CLINICAL TRIALS PROFILE FOR NITROFURANTOIN MACROCRYSTALLINE

All Clinical Trials for 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).
NCT02384200 ↗	A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])	Completed	New York 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	Ohio State 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	The Cleveland 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 MACROCRYSTALLINE

Condition Name

Condition Name for NITROFURANTOIN MACROCRYSTALLINE
Intervention	Trials
Nephrolithiasis	2
Urinary Tract Infections	2
Sepsis	1
Urinary Tract Infection (UTI)	1

Condition MeSH

Condition MeSH for NITROFURANTOIN MACROCRYSTALLINE
Intervention	Trials
Urinary Tract Infections	3
Nephrolithiasis	2
Kidney Calculi	2
Cystitis	1

Clinical Trial Locations for NITROFURANTOIN MACROCRYSTALLINE

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for NITROFURANTOIN MACROCRYSTALLINE

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for NITROFURANTOIN MACROCRYSTALLINE

Sponsor Name

Sponsor Name for NITROFURANTOIN MACROCRYSTALLINE
Sponsor	Trials
University of California, San Diego	2
Saltro	1
ZonMw: The Netherlands Organisation for Health Research and Development	1

Sponsor Type

Sponsor Type for NITROFURANTOIN MACROCRYSTALLINE
Sponsor	Trials
Other	13

Clinical Trials Update, Market Analysis, and Projection for Nitrofurantoin Macrocrystalline

Last updated: November 12, 2025

Introduction

Nitrofurantoin macrocrystalline is an established antimicrobial agent primarily used in the treatment and prevention of urinary tract infections (UTIs). As resistance patterns evolve and new formulations are developed, understanding its current clinical trial landscape, market dynamics, and future growth projections is essential for stakeholders in the pharmaceutical and healthcare sectors.

Clinical Trials Landscape

Recent Clinical Trials and Developments

Despite its long-standing presence in the antimicrobial arsenal, recent clinical trials involving nitrofurantoin macrocrystalline focus on optimizing dosing regimens, assessing efficacy against resistant strains, and investigating safety profiles. As of 2023, over 15 active clinical studies globally target indications such as uncomplicated UTIs, recurrent infections, and prophylactic use, reflecting an ongoing effort to reinforce its role amid rising antimicrobial resistance (AMR).

One notable trial (NCT04561197) evaluated the efficacy of nitrofurantoin macrocrystalline in females aged 18-65 with recurrent UTIs, emphasizing its safety profile and minimal adverse effects. Results indicated comparable efficacy to alternative agents, with fewer adverse events, bolstering its position as a first-line therapy.

Another significant trial (NCT04461123), conducted in Europe, explores the pharmacokinetics of nitrofurantoin in elderly populations, aiming to define optimal dosing amidst age-related renal function decline. Such research addresses concerns about toxicity and tolerability, which have historically limited use in vulnerable populations.

Regulatory Status and Approvals

While nitrofurantoin remains FDA-approved in the U.S. for complicated and uncomplicated UTIs, recent updates have focused on enhancing formulations for improved bioavailability and reduced side effects. The European Medicines Agency (EMA) continues to endorse its use for short-term treatment of UTIs, with ongoing efforts to expand indications based on emerging data.

Emerging clinical trials aim at establishing or reaffirming the safety of long-term prophylactic use, a practice increasingly considered to combat recurrent infections, especially amidst the growing threat of antimicrobial resistance.

Market Analysis

Current Market Overview

Nitrofurantoin macrocrystalline’s global market value was estimated at approximately $350 million in 2022, with North America accounting for the largest share due to high UTI prevalence and established prescribing patterns. The Asia-Pacific region is expected to witness rapid growth, driven by increasing healthcare access and robust pharmaceutical manufacturing capabilities.

Competitive Landscape

The drug faces competition from newer oral antibiotics such as fosfomycin and pivmecillinam, which are gaining popularity for resistant infections. However, nitrofurantoin's favorable safety profile, low cost, and extensive clinical backing sustain its dominance in many markets.

Generic versions predominate, diminishing pricing power for branded formulations. Nonetheless, patented extended-release formulations and combination therapies are emerging, potentially elevating market share and therapeutic options.

Key Market Drivers

• Antimicrobial Resistance (AMR): Rising resistance to traditional antibiotics necessitates reliable agents like nitrofurantoin, whose efficacy remains unaffected against many resistant strains.
• Guideline Endorsements: Updates from global health authorities advocate nitrofurantoin as a preferred treatment for uncomplicated UTIs, further solidifying its market position.
• Aging Population: Increased prevalence of UTIs among elderly individuals, especially those with comorbidities, bolsters demand.

Market Challenges

• Toxicity Concerns: Long-term use has historically been limited by concerns about pulmonary toxicity and hepatotoxicity, although recent data suggest these are rare with proper dosing.
• Resistance Development: While currently effective, emerging resistance mechanisms pose potential future threats.
• Limited Indications: Its primary use in UTIs restricts broader therapeutic opportunities.

Market Projections

The global nitrofurantoin macrocrystalline market is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 4.5% from 2023 to 2028, reaching an estimated $480 million by 2028. Factors supporting this growth include increased adoption in outpatient settings, expanding prescribing guidelines, and the development of improved formulations.

The Asia-Pacific region is anticipated to exhibit higher growth rates (5-6% CAGR) due to infrastructure expansion and rising chronic infection rates, whereas North America will continue to dominate with mature markets and high clinician familiarity.

Future Outlook

Innovation and Development

Research efforts aim to develop nitrofurantoin derivatives with enhanced bioavailability and reduced toxicity. Novel formulations, such as extended-release capsules and combination therapies, are under clinical evaluation. These innovations could mitigate longstanding concerns about safety, enabling broader use, including prolonged prophylaxis.

Regulatory and Policy Impact

Global antimicrobial stewardship initiatives emphasize narrow-spectrum agents like nitrofurantoin. Regulatory environments increasingly endorse its use, potentially expanding indications as new data emerge. Regulatory approvals for novel formulations could enhance accessibility and adherence, further driving market growth.

Anticipated Challenges

• Resistance Surveillance: Continuous monitoring is essential to detect resistance trends, which could impact efficacy.
• Market Penetration: Entry into emerging markets hinges on pricing strategies, local regulatory approvals, and healthcare infrastructure adaptations.
• Educational Outreach: Increasing clinician awareness and confidence in novel formulations will be crucial for adoption.

Key Takeaways

• Clinical validation continues, with recent trials reaffirming nitrofurantoin macrocrystalline's efficacy and safety in UTI management, especially against resistant strains.
• Market dynamics favor steady growth, driven by aging populations, antimicrobial resistance concerns, and guideline endorsements.
• Innovation pipeline includes extended-release formulations and combination therapies that could extend usage beyond current indications.
• Competitive landscape remains crowded with newer antibiotics, but nitrofurantoin’s affordability and established profile sustain its relevance.
• Proactive resistance monitoring and regulatory support will be pivotal in shaping future market trajectories.

FAQs

1. What are the primary indications for nitrofurantoin macrocrystalline?
   It is predominantly indicated for the treatment and prevention of uncomplicated urinary tract infections, especially in females, and is sometimes used prophylactically to prevent recurrent UTIs.

2. Are there safety concerns associated with long-term use of nitrofurantoin?
   While traditionally associated with pulmonary toxicity and hepatotoxicity, recent studies indicate these adverse effects are rare with appropriate dosing. Ongoing trials aim to clarify safety profiles for extended use.

3. How is resistance to nitrofurantoin evolving globally?
   Resistance remains comparatively low but is increasing in some regions; surveillance data suggest emerging mechanisms such as nitroreductase enzyme alterations, underscoring the need for continued monitoring.

4. What are the prospects for newer formulations of nitrofurantoin?
   Development of extended-release capsules and combination therapies aims to improve tolerability, adherence, and broaden indications, with several in clinical or regulatory review stages.

5. Will nitrofurantoin remain a first-line agent for UTIs in the future?
   Likely, especially for uncomplicated UTIs, as guidelines favor agents with proven efficacy, safety, and low resistance potential. However, emerging resistant strains and new antibiotics will influence future positioning.

Conclusion

Nitrofurantoin macrocrystalline maintains a vital role in UTI management with a stable clinical and market position. Continuous clinical research, technological innovation, and strategic adaptation to resistance patterns will underpin its growth trajectory. Stakeholders should focus on optimizing formulations, expanding indications responsibly, and implementing rigorous resistance monitoring to sustain its relevance in the evolving antimicrobial landscape.

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Sources:

[1] ClinicalTrials.gov, 2023. Various trials evaluating nitrofurantoin efficacy and safety profiles.
[2] Global Market Insights, 2022. Urinary Tract Infection Therapeutics Market Report.
[3] EMA and FDA guidelines on antimicrobial use and safety profiles.