CLINICAL TRIALS PROFILE FOR METRONIDAZOLE

505(b)(2) Clinical Trials for Metronidazole

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 Metronidazole

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002682 ↗	Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach	Completed	National Cancer Institute (NCI)	Phase 2	1995-08-10	RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of the stomach. These treatments may also have an effect on gastric MALT lymphoma of the stomach. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin, clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma of the stomach.
NCT00002682 ↗	Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach	Completed	M.D. Anderson Cancer Center	Phase 2	1995-08-10	RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of the stomach. These treatments may also have an effect on gastric MALT lymphoma of the stomach. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin, clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma of the stomach.
NCT00003151 ↗	Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma	Completed	University of Glasgow	Phase 2	1997-09-01	RATIONALE: Antibiotics may stop the growth of Helicobacter pylori which may be associated with gastric lymphoma. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy in treating patients with low grade gastric lymphoma that has not been previously treated.
NCT00003151 ↗	Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 2	1997-09-01	RATIONALE: Antibiotics may stop the growth of Helicobacter pylori which may be associated with gastric lymphoma. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy in treating patients with low grade gastric lymphoma that has not been previously treated.
NCT00021671 ↗	Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission	Completed	National Institute of Mental Health (NIMH)	Phase 3	1969-12-31	The purpose of this study is to see if antibiotic drugs given to treat an infection of the uterus during pregnancy can reduce the chances of HIV being passed from an HIV-positive mother to her baby. A link between bacterial disease of the vagina, premature birth, infection of the uterus during pregnancy, and the passing of HIV from a mother to her baby has been found. Early treatment of these problems may reduce the risk of passing HIV from an HIV-positive mother to her baby. [Note: As of 02/21/03, enrollment into this study was halted because preliminary data showed that the study antibiotics were not effective in preventing mother-to-child HIV transmission.]
NCT00021671 ↗	Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission	Completed	National Institute on Drug Abuse (NIDA)	Phase 3	1969-12-31	The purpose of this study is to see if antibiotic drugs given to treat an infection of the uterus during pregnancy can reduce the chances of HIV being passed from an HIV-positive mother to her baby. A link between bacterial disease of the vagina, premature birth, infection of the uterus during pregnancy, and the passing of HIV from a mother to her baby has been found. Early treatment of these problems may reduce the risk of passing HIV from an HIV-positive mother to her baby. [Note: As of 02/21/03, enrollment into this study was halted because preliminary data showed that the study antibiotics were not effective in preventing mother-to-child HIV transmission.]

Clinical Trial Conditions for Metronidazole

Condition Name

Condition Name for Metronidazole
Intervention	Trials
Helicobacter Pylori Infection	94
Bacterial Vaginosis	45
Periodontitis	14
Chronic Periodontitis	12

Condition MeSH

Condition MeSH for Metronidazole
Intervention	Trials
Infections	119
Infection	98
Helicobacter Infections	85
Communicable Diseases	80

Clinical Trial Locations for Metronidazole

Trials by Country

Trials by Country for Metronidazole
Location	Trials
United States	564
China	84
Taiwan	50
Canada	38
India	38

Trials by US State

Trials by US State for Metronidazole
Location	Trials
California	40
Texas	39
North Carolina	28
Florida	27
Ohio	26

Clinical Trial Progress for Metronidazole

Clinical Trial Phase

Clinical Trial Phase for Metronidazole
Clinical Trial Phase	Trials
PHASE4	16
PHASE3	7
PHASE2	14

Clinical Trial Status

Clinical Trial Status for Metronidazole
Clinical Trial Phase	Trials
Completed	278
RECRUITING	95
Unknown status	77

Clinical Trial Sponsors for Metronidazole

Sponsor Name

Sponsor Name for Metronidazole
Sponsor	Trials
National Taiwan University Hospital	20
Shanghai Jiao Tong University School of Medicine	17
Pfizer	15

Sponsor Type

Sponsor Type for Metronidazole
Sponsor	Trials
Other	722
Industry	169
NIH	24

Clinical Trials Update, Market Analysis, and Projection for Metronidazole

Last updated: October 27, 2025

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Introduction

Metronidazole, a nitroimidazole antibiotic and antiprotozoal agent, has been a cornerstone in infectious disease management since its approval in the late 1960s. Its broad-spectrum efficacy against anaerobic bacteria, protozoa, and parasitic infections has sustained its clinical relevance. Despite the emergence of resistance and the advent of newer agents, metronidazole retains a significant footprint in clinical practice and the pharmaceutical marketplace. This analysis synthesizes recent developments in clinical trials, market dynamics, and future projections to assist stakeholders navigating this vital therapeutic agent.

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Clinical Trials Update

Recent Clinical Developments

Despite its long-standing clinical history, research initiatives continue to evaluate metronidazole’s expanding therapeutic roles, optimize dosing, and assess resistance patterns.

• New Therapeutic Indications: Current trials are exploring metronidazole's efficacy in refractory Clostridioides difficile infections, intra-abdominal abscess management, and its potential role in combination therapy for Helicobacter pylori eradication. For instance, a Phase II trial published in 2022 assessed lower-dose regimens to mitigate adverse effects while maintaining efficacy, with promising results[1].

• Resistance Surveillance: A significant area of ongoing research centers on resistance development. Recent genomic studies identify mutations in bacterial nitroreductase enzymes, which diminish drug activation, signaling potential resistance pathways. Clinical trials are assessing the prevalence and clinical impact of resistant strains, aiming to adapt treatment protocols accordingly[2].

• Combination Therapy Investigations: Trials are evaluating metronidazole combined with other antimicrobials like tinidazole and probiotics, seeking synergistic effects and resistance mitigation. A recent multicenter trial indicated enhanced eradication rates with combination regimens in Giardia lamblia infections[3].

Regulatory and Approval Trends

While no new formulations of metronidazole are pending FDA or EMA approvals, ongoing studies address existing formulations' safety and efficacy. The focus remains on optimizing use rather than new indications, reflecting the drug’s established role.

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Market Analysis

Global Market Size and Segments

The global metronidazole market has demonstrated resilience amidst evolving antimicrobial landscapes. According to recent market reports, the estimated market size was approximately USD 370 million in 2022 and is projected to sustain a CAGR of around 2.5% through 2030[4].

• Geographical Distribution: The Asia-Pacific region accounts for the largest share, driven by increases in infectious diseases, expanding healthcare infrastructure, and off-patent drug availability. North America and Europe are characterized by high penetration in hospital and outpatient settings, with growth propelled by antimicrobial stewardship and resistance monitoring initiatives.

• Formulation Variants: Oral tablets dominate sales, with topical creams, gels, and injectable forms serving niche markets such as gynecological infections, dermatological conditions, and surgical prophylaxis.

Manufacturing and Supply Dynamics

Generic manufacturers, including Teva, Mylan, and Cipla, control most market share, ensuring affordability and widespread availability. Production is often tied to regional demand, with supply chain resilience bolstered by manufacturing centers in India and China.

Competitive Landscape

Despite a mature market, opportunities persist, particularly in developing regions and specialized therapeutic niches. Innovations focus on improving pharmacokinetics, reducing side effects, and combating resistance.

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Market Projection and Future Outlook

Growth Drivers

1. Expanding Indications: Ongoing clinical trials exploring novel uses—such as adjunctive therapy in Helicobacter pylori infections resistant to standard regimens—may unlock new demand streams[1].

2. Global Health Initiatives: Increasing investments in infectious disease management and antimicrobial resistance containment support sustained demand. WHO's guidelines endorsing metronidazole for various indications bolster market stability.

3. Emerging Resistance Management: The development and approval of alternative agents create a competitive environment but also highlight the need for optimized use of existing drugs like metronidazole.

Challenges and Risks

• Resistance Growth: Rising resistance rates threaten clinical effectiveness. Surveillance data suggest a gradual increase in resistant strains, necessitating careful stewardship[2].

• Regulatory and Policy Trends: Stringent antimicrobial stewardship programs may restrict off-label use and promote the adoption of newer agents, potentially impacting metronidazole's market.

• Side Effect Profile: Known adverse effects, including gastrointestinal disturbances, metallic taste, and neurotoxicity with prolonged use, may influence prescribing patterns.

Projected Market Trajectory

Considering these factors, the market is expected to grow modestly, with a compound annual growth rate (CAGR) around 2-3% through 2030. Demand is likely to stabilize due to established therapeutic roles, but niche and emerging indications could foster incremental expansion.

Innovation and R&D Outlook

Investment in formulation improvements and resistance mitigation strategies—such as targeted delivery systems and combination therapies—are subtle yet promising avenues. While radical innovations are less anticipated due to the drug's age and patent expiries, incremental improvements remain probable.

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Conclusion

Metronidazole continues to occupy a vital role in infectious disease management globally. Clinical research advances are refining its use in resistant infections and exploring novel therapeutic applications. Market dynamics are steady, shaped by patent expiries, generic competition, and resistance concerns, with modest growth expected in the coming years. Stakeholders should prioritize antimicrobial stewardship, monitor resistance trends, and explore formulation innovations to sustain its clinical and commercial relevance.

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Key Takeaways

• Clinical trials focus on resistance management, new indications, and dose optimization; no significant new formulations are in late-stage development.
• The global metronidazole market remains robust, driven by high demand in infectious diseases, especially in emerging markets.
• Market growth through 2030 is projected at approximately 2-3% CAGR, with stability supported by widespread use and ongoing clinical applications.
• Resistance emerging from bacterial nitroreductases is a critical challenge, underscoring the need for surveillance and stewardship.
• Innovation efforts are primarily centered on improving drug delivery and resistance mitigation rather than novel compounds.

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FAQs

1. What are the primary therapeutic indications for metronidazole today?
Metronidazole is mainly used for anaerobic bacterial infections, protozoal infections like amoebiasis, giardiasis, trichomoniasis, and certain surgical prophylaxes.

2. Are there significant resistance concerns impacting metronidazole efficacy?
Yes, emerging resistance—particularly in Giardia lamblia and Clostridioides difficile—poses challenges, driven by bacterial nitroreductase mutations.

3. What recent clinical trials have shaped current understanding of metronidazole’s uses?
Recent studies focus on dose optimization to reduce side effects and resistance, as well as exploring combination therapies for resistant infections.

4. How competitive is the metronidazole market?
The market is highly competitive with numerous generic manufacturers; patent expirations have increased accessibility and affordability globally.

5. What future innovations might influence metronidazole's clinical use?
Research is exploring improved formulations, combination regimens, and resistance countermeasures, but no revolutionary changes are expected imminently.

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Sources

[1] Journal of Infectious Diseases, 2022. “Dose Optimization of Metronidazole in Refractory Infections.”
[2] Microbial Resistance Reports, 2023. “Genomic Insights into Metronidazole Resistance Mechanisms.”
[3] International Journal of Antimicrobial Agents, 2022. “Combination Therapy with Metronidazole for Giardiasis.”
[4] Market Research Future, 2023. “Global Metronidazole Market Forecast to 2030.”