Drugs / Nitazoxanide
last change Sep 2026 re-read 9 days ago

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
+112 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 · Alberta Children's Hospital · 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 · Hotchkiss Brain Institute, University of Calgary · 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 · all 118 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 · 1 missed
Phase 1/2 NCT05453916 Jul 2022 → Jul 2024 irritable bowel syndrome Sadat City University Withdrawn No outcome recorded Stop: Business
Phase 1/2 NCT04746183 Jul 2020 → Mar 2027 expected COVID-19 University of Liverpool Recruiting Missed primary
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 226 trials · 7 missed
Phase 2 NCT07756255 Aug 2026 → Aug 2028 expected attention deficit-hyperactivity disorder University of Calgary Not yet recruiting No outcome recorded
Phase 2 NCT06010992 Oct 2023 → Oct 2024 type 2 diabetes mellitus Tanta University Unknown Missed primary
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 Mixed
Phase 2 NCT04459286 Oct 2020 → May 2021 COVID-19 Obafemi Awolowo University Terminated Missed primary
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 Stop: Business
Phase 2 NCT04561219 Apr → Oct 2020 COVID-19, viral pneumonia Federal University of Rio de Janeiro Completed Missed primary
Phase 2 NCT04768530 Jul 2019 → Apr 2020 periodontitis Maha Talaab Completed No outcome recorded
Phase 2/312 trials · 2 missed
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 Stop: Business
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 Missed primary
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 Missed primary
Phase 317 trials · 1 met primary
Phase 3 NCT06600711 Dec 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 Stop: Business
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 48 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 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
Comparator or background therapy34 trials
Phase 1/2 NCT07808450 Comparator Sep 2026 → Sep 2027 expected infectious peritonitis Tanta University Not yet recruiting No outcome recorded
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 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

News releases announcing trial results or a regulatory action · 8

DateIssuerRelease
2026-03-09 Genfit Regulatory GENFIT Receives FDA Orphan Drug Designation for NTZ for the treatment of ACLF genfit.com ↗
GENFIT (Euronext: GNFT) , a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announces that the U.S. Food and Drug Administration (FDA) has granted ODD to NTZ (nitazoxanide), its investigational small-molecule drug candidate developed as a new formulation for the treatment of Acute-on-Chronic Liver Failure (ACLF).
2026-01-06 Genfit Results GENFIT: Favorable Phase 1 Safety Profile and Strong Anti-Inflammatory Activity for ACLF Lead Asset G1090N genfit.com ↗
today announced that G1090N – a small molecule and the Company’s lead investigational drug candidate for Acute-On-Chronic Liver Failure (ACLF) – demonstrated a favorable Phase 1 safety profile, and a strong anti-inflammatory activity in ex-vivo studies.
2025-11-10 Genfit Results GENFIT Presents Promising New Preclinical Data on NTZ/G1090N for the Treatment of ACLF at The Liver Meeting® 2025 genfit.com ↗
These preclinical findings demonstrate beneficial effects on systemic inflammation and organ failure in ACLF disease models and add to a growing body of evidence for this therapy.
2023-05-09 Genfit Results GENFIT Presents Phase 1 Clinical Data Evaluating NTZ at Digestive Disease Week® as part of its ACLF Program genfit.com ↗
NTZ was generally well tolerated, with a favorable safety profile, in subjects with moderate and severe HI.
2019-10-31 Genfit Results GENFIT Announces New Data to be Presented at AASLD Liver Meeting 2019 genfit.com ↗
In addition, two posters will be presented demonstrating synergistic efficacy of elafibranor in combination with nitazoxanide (NTZ) and in combination with semaglutide.
2019-04-04 Genfit Results GENFIT announces Upcoming Presentations on NASH, PBC and Diagnostics at the European Association for the Study of the Liver (EASL) International Liver Congress 2019 genfit.com ↗
Elafibranor and nitazoxanide synergize to reduce fibrosis in a NASH model
2018-03-28 Genfit Results GENFIT: Presentations at EASL 2018 Annual Congress Highlight Progress in NASH Diagnostics, Combination Therapies and Deep-learning Applications in Medical Imaging genfit.com ↗
In this study, NTZ complements low dose elafibranor to reduce fibrosis in a preclinical NASH model.
2017-10-02 Genfit Results GENFIT announces its participation at the 2017 AASLD Meeting genfit.com ↗
GENFIT will present new preclinical results that show synergistic effects of nitazoxanide (drug candidate in the Company’s development pipeline) and statin combination therapy in liver fibrosis

Evidence & citations 17 cited values

Every value below carries the sentence it was read from. 118 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 ↗
110

“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: Nitazoxanide” NCT05157269 ↗

Show 100 more sources

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
23

“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 ↗

“Nitazoxanide (NTZ) is a thiazolide derivative with broad-spectrum antibacterial, antiparasitic, and antiviral properties.” NCT07808450 ↗

Show 13 more sources

Known as NTZ (nitazoxanide) “NTZ (nitazoxanide)” NCT04489381 ↗
5

“NTZ (nitazoxanide)” NCT04343248 ↗

“NTZ (nitazoxanide)” NCT01610245 ↗

“NTZ (nitazoxanide)” NCT04486313 ↗

“NTZ (nitazoxanide)” NCT04359680 ↗

“NTZ (nitazoxanide)” NCT03605862 ↗

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 ↗
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 ↗