Rabeprazole
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
- Rabeprazole
- Rabeprazole: From Peptic Ulcer Disease and Reflux Disease to Smouldering Systemic Mastocytosis
Rabeprazole: From Peptic Ulcer Disease and Reflux Disease to Smouldering Systemic Mastocytosis
One-Sentence Summary
Rabeprazole is a proton pump inhibitor, originally used for peptic ulcer disease, gastroesophageal reflux disease and acid hypersecretory conditions such as Zollinger-Ellison syndrome. The TxGNN model predicts it may be useful for Smouldering systemic mastocytosis, but there are currently 0 clinical trials and 0 publications supporting this specific prediction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Peptic ulcer disease, gastroesophageal reflux disease, duodenal ulcer, Zollinger-Ellison syndrome (the Singapore licence records contain no indication text, so these come from the knowledge-graph indication list) |
| Predicted New Indication | Smouldering systemic mastocytosis |
| TxGNN Prediction Score | 99.44% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 4 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Rabeprazole belongs to the proton pump inhibitor class. These drugs block the gastric H+/K+-ATPase (the proton pump) and so reduce stomach acid. Their efficacy in acid-related disease is well established.
Systemic mastocytosis is already linked to rabeprazole through its acid hypersecretory uses. In this disease, mast cells release large amounts of histamine, which can drive excess stomach acid. The high TxGNN score most likely reflects this symptomatic link.
Rabeprazole does not act on the underlying clonal mast-cell disease, such as KIT-driven proliferation. The data do not support any disease-modifying mechanism. At best, the drug would manage acid-related symptoms, not treat smouldering systemic mastocytosis itself.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Singapore Market Information
All four licences are valid single-ingredient products, and none has been cancelled. The records contain no approved indication text.
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| SIN14910P | Acilesol Gastro-Resistant Tablet 20mg | Tablet, enteric coated | Balkanpharma Dupnitsa AD |
| SIN15259P | Bepraz Gastro Resistant Tablets 20mg | Tablet, delayed release | Sun Pharmaceutical Industries Limited |
| SIN15260P | Bepraz Gastro Resistant Tablets 10mg | Tablet, delayed release | Sun Pharmaceutical Industries Limited |
| SIN14319P | Rabeprazole Sandoz Gastro Resistant Tablet 20mg | Tablet, enteric coated | Novartis Pharmaceutical Manufacturing LLC |
All products are oral formulations.
Safety Considerations
- Conditions flagged in the knowledge graph (not label text): liver disease, gallbladder disease, osteoporosis, postmenopausal osteoporosis, bone fracture.
- Drug Interactions: The interaction search returned 100 interactions in total.
- Major: acalabrutinib and atazanavir.
- Moderate (examples): amikacin, amphetamine, amphotericin B (several formulations), apalutamide, aprepitant, armodafinil, bosutinib, and thiazide diuretics such as bendroflumethiazide.
- Minor (examples): acetylsalicylic acid and axitinib.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests on the model score and a symptomatic acid-suppression link alone. No trials or publications exist for smouldering systemic mastocytosis, and rabeprazole has no proposed effect on the mast-cell disease itself. The indication also largely overlaps with existing acid-hypersecretion uses, so it is not a true new indication.
For context, other predicted terms for this drug have more evidence. Gastric ulcer has 17 registered trials and was rated L1, but it overlaps the existing labeled ulcer use.
To proceed, the following is needed:
- Mechanism of action data, to assess any link beyond acid suppression
- Evidence of a clinical benefit from rabeprazole in smouldering systemic mastocytosis, such as registered trials or published studies
- A clear definition of the intended use, either symptom control of mediator-related acid hypersecretion or disease modification
- Local package insert warnings and contraindications for the Singapore products
- Review of the major interactions (acalabrutinib, atazanavir) and of the liver, gallbladder and bone-related flags, especially for long-term use
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.