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.
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.]

Clinical Trial Conditions for Metronidazole Hydrochloride

Condition Name

Condition Name for Metronidazole Hydrochloride
Intervention	Trials
Helicobacter Pylori Infection	96
Bacterial Vaginosis	46
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	565
China	84
Taiwan	51
India	39
Japan	38

Trials by US State

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

Clinical Trial Status

Clinical Trial Status for Metronidazole Hydrochloride
Clinical Trial Phase	Trials
Completed	283
Recruiting	97
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	731
Industry	170
NIH	24

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

Last updated: April 23, 2026

What is metronidazole hydrochloride in the global drug landscape?

Metronidazole is a nitroimidazole antimicrobial used across multiple indications, including bacterial vaginosis and trichomoniasis, with use also extending to anaerobic bacterial infections (formulation- and label-dependent). The hydrochloride salt form is used to deliver metronidazole as an active ingredient in specific dosage forms (brand and generic products vary by market).

Because metronidazole is an established, off-patent small molecule across major jurisdictions, the market is dominated by generics. Product differentiation tends to concentrate in formulation, dosing convenience, route of administration (oral, topical/vaginal, IV where available), and regional regulatory approvals rather than novel molecular IP.

What is the clinical-trials update (current activity)?

No sufficiently comprehensive, current, trial-by-trial dataset was available in the provided source set to produce a complete and accurate “clinical trials update” covering scope, phase distribution, recruiting status, geography, and endpoints for metronidazole hydrochloride specifically. Under the operating constraints, no partial or guessed trial activity is provided.

What are the market fundamentals driving demand?

Metronidazole demand is driven by:

• High prevalence of target infectious indications (notably bacterial vaginosis and trichomoniasis) and broad standard-of-care use in eligible populations.
• Generic market structure that anchors pricing to cost and regional reimbursement dynamics.
• Route-of-administration mix, with oral and vaginal formulations capturing different use cases and guideline alignment.

Market behavior typically reflects:

• Low price elasticity to clinical necessity for approved indications, offset by payer pressure on generics.
• Ongoing turnover from manufacturing capacity and regional approvals rather than new-entry innovation.

How large is the market and what growth profile is expected?

No single, fully sourced market-sizing series for “metronidazole hydrochloride” (salt form) was available in the provided source set. Metronidazole is usually reported as “metronidazole” rather than the hydrochloride salt, and salt-specific segment reporting is inconsistent across market research providers. Under the operating constraints, no numeric sizing or forecasts are produced.

How do manufacturers capture share in a generic market?

In generic antimicrobial markets, share capture generally follows:

• Submission throughput and regulatory approvals for local dossier variations (formulation and bioequivalence packages).
• Contract manufacturing and supply chain reliability, which reduce stock-out risk for tenders.
• Inclusion in national and payer formularies, where the lowest reimbursed product price often wins.

For metronidazole, the business implication is that share shifts are more sensitive to tender pricing cycles and supply continuity than to label expansion from new clinical evidence.

What regulatory and lifecycle factors matter most?

Key lifecycle realities for metronidazole:

• Off-patent status in most major markets means regulatory strategy and manufacturing compliance drive continuity of supply more than IP prosecution.
• Manufacturing quality and pharmacovigilance performance drive payer and procurement trust.
• Any clinically relevant changes typically come through label updates or guideline evolution rather than new molecular entities.

Because metronidazole is widely available, the practical question for investors and R&D planners becomes whether there is defensible differentiation through dosage-form innovation, improved stability or bioavailability, or improved adherence through regimen design.

What does a projection need to be based on (and what is available here)?

A complete market projection for metronidazole hydrochloride requires at minimum:

• A sourced baseline market size for the relevant geography and formulation classes.
• Historical shipment or sales series and pricing indices.
• Clear mapping between “metronidazole” reporting and “metronidazole hydrochloride” product segments (salt form usage varies by report taxonomy).

No such fully sourced inputs were available in the provided source set. Under the operating constraints, forecasts are not provided.

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What are the highest-value decision levers for R&D and investment?

Even without a quantified forecast, decision levers in this category are consistent:

1) Dosage-form positioning

• Oral vs vaginal vs other routes drive different reimbursement and procurement behavior.
• Product claims that improve tolerability, reduce dosing frequency, or improve adherence typically win formulary traction, even in generics.

2) Supply and cost execution

• In generic antimicrobial markets, gross margin is dominated by input costs, scale utilization, and tender competitiveness.
• Strong supply continuity outperforms marginal differentiation.

3) Regulatory velocity and portfolio breadth

• Fast regulatory approvals for multiple strengths and dosage forms increase the addressable tender pool.
• Maintaining multiple SKUs reduces revenue concentration risk from local policy changes.

4) Compliance and quality systems

• For mature antimicrobials, deviations, recalls, or stability failures can quickly translate into loss of procurement eligibility.

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Key Takeaways

• Metronidazole hydrochloride is a mature, largely generics-led antimicrobial market with demand shaped by guideline-aligned infectious disease burden and procurement dynamics.
• A complete clinical-trials update and a quantified market projection cannot be produced from the provided source set without creating inaccuracies.
• In this category, the most actionable differentiation usually comes from dosage-form execution, regulatory and supply reliability, and tender pricing performance rather than new molecular IP.

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FAQs

1) Is metronidazole hydrochloride still a target for new clinical development?

Metronidazole is mature and widely used; most “new development” in this space typically relates to formulation optimization, dosing regimens, and life-cycle label or efficacy refinements rather than novel mechanisms.

2) Why does the market behave like a generic commodity?

Because metronidazole is off-patent in most major jurisdictions, price competition and procurement tender cycles dominate rather than patent-protected innovation.

3) Does “metronidazole hydrochloride” have a distinct market from “metronidazole”?

Not consistently. Many market datasets report by active ingredient (“metronidazole”) without salt-form granularity, which complicates salt-specific sizing.

4) What determines winners in tenders for antimicrobials?

Reimbursed price, uninterrupted supply, and dossier/formulation acceptance for bioequivalence and quality standards.

5) What is the most credible basis for a forecast?

A sourced baseline market size plus historical sales or shipment data, mapped to product form and geography, followed by pricing and tender assumptions. Without those inputs, numeric projections would be unreliable.

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References

[1] FDA. Drug Approval Reports and labeling information for metronidazole-containing products (accessed via FDA label database).
[2] EMA. EPAR and product information for metronidazole-containing medicinal products (accessed via EMA product database).
[3] WHO. Antimicrobial use guidance and disease burden context relevant to bacterial vaginosis and trichomoniasis (accessed via WHO publications).