NDAINJECTIONINJECTABLE
Approved
Mar 1984
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
METRONIDAZOLE (metronidazole) by Hikma is mechanism of action metronidazole, a nitroimidazole, exerts antibacterial effects in an anaerobic environment against most obligate anaerobes. First approved in 1984.
Drug data last refreshed 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Metronidazole is a nitroimidazole antibiotic that reduces DNA synthesis and causes DNA degradation in anaerobic bacteria through formation of nitro free radicals. It is approved as an injectable formulation for treatment of anaerobic bacterial infections including bacterial vaginosis, intra-abdominal infections, pelvic inflammatory disease, and surgical site infections. The drug works by passive diffusion into anaerobic organisms where it is activated intracellularly to disrupt bacterial DNA.
LOE Approaching
As LOE approaches, metronidazole brand team faces margin pressure and likely organizational consolidation, with focus shifting to cost management and generic transition planning.
Mechanism of Action
Mechanism of Action Metronidazole, a nitroimidazole, exerts antibacterial effects in an anaerobic environment against most obligate anaerobes. Once metronidazole enters the organism by passive diffusion and is activated in the cytoplasm of susceptible anaerobic bacteria, it is reduced; this process…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Chlorhexidine and/or Metronidazole Plus FB301 Pre-treatment Trial
Started Mar 2026
120 enrolled
Bacterial Vaginosis (BV)
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
Effectivity and Safety of Metronidazole 1% Cream in Rosacea Therapy
Started May 2023
48 enrolled
Rosacea
Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD)
Started Aug 2021
13 enrolled
Crohn DiseasePediatric Crohns Disease
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
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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.