NDAVAGINALGEL
Approved
Mar 2014
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
NUVESSA (metronidazole) by Galderma is [see microbiology ( )]. First approved in 2014.
Drug data last refreshed 18h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NUVESSA is a vaginal gel formulation of metronidazole, a nitroimidazole antimicrobial, approved in 2014 for treating bacterial vaginosis and related vaginal infections. It works by disrupting DNA synthesis in anaerobic bacteria through reduction of its nitro group. The product represents a localized vaginal delivery alternative to systemic metronidazole dosing.
$0.11MPart D
Peak6.0 years to LOEProduct is at peak lifecycle maturity with minimal Medicare Part D penetration ($110K annual spending), indicating a niche specialty market with a focused, stable commercial team.
Mechanism of Action
[see Microbiology ( )].
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.