Drugs / Nitazoxanide
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Nitazoxanide

Other / unclassified

Developed for
COVID-19 · chronic hepatitis C virus infection · HIV infectious disease · Helicobacter pylori infectious disease · cryptosporidiosis · hepatic encephalopathy · hepatitis C virus infection · amoebiasis due to Entamoeba histolytica
+34 more · Clostridium difficile colitis · type 2 diabetes mellitus · Clostridium infectious disease · Crohn disease · diarrheal disease · dyspepsia · fibrotic liver disease · gastritis · influenza · intestinal infectious disease · irritable bowel syndrome · lung disorder · metabolic dysfunction-associated steatohepatitis · neoplasm · norovirus infectious disease · nutritional deficiency disease · periodontitis · pneumonia · rheumatoid arthritis · Rotavirus infection · tuberculosis · viral pneumonia · adenoviridae infectious disease · bacterial sexually transmitted disease · bronchiolitis · chronic hepatitis B virus infection · colorectal cancer · common cold · enterovirus infectious disease · gastroenteritis · infectious peritonitis · protozoa infectious disease · ulcerative colitis · viral respiratory tract infection
Investigated by
Romark Laboratories L.C. · Tanta University · National Institute of Allergy and Infectious Diseases (NIAID) · Azidus Brasil · Farmoquimica S.A. · Genfit
+110 more · Tanta University · University of Liverpool · ATCGen · Complexo Hospitalar Municipal de São Caetano do Sul · Federal University of Rio de Janeiro · Helwan University · Laboratorios Roemmers S.A.I.C.F. · Ministry of Science and Technology, Brazil · National Liver Institute, Egypt · National Research Council, Brazil · Obafemi Awolowo University · ANRS, Emerging Infectious Diseases · African Centre of Excellence for Genomics of Infectious Diseases · Ain Shams University · Al-Azhar University · Alliance for International Medical Action · Anahuac University · Assiut University · Aurum Institute · Ayman Magd Eldin Mohammad Sadek · Barcelona Institute for Global Health · Baylor College of Medicine · Bill and Melinda Gates Foundation · Cairo University · Centre Muraz · Centro de Genomas - UNIFESP · Centro de Investigacion y Estudios Avanzados del Instituto Politecnico Nacional (CINVESTAV) · Complexo Hospitalar do Trabalhador de Curitiba · Coordinación de Investigación en Salud, Mexico · Daniel M. Musher MD · Dr. Frank Arguello Cancer Clinic · Egyptian Railway Hospital · Emilio Ribas Institute of Infectious Diseases · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Financiadora de Estudos e Projetos · French National Institute of Health and Medical Research · Fundación Huésped · Future pharmaceutical industries · Getz Pharma · Hakken Enterprise · Haydom Lutheran Hospital · Hospital Casa de Saúde - Vera Cruz - Campinas - SP - Brazil · Hospital Central da Aeronáutica, Rio de Janeiro · Hospital Eduardo de Menezes · Hospital Estadual de Doenças Tropicais Dr Anuar Auad · Hospital Geral de Fortaleza · Hospital Geral de São Mateus Dr Manoel Bifulco · Hospital Municipal de Barueri Dr Francisco Moran · Hospital Naval Marcilio Dias · Hospital Regional da Asa Norte, Brazil · Hospital Regional de Sorocaba Dr Adib Domingos Jatene · Hospital Universitario Pedro Ernesto · Hospital Vera Cruz · Hospital da Força Aérea do Galeão · Hospital das Clínicas Luzia de Pinho Melo · Hospital das Clínicas da Universidade Federal de Pernambuco · Hospital das Forças Armadas, Brazil · Hospital de Força Aérea de São Paulo · Hospital de Transplante Doutor Euryclides de Jesus Zerbini · Hospital e Maternidade Therezinha de Jesus · Hugo Mendieta Zeron · Infectious Disease Hospital Olodo · Instituto de Ciencia y Medicina Genomica, Torreon, Coah. Mexico www.institutodeciencia.com · Johns Hopkins Bloomberg School of Public Health · Juan Macías · Laboratorios Liomont · Liverpool School of Tropical Medicine · Maha Talaab · Mansoura University · Mater Dei Hospital, Brazil · Materno-Perinatal Hospital of the State of Mexico · Mayo Clinic · Medical Research Council, South Africa · Medicines for Malaria Venture · all 116 on the full record

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (2) US (FDA) ALINIA 2004-07-21 – 2005-06-16 fda.gov
Approved US (FDA) ALINIA 2002-11-22 fda.gov

Trials 77 · started per year

today
US approved 2002
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1995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT07110441 Aug → Dec 2025 liver disorder Genfit Completed No outcome recorded
Phase 1 NCT05368935 Apr → Sep 2022 impaired renal function disease Genfit Completed No outcome recorded
Phase 1 NCT05116826 Nov 2021 → Apr 2022 liver disorder Genfit Completed No outcome recorded
Phase 1 NCT01074203 Feb 2009 → Jan 2011 hepatitis C virus infection Mayo Clinic Completed No outcome recorded
Phase 1 NCT00002444 Oct 1995 → Feb 1996 HIV infectious disease Unimed Pharmaceuticals Completed No outcome recorded
Phase 1/24 trials
Phase 1/2 NCT05453916 Jul 2022 → Jul 2024 irritable bowel syndrome Sadat City University Withdrawn No outcome recorded
Phase 1/2 NCT04746183 Jul 2020 → Mar 2027 expected COVID-19 University of Liverpool Recruiting No outcome recorded
Phase 1/2 NCT01185028 Aug 2010 → Oct 2011 HIV infectious disease, chronic hepatitis C virus infection National Institutes of Health Clinical Center (CC) Completed No outcome recorded
Phase 1/2 NCT00055107 ? → May 2006 HIV infectious disease, cryptosporidiosis National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 225 trials
Phase 2 NCT06010992 Oct 2023 → Oct 2024 type 2 diabetes mellitus Tanta University Unknown No outcome recorded
Phase 2 NCT04918927 Oct 2021 → Mar 2023 COVID-19 Coordinación de Investigación en Salud, Mexico Completed No outcome recorded
Phase 2 NCT05041907 Sep 2021 → Jan 2027 expected COVID-19 University of Oxford Recruiting No outcome recorded
Phase 2 NCT04459286 Oct 2020 → May 2021 COVID-19 Obafemi Awolowo University Terminated No outcome recorded
Phase 2 NCT04532931 Sep 2020 → Aug 2021 COVID-19 Shin Poong Pharmaceutical Co. Ltd. Completed No outcome recorded
Phase 2 NCT04552483 Jun → Aug 2020 COVID-19 Federal University of Rio de Janeiro Completed No outcome recorded
Phase 2 NCT04435314 Jun → Aug 2020 COVID-19 Azidus Brasil Withdrawn No outcome recorded
Phase 2 NCT04561219 Apr → Oct 2020 COVID-19, viral pneumonia Federal University of Rio de Janeiro Completed No outcome recorded
Phase 2 NCT04768530 Jul 2019 → Apr 2020 periodontitis Maha Talaab Completed No outcome recorded
Phase 2 NCT03656068 Dec 2018 → Nov 2020 cirrhosis of liver, fibrotic liver disease, metabolic dysfunction-associated steatohepatitis Pinnacle Clinical Research, PLLC Completed No outcome recorded
Phase 2/312 trials
Phase 2/3 NCT04920838 Apr 2021 → Aug 2023 COVID-19 ANRS, Emerging Infectious Diseases Unknown No outcome recorded
Phase 2/3 NCT04959786 Apr 2021 → Nov 2022 pneumonia Mansoura University Unknown No outcome recorded
Phase 2/3 NCT04523090 Aug 2020 → Dec 2021 COVID-19 University of Cape Town Terminated No outcome recorded
Phase 2/3 NCT04441398 Jul → Sep 2020 COVID-19 Azidus Brasil Withdrawn No outcome recorded
Phase 2/3 NCT04463264 Jun → Nov 2020 COVID-19 Laboratorios Roemmers S.A.I.C.F. Unknown No outcome recorded
Phase 2/3 NCT04361318 May → Oct 2020 COVID-19 Tanta University Unknown No outcome recorded
Phase 2/3 NCT04360356 May → Oct 2020 COVID-19 Tanta University Unknown No outcome recorded
Phase 2/3 NCT03268902 Sep 2017 → Feb 2020 intestinal infectious disease, nutritional deficiency disease Haydom Lutheran Hospital Completed No outcome recorded
Phase 2/3 NCT02464124 Jan 2016 → Dec 2017 hepatic encephalopathy Tanta University Unknown No outcome recorded
Phase 2/3 NCT01276756 Dec 2010 → Nov 2012 chronic hepatitis C virus infection Cairo University Completed No outcome recorded
Phase 317 trials
Phase 3 NCT06600711 Sep 2026 → Dec 2028 expected cryptosporidiosis Johns Hopkins Bloomberg School of Public Health Not yet recruiting No outcome recorded
Phase 3 NCT06817096 Feb 2025 → Dec 2026 expected COVID-19, influenza Azidus Brasil Not yet recruiting No outcome recorded
Phase 3 NCT05157243 Aug 2024 → May 2025 COVID-19 Romark Laboratories L.C. Withdrawn No outcome recorded
Phase 3 NCT05480878 Dec 2022 → Mar 2023 rheumatoid arthritis Tanta University Completed No outcome recorded
Phase 3 NCT04423861 Jun 2022 → Mar 2023 COVID-19 Azidus Brasil Unknown No outcome recorded
Phase 3 NCT04415983 Jun 2020 → Oct 2030 expected Helicobacter pylori infectious disease Tanta University Recruiting No outcome recorded
Phase 3 NCT04382846 May 2020 → Dec 2030 expected COVID-19 Tanta University Recruiting No outcome recorded
Phase 3 NCT04161053 Nov 2018 → Nov 2028 expected hepatic encephalopathy Tanta University Recruiting No outcome recorded
Phase 3 NCT03491995 Apr 2018 → Apr 2023 Helicobacter pylori infectious disease Tanta University Unknown No outcome recorded
Phase 3 NCT02422706 Jan 2015 → Dec 2018 gastritis Tanta University Unknown No outcome recorded
Phase 49 trials
Phase 4 NCT06050824 Jul 2022 → Jul 2023 Helicobacter pylori infectious disease Helwan University Completed No outcome recorded
Phase 4 NCT05184491 Oct 2021 → Feb 2022 Helicobacter pylori infectious disease National Liver Institute, Egypt Unknown No outcome recorded
Phase 4 NCT04788407 Dec 2020 → Apr 2022 COVID-19 Fundación Huésped Unknown No outcome recorded
Phase 4 NCT04498936 Jul → Oct 2020 COVID-19 Assiut University Completed No outcome recorded
Phase 4 NCT04406246 May → Dec 2020 COVID-19 Materno-Perinatal Hospital of the State of Mexico Completed No outcome recorded
Phase 4 NCT04341493 Apr → Aug 2020 COVID-19 Hugo Mendieta Zeron Terminated No outcome recorded
Phase 4 NCT04039412 Jun → Dec 2018 Helicobacter pylori infectious disease Ayman Magd Eldin Mohammad Sadek Completed No outcome recorded
Phase 4 NCT01896609 Jun 2013 → Jan 2015 chronic hepatitis C virus infection MinaPharm Pharmaceuticals Unknown No outcome recorded
Phase 4 NCT01770483 Jul 2011 → Mar 2013 chronic hepatitis C virus infection, type 2 diabetes mellitus Services Institute of Medical Sciences, Pakistan Completed No outcome recorded
Phase not applicable5 trials
NCT07086937 Jan → Jun 2025 Helicobacter pylori infectious disease Muhammad Aamir Latif Completed No outcome recorded
NCT05648422 Jan 2023 → Jan 2025 protein-energy malnutrition, spastic cerebral palsy Anahuac University Unknown No outcome recorded
NCT05680792 Sep 2020 → Jan 2023 Obafemi Awolowo University Completed No outcome recorded
NCT04348409 May → Dec 2020 COVID-19 Azidus Brasil Completed No outcome recorded
NCT00002158 HIV infectious disease, cryptosporidiosis Romark Laboratories L.C. Unknown No outcome recorded
Also used as a comparator or background therapy in 32 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT03441893 Comparator Jan 2015 → Jul 2025 helminthiasis, protozoa infectious disease, ulcerative colitis Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan Unknown No outcome recorded
Phase 28 trials
Phase 2 NCT06993974 Comparator May 2025 → Aug 2026 overdue ulcerative colitis Alexandria University Recruiting No outcome recorded
Phase 2 NCT04563208 Comparator Dec 2020 → Feb 2022 COVID-19 University of Witwatersrand, South Africa Completed No outcome recorded
Phase 2 NCT04561063 Comparator Dec 2020 → Feb 2022 COVID-19 University of Witwatersrand, South Africa Completed No outcome recorded
Phase 2 NCT04605588 Comparator Dec 2020 → Jan 2021 COVID-19 Rutgers, The State University of New Jersey Terminated No outcome recorded
Phase 2 NCT03905655 Comparator Oct 2019 → Mar 2021 chronic hepatitis B virus infection Romark Laboratories L.C. Completed No outcome recorded
Phase 2/35 trials
Phase 2/3 NCT05897034 Comparator Jun 2023 → Jun 2024 overdue bacterial sexually transmitted disease Tanta University Not yet recruiting No outcome recorded
Phase 2/3 NCT04729491 Comparator Jun → Sep 2020 COVID-19 Corpometria Institute Completed No outcome recorded
Phase 2/3 NCT02165813 Comparator Nov 2014 → Apr 2021 gastroenteritis Telethon Kids Institute Terminated No outcome recorded
Phase 2/3 NCT01227421 Comparator Dec 2010 → Apr 2011 influenza Romark Laboratories L.C. Completed No outcome recorded
Phase 2/3 NCT00302640 Comparator Feb → Sep 2005 Rotavirus infection, adenoviridae infectious disease, norovirus infectious disease Romark Laboratories L.C. Completed No outcome recorded
Phase 314 trials
Phase 3 NCT05157269 Comparator Aug 2024 → Mar 2025 COVID-19 Romark Laboratories L.C. Withdrawn No outcome recorded
Phase 3 NCT05894954 Background Jul 2023 → Oct 2025 cognitive impairment with or without cerebellar ataxia, dementia Alzheimer's Prevention and Reversal Project, Inc. Completed No outcome recorded
Phase 3 NCT06049901 Comparator Mar 2023 → Mar 2025 colorectal cancer Tanta University Unknown No outcome recorded
Phase 3 NCT06101420 Background Jan 2022 → Jun 2023 Ain Shams University Completed No outcome recorded
Phase 3 NCT04746937 Comparator Mar 2021 → Mar 2022 infectious peritonitis Tanta University Unknown No outcome recorded
Phase 42 trials
Phase 4 NCT06827756 Comparator Mar → Dec 2021 cirrhosis of liver, infectious peritonitis Tanta University Completed No outcome recorded
Phase 4 NCT01641341 Comparator Nov 2010 → Mar 2012 irritable bowel syndrome American Academy of Family Physicians Completed No outcome recorded
Phase not applicable2 trials
NCT01135628 Comparator Aug 2010 → May 2014 cirrhosis of liver, hepatic encephalopathy National Institute of Medical Sciences and Nutrition Salvador Zubiran Completed No outcome recorded
NCT00683982 Comparator Aug 2007 → May 2008 Rotavirus infection, diarrheal disease Centro Pediatrico Albina de Patino Completed No outcome recorded

Evidence & citations 18 cited values

Every value below carries the sentence it was read from. 116 sources stand behind the page.

FieldValueCited text
Known as Nitazoxanide “Bacterial or Viral infection treatment may include: Doxycycline, Minocycline, Nitazoxanide, Hydroxychloroquine, Rifampin, Dapsone, Azithromycin, Tetracycline, Benzathine...” NCT05894954
107

“patients will receive LOAD therapy comprising of levofloxacin (250 mg with breakfast), omeprazole (40 mg before breakfast), nitazoxanide (Alina) (500 mg twice daily with meals)...” NCT06050824

“Group3: (110) participants received Levofloxacin quadruple regimen (LOAD) in the form of nitazoxanide 500 mg bid, levofloxacin 250 mg QD, omeprazole 40 mg QD, and doxycycline...” NCT04039412

Nitazoxanide, Chloroquine, Albendazole, Ivermectin, Mebendazole, Metronidazole, Praziquantel, Levamisole” NCT02366884

“Naïve patients will receive Levofloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days” NCT05184491

“Pharmacokinetic Study on G1090N (Nitazoxanide) Capsules in Healthy Volunteers” NCT07110441

“Moxifloxacin, omeprazole sodium bicarbonate, nitazoxanide, doxycyclin” NCT03491995

nitazoxanide at a dosage of 7.5 mg / kg every 12 hours for 3 days” NCT05648422

“Ribavirin/Nitazoxanide (RBV/NTZ) administered” NCT04563208

Nitazoxanide 500 mg tablets BID” NCT06101420

“Drug: NitazoxanideNCT05157269

NCT00418639

NCT03605862

NCT02464124

NCT04341493

NCT03395405

NCT06049901

NCT04561063

NCT00001081

NCT04768530

NCT01770483

NCT04605588

NCT04746937

NCT00763568

NCT05116826

NCT04459286

NCT04489381

NCT00304356

NCT06817096

NCT03336619

NCT04423861

NCT00366236

NCT00384527

NCT05680792

NCT00683982

NCT04729491

NCT04359680

NCT01227421

NCT04920838

NCT04382846

NCT02612922

NCT05897034

NCT04498936

NCT04523090

NCT01529073

NCT00130390

NCT01328925

NCT01074203

NCT00421434

NCT04406246

NCT04959786

NCT06993974

NCT00417872

NCT05480878

NCT00418054

NCT05453916

NCT01135628

NCT04360356

NCT04552483

NCT00055107

NCT04161053

NCT04392427

NCT03905655

NCT07086937

NCT01197157

NCT06827756

NCT00991289

NCT03441893

NCT04361318

NCT04415983

NCT01610245

NCT01641341

NCT04746183

NCT01326338

NCT05368935

NCT06600711

NCT04486313

NCT02422706

NCT05041907

NCT04561219

NCT04348409

NCT01056380

NCT05157243

NCT00302640

NCT00366730

NCT00637923

NCT04463264

NCT06010992

NCT02621359

NCT02165813

NCT03656068

NCT04532931

NCT04918927

NCT03268902

NCT04435314

NCT00002444

NCT02684240

NCT02452905

NCT00004986

NCT02057757

NCT01276756

NCT01185028

NCT04788407

NCT04441398

NCT00495391

NCT04343248

NCT00002158

NCT02334163

Known as Alina “nitazoxanide (Alina) (500 mg twice daily with meals)” NCT06050824
Known as Alinia Alinia (nitazoxanide)” NCT00302640
Known as G1090N ClinicalTrials.gov intervention name — accepted as the source's own label NCT07110441
Known as Netazox “ciclezonide (Alvesco® 160 µg ) / nitazoxanide (Netazox® 500 mg)” NCT04920838
Known as Nitazoxanida ChEMBL registry synonym — accepted as the source's own label CHEMBL1401
Known as NSC-697855 ChEMBL registry synonym — accepted as the source's own label CHEMBL1401
Known as NSC-760057 ChEMBL registry synonym — accepted as the source's own label CHEMBL1401
Known as NTX “Efficacy and Safety Study of Nitazoxanide (NTX) in the Treatment of Patients With SARS-CoV-2 Virus Infection (COVID-19)” NCT04463264
Known as NTZ “We conducted a National Institute of Health-sponsored multicenter, prospective, randomized, double-blind study of nitazoxanide (NTZ) for the treatment of NoV-infected adult...” PMID 42177030 May 2026
21

“Nitazoxanide (NTZ) plus pegylated interferon and ribavirin (Peg-IFN/RBV) improved the sustained virological response (SVR) achieved with Peg-IFN/RBV in hepatitis C virus...” PMID 26640956 Dec 2015

“Nitazoxanide (NTZ), an oral thiazolide anti-infectious agent, was safe, well tolerated and effective in achieving sustained viral response in patients with chronic HCV genotype 4.” NCT01074203

“This research is being done to determine if Nitazoxanide (NTZ) will cause a significant decrease in the number of M. tuberculosis bacteria in sputum after 14 days of treatment.” NCT02684240

“Randomized controlled study of a novel triple nitazoxanide (NTZ)-containing therapeutic regimen versus the traditional regimen for eradication of Helicobacter pylori infection.” PMID 28524341 May 2017

“Nitazoxanide (NTZ) is a novel anti-infective medication that is licenced for use in the United States (US), including in children and infants for treating some infections.” NCT02452905

“To determine the pharmacokinetics profile of single doses of nitazoxanide (NTZ) in patients with AIDS-related cryptosporidial diarrhea.” NCT00002444

“The goal of this clinical trial is to learn if nitazoxanide (NTZ) can treat Cryptosporidium infection in children age 6-12 months.” NCT06600711

“The purpose of this study is to see if nitazoxanide (NTZ) can be used to treat AIDS patients suffering from cryptosporidiosis” NCT00002158

“Nitazoxanide (NTZ) is licensed in the USA for treatment of diarrhoea caused by Cryptosporidium parvum and Giardia lamblia.” NCT04523090

“Preclinical data suggest nitazoxanide (NTZ) as a potential PPAR-γ agonist with potential benefits in type 2 diabetes.” PMID 40815384 Aug 2025

“Nitazoxanide (NTZ) is a thiazolide anti-infective with activity against anaerobic bacteria, protozoa and viruses.” NCT02334163

“Children in NTZ-based group were given triple regimen, i.e., nitazoxanide, PPI, and clarithromycin for 14 days.” NCT07086937

“A Phase II/III Placebo-Controlled Study of Nitazoxanide (NTZ) For Persons With AIDS and Cryptosporidiosis” NCT00001081

“An oral agent, nitazoxanide (NTZ), with broad in vitro anti-microbial activity and a good safety profile” NCT01185028

“Enrolled participants will be randomised 1:1 to Nitazoxanide (NTZ) or placebo.” NCT02165813

“C. parvum infection can be treated with the drug nitazoxanide (NTZ).” NCT00055107

“Study of Nitazoxanide (NTZ) for Helicobacter Pylori in Children” NCT04415983

“Nitazoxanide (NTZ) has a broad antiviral effect.” PMID 34222847 Jun 2021

“Ribavirin/Nitazoxanide (RBV/NTZ) administered” NCT04563208

“Arm B: Nitazoxanide (NTZ)” NCT04561063

“Nitazoxanide (NTZ)” NCT00991289

Known as NTZ (nitazoxanide) NTZ (nitazoxanide)NCT04343248
5

NTZ (nitazoxanide)NCT04486313

NTZ (nitazoxanide)NCT03605862

NTZ (nitazoxanide)NCT04359680

NTZ (nitazoxanide)NCT01610245

NTZ (nitazoxanide)NCT04489381

Known as NTZx “Nitazoxanide (NTZx) is a derivative of 5-nitrothiazole, synthesized in 1974 by Rosignol - Cavier.” NCT04341493
Known as PH 5776 ChEMBL registry synonym — accepted as the source's own label CHEMBL1401
Known as Viranitta (Nitazoxanide) Viranitta (Nitazoxanide)NCT04423861
Known as Xerovirinc ClinicalTrials.gov intervention name — accepted as the source's own label NCT01896609
Action Inhibit “it inhibits secretion of pro-inflammatory cytokines” NCT00130390
Modality Other / unclassified “nitazoxanide, a thiazolide anti-infective” PMID 24852376 May 2014
Route Oral “Days 22 - 42, Arm I and Arm II will receive oral NTZ (open-label).” NCT00001081