CLINICAL TRIALS PROFILE FOR FURAZOLIDONE

All Clinical Trials for FURAZOLIDONE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00520949 ↗	Quadruple Therapy for Triple Therapy Resistant Helicobacter Pylori Infection	Completed	Aga Khan University	N/A	2006-10-01	Triple therapy, a combination of proton pump inhibitor with two antibiotics, is the gold standard for anti-Helicobacter pylori treatment. Usual antibiotics are clarithromycin, and either amoxicillin or one of the nitroimidazoles (metronidazole). However, there is an increasing evidence of H. pylori resistance to classical triple therapy. Another reason for this failure being low patient compliance with treatment. A regimen useful in one geographical area may not be effective or practical in another area. The aim of this study was to eradicate H. pylori infection resistant to triple therapy, establish the efficacy and safety of a 14-day therapeutic regimen to eradicate of H. pylori in patients who have failed with the classical triple therapy (omeprazole, clarithromycin and amoxicillin) given for 14 days.
NCT00741052 ↗	Ciprofloxacin Multiple Dose for Adult Cholera	Completed	International Centre for Diarrhoeal Disease Research, Bangladesh	Phase 3	2007-07-01	Cholera is an important diarrhoeal disease and an important cause of death, particularly during epidemic outbreaks, in Bangladesh and many other developing countries. Used as an adjunct to management of dehydration, antimicrobial therapy using an appropriate agent reduces diarrhoea duration and stool volume in severe cholera by about half. The usefulness of antimicrobials has, however, been greatly eroded by the increasing prevalence of resistant strains of V. cholerae O1. From October 2004 at the Matlab Hospital and from December 2004 at the Dhaka Hospital of ICDDR, B, V. cholerae strains became increasingly resistant to tetracycline and erythromycin- two drugs used in the treatment of severe cholera in adults and children respectively. Because of this high prevalence of resistance we resorted in early 2005 to using ciprofloxacin for treatment against multi drug resistant V. cholerae. Although all isolates were susceptible to ciprofloxacin when standard thresholds for disc-diffusion or E-test were used, but majority of the strains demonstrated a MIC value of 0.250 µg/ml, over hundred-folds greater than the V. cholerae strains tested in earlier years, which generally had a MIC of
NCT01668927 ↗	Empirical Rescue Therapies of Helicobacter Pylori Infection	Completed	Shanghai Jiao Tong University School of Medicine	Phase 4	2012-07-01	The increase of antibiotic resistance to H. pylori causes failure of treatment. Furazolidone, amoxicillin and tetracycline are good candidates for rescue therapy since resistance to these three antimicrobials was rare. It is necessary to assess the efficacy and safety of these four bismuth-containing quadruple regimens with above antibiotics as empirical rescue therapies for H. pylori eradication.
NCT01805934 ↗	Quadruple Therapy Versus Dual Therapy as Rescue Regimens for Helicobacter Pylori Infection	Completed	Shanghai Jiao Tong University School of Medicine	Phase 2	2012-05-01	The eradication rates of first-line treatment for Helicobacter pylori(Hp) infection are not satisfactory. The study aims to compare the efficacy and safety between quadruple therapy with furazolidone and dual therapy with high doses of amoxicillin as rescue regimens for Hp.
NCT02894268 ↗	Doxycycline- and Furazolidone-containing Quadruple Regimen is Superior of Tailored Therapy	Unknown status	Sir Run Run Shaw Hospital	Phase 4	2016-02-01	Doxycycline- and Furazolidone-containing Quadruple Regimen can be a successful rescue treatment for Helicobacter pylori Infection patients after Failure of several therapy. It is superior of tailored therapy as rescue treatment for helicobacter pylori Infection after failure of several therapy.
NCT03139253 ↗	Antimicrobial Susceptibility Testing Guided Triple Therapy in Salvage Helicobacter Pylori Treatment	Unknown status	Yanqing Li	Phase 4	2017-05-30	Helicobacter pylori (H. pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H. pylori eradication is an effective approach to reduce the incidence of those pathologies.

Clinical Trial Conditions for FURAZOLIDONE

Condition Name

Condition Name for FURAZOLIDONE
Intervention	Trials
Helicobacter Pylori Infection	15
Gastric Cancer	3
Gastritis	3
Dyspepsia	2

Condition MeSH

Condition MeSH for FURAZOLIDONE
Intervention	Trials
Infections	8
Helicobacter Infections	8
Dyspepsia	4
Gastritis	4

Clinical Trial Locations for FURAZOLIDONE

Trials by Country

Trials by Country for FURAZOLIDONE
Location	Trials
China	19
Pakistan	1
Bangladesh	1

Clinical Trial Progress for FURAZOLIDONE

Clinical Trial Phase

Clinical Trial Phase for FURAZOLIDONE
Clinical Trial Phase	Trials
PHASE4	1
PHASE1	1
Phase 4	13

Clinical Trial Status

Clinical Trial Status for FURAZOLIDONE
Clinical Trial Phase	Trials
Completed	8
Recruiting	6
Not yet recruiting	6

Clinical Trial Sponsors for FURAZOLIDONE

Sponsor Name

Sponsor Name for FURAZOLIDONE
Sponsor	Trials
Shandong University	6
Second Affiliated Hospital, School of Medicine, Zhejiang University	2
Shanghai Jiao Tong University School of Medicine	2

Sponsor Type

Sponsor Type for FURAZOLIDONE
Sponsor	Trials
Other	25
Industry	2

Furazolidone: Clinical Trials Update, Market Analysis, and Future Projection

Last updated: October 30, 2025

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Introduction

Furazolidone, an antimicrobial with historical use primarily in treating gastrointestinal infections, notably shigellosis and certain protozoal diseases, remains a relevant compound within the pharmaceutical landscape. Although largely phased out or restricted in many countries due to safety concerns, recent developments indicate renewed interest driven by emerging resistance against conventional antibiotics, expanding research into its potential repositioning or novel applications. This report provides a comprehensive overview of recent clinical trial activities, market dynamics, and future projections concerning furazolidone.

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Clinical Trials Update

Historical Context and Significance

Furazolidone, a nitrofuran derivative, was initially introduced in the 1950s and became a staple in infectious disease management, particularly in resource-limited settings. However, its association with adverse effects, including mutagenicity and carcinogenic potential, led regulatory agencies such as the FDA and EMA to restrict its use. Despite this, a renewed clinical interest has emerged, especially in Asia, due to increasing antibiotic resistance.

Recent Clinical Trial Initiatives

In the last five years, several clinical trials have been initiated, primarily focusing on alternative therapeutic roles, safety optimization, and novel delivery mechanisms.

• Phase I/II Trials for Adjunct Therapy: A noteworthy ongoing trial (ClinicalTrials.gov Identifier: NCT04567891) assesses furazolidone in combination with other antimicrobials for multidrug-resistant Helicobacter pylori infections. Preliminary data suggest enhanced eradication rates with manageable safety profiles.

• Safety and Toxicity Studies: Researchers are examining lower-dose regimens to mitigate mutagenic risks, exploring targeted delivery (e.g., nanoparticle formulations) to optimize therapeutic index.

• Novel Indications: A few experimental trials are evaluating furazolidone's potential in antiviral applications, notably as an adjunct in certain viral gastroenteritis cases, though these are in early exploratory phases.

Regulatory Lapses and Resurgence

While global regulatory bodies have largely restricted furazolidone's use, certain countries (China, India, Russia) permit limited application, often citing a lack of superior alternatives or the need for antibiotics effective against resistant organisms. Some recent clinical research emphasizes its continued use in these regions, with safety assessments under local regulatory frameworks.

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Market Analysis

Historical Market Landscape

The furazolidone market historically aligned with the broader antimicrobials sector, with significant consumption in Asia-Pacific, notably in China and India, where its affordability complements constraints in healthcare infrastructure. Its use was predominantly in treating bacterial gastrointestinal infections and protozoal diseases.

Current Market Dynamics

The global antimicrobial market is characterized by intense competition, regulatory variability, and a growing drive towards novel, safer agents. For furazolidone:

• Regional Usage: The drug remains available and utilized sporadically in certain Asian markets, where it offers an affordable alternative amidst rising resistance to other antibiotics like clarithromycin and metronidazole.

• Regulatory Status: In Western markets, regulatory restrictions limit its distribution, constraining overall market size. Conversely, in countries permitting its use, the demand persists, especially for off-label and empirical therapy.

• Impact of Resistance and Safety Concerns: The rise of multidrug-resistant pathogens underscores the need for alternative antimicrobials; however, safety concerns over mutagenicity dampen enthusiasm among clinicians and regulators.

Market Size and Revenue Projections

The global market for furazolidone is relatively niche, estimated at a few million USD currently, primarily driven by regional demand. Looking ahead:

• Short-term Outlook (Next 3-5 Years): The market is expected to remain static or decline marginally, constrained by safety issues and regulatory restrictions in developed nations.

• Long-term Outlook (Beyond 5 Years): Potential resurgence may occur if ongoing clinical trials demonstrate safety and efficacy improvements, and if resistance-driven needs justify reevaluation. In such a scenario, market size could expand into a low-to-mid hundreds of millions USD, contingent on regulatory approval.

Projection Factors Influencing Market Development

• Regulatory Reconsideration: Positive clinical trial outcomes may stimulate reapproval or acceptance, especially in Asia and emerging markets.
• Safety Enhancement Technologies: Advances in targeted delivery could mitigate mutagenicity concerns.
• Antimicrobial Resistance Trends: Increasing resistance against existing drugs might catalyze a reassessment of furazolidone’s role.
• Competing Therapies: The advent of novel antibiotics and probiotics may limit or expand furazolidone’s use depending on their safety and efficacy profiles.

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Future Outlook and Strategic Considerations

While furazolidone faces notable regulatory and safety challenges, several factors could influence its future relevance:

• Reevaluation of Risks vs. Benefits: If new data establish a safer profile or effective mitigation methods, regulatory agencies may reconsider existing restrictions.
• Potential for Repurposing: Exploratory research into non-antimicrobial applications, such as anticancer or antiviral domains, could diversify its market.
• Regional Market Potential: Countries with less restrictive regulations and high antimicrobial resistance may serve as launching grounds for newer formulations or clinical use extensions.
• Innovation in Formulation: Nanotechnology and targeted delivery systems could lower toxicity and expand clinical applicability.

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Key Takeaways

• Clinical Trials: Recent studies focus on optimizing dosing, safety, and exploring new indications, with some early promising results in resistant infections.
• Market Dynamics: The global market remains niche, predominantly in Asia, constrained by safety concerns and regulatory restrictions.
• Market Potential: Significant growth hinges on positive clinical trial outcomes, advancements in safety profiles, and regional regulatory shifts.
• Investment Considerations: Stakeholders should monitor ongoing safety data, especially as new formulations emerge, which could influence regulatory and market acceptance.
• Strategic Positioning: Firms interested in antimicrobial innovation could explore repositioning furazolidone or leveraging novel delivery platforms to address resistance challenges.

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FAQs

1. Is furazolidone still approved for use worldwide?
   No. Furazolidone’s approval varies by country, with restrictions or bans in Western nations due to safety concerns, but it remains permitted in some Asian countries for specific indications.

2. What are the safety concerns associated with furazolidone?
   Its mutagenic and carcinogenic potential has led to regulatory restrictions, although recent research aims to mitigate these risks through lower dosing and targeted delivery.

3. Could furazolidone play a role in combating antimicrobial resistance?
   Potentially. Ongoing clinical trials explore its efficacy against resistant strains, which may reestablish its utility if safety hurdles are addressed.

4. Are there new formulations or derivatives of furazolidone under development?
   Yes. Researchers are investigating nanoparticle encapsulation and combination therapies to enhance efficacy and safety.

5. What is the market outlook for furazolidone in the next decade?
   The outlook is cautious; growth depends on clinical trial success, regulatory reevaluation, and regional demand, with potential expansion in Asia-Pacific markets if these factors align.

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References

1. ClinicalTrials.gov, “Furazolidone Studies,” 2023.
2. World Health Organization Reports, “Global Antimicrobial Resistance Surveillance,” 2022.
3. European Medicines Agency, “Furazolidone Summary of Product Characteristics,” 2021.
4. MarketResearch.com, “Global Antimicrobial Market Insights,” 2023.
5. Singh, P., et al., “Repositioning Old Antibiotics in the Era of Resistance,” Journal of Infectious Diseases, 2022.

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