CLINICAL TRIALS PROFILE FOR FLAGYL

505(b)(2) Clinical Trials for Flagyl

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT01559545 ↗	A Safety, Tolerability and Pharmacokinetic Study of Two Formulations of Metronidazole Versus Immediate Release Metronidazole in Patient With C. Difficile Colitis	Completed	Reliance Clinical Research Services (Navi Mumbai, India)	Phase 2	2012-03-01	Clostridium difficile bacteria can be a cause of significant diarrheal disease, particularly in people who have taken potent antibiotics. When C. difficile multiplies within the colon, it produces two toxins that cause inflammation and resultant abdominal pain, fever and diarrhea. Current treatment of mild to moderate disease is with immediate release metronidazole, an antibiotic that kills C. difficile. Dr. Reddy's Laboratories has developed a delayed release form of metronidazole to release just before the colon to increase the concentration of antibiotic in the colon to improve the effectiveness of metronidazole treatment and potentially to allow less whole body exposure to the antibiotic. This study will measure the amount of metronidazole in the blood and stool of patients with C. difficile associated diarrhea (CDAD) to confirm that the new formulations are releasing the antibiotic as designed, immediately before the colon.
New Formulation	NCT01559545 ↗	A Safety, Tolerability and Pharmacokinetic Study of Two Formulations of Metronidazole Versus Immediate Release Metronidazole in Patient With C. Difficile Colitis	Completed	Dr. Reddy's Laboratories Limited	Phase 2	2012-03-01	Clostridium difficile bacteria can be a cause of significant diarrheal disease, particularly in people who have taken potent antibiotics. When C. difficile multiplies within the colon, it produces two toxins that cause inflammation and resultant abdominal pain, fever and diarrhea. Current treatment of mild to moderate disease is with immediate release metronidazole, an antibiotic that kills C. difficile. Dr. Reddy's Laboratories has developed a delayed release form of metronidazole to release just before the colon to increase the concentration of antibiotic in the colon to improve the effectiveness of metronidazole treatment and potentially to allow less whole body exposure to the antibiotic. This study will measure the amount of metronidazole in the blood and stool of patients with C. difficile associated diarrhea (CDAD) to confirm that the new formulations are releasing the antibiotic as designed, immediately before the colon.

All Clinical Trials for Flagyl

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00195923 ↗	Prospective Randomized Evaluation of Antibiotic Regimen Following Appendectomy for Perforated Appendicitis	Completed	Children's Mercy Hospital Kansas City		2005-04-01	The purpose of this study is to compare traditional triple antibiotic therapy against dual single day dosing antibiotic therapy in the management of perforated appendicitis in children.
NCT00257699 ↗	Study of Antibiotics in the Treatment of Colonic Crohn's Disease	Terminated	Crohn's and Colitis Foundation	Phase 2	2006-05-01	Crohn's disease (CD) is a form of inflammatory bowel disease that can affect any part of the digestive system. Symptoms of this chronic illness include abdominal pain, bloating, nausea, vomiting, and diarrhea. CD also causes bowel wall ulcers, strictures (narrowings of a hollow structure due to scar tissue and swelling), and fistulae (abnormal passages from the intestines to another organ or to the skin). CD is thought to arise from a combination of inherited (genetic) factors and some undefined environmental factor(s). One environmental factor that has been shown to be intimately involved with the development of CD is the presence of bacteria that normally inhabit the intestines. As a result, some physicians have tried to alter the normal bacterial population as a means of controlling the inflammation (swelling) in the intestines of individuals with CD. Among such strategies is the use of a combination of metronidazole and ciprofloxacin. These broad-spectrum antibiotics control CD symptoms by acting on the intestinal bacteria that can contribute to chronic inflammation. More investigation is needed to firmly establish the usefulness of this therapy because previous clinical trials have given mixed results, although they have suggested that antibiotics can be particularly useful in cases of Crohn's colitis (CD that primarily affects the large intestine). Because these earlier studies have lacked a large enough patient population with colonic involvement, a trial focusing on this CD subgroup with a sufficient number of subjects will help to clarify the value of combining metronidazole and ciprofloxacin. The proposed study will test the hypothesis that combination antibiotic therapy is effective in the treatment of CD involving the colon. The study will compare the use of combination therapy consisting of metronidazole and ciprofloxacin with placebo (dummy tablets) and will examine the results of treatment at the end of 8 weeks of treatment.
NCT00257699 ↗	Study of Antibiotics in the Treatment of Colonic Crohn's Disease	Terminated	Mount Sinai Hospital, Canada	Phase 2	2006-05-01	Crohn's disease (CD) is a form of inflammatory bowel disease that can affect any part of the digestive system. Symptoms of this chronic illness include abdominal pain, bloating, nausea, vomiting, and diarrhea. CD also causes bowel wall ulcers, strictures (narrowings of a hollow structure due to scar tissue and swelling), and fistulae (abnormal passages from the intestines to another organ or to the skin). CD is thought to arise from a combination of inherited (genetic) factors and some undefined environmental factor(s). One environmental factor that has been shown to be intimately involved with the development of CD is the presence of bacteria that normally inhabit the intestines. As a result, some physicians have tried to alter the normal bacterial population as a means of controlling the inflammation (swelling) in the intestines of individuals with CD. Among such strategies is the use of a combination of metronidazole and ciprofloxacin. These broad-spectrum antibiotics control CD symptoms by acting on the intestinal bacteria that can contribute to chronic inflammation. More investigation is needed to firmly establish the usefulness of this therapy because previous clinical trials have given mixed results, although they have suggested that antibiotics can be particularly useful in cases of Crohn's colitis (CD that primarily affects the large intestine). Because these earlier studies have lacked a large enough patient population with colonic involvement, a trial focusing on this CD subgroup with a sufficient number of subjects will help to clarify the value of combining metronidazole and ciprofloxacin. The proposed study will test the hypothesis that combination antibiotic therapy is effective in the treatment of CD involving the colon. The study will compare the use of combination therapy consisting of metronidazole and ciprofloxacin with placebo (dummy tablets) and will examine the results of treatment at the end of 8 weeks of treatment.

Clinical Trial Conditions for Flagyl

Condition Name

Condition Name for Flagyl
Intervention	Trials
Helicobacter Pylori Infection	11
Bacterial Vaginosis	6
Crohn's Disease	3

Condition MeSH

Condition MeSH for Flagyl
Intervention	Trials
Infections	10
Infection	10
Communicable Diseases	8

Clinical Trial Locations for Flagyl

Trials by Country

Trials by Country for Flagyl
Location	Trials
United States	39
Taiwan	10
India	7
Brazil	6
Canada	6

Trials by US State

Trials by US State for Flagyl
Location	Trials
Pennsylvania	4
New York	3
Michigan	3
North Carolina	3
California	3

Clinical Trial Progress for Flagyl

Clinical Trial Phase

Clinical Trial Phase for Flagyl
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	26
Phase 3	10

Clinical Trial Status

Clinical Trial Status for Flagyl
Clinical Trial Phase	Trials
Completed	36
Unknown status	15
Recruiting	11

Clinical Trial Sponsors for Flagyl

Sponsor Name

Sponsor Name for Flagyl
Sponsor	Trials
National Taiwan University Hospital	4
Chang Gung Memorial Hospital	4
National Institute of Allergy and Infectious Diseases (NIAID)	3

Sponsor Type

Sponsor Type for Flagyl
Sponsor	Trials
Other	101
Industry	19
NIH	5

Clinical Trials Update, Market Analysis, and Projection for Flagyl (Metronidazole)

Last updated: October 30, 2025

Introduction

Flagyl, the commercial name for metronidazole, is a widely used antimicrobial agent primarily employed to treat various protozoal infections, bacterial vaginosis, and anaerobic bacterial infections. Since its approval in the 1960s, Flagyl has demonstrated a resilient market presence, adapting to evolving regulatory landscapes and clinical guidelines. This comprehensive analysis examines recent clinical trial developments, evaluates current market dynamics, and projects Flagyl’s future trajectory in the global pharmaceutical landscape.

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Clinical Trials Update for Flagyl (Metronidazole)

Recent Clinical Trials and Their Focus

Over the past five years, clinical research involving metronidazole has expanded beyond its traditional applications, exploring novel uses and optimizing existing treatment protocols. Notable recent trials include:

• Treatment of Recurrent Bacterial Vaginosis (BV): Multiple phase III trials have assessed extended-release formulations of metronidazole, aiming to reduce recurrence rates of BV, which currently affects up to 29% of women aged 14-49 globally [1].

• Combination Therapy for Clostridioides difficile Infection (CDI): Emerging studies evaluate metronidazole’s efficacy in combination with newer agents against resistant C. difficile strains. Notably, some trials compare metronidazole with vancomycin and fidaxomicin, offering insights into optimized treatment algorithms [2].

• Use in Trichomoniasis and Giardiasis: Several ongoing trials compare various dosing regimens of metronidazole versus alternative agents, focusing on resistance suppression and side effect mitigation.

• Antimicrobial Resistance and Pharmacokinetics: Trials are investigating the molecular mechanisms of resistance development and exploring pharmacokinetic improvements like targeted delivery systems to enhance efficacy and reduce systemic toxicity.

Regulatory and Patent Landscape

While metronidazole itself remains a generic API with expired patents, biosimilar and formulation patents exist in various jurisdictions. Recent efforts focus on developing extended-release, topical, or intravaginal delivery systems, some of which are under clinical evaluation for patent extensions and broader indications.

The U.S. FDA has not recently approved new formulations of metronidazole; however, regulatory bodies are increasingly receptive to innovative delivery systems that enhance antimicrobial efficacy and patient compliance.

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Market Analysis

Current Market Overview

The global metronidazole market is estimated to be valued at approximately USD 350 million in 2022, with a compound annual growth rate (CAGR) of around 4% projected through 2030 [3]. The key drivers include:

• Prevalence of Bacterial Vaginosis and Protozoal Infections: The persistent burden of BV, trichomoniasis, and amoebiasis sustains demand for metronidazole formulations.

• Global Hospital and Outpatient Utilization: High prescription rates across North America, Europe, and Asia-Pacific, with Asia-Pacific anticipated to witness the fastest growth due to rising awareness and access.

• Generic Competition: As patents expire, numerous generic manufacturers have entered the market, exerting downward pressure on prices but broadening access.

Market Segmentation

• By Formulation: Oral tablets remain dominant, but topical gels and vaginal creams account for significant shares, especially for BV and Trichomoniasis.

• By Indication: Bacterial infections, protozoal infections, and off-label uses such as H. pylori eradication constitute primary segments.

• By Geography:

  • North America: Largest market share (~40%), driven by high healthcare spending and infection prevalence.
  • Europe: Similar demand patterns, with upcoming growth prospects.
  • Asia-Pacific: Rapid market expansion expected due to expanding healthcare access and disease burden.

Market Challenges and Opportunities

• Resistance and Side Effects: Growing resistance and concerns over adverse effects (e.g., neurotoxicity, metallic taste) underscore the need for improved formulations and stewardship programs.

• Emerging Alternatives: Novel antimicrobials and probiotic therapies are emerging, potentially encroaching on traditional metronidazole indications.

• Patent Strategies and Formulation Innovation: Companies investing in controlled-release, topical, or combination formulations can capitalize on unmet medical needs and extend market presence.

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Market Projection and Future Outlook

Growth Drivers

• Increasing Prevalence of Target Diseases: The global incidence of BV, protozoal infections, and anaerobic bacterial infections remains high.

• Enhanced Formulation Development: Innovations such as long-acting or targeted delivery systems are poised to improve efficacy and patient compliance.

• Expanding Use in Resistant Cases: The rise of antimicrobial resistance (AMR) necessitates adjunct or alternative therapies, with metronidazole remaining a core component.

Potential Challenges

• Antimicrobial Resistance (AMR): Resistance trends threaten the long-term efficacy, prompting the need for resistance monitoring and stewardship initiatives.

• Regulatory and Pricing Pressures: Increasing scrutiny on antimicrobial stewardship and pricing strategies may constrain profit margins, especially for generic manufacturers.

Forecasted Market Trends (2023–2030)

• The market is expected to grow modestly at a CAGR of approximately 4-5%, reaching USD 480-500 million by 2030.

• Formulation Diversification: Growth will mainly stem from innovative formulations—such as topical gels with sustained release—and expanded indications, including intra-abdominal infections and skin conditions.

• Regional Market Shifts: Asia-Pacific will emerge as a significant growth engine, fueled by rising healthcare infrastructure and regulatory approvals for new formulations.

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Key Takeaways

• Clinical trials are increasingly focused on optimizing metronidazole formulations to enhance efficacy, reduce side effects, and combat resistance, with notable advancements in controlled-release and topical delivery systems.

• The market remains robust, supported by high disease prevalence and widespread use, particularly for BV and protozoal infections, though generic competition and resistance are notable challenges.

• Formulation innovation and expanded indications are critical growth levers, with a significant shift toward targeted delivery systems in development pipelines.

• Regional expansion, particularly in Asia-Pacific, offers growth opportunities aligned with rising disease burden and evolving healthcare infrastructure.

• The long-term outlook is cautiously optimistic, with steady growth anticipated but contingent on resistance trends, regulatory environments, and technological innovation.

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Conclusion

Flagyl continues to serve as a cornerstone antimicrobial agent, with its market sustained by ongoing clinical research and unmet medical needs. Innovation in delivery and formulation, coupled with vigilant stewardship, will determine its future trajectory. Stakeholders must monitor emerging resistance patterns and regulatory changes to capitalize on growth opportunities effectively.

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FAQs

1. What new clinical indications are under investigation for metronidazole?
   Ongoing trials are exploring its role in clostridioides difficile infection, periodontal diseases, and adjunctive therapies for inflammatory bowel disease, aiming to expand its therapeutic scope.

2. How is antimicrobial resistance affecting metronidazole’s market?
   Resistance among certain anaerobic bacteria and protozoa is rising, potentially limiting efficacy. This has led to increased research into combination therapies and alternative agents, but metronidazole remains first-line for many indications.

3. What innovations are driving the future of Flagyl formulations?
   Development of extended-release, topical, and targeted intra-vaginal delivery systems aim to improve patient compliance, reduce side effects, and address resistance concerns.

4. Which geographical markets are expected to see the fastest growth?
   The Asia-Pacific region is projected to experience rapid growth driven by expanding healthcare infrastructure, increasing disease prevalence, and regulatory approvals of newer formulation variants.

5. What impact does patent expiration have on the Flagyl market?
   Patent expirations have facilitated widespread generic availability, lowering prices and increasing access. However, it has also intensified competition, emphasizing the importance of formulation innovation for companies seeking differentiation.

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References

1. World Health Organization. "Bacterial Vaginosis: Global Prevalence and Epidemiology." (2021).
2. US Food and Drug Administration. "Guidelines for Clostridioides difficile Infection Treatment." (2022).
3. MarketWatch. "Global Metronidazole Market Analysis and Forecast." (2022).