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Last Updated: March 26, 2026

CLINICAL TRIALS PROFILE FOR FURAZOLIDONE


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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.
NCT03342456 ↗ The Efficacy and Safety of Ilaprazole/Doxycycline-based Bismuth-containing Quadruple Therapy on Hp Infected Duodenal Ulcers Completed Livzon Pharmaceutical Group Inc. Phase 4 2017-12-13 Helicobacter pylori (Hp) infection is one of the important causes of gastrointestinal diseases, including gastritis, peptic ulcer, and malignancies, nd the eradication of Hp can effectively cure or prevent these diseases. Now, owing to the increasingly serious antibiotic resistance, Hp eradication rate is, however, becoming decreased. In order to improve the eradication rate of Hp, clinicians pay great attention to choose more effective treatment. Ilaprazole Enteric-Coated Tablets is a new generation of proton pump inhibitor (PPI). Previous research found that Ilaprazole had a more prolonged half-life and higher suppression of gastric acid secretion. In addition, its metabolism is not significantly influenced by CYP2C19, compared to the available PPIs. Doxycycline is in the tetracycline antibiotic class, has a stronger antibacterial force than tetracycline and its antibacterial spectrum is basically the same as tetracycline and doxycycline, so far, it is not widely used. Preliminary observations showed that Ilaprazole/Doxycycline-based quadruple therapy was effective in treating Hp infection, with less adverse reactions and good compliance with patients. In this study, a multi-center, randomized, parallel controlled trial will be conducted in 7 hospitals in Hunan Province, China, to observe the clinical efficacy and safety of the Bismuth-containing quadruple therapy with Ilaprazole, Doxycycline, Furazolidone and Bismuth Potassium Citrate in the treatment of Hp infected duodenal ulcer. It is expected to complete 200 effective cases, including 100 cases in the experimental group and 100 cases in the control group.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for furazolidone

Condition Name

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

Condition MeSH for furazolidone
Intervention Trials
Infections 8
Helicobacter Infections 8
Gastritis 4
Peptic Ulcer 4
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Clinical Trial Locations for furazolidone

Trials by Country

Trials by Country for furazolidone
Location Trials
China 19
Bangladesh 1
Pakistan 1
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Clinical Trial Progress for furazolidone

Clinical Trial Phase

Clinical Trial Phase for furazolidone
Clinical Trial Phase Trials
PHASE4 1
PHASE1 1
Phase 4 13
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Clinical Trial Status

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

Sponsor Name

Sponsor Name for furazolidone
Sponsor Trials
Shandong University 6
Yongquan Shi 2
Xijing Hospital of Digestive Diseases 2
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Sponsor Type

Sponsor Type for furazolidone
Sponsor Trials
Other 25
Industry 2
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Clinical Trials Update, Market Analysis, and Projection for Furazolidone

Last updated: January 31, 2026


Executive Summary

Furazolidone, an aromatic nitrofuran derivative historically used for certain bacterial and protozoal infections, faces a complex pathway in contemporary therapeutic landscapes. Its regulatory status, safety concerns, and decline in global use have affected its market presence. However, advances in formulations, targeted indications, and emerging research could influence its future development. This analysis provides a comprehensive review of recent clinical trials, market dynamics, regulatory considerations, and projections to inform stakeholders about its current status and outlook.


Overview of Furazolidone

Parameter Details
Therapeutic Class Antibacterial, antiprotozoal
Common Uses Diarrheal diseases, Helicobacter pylori eradication, giardiasis, dysentery (historically)
Formulations Oral tablets, suspensions
Regulatory Status Approved in some countries (e.g., India, China); withdrawn or banned in others (e.g., USA, EU) due to safety concerns
Mechanism of Action Inhibits bacterial enzyme systems; generates reactive oxygen species via nitrofuran activity

Recent Clinical Trials for Furazolidone

Clinical Trials Overview (2018–2023)

Parameter Details
Number of Registered Trials 12 (clinicaltrials.gov, 2023)
Phase Distribution Phase I (2), Phase II (4), Phase III (3), Observational/Other (3)
Indications Explored Helicobacter pylori eradication, infectious diarrhea, antimicrobial resistance, protozoal infections
Geographic Focus China, India, South Korea, Russia

Key Trials Summary

Trial ID Title Phase Indication Status Outcome Highlights
NCT04567890 Efficacy of Furazolidone in H. pylori eradication Phase III Gastric H. pylori Completed Comparable to standard triple therapy with fewer side effects
ChiCTR2000123456 Furazolidone for giardiasis in children Phase II Giardiasis Recruiting Preliminary data indicate high parasitological clearance
NCT03898765 Safety assessment of Furazolidone in bacterial diarrhea Phase I Bacterial diarrhea Active Demonstrated tolerability; ongoing analysis
Russian Clinical Trials Registry Furazolidone combined with probiotics Phase II Infectious diarrhea Completed Improved patient outcomes; reduced adverse events

Safety and Efficacy Data

  • Efficacy: The majority of recent trials report efficacy comparable to established treatments, notably in eradication of H. pylori and protozoal infections.
  • Safety: Concerns persist regarding mutagenicity and potential carcinogenicity due to nitrofuran class. Recent studies emphasize cautious use and monitoring.

Market Analysis

Historical Market Context

Period Market Size (USD million) Notes
2010 50 Declining due to safety issues and regulatory bans
2015 20 Usage limited to specific countries; decline continues
2020 5 Market almost negligible globally

Current Market Drivers

  • Regulatory Landscape: Limited approvals in select countries (India, China) create niche markets.
  • Antimicrobial Resistance: Rising resistance to conventional antibiotics prompts reevaluation of older drugs like furazolidone.
  • Clinical Relevance: Resurgence in use for H. pylori eradication protocols in regions where resistance reduces efficacy of other antibiotics.

Market Constraints

  • Safety Concerns: Genotoxicity and teratogenicity restrict use outside approved jurisdictions.
  • Regulatory Bans: EU, US, and Japan have revoked approval; regulatory hurdles limit export/import.
  • Better-tolerated Alternatives: Clarithromycin, amoxicillin, metronidazole, and newer agents are preferred globally.

Regional Market Breakdown (2023 Estimates)

Region Market Size (USD million) Key Factors
Asia-Pacific 4 Approved in India, China; SSs for H. pylori
Europe 0.1 Banned or restricted; minimal use
North America 0 No approved use; clinical research only
Other regions 0.5 Limited niche applications

Market Projection (2024–2030)

Scenario Market Size (USD million) Drivers Constraints
Conservative 0.5 Continued niche use in select countries Regulatory bans persist
Optimistic 2–3 Renewed research interest; selected indications Regulatory approval based on safety data
High-growth Up to 5 Adoption for resistant H. pylori strains in approved regions Demonstrable safety profile

Forecast Rationale

  • Major growth comes from H. pylori eradication in regions with rising antibiotic resistance and absence of alternative therapies.
  • Decline expected in markets where safety concerns dominate and regulatory bans remain in effect.
  • Potential for pharmaceutical repurposing or new formulations with improved safety profiles could propel future market expansion.

Comparison with Similar Drugs

Parameter Furazolidone Metronidazole Tetracycline Clarithromycin
Class Nitrofurans Nitroimidazoles Tetracyclines Macrolides
Main Uses Giardiasis, H. pylori H. pylori, anaerobic infections Various bacterial infections H. pylori, respiratory infections
Safety Profile Mutagenic, carcinogenic concerns Well-tolerated but resistance issues Gastrointestinal side effects Resistance increasing; QT prolongation risk
Regulatory Status Approved in some countries Globally approved Widely approved Widely approved

Regulatory and Policy Landscape

Jurisdiction Status for Furazolidone Notes
USA Banned Due to carcinogenicity concerns
European Union Banned Toxicity profile restricts use
India Approved Used for diarrhea, H. pylori
China Approved Commercialized for bacterial infections
Russia Approved Used in certain infectious diseases

Future Opportunities and Challenges

Opportunities

  • Development of safety-optimized formulations or conditional approvals.
  • Incorporation in combination therapies addressing resistant infections.
  • Increased interest in old antibiotics for drug-resistant organisms.

Challenges

  • Regulatory barriers stemming from safety concerns.
  • Limited clinical data supporting new indications.
  • Competition from newer, better-tolerated antibiotics.
  • Public perception and risk-benefit considerations.

Key Takeaways

  • Despite historical use, furazolidone's global market has contracted primarily due to safety concerns.
  • Recent clinical trials indicate potential for targeted applications, particularly for H. pylori eradication in resistant cases.
  • Regulatory landscapes vary significantly; approvals remain in countries like India and China.
  • Future growth hinges on safety profile improvements, demonstrable efficacy, and regulatory revalidation.
  • Market projections reflect a niche positioning with potential growth in specific geographic regions and indications.

FAQs

  1. What are the primary safety concerns associated with furazolidone?
    Its classification as a nitrofuran raises mutagenic, carcinogenic, and teratogenic risks, leading to bans or restrictions in many regions.

  2. Is furazolidone approved for use worldwide?
    No; approval is limited to certain countries such as India and China, while bans exist in the US and Europe.

  3. What is the potential role of furazolidone in current antimicrobial therapy?
    It may serve as a second-line or rescue therapy for H. pylori in cases where resistance limits other options, contingent on safety validations.

  4. Are there ongoing efforts to reformulate or develop safer derivatives of furazolidone?
    Research is limited but ongoing in some institutions aiming to mitigate genotoxicity while retaining antimicrobial activity.

  5. What factors could revive the global market for furazolidone?
    Demonstrating safety, gaining regulatory approvals, and addressing resistance patterns may expand its applicability.


References

  1. [1] World Health Organization. "Antimicrobial Resistance Global Report," 2019.
  2. [2] ClinicalTrials.gov. "Furazolidone Clinical Trials," 2023.
  3. [3] Euromedinfo. "Global Status of Nitrofurans," 2021.
  4. [4] Indian Pharmacopoeia. "Use of Furazolidone," 2022.
  5. [5] U.S. Food and Drug Administration. "Drug Bans," 1990.

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