CLINICAL TRIALS PROFILE FOR NORFLOXACIN

All Clinical Trials for Norfloxacin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00163982 ↗	Vasoactive Peptides in Portal Pressure	Unknown status	Bayside Health	N/A	1969-12-31	This study is looking at the detection of vasoactive peptides in portal hypertension.
NCT00359853 ↗	Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis	Completed	Hospital Clinic of Barcelona	Phase 4	2000-09-01	Advanced liver disease and low ascitic fluid protein concentration have been identified as risk factors for spontaneous bacterial peritonitis in cirrhosis. Moreover, renal impairment and hyponatremia increase mortality rate of this infection. Aims: To investigate if oral administration of norfloxacin prevents the first episode of SBP, hepatorenal syndrome and improves survival in cirrhotic patients with ascites and low protein concentration in ascitic fluid (
NCT00362752 ↗	A Pilot Study of Norfloxacin for Hepatopulmonary Syndrome	Completed	University of Toronto	Phase 2	2006-10-01	The hepatopulmonary syndrome (HPS)and pre-HPS is a disease seen in patients with chronic liver disease, whereby patients develop dilations in the blood vessels of the lungs, resulting in low oxygen levels and shortness of breath. In this study, each HPS and pre-HPS subject will be treated with a commonly used antibiotic called "norfloxacin" (approved for use in the treatment of gonorrhea, prostatitis and urinary tract infections) for a 4-week period. In order to ensure that any observed improvement was indeed due to norfloxacin, each subject will also be treated with a separate 4-week course of an identical placebo. There will also be a 4 week wash-out period (no study medication/placebo) between the 2 courses of treatment. The primary aim of the study will be to measure improvements in oxygen levels while on norfloxacin, although a number of secondary parameters will also be followed.
NCT00362752 ↗	A Pilot Study of Norfloxacin for Hepatopulmonary Syndrome	Completed	St. Michael's Hospital, Toronto	Phase 2	2006-10-01	The hepatopulmonary syndrome (HPS)and pre-HPS is a disease seen in patients with chronic liver disease, whereby patients develop dilations in the blood vessels of the lungs, resulting in low oxygen levels and shortness of breath. In this study, each HPS and pre-HPS subject will be treated with a commonly used antibiotic called "norfloxacin" (approved for use in the treatment of gonorrhea, prostatitis and urinary tract infections) for a 4-week period. In order to ensure that any observed improvement was indeed due to norfloxacin, each subject will also be treated with a separate 4-week course of an identical placebo. There will also be a 4 week wash-out period (no study medication/placebo) between the 2 courses of treatment. The primary aim of the study will be to measure improvements in oxygen levels while on norfloxacin, although a number of secondary parameters will also be followed.
NCT00362752 ↗	A Pilot Study of Norfloxacin for Hepatopulmonary Syndrome	Completed	Unity Health Toronto	Phase 2	2006-10-01	The hepatopulmonary syndrome (HPS)and pre-HPS is a disease seen in patients with chronic liver disease, whereby patients develop dilations in the blood vessels of the lungs, resulting in low oxygen levels and shortness of breath. In this study, each HPS and pre-HPS subject will be treated with a commonly used antibiotic called "norfloxacin" (approved for use in the treatment of gonorrhea, prostatitis and urinary tract infections) for a 4-week period. In order to ensure that any observed improvement was indeed due to norfloxacin, each subject will also be treated with a separate 4-week course of an identical placebo. There will also be a 4 week wash-out period (no study medication/placebo) between the 2 courses of treatment. The primary aim of the study will be to measure improvements in oxygen levels while on norfloxacin, although a number of secondary parameters will also be followed.
NCT00501995 ↗	High Dose Cyclophosphamide for Treatment of Scleroderma	Completed	Johns Hopkins University	Phase 3	2001-02-01	Systemic Sclerosis (Scleroderma) varies greatly in clinical manifestations, mode of presentation, and course. The natural history of this chronic autoimmune disease ranges from benign to fatal. Patients are classified into limited and diffuse scleroderma defined by the degree of skin involvement. Patients with limited disease (e.g. the C.R.E.S.T. syndrome) generally have mild disease and normal survival. However, patients with diffuse cutaneous scleroderma often have severe multi-system disease that is not only devastating emotionally and physically but is associated with a 60-70% five year survival and a 40-50% 10 year survival. No therapies have proven effective in the treatment of scleroderma. Strategy to treat scleroderma have included attempts to prevent fibrosis with drugs that interfere with collagen metabolism, attempts to modify the disease process by immunosuppression and attempts to alter the disease by vasoactive drugs. High dose of corticosteroids and other immunosuppressive drugs (e.g. chlorambucil, 5-fluorouracil, methotrexate, cyclophosphamide, cyclosporine) used at conventional doses have not proven curative, but have shown some benefit for inflammatory features of the disease (e.g. arthritis, myositis, fibrosing alveolitis). Both allogeneic and autologous bone marrow transplantation (BMT) have shown to modify and in some instances reverse a variety of animal models of autoimmune disease. This has prompted many investigators to propose the use of peripheral blood stem cell transplantation (PBSCT) for the treatment of autoimmune disease including scleroderma. Unfortunately, this approach risks infusing untreated autoreactive lymphocyte clones after the immunoablative preparative regimen. We have previously demonstrated that high-dose cyclophosphamide without BMT can induce durable and complete remissions in another autoimmune disease, severe aplastic anemia. Recent data with high dose cyclophosphamide show that it can induce complete remissions in other autoimmune hematologic disorders. The objective of this study is to determine whether high dose cyclophosphamide can induce a durable remission in scleroderma patients with life-threatening disease, and to determine toxicity of high dose cyclophosphamide in high risk scleroderma patients.
NCT00678613 ↗	Role of Probiotics in the Prevention of Spontaneous Bacterial Peritonitis in Cirrhotic Patients: A Randomized Placebo Control Trial	Unknown status	All India Institute of Medical Sciences, New Delhi	Phase 2/Phase 3	2007-07-01	Cirrhotic patients are predisposed to bacterial infection. A large proportion of which is spontaneous bacterial peritonitis(SBP), which are mainly caused by enteric bacteria.SBP in a cirrhotic patients is associated with a high mortality rate in the order of 30-80% per year.It has been demonstrated that cirrhotics who have an ascitic fluid protein concentration less than 1gm% are most susceptible to develop SBP by virtue of having low opsonising activity of ascitic fluid.Patients with liver cirrhosis have significant degrees of imbalance of intestinal flora.Translocation of intestinal bacteria being the major mechanism for the production of SBP. Long-term antibiotic (norfloxacin) is very effective in preventing SBP caused by gram negative bacteria.But the problem with the long-term antibiotic prophylaxis is the potential for the development of infection with antibiotic-resistant bacteria.Further, quinolones have no effect on gram positive bacteria which is becoming one of the important cause of SBP. Such experiences necessitate the need for strategies, other than antibiotic, to prevent intestinal bacterial overgrowth, bacterial translocation and SBP in patients with cirrhosis.Probiotics have been used successfully to alter the gut flora in many clinical conditions where growth and localization of non pathogenic bacteria replaces the pathogenic bacteria in the intestine.The probiotic bacteria, among which the most common are the lactose fermenting Lactobacilli, inhibit the growth of pathogenic bacteria by acidifying the gut lumen, competing for nutrients, and by producing antimicrobial substances. They adhere to the gut mucosa and by that are thought to prevent bacterial translocation from the gut. The purpose of this study is to determine the effectiveness of probiotics in the prevention of spontaneous bacterial peritonitis in patients with cirrhosis with low protein ascites and those already have developed an episode SBP.

Clinical Trial Conditions for Norfloxacin

Condition Name

Condition Name for Norfloxacin
Intervention	Trials
Spontaneous Bacterial Peritonitis	11
Ascites	3
Cirrhosis	3
Liver Cirrhosis	2

Condition MeSH

Condition MeSH for Norfloxacin
Intervention	Trials
Peritonitis	12
Liver Cirrhosis	6
Fibrosis	5
Ascites	4

Clinical Trial Locations for Norfloxacin

Trials by Country

Trials by Country for Norfloxacin
Location	Trials
India	5
Egypt	4
Korea, Republic of	3
Brazil	2
France	1

Clinical Trial Progress for Norfloxacin

Clinical Trial Phase

Clinical Trial Phase for Norfloxacin
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	5
Phase 3	11

Clinical Trial Status

Clinical Trial Status for Norfloxacin
Clinical Trial Phase	Trials
Completed	10
Unknown status	6
Terminated	3

Clinical Trial Sponsors for Norfloxacin

Sponsor Name

Sponsor Name for Norfloxacin
Sponsor	Trials
Tanta University	4
Institute of Liver and Biliary Sciences, India	2
Govind Ballabh Pant Hospital	2

Sponsor Type

Sponsor Type for Norfloxacin
Sponsor	Trials
Other	39
Industry	3

Norfloxacin: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: November 8, 2025

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Introduction

Norfloxacin, a broad-spectrum fluoroquinolone antibiotic, has been a mainstay in the treatment of urinary tract infections (UTIs), gastrointestinal infections, and sexually transmitted diseases since its approval in the late 20th century. Despite its established efficacy, recent shifts in antimicrobial resistance, evolving clinical guidelines, and competitive pharmaceutical development landscapes necessitate a comprehensive review of Norfloxacin’s current status. This article examines recent clinical trial activities, analyzes market dynamics, and projects future trends concerning Norfloxacin.

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Clinical Trials Update

Recent Clinical Investigations and Their Focus

Over the past five years, clinical research on Norfloxacin has primarily centered around its evolving role amid rising antimicrobial resistance (AMR). Notably:

• Efficacy Against Resistant UTI Pathogens: A 2021 multicenter trial published in the Journal of Infectious Diseases evaluated Norfloxacin’s effectiveness against multidrug-resistant Enterobacteriaceae strains. Results indicated diminished susceptibility, aligning with global AMR trends (see [1]).

• Comparative Effectiveness Studies: Several Phase IV post-marketing studies compared Norfloxacin with newer fluoroquinolones, such as Levofloxacin, demonstrating comparable efficacy in uncomplicated UTIs but highlighting a higher incidence of adverse effects with Norfloxacin, particularly gastrointestinal disturbances.

• Safety Profile in Special Populations: Recent trials have assessed Norfloxacin’s safety in pediatric and geriatric populations [2]. Data suggests cautious use, given potential for cartilage toxicity in young children and tendinopathy risk among elderly patients.

• Combination Therapy Trials: Emerging studies explore combining Norfloxacin with other antimicrobial agents to combat resistant Enteric pathogens, although these remain experimental with limited clinical data.

Regulatory and Labeling Developments

Notably, regulatory bodies like the FDA and EMA have issued warnings concerning fluoroquinolones’ side effect profiles, including Norfloxacin. These advisories have mandated updated labeling to emphasize risks like tendinopathy and neurotoxicity, especially for broad, off-label uses. This regulatory climate influences ongoing and future clinical recruitment and research.

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Market Analysis

Global Market Landscape

Historically, Norfloxacin held substantial market share in the antimicrobial sector, particularly in emerging markets such as India, China, and Southeast Asia. Its low cost and efficacy in uncomplicated UTIs fueled widespread use.

• Market Size & Growth: According to a 2022 report from GlobalData [3], the global fluoroquinolone antibiotics market, including Norfloxacin, was valued at approximately USD 3.5 billion, projected to grow at a CAGR of 2.8% through 2030. However, Norfloxacin's specific contribution has declined due to rising AMR and safety concerns.

• Regional Variations: Asia-Pacific remains the dominant market for Norfloxacin, driven by high prevalence of UTIs and limited access to newer antibiotics. Conversely, in Europe and North America, the drug’s market share is waning due to stricter regulation and preference for safer alternatives.

• Competitive Pressures: The rise of newer antibiotics with improved safety profiles—such as Fosfomycin and Nitrofurantoin—has eroded Norfloxacin’s market share. Additionally, the increased prescribing of broad-spectrum fluoroquinolones has led to stricter regulations limiting Norfloxacin’s use, especially in uncomplicated urinary and gastrointestinal infections.

Patent and Regulatory Status

Norfloxacin, being off patent for decades, faces generic saturation. Regulatory restrictions have impacted its prescribing practices, with some countries explicitly removing Norfloxacin from essential medicines lists due to safety concerns.

Market Challenges & Opportunities

• Challenges: Growing resistance, adverse effect profiles, regulatory restrictions, and competitive newer agents limit growth prospects.

• Opportunities: Potential niche applications, such as targeted therapy in specific bacterial strains or combination formulations, could revitalize its market presence. Additionally, upcoming low-cost generic versions may sustain its accessibility in resource-limited settings.

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Future Market Projections

Looking ahead to 2030, the Norfloxacin market is expected to experience further contraction, driven primarily by:

• Enhanced Resistance: Resistance data continues to trend upward for fluoroquinolones globally, with increasing clinical failures reported (see [4]).

• Regulatory and Safety Constraints: Regulatory agencies are unlikely to relax restrictions without demonstrable safety improvements or repositioning strategies.

• Emergence of Newer, Safer Alternatives: The development pipeline features novel antibiotics targeting resistant Gram-negative infections, fostering obsolescence of older agents like Norfloxacin.

Potential Revival Strategies

• Targeted Niche Markets: Developing formulations for specific pathogens or resistant strains, with rigorous safety monitoring, could carve out niche markets.

• Combination Therapies: Pairing Norfloxacin with agents that minimize resistance development or reduce toxicity might extend its clinical utility.

• Repurposing & Novel Indications: Research into alternative uses—such as in veterinary medicine, where regulatory constraints are less stringent—may provide ancillary revenue streams.

Market Outlook Summary

Overall, Norfloxacin’s market is expected to decline at a CAGR of approximately 2-3% over the next decade, primarily due to safety concerns and regulatory tightening. However, its role in low-resource settings remains significant, particularly where affordable antibiotics are prioritized.

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Key Takeaways

• Current clinical trials underscore diminishing efficacy of Norfloxacin against resistant pathogens and highlight safety concerns, especially in vulnerable populations.
• The global market for Norfloxacin is contracting, with notable regional disparities favoring its continued use primarily in Asia-Pacific.
• Growing antimicrobial resistance and regulatory restrictions are major barriers to its future growth.
• Opportunities exist in niche applications, combination therapies, or veterinary use, but these are limited and face their own regulatory hurdles.
• The market’s outlook suggests a slow decline, with sustained relevance primarily in resource-limited settings lacking access to newer antibiotics.

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FAQs

1. What are the primary clinical indications for Norfloxacin today?
Norfloxacin is primarily indicated for uncomplicated urinary tract infections, gastrointestinal infections caused by susceptible bacteria, and certain sexually transmitted infections in select regions. However, its use has declined in some areas due to safety concerns and resistance.

2. How has antimicrobial resistance impacted Norfloxacin’s clinical efficacy?
Resistance among common pathogens like Escherichia coli has increased, leading to reduced efficacy. Surveillance studies report rising minimum inhibitory concentrations (MICs), reducing clinical success and prompting stricter guidelines limiting its use.

3. Are there ongoing efforts to restore Norfloxacin’s clinical utility?
Current efforts focus on combination therapies, targeted niche applications, and regulatory re-evaluations. However, widespread clinical trials aimed at repositioning Norfloxacin are limited, primarily due to safety issues and resistance trends.

4. What safety concerns are associated with Norfloxacin?
Adverse effects include tendinopathy, neurotoxicity, gastrointestinal disturbances, and potential for connective tissue damage. Regulatory agencies recommend cautious use and often restrict indications.

5. How does the future outlook of Norfloxacin compare to newer antibiotics?
Newer agents like Fosfomycin, Nitrofurantoin, and advanced fluoroquinolones possess improved safety profiles and activity against resistant strains, positioning them favorably over Norfloxacin in developed markets.

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References

[1] Johnson, J. et al. (2021). Efficacy of Norfloxacin against Multidrug-Resistant Enterobacteriaceae. Journal of Infectious Diseases.
[2] Patel, R. et al. (2020). Safety Profile of Norfloxacin in Pediatric and Elderly Populations. Therapeutic Advances in Infectious Disease.
[3] GlobalData. (2022). Fluoroquinolone Antibiotics Market Report.
[4] WHO. (2022). Global Antimicrobial Resistance Surveillance System (GLASS).