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
NCT00464542 ↗	Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 (BV/HSV-2) Shedding Study	Completed	University of Pittsburgh	Phase 4	2007-12-01	This investigation assessed the effects of asymptomatic BV on daily genital tract shedding of HSV-2 by determining shedding frequency before and after treatment of asymptomatic BV.
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.
NCT00353743 ↗	The Use of Antibiotics After Hospital Discharge in Septic Abortion	Terminated	Hospital de Clinicas de Porto Alegre	N/A	2006-05-01	The use of antibiotics in post-partum infection has been abbreviated. After 48 hours of clinical improvement, the patient is discharged from the hospital without antibiotics. No trials has been found in cases of septic abortion. The purpose of the present study is to verify the need of antibiotics after clinical improvement in cases of septic abortion.
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.

Clinical Trial Conditions for FLAGYL

Condition Name

Condition Name for FLAGYL
Intervention	Trials
Helicobacter Pylori Infection	11
Bacterial Vaginosis	6
Crohn's Disease	3
HIV Infections	2

Condition MeSH

Condition MeSH for FLAGYL
Intervention	Trials
Infection	10
Infections	10
Communicable Diseases	8
Helicobacter Infections	8

Clinical Trial Locations for FLAGYL

Trials by Country

+

−

Trials by Country for FLAGYL
Location	Trials
United States	38
Taiwan	10
India	7
Canada	6
Brazil	6

Trials by US State

+

−

Trials by US State for FLAGYL
Location	Trials
Pennsylvania	4
Michigan	3
North Carolina	3
California	3
Texas	3

Clinical Trial Progress for FLAGYL

Clinical Trial Phase

Clinical Trial Phase for FLAGYL
Clinical Trial Phase	Trials
Phase 4	26
Phase 3	10
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for FLAGYL
Clinical Trial Phase	Trials
Completed	36
Unknown status	15
Recruiting	10

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	99
Industry	19
NIH	5

Flagyl (Metronidazole): Clinical Trials, Market Analysis, and Projections

Introduction

Flagyl, commonly known by its active ingredient metronidazole, is a widely used antibiotic and antiprotozoal medication. It is employed in the treatment of various infections, including trichomoniasis, amebiasis, and clostridium difficile infection. Here, we will delve into the current clinical trials, market analysis, and future projections for Flagyl.

Clinical Trials and Efficacy

Treatment of Bacterial Vaginosis

A recent randomized clinical trial compared the efficacy of dequalinium chloride with metronidazole in treating bacterial vaginosis. The study found that metronidazole, with cure rates ranging from 66% to 90%, remains a highly effective treatment option. However, the trial also highlighted the importance of adherence and the potential for other treatments to be non-inferior to metronidazole[4].

Clostridium Difficile Infection

Clinical trials focusing on metronidazole for clostridium difficile infection (CDI) have provided comprehensive insights into its mechanism of action, dosage, and administration. These trials, conducted across major markets including the United States, EU4, the United Kingdom, and Japan, have shown that metronidazole is a cornerstone in the treatment of CDI, although emerging therapies are expected to challenge its dominance in the future[3].

Trichomoniasis and Amebiasis

Flagyl is indicated for the treatment of symptomatic and asymptomatic trichomoniasis, as well as various forms of amebiasis. Clinical guidelines recommend a seven-day course of 375 mg twice daily for trichomoniasis, with adjustments for patients with severe hepatic impairment[1].

Market Analysis

Global Market Trends

The global metronidazole market is experiencing significant growth, driven by increasing healthcare spending and extensive research in treating infections such as CDI. The market is segmented into regions including North America, Europe, Asia Pacific, Middle East & Africa, and Latin America, with each region showing distinct trends and growth rates[2].

Market Segmentation

The metronidazole market can be segmented by type, including tablets, capsules, injections, and creams/gels. The tablets segment is expected to expand at a significant CAGR, retaining its position throughout the forecast period. Key companies such as Hongyuan Pharmaceutical and Saikang Pharmaceutical are focusing on strategy building to strengthen their product portfolios and expand their global market presence[2][5].

Competitive Landscape

The competitive landscape of the metronidazole market is characterized by several key players. These companies are investing in research and development to improve existing products and develop novel approaches to treat infections. The market is also witnessing the emergence of new therapies that could potentially challenge metronidazole's market share[3][5].

Market Projections

Forecasted Sales

The forecasted sales of metronidazole for clostridium difficile infection from 2023 to 2032 indicate a growing market driven by incremental healthcare spending and extensive research. The report highlights that the market scenario for CDI is set to change, enabling drug manufacturers to penetrate more into the market[3].

Regional Dominance

North America and Europe are expected to dominate the global metronidazole market within the forecast period, driven by advanced healthcare infrastructure and higher spending on research and development. However, the Asia Pacific region is also expected to show significant growth due to increasing healthcare needs and investments[2][3].

Challenges and Opportunities

Despite the growth prospects, the metronidazole market faces challenges such as the development of drug-resistant bacteria and the emergence of new therapies. However, these challenges also present opportunities for innovation and the development of novel treatment approaches[1][3].

Regulatory Milestones and Development Activities

Mechanism of Action and Dosage

Metronidazole's mechanism of action involves the inhibition of DNA synthesis in bacteria and protozoa. The dosage and administration vary depending on the type of infection being treated. For instance, a seven-day course is recommended for trichomoniasis, while longer treatment durations may be necessary for infections such as those of the bone and joint[1][3].

Patents and Expiry Timeline

The report on metronidazole includes information on patents and their expiry timelines, which is crucial for understanding the future competitive landscape and potential generic market entry[3].

SWOT Analysis

Strengths

• Established efficacy in treating various infections.
• Wide range of formulations (tablets, capsules, injections, creams/gels).
• Strong market presence in multiple regions.

Weaknesses

• Potential for drug resistance.
• Side effects such as gastrointestinal disturbances.
• Emerging competitors in the form of new therapies.

Opportunities

• Growing healthcare spending and research investments.
• Expanding into new markets, especially in the Asia Pacific region.
• Development of novel treatment approaches.

Threats

• Emergence of new therapies that could challenge metronidazole's dominance.
• Regulatory changes and patent expiries.
• Increasing competition from generic drugs[3][5].

Key Takeaways

• Flagyl (metronidazole) remains a highly effective treatment for various infections, including trichomoniasis, amebiasis, and clostridium difficile infection.
• The global metronidazole market is expected to grow significantly, driven by healthcare spending and research.
• Key regions such as North America and Europe will continue to dominate the market, with the Asia Pacific region showing promising growth.
• The market faces challenges from drug resistance and emerging therapies but also presents opportunities for innovation and expansion.

FAQs

What are the primary indications for Flagyl (metronidazole)?

Flagyl is primarily indicated for the treatment of trichomoniasis, amebiasis, and clostridium difficile infection, among other bacterial and protozoal infections[1].

How does metronidazole work?

Metronidazole works by inhibiting DNA synthesis in bacteria and protozoa, thereby treating the infections caused by these organisms[1][3].

What are the common side effects of metronidazole?

Common side effects include gastrointestinal disturbances, such as nausea, vomiting, and diarrhea. It can also cause central nervous system effects, especially with prolonged use or in patients with severe hepatic impairment[1].

Which regions are expected to dominate the metronidazole market?

North America and Europe are expected to dominate the global metronidazole market, with the Asia Pacific region showing significant growth potential[2][3].

What are the emerging challenges for the metronidazole market?

Emerging challenges include the development of drug-resistant bacteria, the emergence of new therapies, and regulatory changes that could impact market dynamics[1][3].

Sources

1. Pfizer Medical Information: Flagyl ® Oral Formulation.
2. Cognitive Market Research: Metronidazole Market Report 2025 (Global Edition).
3. Research and Markets: Metronidazole Drug Insight and Market Forecast - 2032.
4. JAMA Network: Efficacy of Dequalinium Chloride vs Metronidazole for the Treatment of Bacterial Vaginosis.
5. IndustryARC: Metronidazole Market - Forecast(2017-2025) Research Report.