NDATOPICALGEL
Approved
Jun 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
METROGEL (metronidazole) by Galderma is 12. First approved in 2005.
Drug data last refreshed 38m ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MetroGel is a topical gel formulation of metronidazole, a nitroimidazole antimicrobial, approved by the FDA in 2005 for the treatment of rosacea. The mechanism of action in rosacea remains unknown, though metronidazole is known to have antimicrobial and anti-inflammatory properties. It is applied directly to affected facial skin and achieves minimal systemic absorption, with topical plasma levels less than 1% of oral dosing.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), indicating potential team consolidation and shift toward defensive positioning.
Mechanism of Action
12.1 Mechanism of Action The mechanism of action of metronidazole in the treatment of rosacea is unknown. 12.2 Pharmacodynamics The pharmacodynamics of metronidazole in association with the treatment of rosacea are unknown. Cardiac Electrophysiology: The effect of Metronidazole Gel, 1% on the QTc…
Pharmacologic Class:
Nitroimidazole Antimicrobial
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.