METRONIDAZOLE
LOE ApproachingNDAORALTABLET
Approved
Oct 1982
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
2/8 — Basic
Drug data last refreshed 5h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Metronidazole is a nitroimidazole small-molecule antibiotic used to treat parasitic infections (asymptomatic trichomoniasis, amebiasis) and serious anaerobic bacterial infections. It is well absorbed orally with peak plasma concentrations 1-2 hours post-administration and distributes widely including to CSF and hepatic abscess sites. The drug works via bactericidal mechanism against susceptible anaerobic organisms and protozoan parasites.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30), indicating defensive positioning and potential team restructuring.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
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.