Flagyl

(Metronidazole)

ApprovedSmall molecule

Metronidazole is an antibiotic used to treat infections caused by bacteria and parasites, commonly prescribed for bacterial vaginosis, trichomoniasis, and certain digestive tract infections.[2] Flagyl is currently approved and in use across 81 indications[4].[1]

Flagyl is one of 1190 small molecule programs targeting Malnutrition. It is currently in Approved.

Indications

226

Total Trials

Active Trials

1,189

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

MalnutritionActive, not recruiting

ColitisActive, not recruiting

Bacterial DiseaseActive, not recruiting

AbscessApproved

ChorioamnionitisActive, not recruiting

AllergyActive, not recruiting

Perianal Crohn's DiseaseActive, not recruiting

Pelvic Inflammatory DiseaseApproved

EndocervicitisActive, not recruiting

Peritonsillar AbscessActive, not recruiting

MalnutritionPhase 3

Active, not recruiting

ColitisPhase 2

Active, not recruiting

Bacterial DiseaseApproved

Active, not recruiting

AbscessApproved

Approved

ChorioamnionitisPhase 3

Active, not recruiting

AllergyApproved

Active, not recruiting

Perianal Crohn's DiseasePhase 1

Active, not recruiting

Pelvic Inflammatory DiseaseApproved

Approved

EndocervicitisApproved

Active, not recruiting

Peritonsillar AbscessPreclinical

Active, not recruiting

Showing 10 of 79 indications

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

Flagyl

DDePuy Orthopaedics

Approved

1 2

Blenoxane

SSequus Pharmaceuticals

Preclinical

25 3

Velban

EEastern Cooperative Oncology Group

Preclinical

15 4

Zofran

Novartis

Preclinical

2 5

Norvir

AbbVie

Preclinical

1 6

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 7

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 8

Nuvigil

NNuvo Research GmbH

Preclinical

1 9

PEG-Intron

Merck & Co.

Preclinical

1 10

Systemic Therapy

Bristol-Myers Squibb

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Not yet recruiting

Colorectal Cancer

NCT05720559

Q4 2026

Post-ApprovalRecruiting

PPROM

NCT06396078

Not yet recruiting

Helicobacter Pylori Infection

NCT06731023

Phase 2Recruiting

Preoperative

NCT05748145

Q2 2027

Phase 2Not yet recruiting

Chlorhexidine

NCT07481955

Phase 3Not yet recruiting

Efficacy and Safety

NCT06633718

Clinical

Trials by Indication[1]

Bacterial Vaginosis23 trials

Optimization of Bacterial Vaginosis Treatment in Women of Reproductive Age

Recruiting·II.M. Sechenov First Moscow State Medical University·Phase 4·NCT06458543·100 enrolled

The Effect of Probiotics on the Immune Status, Diarrhea and Bacterial Vaginosis Cure Rate Among HIV Patients

Unknown status·NNational Institute for Medical Research, Tanzania·Phase 2/3·NCT00536848·65 enrolled

Treatment Comparison of Antibiotics Versus Vaginal Lactic Acid in Non-pregnant Women With Acute Symptomatic Bacterial Vaginosis

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 4·NCT02042287·32 enrolled

Show 20 more trials

Role of N-Acetylcysteine in Treatment of Bacterial Vaginosis

Unknown status·MMinia University·Phase 4·NCT01841411·90 enrolled

A Pilot Open-label Randomized Study of Lactofiltrum in Women With Bacterial Vaginosis

Unknown status·AAvva Rus, JSC·Phase 2/3·NCT01089348·90 enrolled

Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 (BV/HSV-2) Shedding Study

Completed·UUniversity of Pittsburgh·Phase 4·NCT00464542·12 enrolled

Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)

Completed·SStarpharma Pty Ltd·Phase 3·NCT02236156·637 enrolled

Safety and Efficacy of Vaginal Microbiota Transplant (VMT) in Women With Bacterial Vaginosis (BV)

Withdrawn·JJohns Hopkins University·Phase 1·NCT03769688

Probiotics as Adjuvant Treatment for Bacterial Vaginosis

Completed·PPeking University Shenzhen Hospital·Phase 4·NCT03894813·126 enrolled

Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity

Terminated·TThe University of Texas Medical Branch, Galveston·Phase 1·NCT03954990·75 enrolled

Oral Metronidazole With Lactobacillus Vaginal Suppositories to Prevent Recurrence of Bacterial Vaginosis

Completed·PPeking University Shenzhen Hospital·Phase 4·NCT03099408·66 enrolled

The Efficacy and Safety Study of Clindamycin Palmitate Hydrochloride Dispersible Tablet Treatment of Bacterial Vaginosis

Unknown status·GGuangzhou Yipinhong Pharmaceutical CO.,LTD·Phase 4·NCT03080740·300 enrolled

Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)

Completed·SStarpharma Pty Ltd·Phase 3·NCT02237950·586 enrolled

Comparison of Dequalinium Chloride (Fluomizin) vs Oral Metronidazole for the Treatment of Bacterial Vaginosis

Terminated·MMedinova AG·Phase 4·NCT05788991·151 enrolled

LUXSOL(TM) Topical Cream for the Treatment of Symptomatic Bacterial Vaginosis; A Proof of Concept Study

Terminated·CCDA Research Group, Inc.·Phase 1·NCT02197182·50 enrolled

Bioequivalence of Metronidazole Gel, 0.75% in the Treatment of Bacterial Vaginosis

Completed· Teva logo

Teva·Phase 1/2·NCT01020396·579 enrolled

GoldenCareTM for the Treatment of Bacterial Vaginosis

Terminated·CCDA Research Group, Inc.·Phase 1/2·NCT01762670·8 enrolled

Colposeptine for the Treatment of Bacterial Vaginosis

Terminated· Merck & Co. logo

Merck & Co.·Phase 4·NCT01153958·133 enrolled

Bacterial Vaginosis Home Screening to Prevent STDs

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00667368·1,370 enrolled

Inflammation and Treatment of Bacterial Vaginosis Near Term

Completed·MMedical University of South Carolina·N/A·NCT00720291·59 enrolled

Study of How Bacterial Vaginosis and Its Treatment Affects Cervical and Vaginal Tissue

Completed·CCONRAD·N/A·NCT01347632·35 enrolled

Effect of Bacterial Vaginosis on HIV Susceptibility and Female Genital Immunology

Completed·UUniversity of Toronto·Phase 1·NCT02527941·50 enrolled

LACTIN-V Study for Recurrent Bacterial Vaginosis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT02766023·228 enrolled

Helicobacter Pylori Infection9 trials

High Dose Amoxicillin Versus Tetracycline as Second-line Treatment of Resistant Helicobacter Pylori Infection

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT02175927·312 enrolled

Quadruple vs Tailored Therapy in the Treatment of Helicobacter Pylori Infection

Completed·UUniversity of Split, School of Medicine·N/A·NCT04621487·80 enrolled

Levoﬂoxacin and Bismuth-containing Therapy Versus Quadruple Therapy as Second-line Treatment of Resistant Helicobacter Pylori Infection

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT01742429·200 enrolled

Show 6 more trials

Efficacy of a 14-Day Bismuth-Containing Quadruple Therapy Guided by Drug Susceptibility Testing in Patients with Extremely Refractory Helicobacter Pylori Infection: an Exploratory Study

Not yet recruiting·XXiuli Zuo··NCT06731023·30 enrolled

Non-invasive Test-guided Tailored Therapy Versus Empiric Treatment for Helicobacter Pylori Infection.

Unknown status·UUniversity of Bari·Phase 3·NCT04107194·362 enrolled

Empirical Rescue Therapies of Helicobacter Pylori Infection

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT01668927·424 enrolled

Intraluminal Metronidazole Powder Monotherapy for Helicobacter Pylori Infection

Completed·MMackay Memorial Hospital·Phase 4·NCT03524833·20 enrolled

Susceptibility-Guided Therapy for Helicobacter Pylori Infection Treatment

Unknown status·SShanghai Zhongshan Hospital·Phase 4·NCT05250050·388 enrolled

15-day Sequential Therapy for Helicobacter Pylori Infection in Korea

Completed·SSeoul National University Bundang Hospital·Phase 4·NCT01887249·287 enrolled

Helicobacter Pylori Eradication9 trials

Helicobacter Pylori Eradication and Follow-up

Recruiting·SShanghai Zhongshan Hospital·Phase 4·NCT05061732·4,447 enrolled

Comparison of 7-day and 14-day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication

Completed·—·Phase 4·NCT00841854·199 enrolled

Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication

Completed·SShandong University·Phase 4·NCT05049902·1,300 enrolled

Show 6 more trials

Drug Use Surveillance of Takecab for "Supplement to Helicobacter Pylori Eradication"

Completed· Takeda logo

Takeda··NCT03219723·560 enrolled

Helicobacter Pylori Eradication Study

Completed·IInje University·Phase 4·NCT03130452·423 enrolled

Optimal Duration of Bismuth Quadruple Therapy for Helicobacter Pylori Eradication in Females As Compared with Males

Enrolling by invitation·NNational Cheng-Kung University Hospital·Phase 4·NCT06509139·661 enrolled

Amoxicillin/Metronidazole Based Quadruple Therapy for Helicobacter Pylori Eradication

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT02175901·215 enrolled

A "Screen and Treat" Helicobacter Pylori Eradication Trial in Adolescents in Three Regions of Chile

Recruiting·MMiguel O'Ryan Gallardo·N/A·NCT05926804·500 enrolled

Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Clinical Trial of 10 and 14 Days

Unknown status·SShandong University·Phase 4·NCT04901117·1,300 enrolled

Helicobacter Pylori8 trials

Tailored Versus Empiric Therapy for Helicobacter Pylori Treatment

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT02935010·382 enrolled

Study of Nitazoxanide (NTZ) Based New Therapeutic Regimens for Helicobacter Pylori

Unknown status·SSherief Abd-Elsalam·Phase 3·NCT02422706·120 enrolled

Tailored Therapy for Helicobacter Pylori Rescue Treatment

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT03413020·200 enrolled

Show 5 more trials

Compare Sequential and Quadruple Therapy for the Eradication of Helicobacter Pylori in Korea

Completed·SSeoul National University Bundang Hospital·N/A·NCT02159976·390 enrolled

Study of Nitazoxanide (NTZ) for Helicobacter Pylori in Children

Recruiting·TTanta University·Phase 3·NCT04415983·100 enrolled

Doxycycline for Helicobacter Pylori Rescue Treatment

Recruiting·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT05874570·368 enrolled

Helicobacter Pylori Rescue Treatment in Patients Allergic to Penicillin

Unknown status·SShandong University·Phase 4·NCT05135182·170 enrolled

High Dose of Dual Therapy Plus Metronidazole for Helicobacter Pylori RescueTreatment

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT04024527·306 enrolled

Antibiotics5 trials

Systems Biology of Flu Vaccine in Healthy Adults With and Without the Use of Antibiotics

Completed·EEmory University·N/A·NCT02154061·33 enrolled

Combination Study of Antibiotics With Enzalutamide (PROMIZE)

Recruiting·IInstitute of Cancer Research, United Kingdom·Phase 1/2·NCT06126731·39 enrolled

Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice

Recruiting·RRutgers, The State University of New Jersey·Phase 3·NCT06131021·150 enrolled

Show 2 more trials

Responses to Rabies Vaccine in Adults With or Without Antibiotics

Completed·EEmory University·Phase 4·NCT03557008·37 enrolled

Effect of Antibiotics on Penile Microbiome and HIV Susceptibility Study in Ugandan Men

Unknown status·UUniversity of Toronto·N/A·NCT03412071·125 enrolled

96 more indications

Infections5 trials

Treatment of Giardia Lamblia Infections in Children

Terminated·HHelsinki University Central Hospital·Phase 4·NCT02942485·8 enrolled

Multi-Center Study of New Medications to Treat Vaginal Infections

Completed·CCuratek Pharmaceuticals, LLC·Phase 3·NCT02308007·475 enrolled

Compare Ceftazidime-Avibactam + Metronidazole vs Meropenem for Hospitalized Adults With Complicated Intra-Abd Infections

Completed· Pfizer logo

Pfizer·Phase 3·NCT01726023·486 enrolled

Show 2 more trials

Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens

Completed· Pfizer logo

Pfizer·Phase 3·NCT01644643·345 enrolled

Multi-Center Study of New Medications to Treat Vaginal Infections

Completed·CCuratek Pharmaceuticals, LLC·Phase 3·NCT02308033·204 enrolled

Periodontitis4 trials

Alternative Antibiotic Regimen in Periodontitis Treatment

Completed·IIstanbul Medipol University Hospital·Phase 4·NCT04353362·74 enrolled

The Use of Erythritol Powder and Metronidazole Gel for the Non-surgical Treatment of Periodontitis

Completed·PProed, Torino, Italy·Phase 4·NCT02023840·20 enrolled

Locally Delivered Antibiotics for the Treatment of Periodontitis

Unknown status·RRiyadh Elm University·N/A·NCT04125706·44 enrolled

Show 1 more trial

Porous Metronidazole Loaded Matrix for Local Treatment of Periodontitis.

Unknown status·WWroclaw Medical University·Phase 4·NCT03791099·40 enrolled

Intra-abdominal Infection4 trials

Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem for Participants With Complicated Intra-abdominal Infection (MK-7625A-015)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT03830333·268 enrolled

MK-7625A Plus Metronidazole Versus Meropenem in Pediatric Participants With Complicated Intra-Abdominal Infection (cIAI) (MK-7625A-035)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT03217136·94 enrolled

Study of Ceftolozane/Tazobactam (MK-7625A) in Combination With Metronidazole in Japanese Participants With Complicated Intra-abdominal Infection (MK-7625A-013)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT02739997·100 enrolled

Show 1 more trial

Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)

Completed·IIterum Therapeutics, International Limited·Phase 3·NCT03358576·674 enrolled

Diarrhea3 trials

Efficacy of Metronidazole Prophylaxis Against Clostridium Difficile-Associated Diarrhea in High Risk Adult Patients

Terminated·AAlison Schneider·Phase 4·NCT02200328·76 enrolled

Transplantation of Cultured Gut Microflora to Repeat Antibiotic-induced Diarrhea Due to Clostridium Difficile

Completed·PPer Hellström·Phase 2·NCT02857582·60 enrolled

Comparative Evaluation of Herbal and Allopathic Drugs for the Treatment of Chronic Diarrhea

Completed·SShifa Ul Mulk Memorial Hospital·Phase 2/3·NCT02642250·70 enrolled

Efficacy and Safety3 trials

Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in CIAI

Not yet recruiting· Qilu Pharmaceutical Co., Ltd. logo

Qilu Pharmaceutical Co., Ltd.·Phase 3·NCT06633718·786 enrolled

Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo

Completed·GGalderma R&D·Phase 4·NCT01426269·235 enrolled

Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01254344·599 enrolled

Crohn's Disease3 trials

Study of Antibiotics in the Treatment of Colonic Crohn's Disease

Terminated·MMount Sinai Hospital, Canada·Phase 2·NCT00257699·12 enrolled

Flagyl Microbiome in Crohn's Disease

Completed·UUniversity of Louisville·Phase 4·NCT04682522·4 enrolled

Azithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease

Completed·PProf. Arie Levine·Phase 4·NCT01596894·73 enrolled

Growth3 trials

EFESO - EFficacy Enterogermina Small Intestinal Bacterial Overgrowth

Completed· Sanofi logo

Sanofi·Phase 4·NCT00331994·250 enrolled

Antibiotic Treatment Trial for Small Intestinal Bacterial Overgrowth

Unknown status·SSan Antonio Military Medical Center·Phase 4·NCT02458781·180 enrolled

Comparative Efficacy of Antibiotics for Small Intestine Bacterial Overgrowth in Bangladeshi Children

Not yet recruiting·UUniversity of Virginia·Phase 2·NCT07451171·60 enrolled

Ulcerative Colitis3 trials

Antibiotics for the Treatment of Ulcerative Colitis

Completed·UUniversity of Dundee·N/A·NCT00355602·40 enrolled

Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis

Completed·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 2·NCT03794765·50 enrolled

Refined Fecal Microbiota Transplantation (FMT) for Ulcerative Colitis (UC)

Terminated·AAri M Grinspan·Phase 1·NCT04968951·4 enrolled

Antibiotic3 trials

Impact of Oral Antibiotic Treatment on C. Difficile

Completed·—·Phase 4·NCT02057198·33 enrolled

Optimising Antibiotic Treatment for Sick Malnourished Children

Unknown status·UUniversity of Oxford·Phase 2·NCT02746276·81 enrolled

Alternative Antibiotic Regime in the Treatment of GAgP

Completed·KKocaeli University·Phase 4·NCT02223702·39 enrolled

Treatment3 trials

Determine the PK and Safety and Tolerability of ATM-AVI for the Treatment of cIAIs in Hospitalized Adults (REJUVENATE)

Completed· Pfizer logo

Pfizer·Phase 2·NCT02655419·40 enrolled

Non Surgical Treatment of Periimplantitis

Completed·PProed, Torino, Italy·Phase 4·NCT02023853·20 enrolled

Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metronidazole and Secnidazole

Recruiting·TTulane University·Phase 4·NCT06261840·1,200 enrolled

Gingivitis3 trials

Effectiveness of Metronidazole Gel and Mobile SMS Reminders on Gingivitis in Orthodontic Patients

Completed·—·Phase 4·NCT03508999·63 enrolled

Comparative Evaluation of Chlorhexidine, Metronidazole and Combination Gels on Gingivitis

Unknown status·—·Phase 3·NCT03142607·90 enrolled

Comparisons Of Different Antiplaque Agents On Gingivitis In Orthodontic Patients

Completed·AAnam Sattar·N/A·NCT06305546·80 enrolled

Pelvic Inflammatory Disease2 trials

The Importance of Anti-anaerobic Therapy for Acute Pelvic Inflammatory Disease (PID)

Completed·HHarold Wiesenfeld·Phase 2·NCT01160640·233 enrolled

Moxifloxacin Versus Ofloxacin Plus Metronidazole in Uncomplicated Pelvic Inflammatory Disease: Multicenter Randomized Controlled Trials

Completed·IIstanbul Bakirkoy Maternity and Children Diseases Hospital·Phase 4·NCT01799356·1,303 enrolled

First-line Treatment2 trials

Clarithromycin Triple Therapy Plus Bismuth for Helicobacter Pylori First-line Treatment

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT02732249·66 enrolled

Bismuth-Metronidazole Triple Therapy for H. Pylori First-line Treatment

Unknown status·SShanghai Zhongshan Hospital·Phase 4·NCT04667299·270 enrolled

Parasitic Infection2 trials

Parasitic Infection in Anemic Pregnant Women

Unknown status·—·Phase 4·NCT04391998·200 enrolled

Parasitic Infections and Ulcerative Colitis: Combining Anti-parasitic and Immunomodulatory Treatments May Achieve Remission

Completed·—·N/A·NCT06583863·120 enrolled

Colitis2 trials

Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis

Completed·RRomark Laboratories L.C.·Phase 2·NCT00417872·114 enrolled

A Safety, Tolerability and Pharmacokinetic Study of Two Formulations of Metronidazole Versus Immediate Release Metronidazole in Patient With C. Difficile Colitis

Completed·—·Phase 2·NCT01559545·60 enrolled

Clostridium Difficile Infection2 trials

Fecal Microbiota Therapy for Recurrent Clostridium Difficile Infection

Unknown status·QQueen Elizabeth II Health Sciences Centre·Phase 2/3·NCT02686645·50 enrolled

IMT for Primary Clostridium Difficile Infection

Terminated·OOslo University Hospital·Phase 2/3·NCT02301000·21 enrolled

Infection2 trials

Antimicrobial PK in Infants With Suspected or Confirmed Infection

Completed·—··NCT00491426·450 enrolled

Kefazolin Versus Kefazolin Plus Metronidazole to Reduce Postpartum Infection

Unknown status·UUniversity of Pretoria·Phase 4·NCT04792710·1,000 enrolled

Surgery2 trials

Metronidazole vs Placebo as Adjuncts to Periodontal Surgery for Patients Positive to Porphyromonas Gingivalis

Completed·UUniversidad Complutense de Madrid·N/A·NCT03880448·17 enrolled

Topical vs Oral Metronidazole After Benign Anorectal Surgery

Completed·MMansoura University·N/A·NCT05038605·108 enrolled

Complicated Intra-abdominal Infections2 trials

Compare Ceftazidime-Avibactam + Metronidazole Versus Meropenem for Hospitalized Adults With Complicated Intra-Abdominal Infections

Completed· Pfizer logo

Pfizer·Phase 3·NCT01499290·493 enrolled

Evaluation of Safety,Pharmacokinetics and Efficacy of CAZ-AVI With Metronidazole in Children Aged 3 Months to 18 Years Old With Complicated Intra-abdominal Infections (cIAIs).

Completed· Pfizer logo

Pfizer·Phase 2·NCT02475733·83 enrolled

Oral2 trials

Evaluate the PK of Multiple Oral Doses of Tegoprazan, Metronidazole, Tetracycline and Bismuth in Healthy Volunteers

Completed·HHK inno.N Corporation·Phase 1·NCT04066257·32 enrolled

Topical Versus Oral Metronidazole Following Excisional Haemorrhoidectomy

Completed·UUniversity of Auckland, New Zealand·Phase 4·NCT03343509·120 enrolled

Colorectal Surgery2 trials

Parenteral Antibiotics Compared to Combination of Oral and Parenteral Antibiotics in Colorectal Surgery Prophylaxis

Completed·HHospital Universitari Vall d'Hebron Research Institute·Phase 4·NCT02505581·536 enrolled

Bowel Preparation in Elective Pediatric Colorectal Surgery

Unknown status·MMcMaster University·N/A·NCT03593252·81 enrolled

Randomized Controlled Trial2 trials

Preoperative Oral Antibiotics With vs Without Mechanical Bowel Preparation to Reduce Surgical Site Infections Following Colonic Resection: an International Randomized Controlled Trial.

Unknown status·HHospital Universitari Vall d'Hebron Research Institute·Phase 4·NCT04161599·968 enrolled

Randomized Controlled Trial of Treatment of Male Partners of Women With BV

Completed·UUniversity of Alabama at Birmingham·Phase 3·NCT02209519·214 enrolled

Tics2 trials

Study of Metronidazole Delayed-Release Capsules in Comparison With Immediate-Release Tablets (Flagyl) for Safety and Pharmacokinetics

Completed·GGateway Pharmaceutical LLC·Phase 1·NCT07251127·18 enrolled

Pharmacokinetics of Metronidazole Dermal Products

Completed·UUniversity of Maryland, Baltimore·Phase 1·NCT03271983·7 enrolled

Peri-Implantitis2 trials

Metronidazole as an Adjunct of Non- Surgical Treatment of Peri-implantitis

Completed·JJuan Blanco Carrión·Phase 4·NCT03564301·20 enrolled

Surgical Access Combined With Systematically Administered Antibiotics in the Treatment of Peri-implantitis

Completed·UUniversity of Guarulhos·N/A·NCT05444218·89 enrolled

Rosacea2 trials

Efficacy of Topical Azelaic Acid 15% Gel Plus Anti-inflammatory Dose Doxycycline or Metronidazole Gel 1% Plus Anti-inflammatory Dose Doxycycline in Moderate Papulopustular Rosacea

Completed· LEO Pharma logo

LEO Pharma·Phase 4·NCT00855595·207 enrolled

Preferences & Treatment Satisfaction Drivers in Rosacea Patients

Completed· LEO Pharma logo

LEO Pharma··NCT02602470·206 enrolled

Aggressive Periodontitis2 trials

Periodontal Debridement Associated With Systemic Antibiotics and Single/Repeated PDT to Treat Aggressive Periodontitis

Completed·UUniversidade Estadual Paulista Júlio de Mesquita Filho·Phase 2/3·NCT03132714·46 enrolled

Two Different Antibiotic Agents to Treat Generalized Aggressive Periodontitis

Completed·UUniversidade Estadual Paulista Júlio de Mesquita Filho·Phase 2/3·NCT02969928·46 enrolled

Preoperative2 trials

Metronidazole as Preoperative Therapy in CRC / FusoMetro-001

Recruiting·OOncology Institute of Southern Switzerland·Phase 2·NCT05748145·40 enrolled

Prevention of Dry Socket by Means of Single Preoperative Antibiotics Compared to Conventional Therapy

Completed·—·Phase 2·NCT03992144·225 enrolled

Colorectal Cancer2 trials

Study of Oral Metronidazole on Postoperative Chemotherapy in Colorectal Cancer

Unknown status·SShanghai Jiao Tong University School of Medicine·Phase 2·NCT04264676·294 enrolled

Early Blocking Strategy for Metachronous Liver Metastasis of Colorectal Cancer Based on Pre-hepatic CTC Detection

Not yet recruiting·LLiaoning Cancer Hospital & Institute·Phase 2·NCT05720559·100 enrolled

H Pylori Infection2 trials

Feasibility Study of the Proposed Test-and-treat Screening Program in Younger Participants With H. Pylori Infection

Unknown status·NNational Institute of Public Health, Slovenia··NCT06216639·2,000 enrolled

Genotypic Resistance Guided Therapy for Refractory H. Pylori Infection

Unknown status·NNational Taiwan University Hospital·Phase 4·NCT03555526·320 enrolled

Withdrawn·TThe Catholic University of Korea·Phase 3·NCT01658852

Pilot Study1 trial

The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in H.Pylori Patients

Completed·KKyungpook National University Hospital·Phase 4·NCT02648659·50 enrolled

Abortion1 trial

A Randomized Controlled Trial of Three Antibiotic Regimens for First Trimester Abortions

Completed·MMedstar Health Research Institute·N/A·NCT02756403·181 enrolled

Overlap Syndrome1 trial

"Overlap Syndrome and PSC: Evaluating Role of Gut Microflora and Its Identification With Antibiotics in Children"

Completed·CCliniques universitaires Saint-Luc- Université Catholique de Louvain·N/A·NCT03069976·15 enrolled

Infertility1 trial

Efficacy Study of Preconception Treatment of an Asymptomatic Bacterial Infection in an Infertility Population

Terminated·SStanford University·N/A·NCT01322971·2 enrolled

Immune Response1 trial

The Role of the Microbiota in the Systemic Immune Response

Completed·—·N/A·NCT02340182·12 enrolled

Treatment Failure1 trial

Malabsorption as a Cause of Iron Treatment Failure in Infants

Completed·HHaEmek Medical Center, Israel·N/A·NCT00456729·100 enrolled

Liver Metastases1 trial

Quintuple Method for Treatment of Multiple Refractory Colorectal Liver Metastases

Unknown status·LLiaoning Cancer Hospital & Institute·Phase 2·NCT05774964·100 enrolled

Interaction1 trial

VNRX-5133 Drug-Drug Interaction in Healthy Adult Volunteers

Completed·VVenatorx Pharmaceuticals, Inc.·Phase 1·NCT03332732·42 enrolled

Adolescent1 trial

Study of Tedizolid Phosphate in Adolescents With Complicated Skin and Soft Tissue Infection (cSSTI) (MK-1986-012)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT02276482·120 enrolled

Randomised Controlled Trial1 trial

A Randomised Controlled Trial of the Use of Topical Metronidazole (10%) to Reduce Pain After Haemorrhoidectomy

Completed·SS.L.A. Pharma AG·Phase 2/3·NCT00774722·59 enrolled

Complication1 trial

Preoperative Dose of Co-amoxiclav for Prevention of Postoperative Complications in Dentoalveolar Surgery

Unknown status·TTaibah University·N/A·NCT03844776·135 enrolled

Ischemia1 trial

ORal Antibiotics in Acute Mesenteric Ischemia

Recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT06387147·196 enrolled

Single Dose1 trial

A Single-center, Open-label, Study Evaluating Safety and Pharmacokinetics of Single Doses of Zidebactam-Cefepime and Metronidazole Alone or in Combination.

Completed·WWockhardt·Phase 1·NCT06806995·30 enrolled

Locally-advanced Rectal Cancer1 trial

Intestinal Microbiome Modulation With Antibiotics in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer

Recruiting·—·Phase 2·NCT06793137·100 enrolled

Malnutrition1 trial

First Line Antimicrobials in Children With Complicated Severe Acute Malnutrition

Unknown status·UUniversity of Oxford·Phase 3·NCT03174236·2,000 enrolled

Fasting Conditions1 trial

Bioavailability Study of Metronidazole Capsules Under Fasting Conditions

Completed·PPar Pharmaceutical, Inc.·Phase 1·NCT01380509·28 enrolled

Rescue Therapy for Helicobacter Pylori1 trial

Rescue Therapy for Helicobacter Pylori Infection

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT05874544·360 enrolled

Rectal Adenocarcinoma1 trial

Trial Utilizing Metronidazole to Optimize the Microbiome of Rectal Adenocarcinoma Undergoing Neoadjuvant Therapy

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06569368·60 enrolled

Pregnant Women1 trial

Screen-and-treat Strategy for Vaginal Flora Abnormalities in Pregnant Women at High Risk of Preterm Birth

Not yet recruiting·AAssistance Publique Hopitaux De Marseille·Phase 4·NCT06349122·1,292 enrolled

Amputation1 trial

The Amputation Surgical Site Infection Trial (ASSIT)

Completed·HHull University Teaching Hospitals NHS Trust·Phase 4·NCT02018094·160 enrolled

Probiotics1 trial

Systemic Probiotics in the Periodontal Treatment

Unknown status·BBelén Retamal-Valdes·Phase 3·NCT03733379·176 enrolled

Recurrence1 trial

Trichomonas Vaginalis Recurrence Among HIV+ Women

Completed·TTulane University Health Sciences Center·Phase 4·NCT01018095·270 enrolled

Pneumonia1 trial

Efficacy and Safety Trial to Assess Moxifloxacin in Treating Community-Acquired Pneumonia (CAP) With Aspiration Factors

Unknown status·—·Phase 4·NCT00752947·186 enrolled

Surgical1 trial

Glycemic Control in T2DM Through Non-Surgical Periodontal Therapy

Completed·—·Phase 2/3·NCT03343366·150 enrolled

Brain Injury1 trial

Cerebral Antibiotics Distribution After Acute Brain Injury

Completed·PPoitiers University Hospital·Phase 1·NCT01059890·18 enrolled

Clostridium Difficile1 trial

Prospective Study of Clostridium Difficile in Children Undergoing Colonoscopy

Withdrawn·SState University of New York at Buffalo·N/A·NCT01472978

Clindamycin Vs Metronidazole1 trial

Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies

Completed·HHaEmek Medical Center, Israel·N/A·NCT01722708·166 enrolled

ESS1 trial

A Study to Assess the Levels of CAZ-AVI and Metronidazole in the Blood When Given Together and Separately

Completed· Pfizer logo

Pfizer·Phase 1·NCT01534247·28 enrolled

PPROM1 trial

Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)

Recruiting·OOhio State University·Phase 4·NCT06396078·56 enrolled

Steroid1 trial

Anti-protozoal Effect of Steroid Hormone 20-hydroxyecdysone

Active, not recruiting·RResearch Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan·Phase 2/3·NCT04827537·200 enrolled

Chlorhexidine1 trial

Chlorhexidine and/or Metronidazole Plus FB301 Pre-treatment Trial

Not yet recruiting·FFreya Biosciences ApS·Phase 2·NCT07481955·120 enrolled

Chronic Periodontitis1 trial

Full-mouth Periodontal Debridement and Metronidazole Gel in Patients With Chronic Periodontitis

Completed·UUniversity of Campinas, Brazil·Phase 2·NCT01938183·30 enrolled

Endometriosis1 trial

The Use of Low Dose Metronidazole to Decrease Postoperative Pain After Endometriosis Surgery

Active, not recruiting·UUniversity of Louisville·Phase 4·NCT04554693·90 enrolled

Randomized1 trial

Vaginal lIve Biotherapeutic RANdomized Trial

Completed·MMassachusetts General Hospital·Phase 1·NCT06135974·24 enrolled

Open Heart Surgery1 trial

The Effects of Gut Micribiota Disruption on the Immune Response After Open Heart Surgery

Unknown status·RRadboud University Medical Center·N/A·NCT03939273·80 enrolled

Gut Microbiome1 trial

Impact of Non-surgical Periodontal Therapy on Oral and Gut Microbiome

Unknown status·UUniversity of Campinas, Brazil·Phase 4·NCT04580355·30 enrolled

Analgesia1 trial

Topical Analgesia Post-Haemorrhoidectomy

Completed·UUniversity of Auckland, New Zealand·Phase 2/3·NCT04276298·192 enrolled

Second-line Treatment1 trial

Sequential Versus Quadruple Therapy in the Second-line Treatment

Unknown status·NNational Taiwan University Hospital·Phase 4·NCT03208426·240 enrolled

Abscess1 trial

Antibiotic Treatment foLlowing Surgical drAinage of Perianal abScess; the ATLAS Trial

Unknown status·Ddr. IJM Han-Geurts·N/A·NCT05385887·298 enrolled

Trichomoniasis1 trial

Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis

Completed·UUniversity of Alabama at Birmingham·Phase 2·NCT01361048·40 enrolled

Resistance1 trial

Genotypic Resistance-guided Versus Empirical Therapy for H. Pylori Eradication.

Unknown status·—·Phase 4·NCT04090021·304 enrolled

First-line1 trial

The Efficacy of 10-day and 14-day Bismuth-based Quadruple Therapy in First-line H. Pylori Eradication

Enrolling by invitation·NNational Cheng-Kung University Hospital·Phase 4·NCT04527055·312 enrolled

Hysterectomy1 trial

PROJECT PREVENT: Metronidazole Antibiotic Per Vagina Before Hysterectomy: Is Additional Antibiotic Prophylaxis Beneficial?

Unknown status·NNew York Medical College·Phase 4·NCT04478617·136 enrolled

Perianal Crohn's Disease1 trial

Evaluation of the Pharmacokinetics of Metronidazole 10% Ointment Applied Peri Anally in Healthy Volunteers and Patients With Perianal Crohn's Disease

Completed·SS.L.A. Pharma AG·Phase 1·NCT00774969·19 enrolled

Pancreatic Cancer1 trial

Modulation of the Gut Microbiome With Pembrolizumab Following Chemotherapy in Resectable Pancreatic Cancer

Recruiting·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT05462496·25 enrolled

Obesity1 trial

The Impact of Obesity on Nonsurgical Periodontal Therapy

Unknown status·FFederal University of Rio Grande do Sul·N/A·NCT01405365·96 enrolled

Blastocyst1 trial

Is it Effective to Treat Patients With Blastocystis Hominis Infection?

Unknown status·UUniversity of Lausanne Hospitals·Phase 4·NCT01521403·200 enrolled

Current Smoker1 trial

Effect of Three Periodontal Therapies in Current Smokers and Non-Smokers

Completed·TThe Forsyth Institute·Phase 2·NCT00066066·146 enrolled

Cutaneous Leishmaniasis1 trial

Intralesional Injection of Metronidazole for the Management of Cutaneous Leishmaniasis

Recruiting·HHayder Adnan Fawzi·Phase 2·NCT06798415·40 enrolled

Oral Cancer1 trial

Antibiotic Treatment Effects on Intratumoral Bacteria Modulation in Surgical Patients With Oral Cancer

Recruiting·—·Phase 2·NCT06627270·30 enrolled

Fed1 trial

Bioavailability Study of Metronidazole Capsules Under Fed Conditions

Completed·PPar Pharmaceutical, Inc.·Phase 1·NCT01380522·18 enrolled

Allergy1 trial

Tailored Therapy for Helicobacter Pylori Treatment in Patients With Penicillin Allergy

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT03708848·112 enrolled

Pulmonary Tuberculosis1 trial

Metronidazole for Pulmonary Tuberculosis (South Korea)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00425113·35 enrolled

Sclerosing Cholangitis1 trial

A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis

Completed·MMayo Clinic·Phase 1·NCT01085760·35 enrolled

Colon Surgery1 trial

Gut Decolonisation With Neomycin/Metronidazole or Rifaximin Before Colon Surgery

Not yet recruiting·—·Phase 4·NCT07180615·458 enrolled

Appendicitis1 trial

Once Daily Metronidazole for Perforated Appendicitis

Withdrawn·AAhmed Nasr·Phase 4·NCT02561117

Children1 trial

Efficacy of Nitazoxanide Based Therapy vs Standard Triple Therapy in H-pylori in Children

Completed·MMuhammad Aamir Latif·N/A·NCT07086937·66 enrolled

Metastatic Colorectal Cancer1 trial

Fecal Microbiota Transplant and Re-introduction of Anti-PD-1 Therapy (Pembrolizumab or Nivolumab) for the Treatment of Metastatic Colorectal Cancer in Anti-PD-1 Non-responders

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04729322·15 enrolled

Metastatic Prostate Cancer1 trial

Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer

Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT06616597·58 enrolled

Lymphoma1 trial

Helicobacter - Lymphoma - Radiation Part I: Eradication, Part II: Radiation

Unknown status·TTechnische Universität Dresden·Phase 3·NCT00154440·200 enrolled

Premature Infants1 trial

Metronidazole Pharmacokinetics (PK) in Premature Infants

Completed·MMichael Cohen-Wolkowiez·Phase 1·NCT01222585·24 enrolled

Systemic Sclerosis1 trial

Effectiveness of Saccharomyces Boulardii for Gastrointestinal Bacterial-overgrowth in Systemic Sclerosis

Completed·CCoordinación de Investigación en Salud, Mexico·Phase 4·NCT03692299·39 enrolled

Encephalopathy1 trial

The Effects of Nitazoxanide in Hepatic Encephalopathy

Unknown status·—·Phase 2·NCT02334163·36 enrolled

Unspecified7 trials

Bioavailability of Metronidazole Vaginal Gel in Healthy Subjects

Completed· Teva logo

Teva·Phase 1·NCT01020877·38 enrolled

Does the Negativation of the Glucose Hydrogen Breath Test Come Along With a Reduction of the Symptoms of Gaz Incontinence ?

Completed·UUniversity Hospital, Rouen·Phase 3·NCT01275560·16 enrolled

Bioavailability of ATI-1501 With Taste Test Sub Study

Completed·AAppili Therapeutics Inc.·Phase 1·NCT03337126·48 enrolled

Show 4 more trials

Safety and Tolerability of Metronidazole Gel 1.3%

Completed·IInsud Pharma·Phase 4·NCT02392026·60 enrolled

An Evaluation of the Cosmetic Appearance of Metronidazole Gel (MetroGel®) 1%

Completed·GGalderma R&D··NCT00668655·30 enrolled

Metronidazole SC Penetrance With Moisturizers

Completed·—·N/A·NCT06434519·21 enrolled

Tetracycline Versus Doxycycline for HP Rescue Therapy

Unknown status·SShanghai Zhongshan Hospital·Phase 4·NCT05018923·242 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

FLAGYL I.V.

NDA NDA018353

Jan 1, 1982

FLAGYL I.V. RTU IN PLASTIC CONTAINER

NDA NDA018657

Jan 1, 1982

METRONIDAZOLE

NDA NDA018517

Jan 1, 1982

FLAGYL

NDA NDA012623

Mar 4, 1982

METRONIDAZOLE

NDA NDA018620

Aug 31, 1982

METRO I.V.

NDA NDA018674

Sep 17, 1982

METRONIDAZOLE

NDA NDA018599

Sep 17, 1982

METRONIDAZOLE

NDA NDA018764

Oct 22, 1982

METRONIDAZOLE

NDA NDA018740

Feb 16, 1983

METRONIDAZOLE

NDA NDA018818

Mar 2, 1983

PROTOSTAT

NDA NDA018871

Aug 18, 1983

METRONIDAZOLE

NDA NDA018845

Aug 18, 1983

METRONIDAZOLE

NDA NDA018930

Sep 29, 1983

METRO I.V. IN PLASTIC CONTAINER

NDA NDA018900

Nov 18, 1983

METRONIDAZOLE IN PLASTIC CONTAINER

NDA NDA018890

Nov 18, 1983

METRONIDAZOLE

NDA NDA018889

Mar 30, 1984

METRONIDAZOLE

NDA NDA018907

Apr 10, 1984

METRONIDAZOLE

NDA NDA019029

Nov 22, 1988

METROGEL

NDA NDA019737

Aug 17, 1992

METROGEL-VAGINAL

NDA NDA020208

May 3, 1995

FLAGYL

NDA NDA020334

Sep 20, 1995

METROCREAM

NDA NDA020531

Sep 26, 1997

NORITATE

NDA NDA020743

Nov 26, 1997

FLAGYL ER

NDA NDA020868

Nov 24, 1998

METROLOTION

NDA NDA020901

May 20, 2005

VANDAZOLE

NDA NDA021806

Jun 30, 2005

METROGEL

NDA NDA021789

Mar 24, 2014

NUVESSA

NDA NDA205223

Sep 22, 2023

LIKMEZ

NDA NDA216755

Sources

References

[1]
ClinicalTrials.gov — 226 trial records for Metronidazole. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Flagyl drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Metronidazole compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Metronidazole. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA216755). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Flagyl. U.S. Food & Drug Administration.
[7]
SEC EDGAR — DePuy Orthopaedics company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: DDePuy Orthopaedics

Patent Landscape[6]

Patent Cliff

Feb 2, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8877792Feb 2, 2028

7893097Feb 19, 2028

8658678Jun 27, 2028

9198858Jun 28, 2032

8946276Jun 28, 2032

4 more patents

10238634Jun 28, 2032

10596155Jun 28, 2032

12257236Jan 16, 2039

11541035Oct 4, 2039

Flagyl

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q2 2027

Trials by Indication[1]

Bacterial Vaginosis23 trials

Helicobacter Pylori Infection9 trials

Helicobacter Pylori Eradication9 trials

Helicobacter Pylori8 trials

Antibiotics5 trials

Infections5 trials

Periodontitis4 trials

Intra-abdominal Infection4 trials

Diarrhea3 trials

Efficacy and Safety3 trials

Crohn's Disease3 trials

Growth3 trials

Ulcerative Colitis3 trials

Antibiotic3 trials

Treatment3 trials

Gingivitis3 trials

Pelvic Inflammatory Disease2 trials

First-line Treatment2 trials

Parasitic Infection2 trials

Colitis2 trials

Clostridium Difficile Infection2 trials

Infection2 trials

Surgery2 trials

Complicated Intra-abdominal Infections2 trials

Oral2 trials

Colorectal Surgery2 trials

Randomized Controlled Trial2 trials

Tics2 trials

Peri-Implantitis2 trials

Rosacea2 trials

Aggressive Periodontitis2 trials

Preoperative2 trials

Colorectal Cancer2 trials

H Pylori Infection2 trials

Vaginal Discharge1 trial

Chorioamnionitis1 trial

Gastrectomy1 trial

Pilot Study1 trial

Abortion1 trial

Overlap Syndrome1 trial

Infertility1 trial

Immune Response1 trial

Treatment Failure1 trial

Liver Metastases1 trial

Interaction1 trial

Adolescent1 trial

Randomised Controlled Trial1 trial

Complication1 trial

Ischemia1 trial

Single Dose1 trial

Locally-advanced Rectal Cancer1 trial

Malnutrition1 trial

Fasting Conditions1 trial

Rescue Therapy for Helicobacter Pylori1 trial

Rectal Adenocarcinoma1 trial

Pregnant Women1 trial

Amputation1 trial

Probiotics1 trial

Recurrence1 trial

Pneumonia1 trial

Surgical1 trial

Brain Injury1 trial

Clostridium Difficile1 trial

Clindamycin Vs Metronidazole1 trial

ESS1 trial

PPROM1 trial

Steroid1 trial

Chlorhexidine1 trial

Chronic Periodontitis1 trial

Endometriosis1 trial

Randomized1 trial

Open Heart Surgery1 trial