CLINICAL TRIALS PROFILE FOR FLAGYL I.V.

505(b)(2) Clinical Trials for Flagyl I.v.

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.

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.
NCT00603616 ↗	Induction of Clinical Response Using Rifaximin in Crohn's Disease	Completed	Bausch Health Americas, Inc.	Phase 2	2008-11-01	Antibiotics have been used to treat Crohn's disease symptoms with the best studied antibiotics being Cipro and Flagyl. Rifaximin is a poorly absorbed oral antibiotic that is FDA approved for travelers' diarrhea. It works by inhibiting bacterial reproduction. It is very poorly absorbed and over 97% of the drug taken orally is excreted in the feces. The purpose of this study is to evaluate the potential benefits and safety of Rifaximin for the treatment of moderate to severe symptoms of Crohn's Disease.

Clinical Trial Conditions for Flagyl I.v.

Condition Name

Condition Name for Flagyl I.v.
Intervention	Trials
Helicobacter Pylori Infection	11
Bacterial Vaginosis	6
Crohn's Disease	3
HIV Infections	2

Condition MeSH

Condition MeSH for Flagyl I.v.
Intervention	Trials
Infections	10
Infection	10
Communicable Diseases	8
Helicobacter Infections	8

Clinical Trial Locations for Flagyl I.v.

Trials by Country

Trials by Country for Flagyl I.v.
Location	Trials
United States	39
Taiwan	10
India	8
Brazil	6
Canada	6

Trials by US State

Trials by US State for Flagyl I.v.
Location	Trials
Pennsylvania	4
California	3
Texas	3
New York	3
Michigan	3

Clinical Trial Progress for Flagyl I.v.

Clinical Trial Phase

Clinical Trial Phase for Flagyl I.v.
Clinical Trial Phase	Trials
PHASE2	1
PHASE1	1
Phase 4	26

Clinical Trial Status

Clinical Trial Status for Flagyl I.v.
Clinical Trial Phase	Trials
Completed	37
Unknown status	15
Recruiting	11

Clinical Trial Sponsors for Flagyl I.v.

Sponsor Name

Sponsor Name for Flagyl I.v.
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.
Sponsor	Trials
Other	101
Industry	20
NIH	5

Flagyl I.v. Market Analysis and Financial Projection

Last updated: April 30, 2026

Flagyl I.V. (metronidazole) — Clinical-Stage Reality Check, Market Position, and Forward Projection

What is Flagyl I.V. in global clinical and regulatory terms?

Flagyl I.V. is an intravenous formulation of metronidazole. Metronidazole is an established nitroimidazole antibacterial/antiprotozoal with long-running global use; clinical development is dominated by label maintenance, formulation changes, and use-case expansions rather than broad, new phase programs. No current, drug-defining late-stage (Phase 3) development program tied specifically to “Flagyl I.V.” has been identified in the public record at the granularity needed for a trial-by-trial update.

Implication for “clinical trials update”

• For business planning tied to pipeline milestones (Phase 2b/3 starts, pivotal readouts), the public record does not support a credible, Flagyl I.V.-specific, current-horizon update.

Where does Flagyl I.V. sit in the competitive landscape?

Flagyl I.V. competes in the intravenous metronidazole segment against:

• Generic IV metronidazole products (multiple manufacturers globally)
• Substitute routes (oral metronidazole where clinically appropriate)
• Therapeutic alternatives for specific indications (e.g., other antibacterials/anti-infectives), depending on the infection syndrome and stewardship guidelines

Commercial dynamic

• The IV metronidazole category is mature, with price pressure and tender-driven contracting.
• Substitution between IV and oral forms reduces incremental IV share unless the indication requires IV administration (e.g., inability to take oral medication or severe infections).

What do the label-defining use cases imply for demand stability?

Metronidazole IV is used for infection and anaerobic coverage in defined clinical contexts. Demand is driven by:

• hospital admissions and inpatient procedure volumes
• surgical prophylaxis and post-op anaerobic coverage protocols (where used)
• management of anaerobic bacterial infections and protozoal diseases
• antimicrobial stewardship policies that favor narrow-spectrum regimens when indicated

In practice, these drivers support steady, but not fast-growing demand patterns typical for off-patent small molecules.

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Clinical Trials Update: what is actually actionable?

Is there a current, Flagyl I.V.-specific Phase 2/3 catalyst?

No. For a “clinical trials update” that is specific to Flagyl I.V. (not just metronidazole generally), the evidence base does not support naming active pivotal trials, recruitment status, or readout windows.

Actionable conclusion

• Treat Flagyl I.V. as a mature asset: planning should focus on access, supply, contracts, and substitution dynamics rather than near-term clinical catalysts.

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Market Analysis: size, pricing pressure, and channel behavior

How does the IV metronidazole market behave commercially?

The IV metronidazole market typically shows:

• high generic share where regulations and formularies allow
• procurement-led purchasing in hospitals (tenders, group purchasing, substitution rules)
• conversion between IV and oral when clinical pathways permit
• low differentiation unless supply reliability and packaging/logistics matter

What are the pricing and reimbursement mechanics?

Metronidazole is usually reimbursed as part of inpatient antimicrobial use. The main commercial levers are:

• formulary placement and interchangeability (generic substitution)
• procurement contract terms
• supply continuity (avoid shortages in tender cycles)
• bundle pricing in hospital pharmacy and purchasing systems

Because metronidazole is mature, incremental pricing power is constrained by:

• generic competition
• therapy class pressure
• stewardship and restricted formulary positioning (where applied)

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Forward Projection (12 to 36 months): base case

What is the most likely outlook for Flagyl I.V. revenue and volume?

Given maturity and generic competition, the most supportable projection is a flat-to-low single digit trajectory in many developed markets, with upside in select geographies where procurement preferences, tender wins, or restricted formularies temporarily favor branded supply.

Projection logic (no pivotal pipeline dependency)

• Volume: stable inpatient demand, offset by IV-to-oral pathway substitution
• Price: pressure from generic interchangeability and tender benchmarks
• Share: depends on contract wins and supply reliability, not clinical differentiation

Scenario table: 12 to 36 month directionality

Scenario	Volume trend	Price trend	Net revenue trend	Drivers
Base case	Flat to slight decline	Flat to slight decline	Flat to low single-digit growth/decline	Generic substitution, stewardship, stable infection admissions
Upside	Slight growth	Flat	Low single-digit growth	Tender wins, reduced shortages, stronger IV pathway retention
Downside	Decline	Decline	Low to mid single-digit contraction	Aggressive tender pricing, increased substitution to oral, supply or compliance friction

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Strategic implications for R&D and investment

What should be prioritized if the goal is commercial resilience?

For a mature IV small molecule, the highest ROI actions usually fall into nonclinical levers:

• securing and expanding hospital contracting and formulary placement
• ensuring uninterrupted supply and compliant distribution (critical for procurement cycles)
• optimizing packaging, handling, and availability at clinical sites
• pursuing product lifecycle extensions that reduce operational friction (where permitted)

What is the competitive risk profile?

Primary risks are structural:

• generic price compression
• procurement-driven switching
• protocol-driven IV-to-oral conversion
• antimicrobial stewardship cycles

Secondary risks are operational:

• supply disruptions
• distribution constraints
• regulatory or labeling maintenance issues

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Key Data Anchors (public, label and product basis)

What product facts define Flagyl I.V. as a marketed drug?

• Active ingredient: metronidazole
• Route: intravenous
• Drug class: nitroimidazole antimicrobial/antiprotozoal
• Clinical use orientation: anaerobic bacterial infections and protozoal diseases, in settings where IV is indicated

Product labeling and prescribing information for Flagyl I.V. provide the authoritative basis for clinical and safety positioning. [1]

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Key Takeaways

• Flagyl I.V. is a mature metronidazole IV product with no clearly supported, Flagyl I.V.-specific late-stage clinical catalyst in the current public evidence record.
• Market performance is governed by generic substitution, hospital procurement, and IV-to-oral clinical pathways, not by new clinical differentiation.
• A realistic 12 to 36 month outlook is flat to low single-digit revenue movement in most mature markets, with upside tied to tender wins and supply reliability and downside driven by aggressive pricing and switching.

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FAQs

1. Is metronidazole still being studied in Phase 3 trials?
   Public, Flagyl I.V.-specific Phase 3 activity is not established in a way that supports a precise trial update; metronidazole use remains clinically established.

2. What drives Flagyl I.V. demand most?
   Inpatient infection incidence, anaerobic coverage protocols, surgical volumes, and whether patients need IV administration rather than oral dosing.

3. How does generic competition affect Flagyl I.V.?
   It compresses pricing and shifts share through hospital tendering and interchangeability rules.

4. What is the best lever for near-term commercial improvement?
   Contracting and formulary placement plus supply continuity; clinical novelty is not the main near-term driver.

5. What is the most likely revenue trajectory over the next 1 to 3 years?
   Flat to low single-digit movement, with scenario outcomes tied to procurement pricing and route substitution.

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References (APA)

[1] Pfizer Inc. (n.d.). Flagyl I.V. (metronidazole) prescribing information. Pfizer.