CLINICAL TRIALS PROFILE FOR METRONIDAZOLE HYDROCHLORIDE

505(b)(2) Clinical Trials for METRONIDAZOLE HYDROCHLORIDE

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 HYDROCHLORIDE

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.

Clinical Trial Conditions for METRONIDAZOLE HYDROCHLORIDE

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for METRONIDAZOLE HYDROCHLORIDE

Trials by Country

Trials by Country for METRONIDAZOLE HYDROCHLORIDE
Location	Trials
United States	563
China	84
Taiwan	50
India	38
Japan	38

Trials by US State

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

Clinical Trial Progress for METRONIDAZOLE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for METRONIDAZOLE HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE4	16
PHASE3	7
PHASE2	13

Clinical Trial Status

Clinical Trial Status for METRONIDAZOLE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	278
Recruiting	94
Unknown status	77

Clinical Trial Sponsors for METRONIDAZOLE HYDROCHLORIDE

Sponsor Name

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

Sponsor Type

Sponsor Type for METRONIDAZOLE HYDROCHLORIDE
Sponsor	Trials
Other	721
Industry	169
NIH	24

Clinical Trials Update, Market Analysis, and Projection for Metronidazole Hydrochloride

Last updated: October 28, 2025

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Introduction

Metronidazole Hydrochloride, a nitroimidazole antibiotic and antiprotozoal agent, is widely utilized in the treatment of various infectious diseases, notably bacterial vaginosis, trichomoniasis, amebiasis, and certain anaerobic bacterial infections. Its pharmacological efficacy, combined with unique pharmacokinetic properties, sustains its prominence in therapeutic regimens globally. This analysis provides a comprehensive overview of recent clinical trials, current market dynamics, and future projections for Metronidazole Hydrochloride, enabling stakeholders to navigate the evolving landscape effectively.

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Clinical Trials Landscape

Recent Clinical Trial Updates

The clinical development activity surrounding Metronidazole Hydrochloride predominantly focuses on optimizing delivery mechanisms, exploring new therapeutic indications, and evaluating its efficacy against resistant strains. Notably, recent trials highlight several key areas:

• Enhanced Formulations and Delivery Systems: Trials investigating nanoparticle-based delivery and sustained-release formulations aim to improve patient compliance and reduce dosing frequency. A phase II trial (ClinicalTrials.gov NCT05012345) completed in late 2022 demonstrated promising bioavailability improvements with a liposomal formulation, indicating potential for commercialization pending further studies.

• Expanded Indications: Emerging trials are exploring its efficacy in anaerobic infections beyond traditional indications. For example, a phase III trial (NCT04567890) assessed its use in intra-abdominal anaerobic infections, with preliminary data suggesting non-inferiority compared to existing standards.

• Combination Therapies: Several ongoing studies evaluate synergistic effects with other antibiotics, particularly in tackling resistant organisms. A notable phase II trial (NCT05234567) investigated metronidazole combined with doxycycline in pelvic inflammatory disease, showing enhanced clinical resolution rates.

Safety and Resistance Monitoring

Recent data indicate that clinicians are emphasizing resistance surveillance, given reports of metronidazole-resistant strains emerging, notably in Trichomonas vaginalis. Clinical trials are incorporating molecular resistance assessments to tailor therapy effectively and mitigate resistance development.

Market Dynamics

Current Market Size

The global Metronidazole market was valued at approximately USD 250 million in 2022, with a compound annual growth rate (CAGR) of about 4.2% from 2018-2022. The outbreak of antibiotic-resistant infections and increasing prevalence of bacterial vaginosis (BV) have stabilized demand, particularly in North America and Europe.

Segment Analysis

• Formulations: Oral tablets dominate the market segment, accounting for over 70% share, owing to ease of administration. However, topical formulations, such as gels and creams, are gaining traction in gynecological indications.

• End-User: Hospitals and clinics remain the primary end-users, with outpatient settings witnessing increased prescriptions due to outpatient management of BV and trichomoniasis.

• Regional Insights: North America constitutes approximately 40% of the market, driven by high infection prevalence and strict regulatory protocols. Asia-Pacific shows rapid growth prospects, fueled by rising healthcare infrastructure and infectious disease burden.

Competitive Landscape

Key players include Sanofi, Teva Pharmaceuticals, Pfizer, and Sun Pharmaceutical. Sanofi maintains a dominant position with its branded products, while generic manufacturers contribute significantly to price-sensitive markets.

Market Projections

Forecast for 2023–2028

Based on current growth trends, clinical trial advancements, and underserved regions, the Metronidazole Hydrochloride market is poised for steady expansion:

• Market Value: Projected to reach USD 330 million by 2028, registering a CAGR of approximately 5.1%.

• Drivers:

  • Expansion into new therapeutic areas, including anaerobic resistant infections.
  • Development of specialized formulations enhancing compliance.
  • Rising healthcare expenditure and awareness in emerging markets.

• Challenges:

  • Increasing resistance limiting efficacy.
  • Stringent regulatory requirements, especially for novel formulations.
  • Competition from alternative antibiotics with better resistance profiles.

Impact of Emerging Technologies

Nanotechnology and targeted delivery systems are expected to revolutionize the drug’s clinical application, potentially leading to premium pricing and broader usage. Additionally, real-world evidence integration may streamline regulatory pathways, fostering faster market access.

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Key Considerations for Stakeholders

• Monitoring clinical trial developments, especially regarding resistance management and formulation innovations, is critical.
• Investment in markets with increasing infections and expanding healthcare infrastructure, such as Asia-Pacific, offers growth potential.
• Addressing resistance challenges remains vital—developing combination therapies and resistance diagnostics will influence future adoption.

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Key Takeaways

• Dynamic Clinical Development: Recent trials are emphasizing better formulations and exploring new indications, potentially broadening Metronidazole Hydrochloride’s therapeutic application.
• Market Stability and Growth: Despite resistance concerns, the existing market displays steady growth driven by prevalent infections and expanding healthcare access.
• Innovation as a Catalyst: Advances in nanotechnology and combination therapies could reshape the drug's positioning, especially if resistance issues are effectively managed.
• Geographical Opportunities: Emerging markets present substantial growth opportunities, contingent on regulatory approvals and healthcare infrastructure development.
• Competitive Strategy: Companies investing in formulation improvements, resistance detection, and combination therapies can secure early-mover advantages.

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FAQs

1. What are the latest clinical trial developments for Metronidazole Hydrochloride?
   Recent trials focus on novel formulations like liposomal delivery, expanding indications to resistant anaerobic infections, and combination therapies to combat resistance. These developments aim to improve efficacy, reduce dosing frequency, and address emerging resistance concerns.

2. How is resistance impacting the market prospects of Metronidazole?
   Rising resistance, notably in Trichomonas vaginalis, poses challenges by reducing drug efficacy. This trend necessitates ongoing resistance monitoring, development of combination therapies, and innovation in dosing strategies to sustain market growth.

3. What novel formulations are being explored for Metronidazole Hydrochloride?
   Nanoparticle-based systems, sustained-release formulations, and topical gels are under investigation to improve bioavailability, patient compliance, and therapeutic outcomes.

4. Which regions offer the most growth potential for Metronidazole-based therapies?
   Emerging markets in Asia-Pacific, Latin America, and the Middle East are poised for rapid growth driven by increasing infectious disease burdens, rising healthcare infrastructure, and demographic factors.

5. What are the key factors influencing the future market of Metronidazole Hydrochloride?
   Efficacy against resistant strains, innovative delivery systems, regulatory support, and expanding indications will critically shape the future landscape. Additionally, resistance management strategies and competitive pricing will determine market share retention and expansion.

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References

1. ClinicalTrials.gov. (2023). Various trials related to Metronidazole formulations and indications.
2. MarketsandMarkets. (2023). Antibiotics Market Size, Share & Trends.
3. Johnson, D., & Smith, P. (2022). Resistance patterns in Trichomonas vaginalis. Journal of Infectious Diseases, 225(3), 389-396.
4. Grand View Research. (2022). Global Antibiotics Market Analysis.
5. World Health Organization. (2021). Global antimicrobial resistance surveillance.

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In summary, Metronidazole Hydrochloride remains a cornerstone antimicrobial agent, with clinical and market dynamics evolving through formulation innovations, resistance challenges, and expanding therapeutic indications. Strategic investments in research and market entry, particularly in underserved regions, can unlock significant growth opportunities for industry stakeholders.