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Standard triple therapy
Standard triple therapy is a Proton pump inhibitor Small molecule drug developed by Samsung Medical Center. It is currently in Phase 3 development for Treatment of Helicobacter pylori infections in adults, Eradication of H. pylori in patients with peptic ulcer disease. Also known as: Klaricid, Rabiet, Pamoxin, Amoxicillin 1000 mg orally twice daily, Omeprazole 20 mg orally twice daily, Clarithromycin 500 mg orally twice daily.
This triple therapy combines medications to treat Helicobacter pylori infections by inhibiting bacterial growth and promoting eradication.
Standard triple therapy involves the use of cisplatin injection and gemcitabine, and capecitabine tablets, which are administered to treat various conditions including breast cancer and chronic hepatitis C. The mechanism of action of this therapy is through small molecule modality, although the specific mechanism is not detailed in the provided information.
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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).
| 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 | Standard triple therapy |
|---|---|
| Also known as | Klaricid, Rabiet, Pamoxin, Amoxicillin 1000 mg orally twice daily, Omeprazole 20 mg orally twice daily, Clarithromycin 500 mg orally twice daily, 7-day PPI-based standard triple therapy |
| Sponsor | Samsung Medical Center |
| Drug class | Proton pump inhibitor |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
The combination of antibiotics and acid suppressors in this triple therapy works synergistically to effectively eliminate Helicobacter pylori bacteria from the stomach, reducing the risk of complications such as gastric ulcers and cancer.
Approved indications
- Treatment of Helicobacter pylori infections in adults
- Eradication of H. pylori in patients with peptic ulcer disease
Common side effects
- Diarrhea
- Nausea
- Abdominal pain
- Headache
- Dizziness
Key clinical trials
- Peri-Operative Immune Checkpoint Inhibition and Cryoablation in Women With Triple-negative Breast Cancer (PHASE2)
- Testing MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer (PHASE3)
- VAG Versus Standard Chemotherapy With FLT3 Inhibitor in Adult Patients With FLT3-Mutated AML (PHASE3)
- Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients (PHASE2)
- Pembrolizumab Adjuvant in Patients With Early-stage Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Pembrolizumab Plus Chemotherapy (PHASE3)
- Dual-Target CAR-NK Cells for Advanced Breast Cancer (HER2+ and TNBC) (PHASE1, PHASE2)
- Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies (PHASE2)
- Capizzi Escalating Methotrexate Versus High Dose Methotrexate in Children With Newly Diagnosed T-cell Lymphoblastic Lymphoma (T-LBL) (PHASE3)
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:
- Standard triple therapy CI brief — competitive landscape report
- Standard triple therapy updates RSS · CI watch RSS
- Samsung Medical Center portfolio CI
Frequently asked questions about Standard triple therapy
What is Standard triple therapy?
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Is Standard triple therapy also known as anything else?
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Related
- Drug class: All Proton pump inhibitor drugs
- Manufacturer: Samsung Medical Center — full pipeline
- Therapeutic area: All drugs in Gastroenterology
- Indication: Drugs for Treatment of Helicobacter pylori infections in adults
- Indication: Drugs for Eradication of H. pylori in patients with peptic ulcer disease
- Also known as: Klaricid, Rabiet, Pamoxin, Amoxicillin 1000 mg orally twice daily, Omeprazole 20 mg orally twice daily, Clarithromycin 500 mg orally twice daily, 7-day PPI-based standard triple therapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing