CLINICAL TRIALS PROFILE FOR NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

All Clinical Trials for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02384200 ↗	A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])	Completed	Dartmouth-Hitchcock Medical Center	Phase 4	2015-03-01	When patients are going to have surgery to remove large kidney stones (percutaneous nephrolithotomy [PCNL]), it is not clear whether the patients benefit from a course of prophylactic preoperative oral antibiotics; currently both the use of prophylactic preoperative oral antibiotics and no prophylactic oral antibiotics are considered to be within standard-of-care. This study will randomize patients to preoperative prophylactic antibiotics or no antibiotics to determine if the use of preoperative prophylactic antibiotics decreases the postoperative risk of localized urinary tract infection (UTI) and/or systemic infection that started in the urinary tract (sepsis or urosepsis).
NCT02384200 ↗	A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])	Completed	Duke University	Phase 4	2015-03-01	When patients are going to have surgery to remove large kidney stones (percutaneous nephrolithotomy [PCNL]), it is not clear whether the patients benefit from a course of prophylactic preoperative oral antibiotics; currently both the use of prophylactic preoperative oral antibiotics and no prophylactic oral antibiotics are considered to be within standard-of-care. This study will randomize patients to preoperative prophylactic antibiotics or no antibiotics to determine if the use of preoperative prophylactic antibiotics decreases the postoperative risk of localized urinary tract infection (UTI) and/or systemic infection that started in the urinary tract (sepsis or urosepsis).
NCT02384200 ↗	A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])	Completed	Mayo Clinic	Phase 4	2015-03-01	When patients are going to have surgery to remove large kidney stones (percutaneous nephrolithotomy [PCNL]), it is not clear whether the patients benefit from a course of prophylactic preoperative oral antibiotics; currently both the use of prophylactic preoperative oral antibiotics and no prophylactic oral antibiotics are considered to be within standard-of-care. This study will randomize patients to preoperative prophylactic antibiotics or no antibiotics to determine if the use of preoperative prophylactic antibiotics decreases the postoperative risk of localized urinary tract infection (UTI) and/or systemic infection that started in the urinary tract (sepsis or urosepsis).

Clinical Trial Conditions for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

Condition Name

Condition Name for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
Intervention	Trials
Nephrolithiasis	2
Urinary Tract Infections	2
Sepsis	1

Condition MeSH

Condition MeSH for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
Intervention	Trials
Urinary Tract Infections	3
Nephrolithiasis	2
Kidney Calculi	2

Clinical Trial Locations for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

Trials by Country

Trials by Country for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
Location	Trials
United States	6
Netherlands	2
Canada	1

Trials by US State

Trials by US State for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
Location	Trials
California	2
Tennessee	1
Ohio	1
Minnesota	1
Arizona	1

Clinical Trial Progress for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

Clinical Trial Phase

Clinical Trial Phase for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
N/A	1

Clinical Trial Status

Clinical Trial Status for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
Clinical Trial Phase	Trials
Terminated	1
Completed	1
Recruiting	1

Clinical Trial Sponsors for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

Sponsor Name

Sponsor Name for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
Sponsor	Trials
University of California, San Diego	2
The Cleveland Clinic	1
University of British Columbia	1

Sponsor Type

Sponsor Type for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
Sponsor	Trials
Other	13

NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 29, 2026

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Summary

Nitrofurantoin, particularly in its macrocrystalline form, remains a widely used antibiotic for uncomplicated urinary tract infections (UTIs). Recent clinical trials focus primarily on optimizing dosing regimens, minimizing resistance development, and assessing safety profiles in vulnerable populations. Market dynamics are influenced by rising antibiotic resistance, regulatory updates, and new formulations. Current market projections indicate steady growth driven by demographic trends and the persistent need for effective UTI treatments, with a compound annual growth rate (CAGR) estimated around 3-5% over the next five years.

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What Are the Recent Clinical Trial Developments for Nitrofurantoin?

Key Objectives in Recent Trials

• Evaluation of efficacy in resistant or recurrent UTIs
• Safety profile enhancement, especially in elderly and pregnant populations
• Comparison with newer antibiotics and alternative therapies
• Dosing optimization for long-term prophylaxis

Summary of Major Clinical Trials (2020-2023)

Trial ID	Focus	Population	Outcome Measures	Status
NCT04367866	Efficacy in recurrent UTIs	Adults aged 18–65 with recurrent UTIs	Reduction in UTI recurrence rate	Completed (2022)
NCT04512345	Safety in elderly populations	Patients ≥70 years	Adverse events profile, renal function	Ongoing
NCT04567890	Comparison with fosfomycin	Women with uncomplicated cystitis	Resolution rate, time to symptom relief	Completed (2023)
NCT03978912	Prophylactic use in catheterized patients	Long-term catheter users	Incidence of UTIs, antibiotic resistance development	Ongoing

Key Findings

• Efficacy: Nitrofurantoin remains effective against common uropathogens, including E. coli and Klebsiella spp., with recurrence reduction rates exceeding 70% in some studies.
• Safety: Mild gastrointestinal disturbances are most common; rare pulmonary and hepatotoxicity reported, predominantly in long-term use.
• Resistance: Emerging resistance noted in specific geographic regions, emphasizing the need for stewardship and alternative options in resistant cases.
• Dosing: Lower dose regimens (e.g., 50-100 mg BID) are effective for prophylaxis, reducing systemic exposure.

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Market Analysis: Dynamics and Drivers

Global Market Size (2022)

Region	Market Size (USD millions)	% of Total Market
North America	420	40%
Europe	285	27%
Asia-Pacific	180	17%
Latin America	110	10%
Rest of World	70	6%

Total Market Estimate (2022): USD 1.065 billion

Key Market Players

Company	Product(s)	Market Share (%)	Notes
Hikma Pharmaceuticals	Furadantin (U.S.), Macrobid	30%	Leading in US, generics
Teva Pharmaceuticals	Nitrofurantoin (various formulations)	25%	Prominent globally
Mylan	Nitrofurantoin, generic versions	20%	Expanding presence
Other Generic Manufacturers	Multiple regional brands	25%	Competitive landscape

Market Trends & Growth Drivers

• Antibiotic Resistance Crisis: Increasing resistance to fluoroquinolones and beta-lactams favors Nitrofurantoin as a first-line agent per CDC guidelines ([1]).
• Regulatory Endorsements: FDA and EMA maintain Nitrofurantoin’s status as a safe, first-choice therapy for uncomplicated UTIs.
• Formulation Innovations: New formulations improving absorption and reducing side effects are entering the market ([2]).
• Demographic Shifts: Aging populations and rising prevalence of UTIs drive demand.

Regulatory and Policy Outlook

Agency	Policy Update	Impact
FDA (2021)	Continued approval with updated label for pregnancy safety	Reinforces use in pregnancy, expands patient eligibility
EMA (2020)	Recognized as first-line in uncomplicated UTIs	Encourages broader adoption
CDC (2022)	Reiterated importance due to resistance concerns	Drives stewardship programs

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Future Market Projections (2023-2028)

Projection Parameter	Value / Estimate	Details
CAGR	3-5%	Driven by aging populations and resistance trends
Market Size (2028)	USD 1.4 – 1.7 billion	Based on compounded growth estimates
Key Growth Areas	Asia-Pacific, hospital-use	Expansion in emerging markets
Innovation Impact	Sustained development of new formulations	Enhanced safety and efficacy profiles

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Comparison with Alternatives and Emerging Therapies

Drug/Method	Mechanism	Pros	Cons	Market Position
Nitrofurantoin	Bacterial DNA synthesis inhibitor	Oral administration, low resistance	Limited to uncomplicated UTIs	First-line, core product
Fosfomycin	Cell wall synthesis inhibition	Single-dose convenience	Resistance emerging	Alternative, especially resistant strains
Bacterial eradication vaccines	Immunization	Long-term prevention	Still in experimental stages	Adjunct therapy
Newer antibiotics (e.g., pivmecillinam)	Beta-lactam	Broad spectrum, alternative to Nitrofurantoin	Resistance concerns	Increasingly prominent in EU markets

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Key Challenges and Opportunities

Challenge	Opportunity
Resistance development	Stewardship protocols, combination therapy
Long-term safety issues	Development of safer formulations
Regulatory hurdles in emerging markets	Local adaptation, regulatory engagement
Market consolidation	Larger players expanding portfolios

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FAQs

1. What is the current regulatory status of Nitrofurantoin globally?
   It is approved by the FDA in the U.S. and EMA in Europe as a first-line treatment for uncomplicated UTIs. Some regions have restrictions for use during pregnancy or in long-term therapy due to safety concerns ([1], [2]).

2. How does resistance impact future use of Nitrofurantoin?
   Resistance is rising in specific regions; however, it remains effective in many areas. Continued surveillance and stewardship are critical to sustain efficacy.

3. Are there new formulations of Nitrofurantoin in development?
   Yes, recent formulations aim to improve absorption, reduce side effects, and enable longer dosing intervals, with some already in late-stage clinical trials.

4. What demographic groups are driving Nitrofurantoin market growth?
   Primarily elderly populations and women with recurrent UTIs. Growth in emerging markets also provides untapped demand.

5. What is the outlook for Nitrofurantoin in the context of global antimicrobial stewardship efforts?
   It is likely to remain central due to its efficacy and low resistance in many regions, but its use will be increasingly governed by stewardship policies to prevent resistance escalation.

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Key Takeaways

• Clinical Status: Nitrofurantoin remains an effective cornerstone antibiotic for uncomplicated UTIs, with recent studies emphasizing safety in special populations and efficacy against resistant strains.
• Market Dynamics: The global market is robust, projected to grow at a CAGR of 3-5%, driven by demographic changes, resistance patterns, and regulatory endorsements.
• Innovation Trends: Focus on formulation improvements and stewardship strategies will shape future development.
• Regulatory Environment: Continued approval and guidance from regulatory authorities support its use but necessitate adherence to safety and resistance management policies.
• Competitive Landscape: Generics dominate the market, with ongoing competition from alternative antibiotics and emerging therapies.

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References

[1] Centers for Disease Control and Prevention (CDC). Antibiotic Resistance Threats in the United States, 2019.
[2] European Medicines Agency (EMA). Safety and Efficacy Data for Nitrofurantoin, 2020.