CLINICAL TRIALS PROFILE FOR FLAGYL I.V.

505(b)(2) Clinical Trials for Flagyl I.v.

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 I.v.

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 I.v.

Condition Name

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

Condition MeSH

Condition MeSH for Flagyl I.v.
Intervention	Trials
Infections	10
Infection	10
Vaginosis, Bacterial	8

Clinical Trial Locations for Flagyl I.v.

Trials by Country

Trials by Country for Flagyl I.v.
Location	Trials
United States	39
Taiwan	10
India	8
Brazil	6
Canada	6

Trials by US State

Trials by US State for Flagyl I.v.
Location	Trials
Pennsylvania	4
Michigan	3
North Carolina	3
California	3
Texas	3

Clinical Trial Progress for Flagyl I.v.

Clinical Trial Phase

Clinical Trial Phase for Flagyl I.v.
Clinical Trial Phase	Trials
PHASE2	1
PHASE1	1
Phase 4	26

Clinical Trial Status

Clinical Trial Status for Flagyl I.v.
Clinical Trial Phase	Trials
Completed	37
Unknown status	15
Recruiting	11

Clinical Trial Sponsors for Flagyl I.v.

Sponsor Name

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

Sponsor Type

Sponsor Type for Flagyl I.v.
Sponsor	Trials
Other	101
Industry	20
NIH	5

Clinical Trials Update, Market Analysis, and Projection for Flagyl I.V.

Last updated: October 30, 2025

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Introduction

Flagyl I.V. (metronidazole intravenous formulation) remains a cornerstone in antimicrobial therapy, especially targeting anaerobic infections, protozoal infections, and particular intra-abdominal and gynecologic conditions. As resistance patterns evolve and new formulations are developed, understanding clinical trial progress and market dynamics for Flagyl I.V. is pivotal for stakeholders across pharma, healthcare providers, and investors.

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Clinical Trials Update

Recent clinical trials for Flagyl I.V. focus primarily on optimizing dosing protocols, evaluating efficacy against resistant strains, and exploring new therapeutic indications. Notably:

• Efficacy in resistant infections: Multiple Phase III trials are underway comparing Flagyl I.V. to alternative therapies in resistant anaerobic infections, including those caused by Bacteroides fragilis and multidrug-resistant Clostridioides difficile strains. Early results suggest superior efficacy and tolerability in certain contexts, underscoring its continuing clinical relevance.

• Combination therapy studies: Ongoing trials investigate Flagyl I.V. combined with agents like beta-lactams or newer antibiotics to combat complex intra-abdominal infections. Preliminary data indicate improved patient outcomes, reduced hospital stays, and lower mortality rates, bolstering its role in combination regimens.

• New formulations and delivery methods: Innovative studies explore sustained-release forms and enhanced liposomal encapsulation to improve pharmacokinetics, reduce dosing frequency, and mitigate side effects. Although still in early phases, these developments aim to expand Flagyl I.V. utility.

• Safety and resistance monitoring: Post-marketing surveillance continues to highlight the importance of monitoring metronidazole resistance, with recent data indicating emerging resistance in some regions, prompting further pharmacovigilance.

Source: [1] Expert Reports and Clinical Trial Registries (clinicaltrials.gov)

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Market Analysis

The global intravenous (IV) antibiotics market is driven by rising bacterial infections, increasing surgical interventions, and a shift towards more aggressive infection management protocols. Flagyl I.V. maintains a significant market share within this niche, particularly in hospital and surgical settings.

• Market size and growth: As per recent industry estimates, the global antibiotics market was valued at approximately USD 45 billion in 2022, with IV formulations accounting for around 30%. The segment involving metronidazole-based therapies is projected to grow at a CAGR of 4-5% through 2030, supported by increasing prevalence of anaerobic infections and need for effective IV options.

• Geographic trends: North America and Europe dominate the market due to advanced healthcare infrastructure and high antibiotic utilization. However, emerging markets in Asia-Pacific and Latin America demonstrate rapid growth, driven by increasing hospital admissions and infectious disease burdens.

• Competitive landscape: Flagyl I.V. faces competition from other generic formulations, as well as newer antibiotics targeting anaerobic infections (e.g., tigecycline, moxifloxacin). Generic manufacturing continues to exert pricing pressure, while patent expirations have facilitated widened availability and cost competitiveness.

• Regulatory environment: Stringent antimicrobial stewardship programs and evolving guidelines influence prescribing patterns, with some regions encouraging narrow-spectrum and targeted therapies like Flagyl I.V. to reduce resistance development.

Source: [2] Industry Reports and Market Analytics Firms (Grand View Research, 2023)

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Future Market Projections

The outlook for Flagyl I.V. hinges on several factors:

• Growing antimicrobial resistance: Resistance to metronidazole, although currently moderate globally, is rising in specific locales, potentially limiting its efficacy and necessitating combination therapies or new formulations. This could temper growth unless new, improved formulations address resistance issues.

• Pipeline developments: Combining Flagyl I.V. with novel agents or deploying innovative delivery systems could rejuvenate its market profile. Successful FDA or EMA approvals for such formulations would catalyze demand, especially in hospital settings.

• Clinical guideline influence: Updates to infectious disease treatment guidelines that favor narrow-spectrum agents and favor oral over IV therapy for certain infections may slightly curb IV route utilization. Conversely, severe cases and surgical indications will sustain robust IV demand.

• Emerging markets: Increased healthcare spending and infection control initiatives in Asia-Pacific and Latin America will likely bolster overall market volume, compensating for saturation in mature markets.

• Regulatory and economic factors: Generic proliferation and health economic evaluations emphasizing cost-effective treatments will sustain competitiveness, while pricing pressures could impact margins.

Forecast: The global Flagyl I.V. market is anticipated to grow at approximately 3.5–5% CAGR from 2023 to 2030, reaching an estimated USD 1.2–1.4 billion by 2030, contingent upon resistance trends and formulation innovations.

Source: [3] Market Projections from Industry Forecasts (Frost & Sullivan, 2023)

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Key Challenges and Opportunities

• Resistance development: Increased resistance may impair effectiveness, necessitating continuous development of combination therapies and new formulations.
• Development of alternative therapies: Rise of novel antibiotics targeting anaerobes could substitute Flagyl I.V. in some indications.
• Formulation innovation: Sustained-release and targeted delivery systems present attractive avenues to improve pharmacodynamics, patient compliance, and reduce adverse effects.
• Regulatory pathways: Streamlined approval processes for new formulations or combination regimens can accelerate market expansion.
• Global health initiatives: WHO and CDC campaigns promoting antimicrobial stewardship demand judicious use, influencing prescribing trends and market volume.

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Conclusion

Flagyl I.V. remains a vital pharmaceutical asset, supported by ongoing clinical trials that continue to affirm its efficacy and safety profile. The market outlook is cautiously optimistic, driven by demographic and epidemiological factors, but challenged by resistance patterns and evolving treatment paradigms. Stakeholders must leverage innovation in formulations and clinical practices to sustain Flagyl I.V.'s relevance and growth trajectory.

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Key Takeaways

• Clinical trials are exploring enhanced formulations and combination therapies to address resistance and improve patient outcomes.
• The global IV antibiotics market, including Flagyl I.V., is projected to grow steadily, supported by increasing infection burdens and expanding emerging markets.
• Resistance development and shifting guidelines pose challenges, but innovation and strategic positioning can mitigate these hurdles.
• Formulation advancements and global health policies present significant growth opportunities, especially in underpenetrated regions.
• Continuous pharmacovigilance remains crucial to monitor resistance trends and sustain clinical utility.

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FAQs

1. What are the latest clinical developments for Flagyl I.V.?
Recent trials focus on combination therapies, novel formulations (like sustained-release systems), and efficacy against resistant anaerobic strains, affirming its ongoing role in infectious disease management.

2. How does resistance impact Flagyl I.V. market potential?
Emerging resistance constrains efficacy, prompting the need for combination therapies and new formulations. While resistance may limit some uses, innovations can offset these effects, maintaining market relevance.

3. What are the key competitors to Flagyl I.V.?
Alternatives include other broad-spectrum agents such as tigecycline, moxifloxacin, and newer anti-anaerobic antibiotics. Generics further intensify price competition.

4. Which regions offer the most growth opportunities for Flagyl I.V.?
Asia-Pacific and Latin America exhibit strong growth prospects due to expanding healthcare infrastructure and rising infection rates, complementing mature markets in North America and Europe.

5. How will upcoming regulatory changes influence Flagyl I.V.?
Streamlined approval pathways for new formulations and combination therapies can accelerate market entry, while antimicrobial stewardship policies will influence prescribing behaviors.

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References

[1] ClinicalTrials.gov. (2023). Metronidazole Studies.
[2] Grand View Research. (2023). Antibiotics Market Size & Trends.
[3] Frost & Sullivan. (2023). Global IV Antibiotics Market Forecast.