Last reviewed · How we verify
PPI, amoxicillin, metronidazole and clarithromycin
This is a quadruple therapy regimen that eradicates Helicobacter pylori by combining acid suppression with three antibiotics that target bacterial protein synthesis and DNA.
This is a quadruple therapy regimen that eradicates Helicobacter pylori by combining acid suppression with three antibiotics that target bacterial protein synthesis and DNA. Used for Helicobacter pylori infection eradication in peptic ulcer disease, H. pylori-associated gastritis.
At a glance
| Generic name | PPI, amoxicillin, metronidazole and clarithromycin |
|---|---|
| Sponsor | Infante, Javier Molina, M.D. |
| Drug class | Antibiotic combination therapy with acid suppression |
| Target | Helicobacter pylori (bacterial pathogen); PPI targets H+/K+-ATPase; amoxicillin targets bacterial cell wall; metronidazole and clarithromycin target bacterial protein synthesis |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
The proton pump inhibitor (PPI) reduces gastric acid to create an optimal environment for antibiotic activity. Amoxicillin, metronidazole, and clarithromycin are bactericidal/bacteriostatic agents that work synergistically to inhibit H. pylori protein synthesis and disrupt bacterial DNA, preventing resistance development through multi-drug targeting.
Approved indications
- Helicobacter pylori infection eradication in peptic ulcer disease
- H. pylori-associated gastritis
Common side effects
- Diarrhea
- Nausea
- Abdominal pain
- Taste disturbance (metallic taste from metronidazole)
- Headache
- Allergic reaction (amoxicillin)
Key clinical trials
- Fourteen-Day Vonoprazan-Based Dual Therapy With Amoxicillin as First-Line Helicobacter Pylori Treatment in Comparison With Extended Sequential Therapy (PHASE4)
- Personalized vs Standard of Care Treatment for Helicobacter Pylori Eradication Among Veterans (PHASE3)
- Efficacies of Susceptibility-guided vs Empiric Therapy for Rescue Treatment of Helicobacter Pylori Infection (PHASE4)
- Tailored Therapy for Clarithromycin-Resistant H. Pylori (NA)
- Comparison of Keverprazan Hydrochloride-Amoxicillin Dual Therapy and Susceptibility-Guided Quadruple Therapy for Helicobacter Pylori Rescue Treatment (PHASE3)
- Real-world Treatment of H. Pylori Eradication in Patients with Comorbidity
- Helicobacter Pylori Eradication According to DPO-PCR Methods (K-CREATE) Study) (PHASE4)
- Tegoprazan-containing Sequential for H. Pylori (NA)
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: