TheraRadar
Data updated: Jun 17, 2026

METRONIDAZOLE

Infectious Disease Approved 1981-10-30

Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion.

Source: FDA Label • FOUGERA PHARMS
Jump to: Indications Approvals Trials Competitors Safety Patents
54
Indications
--
Phase 3 Trials
44
Years on Market

Details

Status
Prescription
First Approved
1981-10-30
Routes
TOPICAL, ORAL, VAGINAL, INJECTION
Dosage Forms
LOTION, TABLET, GEL, CREAM, TABLET, EXTENDED RELEASE, INJECTABLE, CAPSULE

Companies

FOUGERA PHARMS ALEMBIC PHARMS LTD WATSON LABS Lupin CADILA PHARMS LTD ENCUBE SUPERPHARM CHARTWELL RX ZYDUS LIFESCIENCES STRIDES PHARMA ABLE IVAX SUB TEVA PHARMS Hikma ALEMBIC MUTUAL PHARM CHARTWELL MOLECULES TARO SOMERSET THERAPS LLC Aurobindo Pharma ABRAXIS PHARM INNOGENIX SOLARIS PHARMA CORP SCIEGEN PHARMS COSETTE PHARMS NC INTL MEDICATION HALSEY ABBOTT CADILA NOVITIUM PHARMA PADAGIS ISRAEL Teva UNICHEM FLAMINGO PHARMS FOSUN PHARMA GLENMARK PHARMS LTD PLIVA LNK
Active Ingredient: METRONIDAZOLE

METRONIDAZOLE Approval History

1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
703 FDA actions from 1981 to 2026
Mar 2026 SUPPL
Label · Labeling
Mar 2026 SUPPL
Label · Labeling
Feb 2026 SUPPL
Label · Labeling

What METRONIDAZOLE Treats

54 FDA approvals

Originally approved for its first indication in 1981 . Covers 54 distinct patient populations.

  • Other (54)

METRONIDAZOLE Boxed Warning

WARNING Metronidazole has been shown to be carcinogenic in mice and rats (see PRECAUTIONS ). Unnecessary use of the drug should be avoided. Its use should be reserved for the conditions described in the INDICATIONS AND USAGE section below....

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Clinical Trial Registry

94 trials
Trial Sponsor ID Phase Status Title
NCT07451171 302580 1R01HD113733-01A1 Ph 2 recruiting Comparative Efficacy of Antibiotics for Small Intestine Bacterial Overgrowth in Bangladeshi Children
NCT07492134 251398 1R01DK141523-01A1 Ph 2 not yet recruiting APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis)
NCT06569368 2023-0880 NCI-2025-07395 Ph 2 recruiting Trial Utilizing Metronidazole to Optimize the Microbiome of Rectal Adenocarcinoma Undergoing Neoadjuvant Therapy
NCT01275560 2008/073/HP Ph 3 completed Does the Negativation of the Glucose Hydrogen Breath Test Come Along With a Reduction of the Symptoms of Gaz Incontinence ?
NCT06131021 PAAS Pro2023001347 4UH3DE031129-02 Ph 3 completed Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice
NCT06627270 CASE6324 Ph 2 recruiting Antibiotic Treatment Effects on Intratumoral Bacteria Modulation in Surgical Patients With Oral Cancer
NCT06616597 J2485 IRB00453879 Ph 2 recruiting Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer
NCT04729322 2020-0186 NCI-2020-13897, 2020-0186 Ph 2 active not recruiting 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
NCT07180615 NeoRiDe 2025-01074 Ph 4 not yet recruiting Gut Decolonisation With Neomycin/Metronidazole or Rifaximin Before Colon Surgery
NCT06806995 W-5222-106 Ph 1 completed A Single-center, Open-label, Study Evaluating Safety and Pharmacokinetics of Single Doses of Zidebactam-Cefepime and Metronidazole Alone or in Combination.
NCT05874544 rjhy20230001 Ph 4 completed Rescue Therapy for Helicobacter Pylori Infection
NCT04186247 PAZAZ results posted 19-3100 585718 Ph 2 terminated Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD)
NCT06387147 ORIAMI APHP220818 Ph 3 recruiting ORal Antibiotics in Acute Mesenteric Ischemia
NCT06798415 ALM25-003 apporval no (69) Ph 2 recruiting Intralesional Injection of Metronidazole for the Management of Cutaneous Leishmaniasis
NCT06793137 CEP3589/24 Ph 2 recruiting Intestinal Microbiome Modulation With Antibiotics in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer
NCT05874570 rjhy20230002 Ph 4 recruiting Doxycycline for Helicobacter Pylori Rescue Treatment
NCT05784311 SPARROW NL82304.058.22 Ph 4 recruiting Standard Versus Prolonged Antibiotic Prophylaxis After Pancreatoduodenectomy (SPARROW)
NCT05462496 STUDY-21-01814 Ph 2 recruiting Modulation of the Gut Microbiome With Pembrolizumab Following Chemotherapy in Resectable Pancreatic Cancer
NCT06633718 FL058-301 Ph 3 not yet recruiting Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in CIAI
NCT06349122 AUTOP2 2023-509421-41-00 Ph 4 not yet recruiting Screen-and-treat Strategy for Vaginal Flora Abnormalities in Pregnant Women at High Risk of Preterm Birth
NCT04927312 results posted C3591036 Ph 3 completed Study to Assess Efficacy and Safety of PF-06947386 in Japanese Adult Patients With Complicated Intra-abdominal Infection
NCT03187106 PACT 17-0035 Ph 1 completed Prophylactic Antibiotics After Cesarean
NCT05049902 2021-SDU-QILU-G001-2 Ph 4 completed Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication
NCT04578015 results posted 2020H0476 Ph 4 terminated A Randomized Controlled Trial of Treatment of Bacterial Vaginosis
NCT03557008 results posted IRB00101567 Ph 4 completed Responses to Rabies Vaccine in Adults With or Without Antibiotics
NCT03217136 results posted 7625A-035 MK-7625A-035, 2016-004820-41 Ph 2 completed MK-7625A Plus Metronidazole Versus Meropenem in Pediatric Participants With Complicated Intra-Abdominal Infection (cIAI) (MK-7625A-035)
NCT05720559 20230201zzg Ph 2 not yet recruiting Early Blocking Strategy for Metachronous Liver Metastasis of Colorectal Cancer Based on Pre-hepatic CTC Detection
NCT03830333 7625ACNPhase3 results posted 7625A-015 MK-7625A-015 Ph 3 completed Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem for Participants With Complicated Intra-abdominal Infection (MK-7625A-015)
NCT01426269 results posted US10183 Ph 4 completed Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo
NCT02042287 026/13 Ph 4 completed Treatment Comparison of Antibiotics Versus Vaginal Lactic Acid in Non-pregnant Women With Acute Symptomatic Bacterial Vaginosis
NCT02969928 results posted AmxMetClmCFA Ph 2, Ph 3 completed Two Different Antibiotic Agents to Treat Generalized Aggressive Periodontitis
NCT05061732 B2021-376 Ph 4 recruiting Helicobacter Pylori Eradication and Follow-up
NCT04024527 rjyy20190715 Ph 4 completed High Dose of Dual Therapy Plus Metronidazole for Helicobacter Pylori RescueTreatment
NCT02606032 FMT REB# 0163 Ph 2 completed Trial of Antimicrobials Versus Placebo in Addition to Fecal Transplant Therapy in Ulcerative Colitis
NCT03794765 AAASUC NK/5147/DM Ph 2 completed Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis
NCT03358576 results posted IT001-303 Ph 3 completed Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)
NCT02942485 results posted PGLIT2016 Ph 4 terminated Treatment of Giardia Lamblia Infections in Children
NCT02301000 IMT CDI Ph 2, Ph 3 terminated IMT for Primary Clostridium Difficile Infection
NCT01658852 Gastrectomy-MDZ-001 Ph 3 withdrawn Effects and Safety of Metronidazole in Patients With Gastrectomy
NCT03343366 DUHS/DR-O/2017/266 Ph 2, Ph 3 completed Glycemic Control in T2DM Through Non-Surgical Periodontal Therapy
NCT02308007 SMART GIVES results posted MTC-001 (Trial 3) Ph 3 completed Multi-Center Study of New Medications to Treat Vaginal Infections
NCT02308033 SMART GIVES results posted MTC-001 (Trial 2) Ph 3 completed Multi-Center Study of New Medications to Treat Vaginal Infections
NCT04415983 helicobacter children Ph 3 recruiting Study of Nitazoxanide (NTZ) for Helicobacter Pylori in Children
NCT04353362 Istanbul Medipol Ph 4 completed Alternative Antibiotic Regimen in Periodontitis Treatment
NCT02655419 results posted D4910C00009 C3601001, 2015-002726-39 Ph 2 completed Determine the PK and Safety and Tolerability of ATM-AVI for the Treatment of cIAIs in Hospitalized Adults (REJUVENATE)
NCT02766023 results posted 14-0029 HHSN272201300014I Ph 2 completed LACTIN-V Study for Recurrent Bacterial Vaginosis
NCT00667368 results posted 05-0131 HHSN272201300012I Ph 3 completed Bacterial Vaginosis Home Screening to Prevent STDs
NCT03708848 rjkls2017197 Ph 4 completed Tailored Therapy for Helicobacter Pylori Treatment in Patients With Penicillin Allergy
NCT02057198 C-Diff results posted Pro00043361 Ph 4 completed Impact of Oral Antibiotic Treatment on C. Difficile
NCT04066257 CJ_APA_111 Ph 1 completed Evaluate the PK of Multiple Oral Doses of Tegoprazan, Metronidazole, Tetracycline and Bismuth in Healthy Volunteers

Showing 50 of 94 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

METRONIDAZOLE FDA Label Details

Indications & Usage

FDA Label (PDF)

Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, ad...

⚠️ BOXED WARNING

WARNING Metronidazole has been shown to be carcinogenic in mice and rats (see PRECAUTIONS ). Unnecessary use of the drug should be avoided. Its use should be reserved for the conditions described in the INDICATIONS AND USAGE section below....

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Data Sources

FDA Approval: ANDA077197 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.