NDAORALTABLET
Approved
Mar 1983
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
PROTOSTAT (metronidazole) by Johnson & Johnson is mechanism of action metronidazole, a nitroimidazole, exerts antibacterial effects in an anaerobic environment against most obligate anaerobes. First approved in 1983.
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROTOSTAT (metronidazole) is an oral nitroimidazole antibiotic approved in 1983 that treats anaerobic bacterial infections and parasitic conditions including bacterial vaginosis, intra-abdominal infections, and rosacea. The drug works by entering anaerobic bacteria, undergoing reduction to form free radicals that damage bacterial DNA, leading to cell death. Metronidazole is a foundational antimicrobial with broad clinical utility across gynecologic, surgical, and dermatologic indications.
LOE Approaching
Product is in late lifecycle stage with limited commercial growth opportunities; brand teams are typically small and focused on defensive market share and cost management.
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.