CLINICAL TRIALS PROFILE FOR NITAZOXANIDE

All Clinical Trials for NITAZOXANIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001081 ↗	A Study of Nitazoxanide in Patients With AIDS and Diarrhea Caused by Cryptosporidium	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To determine the frequency of complete, marked, and partial clinical responses in patients with cryptosporidiosis treated with 6 weeks of NTZ versus 21 days of placebo. To determine the safety of NTZ in subjects with cryptosporidiosis. There is no proven therapy for cryptosporidiosis in persons with AIDS. Nitazoxanide appears to be a good candidate drug for further evaluation because of its effectiveness in preclinical models, the data from early clinical trials and its safety profile. Cooperation between clinical researchers and basic scientists in clinical trials of agents for HIV infection and its complications is a high priority for the ACTG, the NIAID, and the NIH. Thus, it is important to design a clinical trial of NTZ that includes cooperation with basic scientists.
NCT00002158 ↗	A Study to Evaluate the Use of Nitazoxanide to Treat Cryptosporidiosis	Unknown status	Romark Laboratories L.C.	N/A	1969-12-31	The purpose of this study is to see if nitazoxanide (NTZ) can be used to treat AIDS patients suffering from cryptosporidiosis (diarrhea caused by the parasite Cryptosporidium).
NCT00002444 ↗	A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea	Completed	Unimed Pharmaceuticals	Phase 1	1995-10-01	To determine the pharmacokinetics profile of single doses of nitazoxanide (NTZ) in patients with AIDS-related cryptosporidial diarrhea. To determine steady state concentrations of NTZ following repeated dosing. To assess the safety and efficacy of 4 dose levels of NTZ in these patients. Cryptosporidial enterocolitis in AIDS patients is frequently chronic and severe, contributing substantially to morbidity, mortality, and health care costs in this population. NTZ exhibits antimicrobial activity that may extend to Cryptosporidial infection.
NCT00004986 ↗	Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients	Terminated	Romark Laboratories L.C.	Phase 3	2000-02-01	The purpose of this study is to see if it is safe and effective to treat cryptosporidiosis in AIDS patients with nitazoxanide.
NCT00055107 ↗	Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1/Phase 2	1969-12-31	Cryptosporidium parvum (C. parvum) is a parasite that can cause chronic diarrhea and is a significant problem for HIV infected children in developing countries. C. parvum infection can be treated with the drug nitazoxanide (NTZ). However, NTZ has not been tested in HIV infected children. The purpose of this study is to test the safety of NTZ in HIV infected children who have chronic diarrhea caused by C. parvum. Study hypothesis: Twice-daily NTZ is safe and well tolerated in HIV infected infants, children, and adolescents with chronic diarrhea caused by C. parvum infection.
NCT00055107 ↗	Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1/Phase 2	1969-12-31	Cryptosporidium parvum (C. parvum) is a parasite that can cause chronic diarrhea and is a significant problem for HIV infected children in developing countries. C. parvum infection can be treated with the drug nitazoxanide (NTZ). However, NTZ has not been tested in HIV infected children. The purpose of this study is to test the safety of NTZ in HIV infected children who have chronic diarrhea caused by C. parvum. Study hypothesis: Twice-daily NTZ is safe and well tolerated in HIV infected infants, children, and adolescents with chronic diarrhea caused by C. parvum infection.
NCT00130390 ↗	Study of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's Disease	Terminated	Romark Laboratories L.C.	Phase 2	2005-08-01	The primary objective of this study is to evaluate the efficacy and safety of nitazoxanide compared to a placebo in reducing the signs and symptoms of mild to moderate active Crohn's disease in adults.

Clinical Trial Conditions for NITAZOXANIDE

Condition Name

Condition Name for NITAZOXANIDE
Intervention	Trials
Covid19	13
COVID-19	12
Chronic Hepatitis C	8
Cryptosporidiosis	6

Condition MeSH

Condition MeSH for NITAZOXANIDE
Intervention	Trials
COVID-19	26
Hepatitis	14
Hepatitis C	13
Hepatitis A	13

Clinical Trial Locations for NITAZOXANIDE

Trials by Country

Trials by Country for NITAZOXANIDE
Location	Trials
United States	178
Egypt	32
Australia	11
South Africa	7
Mexico	6

Trials by US State

Trials by US State for NITAZOXANIDE
Location	Trials
Florida	16
New York	15
Texas	12
California	11
Georgia	9

Clinical Trial Progress for NITAZOXANIDE

Clinical Trial Phase

Clinical Trial Phase for NITAZOXANIDE
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	2
PHASE2	1

Clinical Trial Status

Clinical Trial Status for NITAZOXANIDE
Clinical Trial Phase	Trials
Completed	48
Recruiting	23
Not yet recruiting	11

Clinical Trial Sponsors for NITAZOXANIDE

Sponsor Name

Sponsor Name for NITAZOXANIDE
Sponsor	Trials
Romark Laboratories L.C.	29
Tanta University	12
National Institute of Allergy and Infectious Diseases (NIAID)	6

Sponsor Type

Sponsor Type for NITAZOXANIDE
Sponsor	Trials
Other	147
Industry	51
NIH	9

Nitazoxanide Clinical Trials Update and Market Outlook

Last updated: May 10, 2026

What is nitazoxanide and where is it positioned today?

Nitazoxanide is an orally administered small molecule with activity against multiple pathogens (including the antiprotozoal class and antiviral investigations). Commercially, nitazoxanide is marketed in several jurisdictions for parasitic indications and has an established safety database from prior development and use. Recent activity has focused on respiratory viral diseases and other infectious targets, where companies and academic groups have sought to repurpose an existing pharmacology package into time-sensitive trial designs.

Core market relevance drivers

• Repurposing economics: use of known pharmacology and safety allows faster program design than de novo antiviral discovery.
• Oral dosing: trial endpoints and health-economics arguments often favor outpatient oral regimens over infusion-based therapies.
• Resistance and variant resilience: nitazoxanide is evaluated in contexts where broad-spectrum or host-pathway effects are the commercial thesis, not a single viral target.

What do the latest clinical trial updates show?

How do current nitazoxanide studies cluster by indication?

Recent clinical activity around nitazoxanide clusters into two practical buckets for business planning:

1. Acute respiratory viral disease

   • Target populations: early infection and/or hospitalized patients (designs vary by sponsor and pandemic-era protocols).
   • Typical endpoints: time to symptom resolution, viral load kinetics, and escalation to hospitalization or oxygen requirement.

2. Parasitic and gastrointestinal indications

   • These are the most mature commercial-use contexts.
   • Endpoints typically rely on parasitological cure rates and symptom relief.

Evidence posture

• Respiratory virus studies tend to be smaller, time-bounded, and endpoint-intensive (symptom and viral-load logic).
• Parasitic indications show higher feasibility for commercial execution because they fit chronic or recurrent treatment pathways and have established access channels.

What is the trial landscape by phase and design type?

A complete, auditable “latest trials” read requires pulling each active and recently completed nitazoxanide study from trial registries with phase, dates, sponsor, and outcomes. That full registry-level inventory is not present in the provided context, and this response cannot supply trial-by-trial facts without risking inaccuracies.

Business-use summary (what matters for investors)

• If your thesis is respiratory virus commercialization: you need phase-validated clinical endpoints tied to measurable patient benefit and payer logic (speed to resolution, reduction in complications, and clear subpopulation benefit).
• If your thesis is GI/parasitic markets: commercialization is mainly execution driven (distribution, tender dynamics, label expansion) rather than single pivotal efficacy readouts.

What is the intellectual property and regulatory reality for nitazoxanide?

Nitazoxanide has a long development history. In practical terms for planning:

• Patent terms are likely largely expired or near end-of-life in many major markets for the core compound and earlier formulations, shifting value capture to:
  • new formulations (fixed dose combinations, prodrugs, enhanced bioavailability),
  • new dosing regimens,
  • new indication patents (method-of-treatment claims),
  • and regulatory exclusivity in specific jurisdictions.

Actionable implication

• Without robust, jurisdiction-specific exclusivity, the commercial strategy must rely on fast execution, durable label positioning in priority geographies, and defensible lifecycle innovations.

How big is the market and what is the projection logic?

A full market sizing and forecast requires current baseline figures (sales, geographies, indication segmentation), verified pricing and volume assumptions, and specific competitor set coverage. Those are not included in the provided context, and this response cannot produce hard numbers that meet a patent-and-investment grade standard.

That said, market projections for nitazoxanide typically follow a transparent model structure used by commercial teams:

Market model components (inputs that drive the forecast)

• Indication segmentation
  • parasitic/GI use as a stable base case
  • respiratory viral use as an upside case if a label expansion succeeds
• Penetration path
  • existing channel access for established indications
  • formulary inclusion and guideline adoption for new viral indications
• Pricing and tender dynamics
  • gov tender pricing sensitivity in endemic markets
  • private payer reimbursement in high-income settings
• Competitive substitution
  • generic pricing pressure for mature indications
  • competition from newer antiviral classes for respiratory targets

Scenario structure used for projection

• Base case: incremental growth from label maintenance and incremental geographic penetration where nitazoxanide already has commercial footprint.
• Upside case: label expansion in a high-volume respiratory viral use setting with clear payer value.
• Downside case: continued generic erosion, limited uptake due to modest efficacy or mixed endpoint performance.

What are the commercial adoption hurdles for respiratory indications?

The most common commercialization blockers in this class of repurposed antivirals are:

• Clinical endpoint relevance to payers: symptom timing alone may not translate into avoided admissions or lower costs without robust subgroup effects.
• Care pathway fit: outpatient prescribing behavior requires clear eligibility criteria and rapid test-to-treatment workflows.
• Guideline and procurement cycles: even with positive efficacy, uptake depends on comparative effectiveness against standard-of-care.

What does the competitive landscape suggest?

For an oral antiviral positioned against respiratory infections, nitazoxanide competes on:

• Speed to benefit (time window from symptom onset)
• Comparative efficacy against standard oral antivirals
• Safety and tolerability in target populations
• Supply chain readiness for scale and procurement

Business implication

• Nitazoxanide’s best chance for rapid adoption is a narrow, high-confidence segment where endpoints map to operational and payer outcomes (avoid escalation, reduce oxygen requirement, reduce hospitalization in validated windows).

Key Takeaways

• Clinical activity is primarily anchored in respiratory viral research and established parasitic indications, with respiratory studies requiring strong endpoint-to-payer translation for scale.
• Value capture is constrained by the age of the core molecule, making lifecycle differentiation (new formulations, dosing regimens, and indication-specific IP) central to sustained profitability.
• A credible market forecast must be indication-segmented and scenario-based, with respiratory label expansion acting as upside that depends on guideline fit, reimbursement logic, and procurement adoption.

FAQs

1) Is nitazoxanide still under active clinical investigation?
Yes, with ongoing evaluation focused on repurposing-like pathways, especially respiratory viral diseases and established infectious indications.

2) What is the main determinant of nitazoxanide’s commercial upside in respiratory infections?
Whether trial endpoints demonstrate clinically and economically meaningful benefit in the real-world care pathway (avoided escalation and payer-relevant outcomes), not only viral load reduction.

3) Does nitazoxanide face heavy generic competition?
Core-compound economics are typically vulnerable due to the molecule’s long history, so differentiation generally depends on formulation, regimen, or indication-specific exclusivity.

4) What trial designs are most likely to drive regulatory and payer acceptance?
Studies with clear eligibility windows, fast treatment initiation workflows, and endpoints that map to hospitalization avoidance or complications reduction.

5) What are the most important go-to-market risks?
Reimbursement and guideline inclusion delays, uncertain uptake if benefit size is modest, and substitution by newer oral antivirals in the same patient segments.

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References

[1] ClinicalTrials.gov. Nitazoxanide studies and results. (Search page; trial registry content).
[2] WHO. Antiviral and infectious disease technical guidance and general framework for evidence appraisal.
[3] EMA. Regulatory guidance on clinical evaluation for antiviral indications (general principles).
[4] FDA. Guidance for industry on development of therapeutics for infectious diseases (general principles).