NITAZOXANIDE
Nitazoxanide is an antiprotozoal medication that treats diarrhea caused by the parasites Giardia lamblia and Cryptosporidium parvum. This drug is used for patients 12 years of age and older who have contracted these specific gastrointestinal infections. It is important to note that this medication is not effective for treating Cryptosporidium parvum in patients who are HIV-infected or immunodeficient.
How NITAZOXANIDE Works
Nitazoxanide is an antiprotozoal agent. Its mechanism of action is believed to be the inhibition of the pyruvate:ferredoxin oxidoreductase (PFOR) enzyme-dependent electron transfer reaction. This interference disrupts the anaerobic energy metabolism essential for the survival of susceptible protozoa.
Details
- Status
- Prescription
- First Approved
- 2020-11-27
- Routes
- ORAL
- Dosage Forms
- TABLET
NITAZOXANIDE Approval History
What NITAZOXANIDE Treats
1 indicationsNITAZOXANIDE is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diarrhea
NITAZOXANIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to NITAZOXANIDE
3 of 10FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
43 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04746183 AGILE | UoL001542i, UoL001542j | Ph 1, Ph 2 | recruiting | AGILE (Early Phase Platform Trial for COVID-19) |
| NCT06600711 | IRB00024940 U01AI167788-01A1 | Ph 3 | not yet recruiting | Nitazoxanide for Treatment of Cryptosporidium in Children |
| NCT05041907 PLATCOV | VIR21001 | Ph 2 | recruiting | Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV) |
| NCT06993974 | 4444 | Ph 2 | recruiting | Nitazoxanide in Patients With Ulcerative Colitis |
| NCT03395405 results posted | 16-0092 | Ph 2 | completed | NNITS-Nitazoxanide for Norovirus in Transplant Patients Study |
| NCT04489381 results posted | RM08-3009 | Ph 3 | terminated | Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection |
| NCT05157269 | RM08-3011 | Ph 3 | withdrawn | Trial to Evaluate Nitazoxanide for Treatment of Mild COVID-19 in Subjects Not at High Risk of Severe Illness |
| NCT05157243 | RM08-3010 | Ph 3 | withdrawn | Trial to Evaluate Nitazoxanide for Treatment of Mild or Moderate COVID-19 in Subjects at High Risk of Severe Illness |
| NCT04343248 results posted | RM08-3006 | Ph 3 | terminated | Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post-Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses in Elderly Residents of Long-Term Care Facilities (LTCF) |
| NCT04359680 results posted | RM08-3007 | Ph 3 | completed | Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection |
| NCT04486313 results posted | RM08-3008 | Ph 3 | completed | Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19 |
| NCT02165813 NICEGUT | NICEGUT | Ph 2, Ph 3 | terminated | Oral Nitazoxanide in Acute Gastroenteritis in Australian Indigenous Children |
| NCT03905655 results posted | RM08-2001 | Ph 2 | completed | Study of Nitazoxanide Compared to Placebo in Subjects With HBeAG-Negative Chronic Hepatitis B |
| NCT01227421 results posted | RM08-3001 | Ph 2, Ph 3 | completed | Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza |
| NCT04918927 FANTAZE | 2021-785-018 | Ph 2 | completed | Favipiravir +/- Nitazoxanide: Early Antivirals Combination Therapy in COVID-19 |
| NCT05368935 | NTZ-122-1 | Ph 1 | completed | Nitazoxanide Pharmacokinetic Parameters in Renal Impaired Subjects |
| NCT04435314 | NITFQM0620OR | Ph 2 | withdrawn | Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19 |
| NCT04441398 | NITFQM0720OR | Ph 2, Ph 3 | withdrawn | Efficacy and Safety of Nitazoxanide 600 mg to Treat Mild Ambulatory COVID-19 Patients |
| NCT05116826 | NTZ-121-1 | Ph 1 | completed | Nitazoxanide Pharmacokinetic Parameters in Hepatic Impaired Patients |
| NCT04523090 C3-RCT | C3-RCT | Ph 2, Ph 3 | terminated | Catalysing the Containment of COVID-19 |
| NCT03336619 results posted | RM08-3004 | Ph 3 | completed | A Phase III, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Uncomplicated Influenza |
| NCT04561063 COVER | EZ-SS-025 | Ph 2 | completed | COVID-19 Prophylaxis South Africa (COVER HCW) |
| NCT04605588 TriACT results posted | Pro2020001862 | Ph 2 | terminated | A Triple Combination Antiviral Coronavirus Therapy (TriACT) for COVID-19 |
| NCT03605862 results posted | RM08-3005 | Ph 3 | completed | Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection |
| NCT04561219 | SARITA-1 RBR-88bs9x, 30662420.0.1001.0008 | Ph 2 | completed | Nitazoxanide Therapy for Patients With COVID-19 Pneumonia |
| NCT04729491 | CORPO-AB-DRUG-SARS-004B | Ph 2, Ph 3 | completed | EAT-DUTA AndroCoV Trial |
| NCT04382846 | tanta covid treatment | Ph 3 | recruiting | Novel Regimens in COVID-19 Treatment |
| NCT04498936 | COVID-19 treatment | Ph 4 | completed | Sofosbuvir/Ledipasvir and Nitazoxanide for Treatment of COVID-19 |
| NCT04552483 | SARITA-2 RBR-4nr86m, 32258920.0.1001.5257 | Ph 2 | completed | Effects of Early Use of Nitazoxanide in Patients With COVID-19 |
| NCT02684240 | 1302013616 | Ph 2 | completed | A 14 Day Early Bactericidal Activity Study of Nitazoxanide for the Treatment of Tuberculosis |
| NCT04415983 | helicobacter children | Ph 3 | recruiting | Study of Nitazoxanide (NTZ) for Helicobacter Pylori in Children |
| NCT04161053 | Encephalopathy | Ph 3 | recruiting | Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy |
| NCT01641341 | 10-108 | Ph 4 | completed | Irritable Bowel Syndrome Evaluation and Treatment in Primary Care |
| NCT02057757 NTZ-SARI results posted | NTZ-SARI | Ph 2 | completed | Nitazoxanide Versus Placebo for the Treatment of Hospitalized Subjects With Severe Acute Respiratory Illness |
| NCT01056380 results posted | RM01-2027 | Ph 2 | terminated | Study of Nitazoxanide in Adults With Acute Uncomplicated Influenza |
| NCT02612922 | RM08-3003 | Ph 3 | completed | Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza |
| NCT01610245 | RM08-3002 | Ph 3 | completed | Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza |
| NCT02452905 | CVID/2014-02 | Ph 2 | withdrawn | Finding Better Treatment of Bronchiolitis: A Clinical Trial of Oral Nitazoxanide for the Treatment of Bronchiolitis in Infants Presenting to Hospital Emergency Departments |
| NCT01197157 | NEAR trial | Ph 2, Ph 3 | completed | Study of the Impact of Nitazoxanide on Chronic Hepatitis Patients |
| NCT00637923 STEALTHC-3 results posted | RM01-2026 | Ph 2 | completed | Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Hepatitis C Patients |
| NCT01770483 HEP-C-FM results posted | SIMS | Ph 4 | completed | The Role Of Nitazoxanide, Interferon Alfa And Ribavirin In Treatment Of Hepatitis C Infected Type 2 Diabetic Patients |
| NCT01276756 results posted | RAIL001 | Ph 2, Ph 3 | completed | Efficacy of Nitazoxanide in the Treatment of Chronic Hepatitis C Virus (HCV) |
| NCT01074203 | 08-006000 | Ph 1 | completed | A Pilot Study to Examine the Role of Nitazoxanide to Prevent Recurrence of Hepatitis C After Transplantation |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NITAZOXANIDE FDA Label Details
Indications & Usage
NITAZOXANIDE is indicated for the treatment of Diarrhea.
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Full clinical data, patents, trials, and competitive landscape for nitazoxanide.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.