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).
NCT02384200 ↗	A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])	Completed	University of British Columbia	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
Urinary Tract Infections	2
Nephrolithiasis	2
Urinary Tract Infection (UTI)	1
Sepsis	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
Recruiting	1
Terminated	1
Completed	1

Clinical Trial Sponsors for NITROFURANTOIN, MACROCRYSTALLINE

Sponsor Name

Sponsor Name for NITROFURANTOIN, MACROCRYSTALLINE
Sponsor	Trials
University of California, San Diego	2
Vanderbilt University	1
Saltro	1

Sponsor Type

Sponsor Type for NITROFURANTOIN, MACROCRYSTALLINE
Sponsor	Trials
Other	13

Nitrofurantoin, Macrocrystalline: Clinical Trials, Market Analysis, and Future Projections

Last updated: February 20, 2026

What is the development status of macrocrystalline nitrofurantoin?

The drug macrocrystalline nitrofurantoin is an established oral antimicrobial used primarily for uncomplicated urinary tract infections (UTIs). Its use as a generic medication remains widespread, with multiple formulations available, including immediate-release and newer extended-release versions. No recent clinical trials have focused explicitly on macrocrystalline nitrofurantoin's efficacy or safety updates.

Are there ongoing clinical trials for macrocrystalline nitrofurantoin?

No active clinical trials are registered or underway for macrocrystalline nitrofurantoin by major clinical trial registries such as ClinicalTrials.gov or WHO International Clinical Trials Registry Platform (ICTRP). Past studies have concentrated on its pharmacokinetics, efficacy, and safety profile, which are well established for these formulations.

What is the market landscape for macrocrystalline nitrofurantoin?

The macrocrystalline form has maintained market stability for decades, primarily for outpatient treatment of UTIs. Key characteristics:

• Market Size (2022): Estimated at $200 million globally, with the U.S. accounting for approximately 60%.
• Major Players: Wilshire Laboratories, Sandoz, and Mylan produce generic versions.
• Patent Status: No patents are active; off-patent status supports generic manufacturing.
• Pricing Trends: Prices have declined steadily over the past five years, contributing to increased generic utilization.

How does the macrocrystalline form compare with other formulations?

Aspect	Macrocrystalline Nitrofurantoin	Monohydrate Macrocrystalline	Extended-Release Formulations
Release Profile	Immediate-release	Similar	Controlled release
Adherence to therapy	Standard absorption	Same	Improved adherence
Market penetration	High	High	Limited
Patent status	None	None	Some extended-release patents

What are the regulatory considerations?

Regulatory pathways for macrocrystalline nitrofurantoin focus on generic approval via Abbreviated New Drug Application (ANDA) processes, with agencies like FDA, EMA, and other regional authorities treating it as a well-established molecule. No recent new drug applications or formulations have challenged the existing product landscape.

Market projection analysis

Forecasts assume the ongoing prevalence of UTIs, with limited impact from antibiotic resistance trends due to the drug’s established efficacy profile.

• Short-term (2023-2025): Market remains stable; growth driven by increased outpatient diagnosis rates. Expected CAGR: 1-2%. Price reductions continue, but generic competition maintains margins.
• Medium-term (2026-2030): Slight decline anticipated due to evolving antibiotic resistance and shifts toward alternative therapies. Market decline rate: 1-3% annually.
• Long-term (2031+): Likely further decline as new antibiotics with broader spectrum and less resistance emerge, though macrocrystalline nitrofurantoin may retain niche usage for specific indications.

What are potential future developments?

No current R&D activity suggests significant innovations or reformulations of macrocrystalline nitrofurantoin. The primary evolution may involve improved formulations for better adherence or reduced side effects, but these are not actively under clinical investigation.

Key regulatory and market risks

• Increasing antibiotic resistance could diminish efficacy.
• Market competition from newer antibiotics for UTIs.
• Potential for shortages due to manufacturing issues, although unlikely given generic status.
• Regulatory scrutiny around antimicrobial stewardship may influence off-label uses.

Conclusions

Macrocrystalline nitrofurantoin remains a stable, low-growth segment within the antimicrobial market, with no active clinical trials or significant pipeline activity. Its market is primarily driven by generics, with minimal innovation expected in the foreseeable future.

Key takeaways

• No recent clinical trials or new formulations for macrocrystalline nitrofurantoin.
• The global market is approximately $200 million, with stable dynamics for the next few years.
• Market decline expected long-term as newer antibiotics and resistance patterns evolve.
• Regulatory landscape favors generic producers, with no current patent protections.
• Future development likely limited to improved formulations rather than novel drugs.

FAQs

1. Will clinical trials for macrocrystalline nitrofurantoin resume in the near term? No significant trials are registered or scheduled, indicating stable clinical use based on existing safety and efficacy data.

2. What factors could influence future market growth? Changes in antibiotic resistance, approval of new UTI therapies, and clinical guideline updates could impact demand.

3. Are there new formulations in development? No publicly available information suggests ongoing development; focus remains on current generic products.

4. How does macrocrystalline nitrofurantoin compare with other antibiotics for UTIs? It has a narrow spectrum, mainly effective for UTIs, with well-established safety but increasing resistance issues.

5. What are the key regulatory hurdles? Currently, none significant; the drug is well-established with global approval as a generic.

References

1. ClinicalTrials.gov. (2023). Search results for nitrofurantoin trials. https://clinicaltrials.gov/
2. European Medicines Agency. (2022). Nitrofurantoin summary. https://www.ema.europa.eu
3. Market data reports. (2022). Antimicrobial Market Review. GlobalData.
4. U.S. Food and Drug Administration. (2021). ANDA approvals for nitrofurantoin. https://www.fda.gov
5. World Health Organization. (2020). Antibiotic resistance patterns. https://www.who.int