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.]
NCT00021671 ↗	Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	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	96
Bacterial Vaginosis	46
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	565
China	84
Taiwan	51
India	39
Japan	38

Trials by US State

Trials by US State for metronidazole
Location	Trials
California	41
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	18
PHASE3	8
PHASE2	14

Clinical Trial Status

Clinical Trial Status for metronidazole
Clinical Trial Phase	Trials
Completed	283
RECRUITING	97
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	731
Industry	170
NIH	24

Clinical Trials Update, Market Analysis, and Projection for Metronidazole

Last updated: April 26, 2026

What is metronidazole and where is it used today?

Metronidazole is a nitroimidazole antibiotic used for anaerobic bacterial and certain protozoal infections. It is marketed in multiple formulations across major regions, including immediate-release tablets and oral solutions, topical products for certain indications (notably in dermatology), and injectable formulations in some markets. Commercially, it is a mature, off-patent small molecule with ongoing label expansion and formulation updates, but limited true innovation-driven pipeline activity relative to newer antibiotic classes.

How many clinical trials are active, and what do they target?

No single, reliable, complete public dataset is available in this context to produce a defensible count of active interventional and recruiting trials worldwide, with indication-level granularity, for metronidazole specifically. Without an auditable trial registry snapshot and indication mapping, any “active trials” figure would be speculative.

What does the metronidazole clinical program look like in practice?

For an established generic drug, clinical trial activity tends to cluster around:

• Formulation and bioequivalence (especially where generics or alternative dosage forms seek regulatory approvals).
• Topical or local therapies targeting dermatologic indications (where product-specific endpoints may be required).
• Regimen optimization for anaerobic and protozoal infections (often within standard-of-care comparisons rather than novel mechanisms).
• Pharmacokinetic and safety studies in specific populations (pregnancy, pediatrics, hepatic impairment), often under regulatory requirements.

Because metronidazole’s core mechanism and broad label are well established, the commercial upside typically comes more from formulation lifecycle management and market access than from a late-stage “blockbuster” development path.

How large is the metronidazole market today?

A complete market sizing model requires current primary and secondary sources (IQVIA, company reports, payer datasets, or region-specific sales compendia). In this context, no citable, up-to-date market number is provided. Producing a numeric market value without a citable source would not meet a high-stakes investment standard.

What drives metronidazole demand?

Demand drivers for a mature antimicrobial like metronidazole are stable and mechanical rather than innovation-led:

• Incidence of anaerobic infections and recurrent GI and intra-abdominal infection cases treated in hospitals and outpatient settings.
• Ongoing use in guideline-based therapy for susceptible anaerobic bacteria and targeted protozoal infections.
• Switching dynamics within the nitroimidazole class (metronidazole competes with tinidazole and newer alternates in some settings, but metronidazole remains entrenched in many formularies).
• Antimicrobial stewardship constraints that influence duration and selection, but do not remove baseline usage where it remains recommended.

What are the competitive dynamics?

Metronidazole’s competition is primarily:

• Other nitroimidazoles (format and pricing competition).
• Broader-spectrum antibiotics in overlapping infection categories.
• Local treatments in dermatology (for cases where topical nitroimidazoles are used).

Because metronidazole is largely generic, competition is frequently price- and availability-led, with prescriber switching guided by local guideline adoption, formulary status, and side-effect profile preferences.

What is the regulatory and IP status impact?

Metronidazole is a well-established molecule with historic approvals dating back decades. The practical market implication is that:

• Patent protection is not a primary commercial moat in most geographies for the core drug.
• Regulatory exclusivities (where they exist for specific formulations, dosing forms, or combinations) can affect the timeline for certain product entries, but not the molecule-wide market trajectory.
• Bioequivalence and generics drive most entry risk and price compression.

Market projection: what happens next?

A credible projection for metronidazole depends on three measurable variables: (1) volume growth tied to infection epidemiology and prescribing behavior, (2) price erosion from generics, and (3) mix shift across formulations and regions. No citable baseline sales series is provided here, so a numeric forecast would be non-auditable.

The directional outlook for a mature generic antibiotic is typically:

• Low-to-mid single-digit volume changes depending on healthcare access and guideline adherence.
• Continued price pressure as additional suppliers compete.
• Stable-to-slightly positive market value trajectory if volume growth offsets part of the price decline, or negative if price erosion dominates.

For investment-grade accuracy, projections should be built on a region-by-region sales time series with segmentation by formulation (oral vs topical vs injectable) and indication mix. No such citable series is available in the provided context.

What are the key commercial risks and watch items?

For metronidazole, the primary risks are not clinical innovation but market mechanics:

• Further generic entry leading to accelerated price erosion.
• Guideline shifts (infectious disease societies and local antimicrobial stewardship policies) affecting preferred regimens.
• Safety and tolerability scrutiny that can shift utilization toward alternatives in certain patient populations.
• Manufacturing or supply disruptions for active pharmaceutical ingredient (API) and key intermediates, which can cause short-term pricing volatility.

Where can growth come from?

Even without new mechanism innovation, growth pockets can exist:

• Topical dermatologic indications where local therapy is used and product competition remains narrower than oral tablets in some markets.
• New fixed-dose or alternative dosage forms with regulatory exclusivity.
• Hospital contract wins that lock volume even as manufacturer landscape changes.

Because metronidazole is mature, these growth areas generally depend on operational execution and market access rather than patent-driven returns.

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Key Takeaways

• Metronidazole is a mature, largely off-patent nitroimidazole antibiotic with commercial value driven by baseline infectious disease demand and guideline-driven prescribing.
• Clinical trial activity in mature generics typically skews toward bioequivalence, formulation, and regimen optimization rather than mechanism-changing late-stage innovation.
• A high-accuracy market projection requires region- and formulation-level sales series, which are not provided here; therefore, only directional dynamics are supported: stable demand with ongoing price pressure and potential mix-driven value changes.
• The most material commercial risks are generic-driven price erosion, guideline and stewardship shifts, and supply-chain volatility.

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FAQs

1) Is metronidazole still actively developed in clinical trials?

Yes, but in a mature generics context, most trial activity is typically formulation, PK, safety, and bioequivalence focused rather than novel mechanism late-stage development.

2) What drives metronidazole market value more: volume or price?

Price is typically the dominant short-term driver in mature generic antibiotics, with value stabilized or changed only if volume or mix shift offsets price erosion.

3) Does metronidazole have patent protection that supports premium pricing?

In most geographies, the core molecule is off patent, so premium pricing tends to rely on formulation-specific approvals, regulatory exclusivities, and market access rather than broad molecule-level IP.

4) Where are the best opportunities for incremental commercial growth?

Topical dermatology, specific formulation renewals, and hospital/contract access are the most realistic growth pockets for a mature molecule.

5) What is the biggest strategic risk for new entrants?

Accelerating generic competition that compresses pricing faster than volume can grow, combined with guideline-driven shifts in prescribing.

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References

[1] U.S. Food and Drug Administration. Drug Trials Snapshots: Metronidazole (information on indications, safety, and regulatory materials). FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] National Library of Medicine. MedlinePlus: Metronidazole (patient-facing overview of uses and safety considerations). https://medlineplus.gov/
[3] World Health Organization. WHO model formulary and antimicrobial guidance resources (context for nitroimidazole use in anaerobic infections). https://www.who.int/teams/health-product-and-policy-standards/standards-and-specifications/medicines/essential-medicines-and-health-products/model-formulary