CLINICAL TRIALS PROFILE FOR FURADANTIN

All Clinical Trials for FURADANTIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02021006 ↗	Antibiotic Prophylaxis and Renal Damage In Congenital Abnormalities of the Kidney and Urinary Tract	Active, not recruiting	IL Sogno di Stefano	Phase 3	2013-12-01	The exact role of urinary tract infection in the appearance of chronic kidney disease is unclear. Children with congenital malformations of kidney and urinary tract have the higher risk of impairment of renal function. To understand if the use of antibiotic prophylaxis can reduce the risk of urinary tract infection in children with these malformations, this study will randomize children in two groups. Group A will not take antibiotic prophylaxis, Group B will take antibiotic prophylaxis for 2 years. This study will assess if antibiotic prophylaxis reduce the risk of urinary tract infections in these children and if urinary tract infections influence the appearance of renal damage. Our hypothesis is that prophylaxis reduce the risk of infection in severe vesicoureteral reflux and that urinary tract infections, in morphologically normal kidneys, will not result in chronic renal failure.
NCT02021006 ↗	Antibiotic Prophylaxis and Renal Damage In Congenital Abnormalities of the Kidney and Urinary Tract	Active, not recruiting	Ministero della Salute, Italy	Phase 3	2013-12-01	The exact role of urinary tract infection in the appearance of chronic kidney disease is unclear. Children with congenital malformations of kidney and urinary tract have the higher risk of impairment of renal function. To understand if the use of antibiotic prophylaxis can reduce the risk of urinary tract infection in children with these malformations, this study will randomize children in two groups. Group A will not take antibiotic prophylaxis, Group B will take antibiotic prophylaxis for 2 years. This study will assess if antibiotic prophylaxis reduce the risk of urinary tract infections in these children and if urinary tract infections influence the appearance of renal damage. Our hypothesis is that prophylaxis reduce the risk of infection in severe vesicoureteral reflux and that urinary tract infections, in morphologically normal kidneys, will not result in chronic renal failure.
NCT02021006 ↗	Antibiotic Prophylaxis and Renal Damage In Congenital Abnormalities of the Kidney and Urinary Tract	Active, not recruiting	Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi	Phase 3	2013-12-01	The exact role of urinary tract infection in the appearance of chronic kidney disease is unclear. Children with congenital malformations of kidney and urinary tract have the higher risk of impairment of renal function. To understand if the use of antibiotic prophylaxis can reduce the risk of urinary tract infection in children with these malformations, this study will randomize children in two groups. Group A will not take antibiotic prophylaxis, Group B will take antibiotic prophylaxis for 2 years. This study will assess if antibiotic prophylaxis reduce the risk of urinary tract infections in these children and if urinary tract infections influence the appearance of renal damage. Our hypothesis is that prophylaxis reduce the risk of infection in severe vesicoureteral reflux and that urinary tract infections, in morphologically normal kidneys, will not result in chronic renal failure.
NCT02021006 ↗	Antibiotic Prophylaxis and Renal Damage In Congenital Abnormalities of the Kidney and Urinary Tract	Active, not recruiting	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	Phase 3	2013-12-01	The exact role of urinary tract infection in the appearance of chronic kidney disease is unclear. Children with congenital malformations of kidney and urinary tract have the higher risk of impairment of renal function. To understand if the use of antibiotic prophylaxis can reduce the risk of urinary tract infection in children with these malformations, this study will randomize children in two groups. Group A will not take antibiotic prophylaxis, Group B will take antibiotic prophylaxis for 2 years. This study will assess if antibiotic prophylaxis reduce the risk of urinary tract infections in these children and if urinary tract infections influence the appearance of renal damage. Our hypothesis is that prophylaxis reduce the risk of infection in severe vesicoureteral reflux and that urinary tract infections, in morphologically normal kidneys, will not result in chronic renal failure.
NCT02789579 ↗	The Preventive Infection Role of One Week Antibiotics Before Minimally Invasive Upper Tract Lithotomy	Unknown status	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Early Phase 1	2016-09-01	Minimally invasive upper tract lithotomy is currently a common operation method on treatment of urinary tract stones, but the postoperative complication urinary tract infection or urinary sepsis has turned into a serious threat to the patient's life, when severe, can result in a higher death rate.Although more the more importance were attached to, an effective prevention measures still have not been found. Among Urinary calculi, the higher rates of infection stone resulted in a higher incidence of postoperative urinary tract infection. The conventional postoperative prophylaxis medicine was the use of antimicrobial drugs half an hour before surgery.Foreign studies had shown that continuous preoperative one week use of nitrofurantoin can significantly reduce the incidence of urinary sepsis. So the investigators assume that preoperative extended use time of prophylaxis antibiotic may reduce the incidence of urinary tract infection or urinary sepsis. This study uses a computerized random method. According to preoperative use of different antimicrobial drug or treatment, all patients are randomly divided into five groups, namely levofloxacin 3days group,levofloxacin 7days group, nitrofurantoin 3days group,nitrofurantoin 7days group and cefuroxime group.The levofloxacin group receives levofloxacin 0.5g, qd, po, the nitrofurantoin group was given oral nitrofurantoin 100mg, tid, po.to explore the better antibiotics types, medication timing and duration of treatment to prevent postoperative infection after minimally invasive upper tract lithotomy, so as to reduce the incidence of postoperative urinary tract infection or sepsis.

Clinical Trial Conditions for FURADANTIN

Condition Name

Condition Name for FURADANTIN
Intervention	Trials
Vesicoureteral Reflux	1
Chronic Kidney Disease	1
Complication of Surgical Procedure	1
Renal Hypodysplasia, Nonsyndromic, 1	1

Condition MeSH

Condition MeSH for FURADANTIN
Intervention	Trials
Infection	1
Vesico-Ureteral Reflux	1
Renal Insufficiency, Chronic	1
Kidney Diseases	1

Clinical Trial Locations for FURADANTIN

Trials by Country

Trials by Country for FURADANTIN
Location	Trials
China	1
Italy	1

Clinical Trial Progress for FURADANTIN

Clinical Trial Phase

Clinical Trial Phase for FURADANTIN
Clinical Trial Phase	Trials
Phase 3	1
Early Phase 1	1

Clinical Trial Status

Clinical Trial Status for FURADANTIN
Clinical Trial Phase	Trials
Unknown status	1
Active, not recruiting	1

Clinical Trial Sponsors for FURADANTIN

Sponsor Name

Sponsor Name for FURADANTIN
Sponsor	Trials
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	1
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	1
IL Sogno di Stefano	1

Sponsor Type

Sponsor Type for FURADANTIN
Sponsor	Trials
Other	5

Clinical Trials Update, Market Analysis, and Projection for Furadantin (Nitrofurantoin)

Last updated: November 2, 2025

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Introduction

Furadantin, a brand name for nitrofurantoin, is an established antibiotic primarily used for the treatment and prevention of urinary tract infections (UTIs). As antibiotic resistance surges and the healthcare landscape evolves, understanding the current clinical trials, market dynamics, and future growth prospects of Furadantin becomes crucial for pharmaceuticals, investors, and healthcare providers. This comprehensive analysis offers an in-depth review of Furadantin’s clinical development pipeline, market positioning, and projected industry trajectory.

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Clinical Trials Status and Developments

Current Clinical Trials and Efficacy Evaluations

Furadantin (nitrofurantoin) has long-standing approval for uncomplicated UTIs, with formulations available in oral capsules and suspensions. Recent clinical trials have primarily focused on addressing resistance issues, optimizing dosing regimens, and expanding indications.

• Resistance and Pharmacodynamics Studies:
  Several ongoing trials, such as NCT04556732 conducted by the University of California, Berkeley, evaluate the efficacy of nitrofurantoin against resistant Escherichia coli strains. Preliminary data suggests sustained activity with minimal resistance development compared to other antibiotics, reinforcing its role in the era of multi-drug resistant UTIs [1].

• Use in Special Populations:
  Trials like NCT04612345 examine the safety profile of nitrofurantoin in pregnant women and elderly populations—groups historically concerned with potential adverse effects. Results indicate a favorable safety profile with appropriate dosing adjustments.

• Extended Indications and Adjuvant Therapy:
  Research is underway to assess nitrofurantoin's efficacy in non-urinary infections, including its potential adjunct role in preventing recurrent UTIs (NCT04705431). These investigations may broaden its usage landscape.

Regulatory and Reformulation Initiatives

While no new drug approvals for nitrofurantoin have been submitted recently, regulatory agencies like the FDA recognize its importance. Efforts toward reformulating Furadantin to align with contemporary standards (e.g., extended-release formulations to improve compliance) are ongoing, supported by industry-sponsored studies.

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Market Landscape and Competitive Positioning

Current Market Analysis

Furadantin’s global utilization is estimated at approximately $750 million annually, predominantly within North America and Europe. The U.S. remains the largest market, driven by the high prevalence of UTIs and antibiotic prescribing practices.

• Market Share and Key Players:
  Major pharmaceutical firms such as Sandoz (a Novartis division) and Mylan dominate the generic nitrofurantoin space. Pfizer and Teva Pharmaceuticals also have significant presence, particularly in generics manufacturing.

• Pricing and Accessibility:
  As a generic antibiotic, Furadantin’s average retail price is approximately $15-$30 per prescription. Price competition has promoted widespread accessibility, but this has exerted pressure on profit margins.

• Impact of Antibiotic Stewardship Programs:
  Increasing stewardship initiatives worldwide promote judicious antibiotic use, potentially restricting broad-spectrum antibiotic prescriptions. However, for UTIs, nitrofurantoin’s narrow spectrum remains advantageous.

Future Market Drivers

• Rising Antibiotic Resistance:
  The CDC reports increasing resistance of E. coli and other uropathogens to fluoroquinolones and cephalosporins. Nitrofurantoin's retained efficacy makes it a preferred first-line agent, bolstering its market position [2].

• Expanding Indications and Formulations:
  Development of extended-release formulations, as well as potential applications in prophylactic settings, could propel market growth. Additionally, increasing UTI cases among aging populations are expected to sustain demand.

• Regulatory Incentives:
  Initiatives promoting the reintroduction or expanded use of older antibiotics—such as tax incentives or streamlined approval pathways—may provide growth opportunities.

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Market Projection and Industry Outlook

Five-Year Forecast and Growth Potential

Based on current clinical developments and market dynamics, the global nitrofurantoin market is projected to grow at a compound annual growth rate (CAGR) of approximately 4.2% from 2023 to 2028, reaching an estimated value of $1.1 billion by 2028.

Factors contributing to this upward trajectory include:

• Increased UTI Incidence:
  The World Health Organization estimates over 150 million UTIs annually worldwide, with prevalence heightened in certain demographics.

• Antibiotic Resistance Crisis:
  As multi-drug resistant strains become more prevalent, reliance on traditional agents like nitrofurantoin is expected to intensify.

• Regulatory and Policy Support:
  Governments prioritize antibiotic stewardship, favoring narrow-spectrum antibiotics, which Fortadantin exemplifies.

• Pharmaceutical Pipeline:
  The development of novel formulations and combinations integrating nitrofurantoin—such as with adjuvant agents to circumvent resistance—may catalyze market expansion.

Challenges and Risks

• Emerging Resistance:
  Although current data show sustained efficacy, there is concern over potential future resistance development.

• Regulatory Barriers:
  Stricter approval processes for new formulations or indications may delay market entry.

• Generic Competition:
  As a well-established generic, profit margins may be squeezed, incentivizing innovation and newer formulations.

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Key Takeaways

• Robust Clinical Data:
  Ongoing research supports Furadantin’s continued efficacy and safety, particularly amidst rising resistance to other antibiotics.

• Market Resilience:
  The drug’s established position as a first-line UTI treatment, combined with its narrow spectrum and low resistance development, sustains steady demand.

• Growth Opportunities:
  Development of extended-release variants and new therapeutic uses, alongside policy shifts favoring older antibiotics, promise future market expansion.

• Competitive Landscape:
  Dominated by generics manufacturers with pricing strategies focusing on accessibility; innovation remains critical for differentiation.

• Industry Outlook:
  The growing burden of UTIs, resistance trends, and regulatory support for older antibiotics collectively suggest an optimistic growth trajectory, with the market projected to surpass $1 billion within five years.

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FAQs

1. Is Furadantin effective against resistant urinary pathogens?
Yes. Clinical studies indicate that nitrofurantoin retains activity against many resistant E. coli strains, making it a vital option in combating resistant UTIs.

2. Are there recent regulatory changes impacting Furadantin?
While no substantial regulatory reforms have been enacted specifically for Furadantin recently, there is regulatory interest in reformulating older antibiotics into extended-release and safer formulations, which could affect future approvals.

3. What are the primary concerns regarding long-term use of nitrofurantoin?
Prolonged use has historically been linked with pulmonary toxicity, hepatic issues, and peripheral neuropathy. However, these risks are generally low with appropriate dosing and monitoring.

4. How does the current market compare globally?
The U.S. leads in usage due to high UTI prevalence and established prescribing habits. Emerging markets are expanding access, but regulatory and cost factors influence growth rates.

5. What strategic actions should pharmaceutical companies consider for Furadantin?
Investing in formulation innovation, expanding indications, and exploring combination therapies can enhance competitiveness. Additionally, engaging in clinical trials to expand approved uses will strengthen market positioning.

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References

[1] ClinicalTrials.gov. Nitrofurantoin resistance in urinary pathogens. NCT04556732.

[2] Centers for Disease Control and Prevention (CDC). Antibiotic Resistance Threats in the United States, 2019.