Data updated: May 26, 2026
ALINIA (nitazoxanide)
Trial Activity: Declining 7 active trials
Infectious Disease
Approved 2002-11-22
Development Insights
Romark Laboratories L.C. conducting 15 trials (34%)
33 indications explored (Broad Platform)
→ covid19 (9 trials)
→ covid-19 (7 trials)
→ influenza (6 trials)
3
Indications
--
Phase 3 Trials
2
Priority Reviews
23
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2002-11-22
- Routes
- ORAL
- Dosage Forms
- FOR SUSPENSION, TABLET
ALINIA Approval History
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
15 FDA actions from 2002 to 2022 · 1 indication expansions
Mar 2015 SUPPL Priority
Mfg
Sep 2014 SUPPL Priority
Mfg
Jul 2014 SUPPL Priority
Mfg
Dec 2012 SUPPL Priority
Mfg
What ALINIA Treats
3 FDA approvalsOriginally approved for its first indication in 2002 . Covers 3 distinct patient populations.
- Other (3)
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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| NCT05157269 | RM08-3011 | Ph 3 | withdrawn | Trial to Evaluate Nitazoxanide for Treatment of Mild COVID-19 in Subjects Not at High Risk of Severe Illness |
| NCT05157243 | RM08-3010 | Ph 3 | withdrawn | Trial to Evaluate Nitazoxanide for Treatment of Mild or Moderate COVID-19 in Subjects at High Risk of Severe Illness |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 |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
ALINIA FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment