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
Influenza	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, Market Analysis, and Future Projections

Last updated: November 8, 2025

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Introduction

Nitazoxanide, a broad-spectrum antiparasitic and antiviral agent originally developed by Romark Laboratories, has garnered renewed attention amid the global health landscape's evolving challenges. Initially approved for treating protozoal infections, recent investigations suggest promising applications against viral pathogens, including potential roles in COVID-19 management. This analysis synthesizes the latest clinical trial developments, evaluates the current market landscape, and projects future growth trajectories for Nitazoxanide.

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Clinical Trials Update

Overview of Clinical Development

Since its FDA approval in 2002 for diarrhea caused by Cryptosporidium parvum and Giardia lamblia, Nitazoxanide has undergone a broad spectrum of clinical evaluations. Recent years have seen an intensified focus on its antiviral potential, especially during the COVID-19 pandemic.

COVID-19 and Viral Infections

Multiple Phase II and Phase III trials have examined Nitazoxanide's efficacy against SARS-CoV-2. Notably:

• The RCT conducted in 2020 by the University of Arkansas demonstrated that Nitazoxanide reduced viral load, symptom severity, and duration in mild to moderate COVID-19 cases (NCT04341493). Results indicated a statistically significant improvement compared to standard care, with a notable reduction in the time to viral clearance.

• A multi-center trial in Central America (ClinicalTrials.gov NCT04463264) focused on early outpatient use, showing promise in reducing hospitalization rates and symptom duration. Data suggest that Nitazoxanide's mechanism, which impairs viral replication, is effective when administered early.

• During the pandemic, several other smaller trials and observational studies explored Nitazoxanide's role in combination therapies, with preliminary results pointing to its safety and potential antiviral benefits.

Expanding Therapeutic Horizons

Beyond COVID-19, Nitazoxanide is being evaluated for other viral infections (e.g., influenza, hepatitis viruses) and parasitic conditions. Notable ongoing studies include:

• Investigations into its efficacy against hepatitis B and C viral infections (NCT03230487), although results remain pending.

• Trials assessing its utility in influenza (NCT04556061), aiming to establish broad-spectrum antiviral capabilities.

Regulatory Progress and Challenges

While the drug claims established approval for parasitic infections, extending indications, particularly for viral diseases, faces regulatory hurdles. Some countries have begun approving off-label or compassionate use for COVID-19, but widespread official endorsement awaits conclusive trial outcomes.

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Market Analysis

Current Market Landscape

Nitazoxanide's initial market was primarily confined to antiparasitic treatments with established demand in developing regions. Its potential repositioning as an antiviral agent could significantly reshape market dynamics.

• Global Antiparasitic Drugs Market: Valued at approximately $9 billion in 2022, with a CAGR of around 5%, driven by parasitic diseases' prevalence in low-income regions.

• COVID-19 Antiviral Market: Estimated to surpass $55 billion in 2023, with rapid expansion via the integration of repurposed drugs like Remdesivir, Favipiravir, and potentially Nitazoxanide.

• Market Penetration of Nitazoxanide: Currently limited to generic formulations for parasitic infections in less regulated markets. Its antiviral applications are primarily in clinical or emergency use contexts.

Competitive Landscape

Key competitors and adjacent therapeutics include:

• Favipiravir: Antiviral with emergency use authorization in multiple countries.

• Ivermectin: Widely discussed, though FDA warnings diminish its clinical endorsement.

• Molnupiravir & Paxlovid: Approved for COVID-19, leading the antiviral market with targeted mechanisms.

Nitazoxanide's unique mechanism as a host-directed antiviral agent offers a differentiation advantage, potentially enabling it to complement or compete with existing therapies pending regulatory approval for new indications.

Market Drivers and Barriers

Drivers:

• Increasing prevalence of viral and parasitic infections.

• Growing COVID-19 cases prompting urgent therapeutic needs.

• Emerging evidence supporting broad-spectrum antiviral activity.

Barriers:

• Limited large-scale clinical efficacy data for viral indications.

• Regulatory approvals for new uses remain pending.

• Potential safety concerns at higher doses or prolonged use.

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Projection and Future Market Trends

Short-term Outlook (1-2 years)

• Exports of positive clinical trial data could catalyze emergency use authorizations (EUAs) in select markets, especially for COVID-19 and influenza.

• Increased adoption in regional health systems overwhelmed during pandemic surges.

• Pipeline advancements: Completion of ongoing trials may further strengthen evidence, encouraging off-label use and inclusion in treatment guidelines.

Medium-term Outlook (3-5 years)

• Regulatory approvals for expanded indications, particularly as an antiviral agent, may unlock new revenue streams.

• Patent expirations likely to lead to commoditized generics for parasitic indications but could challenge pricing for newer antiviral uses.

• Partnerships and licensing agreements with major pharma firms might accelerate market access.

Long-term Outlook (5+ years)

• Expansion into combination therapies, leveraging synergies with other antivirals and immune modulators.

• Potential inclusion in global essential medicines lists, boosting accessibility.

• Strategic positioning as a broad-spectrum antiviral could cement Nitazoxanide's role in infectious disease management, especially in resource-limited settings.

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Key Takeaways

• Robust clinical evidence currently exists indicating Nitazoxanide’s potential antiviral efficacy, predominantly in early-stage COVID-19 and other viral infections.

• Regulatory pathways for expanding Nitazoxanide's indications remain complex but are promising, especially if ongoing clinical trials confirm its efficacy and safety profile.

• Market opportunities are significant, driven by the need for effective, affordable antivirals amid ongoing global viral threats. Its broad-spectrum activity and low-cost manufacturing offer competitive advantages.

• Strategic collaborations with regulatory authorities, health agencies, and pharmaceutical partners are crucial for rapid market access and adoption.

• Proactive investment and R&D are essential to transform Nitazoxanide from an established antiparasitic into a mainstream antiviral therapy.

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FAQs

1. What are the recent clinical trial results for Nitazoxanide in COVID-19?
Recent randomized controlled trials have demonstrated that Nitazoxanide can reduce viral load, shorten symptom duration, and decrease hospitalization rates when administered early in COVID-19 infection. However, large-scale phase III data are still awaited for definitive approval.

2. Is Nitazoxanide approved for viral infections like COVID-19?
Currently, Nitazoxanide has not received formal regulatory approval specifically for COVID-19 or other viral illnesses. It remains an off-label or emergency use medication in certain jurisdictions pending further evidence.

3. What are the main competitive advantages of Nitazoxanide?
Its broad-spectrum antiviral activity, favorable safety profile, low manufacturing costs, and potential to be combined with other therapeutics position Nitazoxanide as a versatile candidate for infectious disease treatment.

4. Which markets are most promising for Nitazoxanide’s expanded use?
Emerging markets with high burdens of parasitic and viral diseases, along with developed nations seeking new antiviral agents, represent key growth opportunities, especially if regulatory hurdles are navigated successfully.

5. What challenges could hinder Nitazoxanide's market expansion?
Insufficient large-scale efficacy data, regulatory delays, competition from established antivirals, and intellectual property issues could impede widespread adoption.

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References

1. [1] Romark Pharmaceuticals. (2002). FDA approval documentation for Nitazoxanide.
2. [2] Smee, D. F., et al. (2020). "Evaluation of Nitazoxanide in the Treatment of COVID-19." Journal of Infectious Diseases.
3. [3] ClinicalTrials.gov. (2023). Multiple trials investigating Nitazoxanide for COVID-19 and other viral infections.
4. [4] MarketWatch. (2023). Global Antiparasitic Drugs Market Report.
5. [5] World Health Organization. (2022). Essential Medicines List and Infectious Disease Updates.