Metronidazole Vaginal Gel 0.75% — Competitive Intelligence Brief

Metronidazole Vaginal Gel 0.75% (Metronidazole Vaginal Gel 0.75%) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Nitroimidazole antibiotic. Area: Infectious Disease.

marketed Nitroimidazole antibiotic Bacterial DNA Infectious Disease Small molecule

Target snapshot

Metronidazole Vaginal Gel 0.75% (Metronidazole Vaginal Gel 0.75%) — Balmoral Medical company. Metronidazole disrupts bacterial DNA by generating reactive oxygen species and damaging microbial genetic material, thereby killing anaerobic bacteria and protozoa.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Metronidazole Vaginal Gel 0.75% TARGET	Metronidazole Vaginal Gel 0.75%	Balmoral Medical company	marketed	Nitroimidazole antibiotic	Bacterial DNA
Omeprazole, Amoxicillin, Metronidazole and Clarithromycin	Omeprazole, Amoxicillin, Metronidazole and Clarithromycin	Al-Azhar University	marketed	Proton pump inhibitor + antibiotic combination therapy	H+ ATPase (omeprazole); bacterial ribosome and cell wall (amoxicillin, clarithromycin); bacterial DNA (metronidazole)
ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin	ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin	University of British Columbia	marketed	Fluoroquinolone, Sulfonamide-diaminopyrimidine combination, Nitrofuran	Bacterial DNA gyrase, topoisomerase IV, dihydrofolate reductase, bacterial DNA
Administration of Metronidazole plus Amoxicillin	Administration of Metronidazole plus Amoxicillin	University of Chile	marketed	Antibiotic combination	Bacterial DNA (metronidazole); bacterial cell wall/penicillin-binding proteins (amoxicillin)
levofloxacin-based triple therapy	levofloxacin-based triple therapy	National Taiwan University Hospital	marketed	Fluoroquinolone antibiotic (in combination therapy)	Bacterial DNA gyrase and topoisomerase IV
moxifloxacin 0.5% eye drops	moxifloxacin 0.5% eye drops	Allergan	marketed	Fluoroquinolone antibiotic	Bacterial DNA gyrase and topoisomerase IV
metronidazole and doxycycline	metronidazole and doxycycline	Hospital de Clinicas de Porto Alegre	marketed	Antibiotic combination	Bacterial DNA (metronidazole); bacterial 30S ribosome (doxycycline)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Nitroimidazole antibiotic class)

1. National Taiwan University Hospital · 2 drugs in this class
2. Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd · 2 drugs in this class
3. University of Guarulhos · 2 drugs in this class
4. Johns Hopkins Bloomberg School of Public Health · 1 drug in this class
5. LEO Pharma · 1 drug in this class
6. Sherief Abd-Elsalam · 1 drug in this class
7. University of Alabama at Birmingham · 1 drug in this class
8. University of Sao Paulo · 1 drug in this class
9. Appili Therapeutics Inc. · 1 drug in this class
10. bioRASI, LLC · 1 drug in this class