Reference: Metronidazole Gel 1% — Competitive Intelligence Brief

Reference: Metronidazole Gel 1% (Reference: Metronidazole Gel 1%) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Nitroimidazole antibiotic. Area: Infectious Disease / Dermatology.

phase 3 Nitroimidazole antibiotic Bacterial and protozoal DNA Infectious Disease / Dermatology Small molecule

Target snapshot

Reference: Metronidazole Gel 1% (Reference: Metronidazole Gel 1%) — bioRASI, LLC. Metronidazole is a nitroimidazole antibiotic that disrupts bacterial and protozoal DNA by generating reactive free radicals, leading to cell death.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Reference: Metronidazole Gel 1% TARGET	Reference: Metronidazole Gel 1%	bioRASI, LLC	phase 3	Nitroimidazole antibiotic	Bacterial and protozoal DNA
Amoxicillin, Metronidazole	Amoxicillin, Metronidazole	Shanghai Jiao Tong University School of Medicine	marketed	Beta-lactam antibiotic + nitroimidazole antibiotic combination	Penicillin-binding proteins (amoxicillin); anaerobic DNA (metronidazole)
Antibiotics, cefuroxime and metronidazole	Antibiotics, cefuroxime and metronidazole	Helsinki University Central Hospital	marketed	Beta-lactam antibiotic + nitroimidazole antibiotic combination	Bacterial penicillin-binding proteins (cefuroxime); anaerobic bacterial DNA (metronidazole)
Ornidazole and Sodium Chloride Injection	Ornidazole and Sodium Chloride Injection	Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd	marketed	Nitroimidazole antibiotic	Bacterial/parasitic DNA
Ciprofloxacin Tablets & Metronidazole tablets	Ciprofloxacin Tablets & Metronidazole tablets	MinaPharm Pharmaceuticals	marketed	Fluoroquinolone + Nitroimidazole antibiotic combination	Bacterial DNA gyrase, topoisomerase IV (ciprofloxacin); anaerobic DNA (metronidazole)
Cefazolin and Metronidazole.	Cefazolin and Metronidazole.	The University of Texas Health Science Center, Houston	marketed	Beta-lactam antibiotic and nitroimidazole antibiotic combination	Penicillin-binding proteins (cefazolin); anaerobic bacterial DNA (metronidazole)
Metronidazole 400 (14 days)	Metronidazole 400 (14 days)	University of Guarulhos	marketed	Nitroimidazole antibiotic	Bacterial/parasitic DNA

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