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.

Clinical Trial Conditions for FURAZOLIDONE

Condition Name

Condition Name for FURAZOLIDONE
Intervention	Trials
Helicobacter Pylori Infection	15
Gastritis	3
Gastric Cancer	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
Xijing Hospital of Digestive Diseases	2
Second Affiliated Hospital, School of Medicine, Zhejiang University	2

Sponsor Type

Sponsor Type for FURAZOLIDONE
Sponsor	Trials
Other	25
Industry	2

FURAZOLIDONE Market Analysis and Financial Projection

Last updated: April 23, 2026

Furazolidone: Clinical Trial Update, Market Analysis, and Projection

What is furazolidone’s current clinical and regulatory status profile?

Furazolidone is a nitrofuran-class antibacterial used in a limited set of indications by country, with a clinical development footprint that is largely historical rather than continuously expanded. A review of publicly indexed clinical trial registries and the current landscape indicates that there is no broad, ongoing global late-stage development program that would support near-term market expansion based on new Phase 3 readouts. The remaining observable activity is typically country-specific, formulation-focused, or post-marketing use rather than brand-new large-scale registrational trials.

Implication for investors and R&D:

• Market sizing should be treated as near-term supply and access driven, not pipeline driven.
• Competitive dynamics are more tied to local approvals, formularies, procurement, and pricing than to imminent clinical differentiation.

What do the clinical trial signals indicate for near-term pipeline catalysts?

Across major public trial registries, furazolidone’s footprint shows:

• Low frequency of new, large Phase 3/Phase 4 studies in recent years.
• No dominant global registrational program with clear, time-bound milestones widely visible across multiple jurisdictions.
• Development efforts, where present, tend to align with specific formulations, dosing regimens, or local regulatory requirements, which typically do not move global market expectations on their own.

Actionable takeaway:

• Treat furazolidone’s clinical outlook as stable rather than catalytic over a 12 to 36-month window.

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Where does furazolidone sit in the competitive antimicrobial market?

What is the commercial context for nitrofuran antibacterial products?

Furazolidone competes within broader antibacterial segments that include:

• nitrofurans (including older and regionally used products)
• urinary antiseptic and GI antibacterial options
• locally preferred antibiotics shaped by resistance patterns and stewardship rules

Competitive pressure drivers:

• Generic availability and low switching costs where efficacy is considered equivalent.
• Formulary and stewardship restrictions that tighten use of older agents in some markets.
• Supply continuity from manufacturers that retain registrations and meet local quality requirements.

What pricing and access factors dominate?

For older generics and locally used antibacterials, sales usually track:

• regulatory status in the country (and label scope)
• procurement channels (hospital and state tenders)
• reimbursement and whether the product is “standard of care” for specific protocols
• stability and cost relative to alternatives

Net result: the product’s market trajectory is usually volume and access rather than brand-led growth.

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How big is the furazolidone market and where is demand concentrated?

Market sizing basis

Public, consolidated global market datasets for furazolidone are limited because the product is:

• regionally approved and used
• often sold as a generic under multiple strengths and formats
• positioned for narrower indication sets in many jurisdictions

Because of that, any projection must be anchored to procurement-like logic: installed approvals, consumption practices, and generic competitive intensity by geography.

Demand pattern (directional)

Furazolidone demand typically concentrates where it has:

• established historical prescribing patterns
• continued approvals for relevant GI or antimicrobial uses
• stable tender and distribution networks

In markets where alternative antibiotics have displaced nitrofurans, furazolidone’s growth tends to be limited to replacement demand or specific protocol niches.

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Market projection: What is the most likely 3-year outlook?

Base-case forecast

Given the absence of visible late-stage global clinical catalysts and the generic nature of the commercial model, the most realistic 3-year projection is a flat-to-low growth path, driven by:

• population-level baseline demand
• incremental access in countries where approvals remain active
• modest volume changes tied to tender cycles and competitor supply

Directionally:

• 2026-2028: low-single-digit growth where supply and regulatory status remain stable
• Downside scenarios: losses in access due to regulatory re-reviews, substitution by alternatives, or supply disruptions
• Upside scenarios: localized protocol re-adoption or expansion of label scope in a few active geographies (not supported by a visible global Phase 3 pipeline)

Scenario framework (volume-led, not pipeline-led)

Scenario	Growth driver	Likely magnitude (qualitative)	Time horizon
Base case	Stable procurement access and generic competition	Flat to low growth	12-36 months
Downside	Substitution by newer antibacterials or access loss	Low to contraction	12-36 months
Upside	Local label/protocol retention and competitor supply gaps	Moderate uplift	18-36 months

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What does the patent landscape imply for commercial durability?

Patent reality for furazolidone

Furazolidone is an older molecule, and the market is therefore dominated by generics rather than protected brand monopolies. New proprietary value typically comes from:

• formulation/device IP
• method-of-use claims (where enforceable and recognized)
• local manufacturing licenses and regulatory exclusivity (rare for old APIs)

Implication: investment thesis should prioritize:

• manufacturing readiness and regulatory standing
• ability to win tenders and maintain supply
• formulation differentiation only where it translates into access or dosing advantages

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Key Takeaways

• Furazolidone’s clinical development signal is weak for near-term global late-stage catalysts; market movement is likely access and procurement driven.
• Market growth is expected to be flat to low single-digit over the next 3 years in regions where the product retains approvals and tender presence.
• Competitive dynamics are dominated by generic substitution and stewardship/formulary behavior, not by differentiated clinical breakthroughs.
• Commercial durability hinges on regulatory standing, supply continuity, and local protocol fit, not on a new pipeline turning point.

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FAQs

1) Is furazolidone expected to deliver a Phase 3 catalyst that expands demand globally?

No clear global late-stage development catalyst is evident in publicly indexed activity patterns; near-term demand expansion should be treated as unlikely without major regional label shifts.

2) What is the main commercial risk for furazolidone?

Loss of access via regulatory re-evaluation, formulary substitution, or procurement displacement by newer antibiotics.

3) What is the main upside lever for furazolidone sales?

Securing and sustaining tender share in geographies where historical prescribing and protocol use remain active, including benefiting from competitor supply gaps.

4) Does patent protection likely constrain generic competition?

For an older molecule, generic competition is the norm; durability usually comes from regulatory and supply positioning rather than broad molecule-level patent life.

5) What should a market entry plan prioritize?

Country-specific regulatory compliance, consistent supply, and alignment with local prescribing protocols and reimbursement/tender rules.

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References

[1] ClinicalTrials.gov. (n.d.). Furazolidone trials and results (public query). https://clinicaltrials.gov/
[2] WHO. (n.d.). WHO model list of essential medicines (search and historical context for nitrofurans/antibacterials). https://www.who.int/teams/health-product-and-policy-standards/medicines/activities/essential-medicines-and-health-products
[3] PubChem. (n.d.). Furazolidone (compound summary). https://pubchem.ncbi.nlm.nih.gov/