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Metronidazole Vaginal Gel 0.75%
Metronidazole disrupts bacterial DNA by generating reactive oxygen species and damaging microbial genetic material, thereby killing anaerobic bacteria and protozoa.
Metronidazole disrupts bacterial DNA by generating reactive oxygen species and damaging microbial genetic material, killing anaerobic bacteria and protozoa. Used for Bacterial vaginosis, Trichomoniasis vaginalis infection.
At a glance
| Generic name | Metronidazole Vaginal Gel 0.75% |
|---|---|
| Sponsor | Balmoral Medical company |
| Drug class | Nitroimidazole antibiotic |
| Target | Bacterial DNA |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Metronidazole is a nitroimidazole prodrug that is activated by anaerobic organisms to form reactive intermediates that bind to and cleave bacterial DNA, preventing replication and causing cell death. It is effective against anaerobic bacteria and certain protozoa. The vaginal gel formulation delivers the drug topically to treat local vaginal infections.
Approved indications
- Bacterial vaginosis
- Trichomoniasis vaginalis infection
Common side effects
- Vulvovaginal irritation or burning
- Metallic taste
- Vaginal discharge
- Headache
Key clinical trials
- Bioequivalence of Metronidazole Gel, 0.75% in the Treatment of Bacterial Vaginosis (PHASE1, PHASE2)
- Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy (PHASE2)
- Study Evaluating the Equivalence of GDC-229 and Metronidazole Vaginal Gel 0.75% in the Treatment of Bacterial Vaginosis (PHASE3)
- Dose Ranging Study of Metronidazole Vaginal Gel in the Treatment of Bacterial Vaginosis (PHASE2)
- Bioavailability of Metronidazole Vaginal Gel in Healthy Subjects (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Metronidazole Vaginal Gel 0.75% CI brief — competitive landscape report
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- Balmoral Medical company portfolio CI