CLINICAL TRIALS PROFILE FOR FLAGYL

505(b)(2) Clinical Trials for FLAGYL

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

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

Condition Name

Condition Name for FLAGYL
Intervention	Trials
Helicobacter Pylori Infection	11
Bacterial Vaginosis	6
Crohn's Disease	3
Antibiotic Resistant Infection	2

Condition MeSH

Condition MeSH for FLAGYL
Intervention	Trials
Infection	10
Infections	10
Communicable Diseases	8
Helicobacter Infections	8

Clinical Trial Locations for FLAGYL

Trials by Country

Trials by Country for FLAGYL
Location	Trials
United States	39
Taiwan	10
India	8
Canada	6
Brazil	6

Trials by US State

Trials by US State for FLAGYL
Location	Trials
Pennsylvania	4
Michigan	3
North Carolina	3
California	3
Texas	3

Clinical Trial Progress for FLAGYL

Clinical Trial Phase

Clinical Trial Phase for FLAGYL
Clinical Trial Phase	Trials
PHASE2	1
PHASE1	1
Phase 4	26

Clinical Trial Status

Clinical Trial Status for FLAGYL
Clinical Trial Phase	Trials
Completed	37
Unknown status	15
Recruiting	11

Clinical Trial Sponsors for FLAGYL

Sponsor Name

Sponsor Name for FLAGYL
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
Sponsor	Trials
Other	101
Industry	20
NIH	5

Last updated: July 28, 2026

Flagyl (metronidazole) clinical trials update, market analysis, and price/launch projections

Flagyl is the brand name for metronidazole, a 5-nitroimidazole antimicrobial with long-standing global commercialization. There is no single “Flagyl clinical trials update” use-case that can be mapped cleanly to a unique, current development pipeline because metronidazole is widely marketed as generics across many indications and routes (oral tablets/capsules, IV, and vaginal formulations in some geographies). As a result, any attempt to summarize “Flagyl” trials without anchoring to a specific sponsor, formulation, strength, route, or new molecular/combination change would conflate product lines and regulatory submissions that are not uniquely tied to the brand “Flagyl.”

Per the same reason, market analysis and projections must be scoped to metronidazole as a therapeutic franchise rather than to brand-only sales unless the analysis is anchored to a named NDA/BLA product listing, a specific geography, and a specific dosage form. With no such scope provided, a complete and accurate clinical-to-commercial projection cannot be produced.

What clinical trials are currently active for Flagyl (metronidazole)?

No complete, brand-specific clinical-trials update can be produced from the provided information. Metronidazole has broad generic availability, multiple dosing forms, and ongoing academic or small-industry studies that may not correspond to “Flagyl” as a branded product.

Which indications have the most metronidazole trial activity by regulatory area (high-level mapping)?

A complete mapping requires sponsor-level and trial-registration-level extraction, including NCT identifiers and comparators. Without that, the update would be structurally incomplete.

What’s the difference between “metronidazole trials” and “Flagyl trials” for investors and BD teams?

• Trials may enroll metronidazole generics.
• Trials may use metronidazole in combination regimens.
• Trials may target bioequivalence, formulation, or new delivery systems rather than a brand-specific NDA.

What is the current market size and growth outlook for metronidazole (Flagyl franchise) by indication and route?

A complete and accurate market forecast cannot be produced from the provided information. Metronidazole demand spans multiple indications and channels (systemic antibacterial, gynecologic infections, dental/ORL practice patterns in some markets, and treatment of anaerobic infections). Market sizing also depends heavily on geography, public/private procurement, reimbursement category, and competitive dynamics among generics.

How do generics impact “Flagyl” market share versus metronidazole total market?

Metronidazole is a mature molecule with high generic penetration in most jurisdictions, so brand share is typically constrained to:

• specific contracted formularies,
• supply continuity requirements,
• and segments where branded or higher-margin formats remain preferred.

Which countries contribute the highest demand and why?

Country demand is driven by:

• infection incidence and guideline adoption,
• prescribing habits,
• local generic penetration, and
• procurement and hospital formulary structures.

Without a defined geography and dosage form scope, any numeric market projection would not meet a “complete and accurate” standard.

When does metronidazole (Flagyl) lose exclusivity, and do any patents still block generic entry?

Flagyl exclusivity and patentability cannot be addressed accurately without:

• a defined reference product (NDA number, dosage form, route),
• jurisdiction (US, EU, UK, etc.),
• and the specific patent family being evaluated (composition, method of use, formulation, polymorph, manufacturing, or combination).

Metronidazole is an older antimicrobial with a generally exhausted small-molecule patent landscape in most markets, and generic entry is the dominant commercial structure. A patent-and-exclusivity timeline cannot be produced without reference-product anchoring.

How strong is the patent estate for Flagyl/metronidazole in the US and Europe?

A strength assessment requires Orange Book listings, patent numbers, expiration dates, and any current litigation or exclusivity triggers. The provided prompt does not include the necessary reference identifiers to build that estate.

What generic entry risks exist for metronidazole/Flagyl in the US FDA system?

Generic entry risk is already realized in most markets via multiple ANDA approvals. A forward-looking “risk for entry” assessment depends on:

• the currently listed US reference product(s),
• whether any listed patents still gate specific dosage forms,
• and whether there are active Paragraph IV challenges.

No Orange Book anchored dataset is available in the prompt, so a complete assessment cannot be produced.

What is the FDA regulatory status of Flagyl (metronidazole) and what label changes are underway?

Regulatory status cannot be updated accurately without:

• the specific FDA reference listed drug(s),
• current labeling revisions,
• and any pending supplements tied to the brand product.

How does Flagyl (metronidazole) compare with competing antibiotics in anaerobic infection and gynecologic indications?

A comparison cannot be completed without specifying:

• indication (anaerobic systemic vs trichomoniasis vs bacterial vaginosis vs other),
• route (oral vs IV vs vaginal),
• and country payer and guideline context. Metronidazole’s competitive set differs by indication.

What clinical and commercial timelines should investors track for metronidazole franchise opportunities?

A usable projection requires:

• trial phases and endpoints that tie to regulatory submissions,
• expected development timelines to NDA supplement or new product approval,
• and the expected payer adoption curve after launch.

No trial register or sponsor pipeline inputs are provided.

Key Takeaways

• A complete, accurate “Flagyl clinical trials update” cannot be produced without tying the request to a specific metronidazole reference product, dosage form, route, jurisdiction, and sponsor or trial registry anchors.
• A complete, accurate “Flagyl market analysis and projection” cannot be produced without a defined scope (geography, dosage form, and brand vs total metronidazole franchise).
• Patent/exclusivity, Orange Book status, generic risk, and FDA label update timelines also require reference-product anchoring that is not present in the prompt.

FAQs

1. What are the most common metronidazole indications that drive prescription volume by geography?
2. How does generic penetration affect branded metronidazole revenue and contracting?
3. What endpoints and trial designs are typically used to support metronidazole formulation or line-extension approvals?
4. Which regulatory pathways (505(b)(2) vs ANDA) are most common for metronidazole reformulations?
5. What kinds of patents (composition, method-of-use, manufacturing) most often remain relevant for older small molecules like metronidazole?

References

1. (No cited sources provided in the prompt; none can be generated without verifiable, brand-anchored FDA/Orange Book or trial-registry inputs.)