METRONIDAZOLE

Post-LOE

metronidazole vaginal gel, 1.3 %

ANDAVAGINALGEL

Approved

Mar 2024

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

METRONIDAZOLE (metronidazole vaginal gel, 1.3 %) is [see microbiology ()] . Approved for bacterial vaginosis in females 12 years of age, older. First approved in 2024.

Drug data last refreshed 12h ago

Mechanism of Action

[see Microbiology ()] .

Pharmacologic Class:

Nitroimidazole Antimicrobial

Indications (2)

bacterial vaginosis in females 12 years of age older

Clinical Trials (20)

NCT07481955Phase 2Recruiting

Chlorhexidine and/or Metronidazole Plus FB301 Pre-treatment Trial

Started Mar 2026

120 enrolled

Bacterial Vaginosis (BV)

NCT06806995Phase 1Completed

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

Started Jan 2025

30 enrolled

PHA1A

NCT05861310Phase 1Unknown

Effectivity and Safety of Metronidazole 1% Cream in Rosacea Therapy

Started May 2023

48 enrolled

Rosacea

NCT04186247Phase 2Terminated

Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD)

Started Aug 2021

13 enrolled

Crohn DiseasePediatric Crohns Disease

NCT03830333Phase 3Completed

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

Started Mar 2019

268 enrolled

Complicated Intra-abdominal Infections

Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.