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Amoxicillin/omeprazole
Amoxicillin/omeprazole is a Beta-lactam antibiotic + proton pump inhibitor combination Small molecule drug developed by National Cancer Institute (NCI). It is currently in Phase 3 development for Helicobacter pylori eradication as part of triple or quadruple therapy, Peptic ulcer disease associated with H. pylori infection.
Amoxicillin kills bacteria by inhibiting cell wall synthesis, while omeprazole reduces gastric acid to protect the stomach lining and improve antibiotic delivery.
Amoxicillin kills bacteria by inhibiting cell wall synthesis, while omeprazole reduces gastric acid to protect the stomach lining and improve antibiotic delivery. Used for Helicobacter pylori eradication as part of triple or quadruple therapy, Peptic ulcer disease associated with H. pylori infection.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Amoxicillin/omeprazole |
|---|---|
| Sponsor | National Cancer Institute (NCI) |
| Drug class | Beta-lactam antibiotic + proton pump inhibitor combination |
| Target | Bacterial penicillin-binding proteins (amoxicillin); H+/K+-ATPase (omeprazole) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
Amoxicillin is a beta-lactam antibiotic that binds to penicillin-binding proteins and inhibits bacterial cell wall cross-linking, leading to cell lysis. Omeprazole is a proton pump inhibitor that suppresses gastric acid secretion, reducing acid-related damage and potentially enhancing amoxicillin bioavailability in the upper GI tract. This combination is typically used to eradicate Helicobacter pylori infection while minimizing gastric ulceration.
Approved indications
- Helicobacter pylori eradication as part of triple or quadruple therapy
- Peptic ulcer disease associated with H. pylori infection
Common side effects
- Diarrhea
- Nausea
- Abdominal pain
- Headache
- Rash (amoxicillin-related)
- Allergic reaction
Key clinical trials
- Vonoprazan vs Proton Pump Inhibitor With Vitamin D or Probiotics Based Triple Therapy for Eradication of Helicobacter Pylori Infection (PHASE2)
- Perioperative Oxaliplatin With S-1 Combined H. Pylori Eradication in the Management of Locally Advanced Gastric Cancer (PHASE2)
- Tegoprazan-Amoxicillin Dual Therapy vs. Bismuth Quadruple Therapy for H. Pylori Infection (TATH-1) (PHASE4)
- Drug Interaction Study on Linaprazan Glurate Capsules (PHASE1)
- Comparative Effectiveness of Triple Versus Quadruple Therapy in the Treatment of Helicobacter Pylori Induced Gastritis (PHASE4)
- Comparative Study Evaluating Safety and Effectiveness of ( Proton Pump Inhibitor Versus Vonoprazan ) Based Triple Therapy With or Without Zinc to Eradicate H. Pylori Infection (PHASE3)
- Personalized vs Standard of Care Treatment for Helicobacter Pylori Eradication Among Veterans (PHASE3)
- Treatment Efficacy of Regimens With and Without Bismuth in Children With Helicobacter Pylori-Associated Peptic Ulcer Disease (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:
- Amoxicillin/omeprazole CI brief — competitive landscape report
- Amoxicillin/omeprazole updates RSS · CI watch RSS
- National Cancer Institute (NCI) portfolio CI
Frequently asked questions about Amoxicillin/omeprazole
What is Amoxicillin/omeprazole?
How does Amoxicillin/omeprazole work?
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Who makes Amoxicillin/omeprazole?
What drug class is Amoxicillin/omeprazole in?
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What does Amoxicillin/omeprazole target?
Related
- Drug class: All Beta-lactam antibiotic + proton pump inhibitor combination drugs
- Target: All drugs targeting Bacterial penicillin-binding proteins (amoxicillin); H+/K+-ATPase (omeprazole)
- Manufacturer: National Cancer Institute (NCI) — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Gastroenterology
- Indication: Drugs for Helicobacter pylori eradication as part of triple or quadruple therapy
- Indication: Drugs for Peptic ulcer disease associated with H. pylori infection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing