NDATOPICALLOTION
Approved
Nov 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
METROLOTION (metronidazole) by Galderma is clinical pharmacology the mechanisms by which metronidazole acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect. First approved in 1998.
Drug data last refreshed 3h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
METROLOTION is a topical nitroimidazole lotion formulation of metronidazole approved in 1998 for rosacea and other indications including bacterial vaginosis and trichomoniasis. The mechanism of action in rosacea appears to involve anti-inflammatory effects, though the exact pathway remains unknown. Topical application results in minimal systemic absorption (80 times lower than oral dosing), limiting drug-drug interactions and toxicity concerns.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), signaling potential team consolidation and transition to defensive strategy.
Mechanism of Action
CLINICAL PHARMACOLOGY The mechanisms by which metronidazole acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect. Pharmacokinetics: Absorption of metronidazole after topical application of Metronidazole Topical Lotion is less complete and more prolonged…
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.