CLINICAL TRIALS PROFILE FOR FLAGYL I.V. RTU IN PLASTIC CONTAINER

505(b)(2) Clinical Trials for FLAGYL I.V. RTU IN PLASTIC CONTAINER

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 I.V. RTU IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.
NCT00503542 ↗	Management of Vaginal Complaints: A Pilot Study Within a Practice-Based Research Network	Completed	Agency for Healthcare Research and Quality (AHRQ)	Early Phase 1	2007-02-01	Many women present in primary care with vaginal complaints. The best way of managing these complaints is unclear. This trial will test two different methods of managing patients with vaginal complaints. This is a pilot trial.

Clinical Trial Conditions for FLAGYL I.V. RTU IN PLASTIC CONTAINER

Condition Name

Condition Name for FLAGYL I.V. RTU IN PLASTIC CONTAINER
Intervention	Trials
Helicobacter Pylori Infection	11
Bacterial Vaginosis	6
Crohn's Disease	3
Ulcerative Colitis	2

Condition MeSH

Condition MeSH for FLAGYL I.V. RTU IN PLASTIC CONTAINER
Intervention	Trials
Infection	10
Infections	10
Communicable Diseases	8
Helicobacter Infections	8

Clinical Trial Locations for FLAGYL I.V. RTU IN PLASTIC CONTAINER

Trials by Country

Trials by Country for FLAGYL I.V. RTU IN PLASTIC CONTAINER
Location	Trials
United States	39
Taiwan	10
India	8
Canada	6
Brazil	6

Trials by US State

Trials by US State for FLAGYL I.V. RTU IN PLASTIC CONTAINER
Location	Trials
Pennsylvania	4
Michigan	3
North Carolina	3
California	3
Texas	3

Clinical Trial Progress for FLAGYL I.V. RTU IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for FLAGYL I.V. RTU IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE2	1
PHASE1	1
Phase 4	26

Clinical Trial Status

Clinical Trial Status for FLAGYL I.V. RTU IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	37
Unknown status	15
Recruiting	11

Clinical Trial Sponsors for FLAGYL I.V. RTU IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for FLAGYL I.V. RTU IN PLASTIC CONTAINER
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 I.V. RTU IN PLASTIC CONTAINER
Sponsor	Trials
Other	101
Industry	20
NIH	5

Flagyl I.V. RTU in Plastic Container: Clinical Trials Update, Market Analysis, and Projection

Last updated: April 28, 2026

What is Flagyl I.V. RTU in a Plastic Container and what is the active ingredient?

Flagyl I.V. RTU in plastic container is an intravenous ready-to-use (RTU) formulation of metronidazole, an antimicrobial nitroimidazole. It is used for susceptible anaerobic bacterial infections and select protozoal infections, with clinical use governed by standard metronidazole labeling and antimicrobial practice.

Regulatory/labeling context (drug substance and class):

• Active ingredient: metronidazole (nitroimidazole antimicrobial)
• Dosage form for this product: IV RTU (plastic container)

What is the clinical trials status for metronidazole (Flagyl) in 2024-2026 and why does the product-specific RTU packaging matter?

A clinical trials update for the exact packaging configuration “Flagyl I.V. RTU in plastic container” is not the same as a metronidazole-in-general trials update. Metronidazole’s core clinical evidence pool is mature, and current trial activity typically focuses on:

• New indications and endpoints (including site-specific anaerobic infection strategies)
• Formulation or delivery improvements
• Comparative effectiveness against other antimicrobial regimens
• Resistant anaerobe strategies where applicable

Product-specific RTU plastic container trials are uncommon when the pharmacokinetic and stability profile is already established for the metronidazole IV class. Packaging changes often fall under chemistry/manufacturing/controls (CMC) or formulation comparability rather than large clinical endpoint trials. As a result, the actionable clinical “update” for investors and business planners is best read as:

• metronidazole program-level evidence maturity
• ongoing trial signal by indication and setting
• any contemporaneous competitors and regimen shifts that affect utilization

Because this request is constrained to “Flagyl I.V. RTU in plastic container,” a complete clinical trials update with study-level identifiers (NCT numbers, enrollment, phase, results) cannot be produced from the information provided.

What is the market reality for IV metronidazole, and how does Flagyl I.V. utilization typically move?

Market drivers (demand-side)

• Hospital and acute-care utilization: IV metronidazole demand tracks surgical volume and hospital admissions where anaerobic coverage is part of empiric or targeted therapy.
• Guideline practice: Metronidazole is widely used for intra-abdominal infections, pelvic infections, and many anaerobic-coverage protocols.
• Antibiotic stewardship: Stewardship affects duration, escalation, and de-escalation, often without eliminating metronidazole use due to its established role in anaerobic coverage.

Supply-side dynamics (pricing and access)

• Generic pressure: Metronidazole IV is widely genericized in multiple markets. Flagyl brand share depends on payer contracts, hospital group purchasing, and tender economics.
• Formulary position and substitution: Hospitals usually substitute at the formulation level (IV metronidazole) based on availability, cost, and integration into clinical pathways.
• Packaging and compliance: RTU plastic containers can reduce operational burden (mixing, handling) and improve administration workflow. This impacts access and adoption within hospital purchasing rules.

How should you project commercial performance for Flagyl I.V. RTU in plastic container?

A credible projection requires demand, pricing, competitive intensity, and tender dynamics by geography. With only the product description and no market inputs (country, channel mix, brand vs generic share, current revenue base, competitor counts), a complete forecast cannot be calculated.

What can be projected at an operational level without revenue baselines is the directional pattern typical for mature, generic-contested antibiotic products:

• Volume stability tends to be anchored by indication prevalence and hospital admissions.
• Revenue growth tends to be constrained by generics and tends to depend on:
  • contracts that preserve brand share
  • substitution-resistant procurement (workflow, RTU preference)
  • short-term supply constraints that temporarily improve economics for available SKUs
• Cost and margin compression are common where multiple equivalent generics compete.

What is the competitive set that matters for IV metronidazole in RTU form?

Flagyl-branded IV metronidazole competes primarily against:

• Generic IV metronidazole (same active ingredient, similar dosing regimens)
• Therapeutic regimen alternatives that cover anaerobes (depending on institution and formulary)
• Other nitroimidazole or combination regimens where clinicians shift protocols

Because the request is specifically about the RTU plastic container SKU, the key competitive differentiators are:

• RTU availability and administration workflow
• container compatibility with institutional policies
• pricing under group purchasing organization (GPO) contracts

What milestones should you track to validate the investment thesis for this SKU?

For a mature IV antibiotic with generic pressure, execution milestones are less about clinical differentiation and more about:

1. Formulary retention and contract renewals for Flagyl brand SKUs
2. Tender wins where RTU plastic format is preferred
3. Supply continuity (avoidable stockouts can shift switching behavior)
4. Regulatory changes affecting container type, stability, or handling requirements

Key Takeaways

• Flagyl I.V. RTU in plastic container is an IV ready-to-use formulation of metronidazole, a mature antimicrobial with a mature clinical evidence base.
• A product-specific clinical trials update for the exact RTU plastic container configuration is unlikely to mirror metronidazole-in-general trial activity; most new studies typically focus on indications, regimens, or formulation comparability.
• Market outcomes for this SKU are driven more by hospital contracting, formulary placement, and substitution economics than by new clinical differentiation.
• A complete clinical-trial and financial projection requires study-level and market baseline inputs that are not present in the prompt.

FAQs

1) Is Flagyl I.V. RTU in plastic container a new clinical platform?
No. It is a mature metronidazole IV formulation; new clinical activity typically targets indications or regimen strategies rather than container-specific endpoints.

2) Do packaging changes trigger large Phase 3 trials?
Usually not when bioequivalence, stability, and CMC comparability support the change. Trials are more commonly CMC-focused unless clinical differentiation is claimed.

3) What most influences hospital use of this SKU?
Formulary placement, GPO tenders, cost, availability, and administration workflow.

4) How do generic competitors typically affect the brand?
They compress pricing and force substitution at the IV metronidazole level unless contracts preserve brand share or workflow preferences favor RTU format.

5) What should investors monitor if clinical differentiation is limited?
Contract renewals, tender outcomes, brand share in contested hospital categories, and supply stability.

References

[1] FDA. (n.d.). Drug approvals and labeling for metronidazole (Flagyl). U.S. Food and Drug Administration.
[2] EMA. (n.d.). Summary of product characteristics for metronidazole-containing medicines. European Medicines Agency.
[3] ClinicalTrials.gov. (n.d.). Studies on metronidazole by indication and route. U.S. National Library of Medicine.