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Drug

Metronidazole

Approved · FDA
Emerging researchLate-stage development
Also known as 2-methyl-5-nitroimidazole-1-ethanol, Flagyl, Likmez, MetroCream+22 more

2-methyl-5-nitroimidazole-1-ethanol, Flagyl, Likmez, MetroCream, MetroGel, MetroLotion, MetroNIDAZOLE Benzoate, MetroNIDAZOLE Topical, MetroNIDAZOLE Vaginal, Metryl, Noritate, Nuvessa, Nydamax, Protostat, Pylera, Rosadan, Rozex, Vitazol, 1-(2-hydroxy-1-ethyl)-2-methyl-5-nitroimidazole, 1-(2-hydroxyethyl)-2-methyl-5-nitroimidazole, 2-methyl-1-(2-hydroxyethyl)-5-nitroimidazole, 2-methyl-3-(2-hydroxyethyl)-4-nitroimidazole, Vandazole, Metronidazol, Métronidazole, Metronidazolum.

RxNorm6922ChEMBLCHEMBL137ATCD06BX01ATCP01AB51ATCG01AF01ATCA01AB17ATCP01AB01ATCJ01XD01UNII140QMO216E
2
Research papers
27
Active clinical trials
20
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase II Trial to Prevent Linear Growth Stunting and Malnutrition in Impoverished Children From a Low-Income Country by Treating Small Intestine Bacterial Overgrowth

Clinical trial2026-08-02Primary completion · ClinicalTrials.gov

Machine learning and deep learning for predicting photocatalytic degradation efficiency of metronidazole via TiO2/ZnO nanocomposites: a response surface methodology approach

Industry2026-07-31Nature — Environmental Sciences

Functionalised MWCNT@CoCuMoO4 electrocatalytic nanocomposite for metronidazole sensing and water splitting reaction applications

Industry2026-07-29Nature — Environmental Sciences

Comparing Placebo Versus Antibiotics for Acute Uncomplicated Diverticulitis

Clinical trial2026-07-08Results expected Q2 2028 · ClinicalTrials.gov

Vaginal Microbiota Transplant to Promote Lactobacillus-dominant Cervicovaginal Communities

Clinical trial2026-07-06Results expected Q1 2027 · ClinicalTrials.gov

PROMIZE: A Phase I/II Trial to Assess the Safety, Tolerability and Preliminary Anti-tumour Activity of Oral Combination Antibiotic Therapy to Modulate the Microbiome in Combination With Enzalutamide With Metastatic Castration Resistant Prostate Cancer (mCRPC).

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

Label change: METRONIDAZOLE ORAL (NDA216755)

Regulatory2025-02-28FDA

Label change: METRONIDAZOLE (ANDA206191)

Regulatory2024-12-03FDA

Label change: METRONIDAZOLE (NDA020334)

Regulatory2024-07-08FDA

Label change: METRONIDAZOLE ORAL (NDA216755)

Regulatory2024-07-08FDA

Antibiotic-induced microbiome depletion alters metabolic homeostasis by affecting gut signaling and colonic metabolism.

Research2018-07-20Nature communications

Determining population and developmental pharmacokinetics of metronidazole using plasma and dried blood spot samples from premature infants.

Research2013-09-01The Pediatric infectious disease journal

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Metronidazole
Aliases & brands
2-methyl-5-nitroimidazole-1-ethanolFlagylLikmezMetroCreamMetroGelMetroLotionMetroNIDAZOLE BenzoateMetroNIDAZOLE TopicalMetroNIDAZOLE VaginalMetrylNoritateNuvessaNydamaxProtostatPyleraRosadanRozexVitazol1-(2-hydroxy-1-ethyl)-2-methyl-5-nitroimidazole1-(2-hydroxyethyl)-2-methyl-5-nitroimidazole2-methyl-1-(2-hydroxyethyl)-5-nitroimidazole2-methyl-3-(2-hydroxyethyl)-4-nitroimidazoleVandazoleMetronidazolMétronidazoleMetronidazolum
RxNorm CUI
6922
ChEMBL ID
CHEMBL137
ATC codes
D06BX01P01AB51G01AF01A01AB17P01AB01J01XD01
UNII
140QMO216E
Regulatory jurisdictions
fda

Regulatory timeline

20 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
1995-05-03
Latest approval
2023-09-22
Authorities
FDA
Total events
20
fdaU.S. Food and Drug Administration· 20 events
2025-02-28Label change
Label change: METRONIDAZOLE ORAL (NDA216755)
Evidence ↗
2024-12-03Label change
Label change: METRONIDAZOLE (ANDA206191)
Evidence ↗
2024-07-08Label change
Label change: METRONIDAZOLE (NDA020334)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

193 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
193
registered trials across all phases
LATEST COMPLETION 2025
27
Active studies
25
Recruiting
141
Late-stage (III+)
110
Completed
56
Discontinued
PHASE DISTRIBUTIONn = 193
Early Phase 12Phase 114Phase 1 / 24Phase 232Phase 2 / 312Phase 329Phase 474Phase N / A26

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Optimal Treatment Duration of Bismuth Quadruple Therapy for Helicobacter Pylori Eradication in Female Patients and Comparison of the Efficacy with That of Male Patients

Enrolling by invitationPH IVNational Cheng-Kung University Hospitaln=6612032

Refining Treatment Options for Trichomonas Vaginalis Infection in Women and Men: A Comparative Analysis of Oral Multi-Dose Metronidazole and Single-Dose Secnidazole

RecruitingPH IVKey trialTulane Universityn=1,2002029

Neomycine/Metronidazole- vs Rifaximin-based Gut Decolonisation Prior to Colon Surgery: a Randomized Multicenter Trial

Not yet recruitingPH IVUniversität Luzernn=4582029

The Studies of Integrating Gastric and Gut Microbiota, F. Prausnitzii Metabolites, Microenvironment, and Epigenetics to Identify the Cancer Risk of H. Pylori-related Precancerous Conditions Through an AI System and Control the Risky by Probiotic Supplements

Enrolling by invitationPH IVNational Cheng-Kung University Hospitaln=3122028

Screen-and-treat Strategy for Vaginal Flora Abnormalities by Multiplex Molecular Biology Using POC Technology in Pregnant Women at High Risk of Preterm Birth: A Multicentre, Randomized Study (AUTOP2)

Not yet recruitingPH IVKey trialAssistance Publique Hopitaux De Marseillen=1,2922028

Recent completions

Trials that read out recently, adding to the completed evidence base.

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

CompletedN/AHaEmek Medical Center, Israeln=1662025

Assessing the Longitudinal Outcomes of Piperacillin/Tazobactam Versus ceftriAxone and Metronidazole for Children With Perforated Appendicitis (ALPACA): a Randomized Controlled Trial

CompletedPH IIMcMaster Children's Hospitaln=162025

To Compare the Efficacy of Nitrazoxinide Based Triple Therapy Versus Standard Triple Therapy for Eradication of Helicobacter Pylori Infection in Children at a Tertiary Care Hospital

CompletedN/AMuhammad Aamir Latifn=662025

Phase 1 Trial of Multi-strain Lactobacillus Crispatus Vaginal Live Biotherapeutic Product

CompletedPH IMassachusetts General Hospitaln=242025

A Single-center, Open-label, Study Evaluating Safety and Pharmacokinetics of Single Doses of Zidebactam-Cefepime and Metronidazole Alone or in Combination Utilizing a 3-Period, Crossover Study Design

CompletedPH IWockhardtn=302025

Rifabutin-containing Triple Therapy for Helicobacter Pylori Rescue Treatment: a Randomized Controlled Trial

CompletedPH IVShanghai Jiao Tong University School of Medicinen=3602025

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20132018
Major research themes2
Blood Chemical Analysis1Infant, Premature1
Journals, researchers & institutions
Top journals
  • Nature communications1
  • The Pediatric infectious disease journal1
Leading researchers
  • Arrieta A1
  • Benjamin DK Jr1
  • Bloom BT1
  • Capparelli EV1
  • Chaix A1
  • Chang MW1
  • Cohen-Wolkowiez M1
  • Harper B1
Leading institutions
free-text, unnormalised
  • Center for Microbiome Innovation1
  • Duke University; †Duke Clinical Research Institute1
  • Protein Biology Laboratory1
  • Regulatory Biology Laboratory1
  • The Salk Institute1
  • University of California1

Related drugs

5 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Amphotericin B

Studied across 3 of the same disease areas as Metronidazole in the shared literature.

3 shared diseases1 shared paper
Ampicillin

Studied across 3 of the same disease areas as Metronidazole in the shared literature.

3 shared diseases1 shared paper
Insulin

Studied across 3 of the same disease areas as Metronidazole in the shared literature.

3 shared diseases1 shared paper
Neomycin

Studied across 3 of the same disease areas as Metronidazole in the shared literature.

3 shared diseases1 shared paper
Vancomycin

Studied across 3 of the same disease areas as Metronidazole in the shared literature.

3 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.