
NCT04392427 UNKNOWN
COVID; Drug Effect
Mansoura University
 2020-10 PHASE3
NCT04788407 UNKNOWN
Covid19; SARS-CoV-2 Infection; Households Contacts
Fundación Huésped
 2020-12-01 PHASE4
NCT05116826 COMPLETED
Moderate Hepatic Impairment; Severe Hepatic Impairment; Liver Diseases
Genfit
 2021-11-05 PHASE1
NCT05368935 Completed
Renal Impairment|Renal Disease|Kidney Disease
Genfit
 2022-04-25 Phase 1
NCT04746937 UNKNOWN
Spontaneous Bacterial Peritonitis
Tanta University
 2021-03 PHASE3
NCT04561063 COMPLETED
Covid19; SARS-CoV Infection
University of Witwatersrand, South Africa
 2020-12-08 PHASE2
NCT05184491 UNKNOWN
Helicobacter Pylori
National Liver Institute, Egypt
 2021-10-15 PHASE4
NCT04523090 TERMINATED
COVID-19
University of Cape Town
 2020-08-27 PHASE2; PHASE3
NCT06827756 COMPLETED
Spontaneous Bacterial Peritonitis; Cirrhoses, Liver; Ascites
Tanta University
 2021-03-01 PHASE4
NCT05116826 Completed
Moderate Hepatic Impairment|Severe Hepatic Impairment|Liver Diseases
Genfit
 2021-11-05 Phase 1
NCT03395405 COMPLETED
Gastroenteritis Norovirus
National Institute of Allergy and Infectious Diseases (NIAID)
 2018-10-15 PHASE2
NCT04532931 COMPLETED
COVID-19
Shin Poong Pharmaceutical Co. Ltd.
 2020-09-03 PHASE2
NCT04459286 TERMINATED
Covid-19
Obafemi Awolowo University
 2020-10-09 PHASE2
NCT02165813 TERMINATED
Gastroenteritis
Telethon Kids Institute
 2014-11 PHASE2; PHASE3
NCT04359680 COMPLETED
COVID-19; Viral Respiratory Illnesses
Romark Laboratories L.C.
 2020-05-13 PHASE3
NCT03905655 COMPLETED
Chronic Hepatitis B
Romark Laboratories L.C.
 2019-10-22 PHASE2
NCT04486313 COMPLETED
COVID-19
Romark Laboratories L.C.
 2020-08-13 PHASE3
NCT04343248 TERMINATED
COVID-19; Viral Respiratory Illnesses
Romark Laboratories L.C.
 2020-05-12 PHASE3
NCT04489381 TERMINATED
Enterovirus; Rhinovirus
Romark Laboratories L.C.
 2020-08-19 PHASE3
NCT04605588 TERMINATED
SARS-CoV Infection; Covid19
Rutgers, The State University of New Jersey
 2020-12-02 PHASE2
NCT04406246 COMPLETED
Coronavirus Infection
Materno-Perinatal Hospital of the State of Mexico
 2020-05-21 PHASE4
NCT04348409 COMPLETED
COVID-19
Azidus Brasil
 2020-05-25
NCT03656068 COMPLETED
Non-alcoholic Steatohepatitis; Fatty Liver; Fibrosis, Liver; Compensated Cirrhosis
Pinnacle Clinical Research, PLLC
 2018-12-04 PHASE2
NCT04463264 UNKNOWN
COVID-19
Laboratorios Roemmers S.A.I.C.F.
 2020-06-26 PHASE2; PHASE3
NCT04498936 COMPLETED
COVID
Assiut University
 2020-07-15 PHASE4
NCT04561219 COMPLETED
Covid19; Corona Virus Infection; Pneumonia, Viral
Universidade Federal do Rio de Janeiro
 2020-04-19 PHASE2
NCT04361318 UNKNOWN
COVID-19
Tanta University
 2020-05 PHASE2; PHASE3
NCT04360356 UNKNOWN
COVID-19
Tanta University
 2020-05 PHASE2; PHASE3
NCT04729491 COMPLETED
Covid19
Corpometria Institute
 2020-06-30 PHASE2; PHASE3
NCT04441398 WITHDRAWN
covid19
Azidus Brasil
 2020-07 PHASE2; PHASE3
NCT04341493 TERMINATED
Coronavirus Infection
Hugo Mendieta Zeron
 2020-04-06 PHASE4
NCT04552483 COMPLETED
Covid19; Coronavirus
Universidade Federal do Rio de Janeiro
 2020-06-08 PHASE2
NCT04435314 WITHDRAWN
covid19
Azidus Brasil
 2020-06 PHASE2
NCT04768530 COMPLETED
Periodontitis
Maha Talaab
 2019-07-20 PHASE2
NCT03268902 COMPLETED
Malnutrition; Stunting; Cognitive Development; Enteric Pathogens
Haydom Lutheran Hospital
 2017-09-05 PHASE2; PHASE3
NCT03336619 COMPLETED
Influenza
Romark Laboratories L.C.
 2018-01-17 PHASE3
NCT03605862 COMPLETED
Enterovirus; Rhinovirus
Romark Laboratories L.C.
 2018-09-11 PHASE3
NCT03656068 Completed
Non-alcoholic Steatohepatitis|Fatty Liver|Fibrosis Liver|Compensated Cirrhosis
Pinnacle Clinical Research PLLC
 2018-12-04 Phase 2
NCT02422706 UNKNOWN
Helicobacter-associated Gastritis
Sherief Abd-Elsalam
 2015-01 PHASE3
NCT02684240 COMPLETED
Tuberculosis
Weill Medical College of Cornell University
 2016-02 PHASE2
NCT02464124 UNKNOWN
Encephalopathy, Hepatic
Sherief Abd-Elsalam
 2016-01 PHASE2; PHASE3
NCT02452905 WITHDRAWN
Bronchiolitis
Telethon Kids Institute
 2016-12 PHASE2
NCT02057757 COMPLETED
Severe Acute Respiratory Illness
National Institute of Allergy and Infectious Diseases (NIAID)
 2014-02 PHASE2
NCT02612922 COMPLETED
Influenza
Romark Laboratories L.C.
 2015-12 PHASE3
NCT02684240 Completed
Tuberculosis
Weill Medical College of Cornell University
 2016-02 Phase 2
NCT01610245 COMPLETED
Influenza
Romark Laboratories L.C.
 2013-03 PHASE3
NCT01529073 UNKNOWN
HCV Coinfection; HIV Infection
Juan Macías
 2012-02 PHASE2
NCT02334163 UNKNOWN
Hepatic Encephalopathy
Ain Shams University
 2014-12 PHASE2
NCT01896609 UNKNOWN
Chronic Hepatitis c
MinaPharm Pharmaceuticals
 2013-06 PHASE4
NCT01135628 COMPLETED
Hepatic Cirrhosis; Minimal Hepatic Encephalopathy
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
 2010-08
NCT01197157 COMPLETED
Hepatitis C
National Liver Institute, Egypt
 2010-09 PHASE2; PHASE3
NCT01770483 COMPLETED
Hepatitis C, Chronic; DIABETES MELLITUS Type 2
Services Institute of Medical Sciences, Pakistan
 2011-07 PHASE4
NCT01276756 COMPLETED
Chronic Hepatitis c
Cairo University
 2010-12 PHASE2; PHASE3
NCT01641341 COMPLETED
Irritable Bowel Syndrome
American Academy of Family Physicians
 2010-11 PHASE4
NCT01185028 COMPLETED
Hepatitis C Infection; HIV Infection
National Institutes of Health Clinical Center (CC)
 2010-08 PHASE1; PHASE2
NCT01227421 COMPLETED
Influenza
Romark Laboratories L.C.
 2010-12 PHASE2; PHASE3
NCT01074203 COMPLETED
Hepatitis C Recurrence
Mayo Clinic
 2009-02 PHASE1
NCT01056380 TERMINATED
Influenza
Romark Laboratories L.C.
 2010-01 PHASE2
NCT00991289 COMPLETED
HIV Infection; Hepatitis C Infection
National Institute of Allergy and Infectious Diseases (NIAID)
 2010-01 PHASE2
NCT00637923 COMPLETED
Chronic Hepatitis C
Romark Laboratories L.C.
 2008-03 PHASE2
NCT00495391 COMPLETED
Chronic Hepatitis C
Romark Laboratories L.C.
 2007-07 PHASE2
NCT00421434 COMPLETED
Chronic Hepatitis C
Romark Laboratories L.C.
 2006-06 PHASE2; PHASE3
NCT00763568 COMPLETED
Chronic Hepatitis C
Romark Laboratories L.C.
 2006-08 PHASE2
NCT00683982 COMPLETED
Diarrhea; Rotavirus Infection
Centro Pediatrico Albina de Patino
 2007-08
NCT00130390 TERMINATED
Crohn's Disease
Romark Laboratories L.C.
 2005-08 PHASE2
NCT00384527 TERMINATED
Clostridium Infections
Romark Laboratories L.C.
 2006-12 PHASE3
NCT00304356 COMPLETED
Clostridium Enterocolitis; Pseudomembranous Colitis
Daniel M. Musher MD
 2004-01 PHASE3
NCT01328925 COMPLETED
Rotavirus Infection; Viral Gastroenteritis Due to Rotavirus
Romark Laboratories L.C.
 2005-12 PHASE2
NCT01326338 COMPLETED
Diarrhea
Romark Laboratories L.C.
 2005-03 PHASE3
NCT00002444 COMPLETED
HIV Infections
Unimed Pharmaceuticals
 1995-10 PHASE1
NCT00004986 TERMINATED
Cryptosporidiosis; HIV Infections
Romark Laboratories L.C.
 2000-02 PHASE3
NCT00417872 COMPLETED
Clostridium Difficile
Romark Laboratories L.C.
 2004-01 PHASE2
NCT00302640 COMPLETED
Rotavirus Infection; Adenoviridae Infection; Norovirus Infection
Romark Laboratories L.C.
 2005-02 PHASE2; PHASE3
NCT00001081 COMPLETED
Cryptosporidiosis; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002158 UNKNOWN
Cryptosporidiosis; HIV Infections
Romark Laboratories L.C.
NCT00418639 COMPLETED
Chronic Hepatitis C
Romark Laboratories L.C.
 2005-02 PHASE2
NCT00366730 COMPLETED
Amebiasis
Romark Laboratories L.C.
 2004-02 PHASE3
NCT00055107 COMPLETED
HIV Infections; Cryptosporidiosis
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1; PHASE2
NCT00366236 COMPLETED
Amebiasis
Romark Laboratories L.C.
 2004-02 PHASE3
NCT00418054 COMPLETED
Chronic Hepatitis C
Romark Laboratories L.C.
 2005-12 PHASE2

(data from https://clinicaltrials.gov, updated on 2020-12-04)

Check the Nitazoxanide product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nitazoxanide disrupts anaerobic energy metabolism by interfering with pyruvate:ferredoxin oxidoreductase (PFOR) enzyme-dependent electron transfer while modulating cellular autophagy and inhibiting mTORC1 signaling. This inhibition suppresses pathogen viability and dysregulates critical cellular proliferation pathways, providing the rationale for clinical trials investigating nitazoxanide in parasitic and bacterial enteritis, respiratory viral infections, and metastatic colorectal cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.