Magnesium Trisilicate
| Evidence Level: L3 | Predicted Indications: 10 |
Table of Contents
- Magnesium Trisilicate
- Magnesium Trisilicate: From Peptic Ulcer Disease to Active Peptic Ulcer Disease
Magnesium Trisilicate: From Peptic Ulcer Disease to Active Peptic Ulcer Disease
One-Sentence Summary
Magnesium trisilicate is a non-systemic antacid, originally used for peptic ulcer disease, reflux disease, esophagitis and dyspepsia. The TxGNN model predicts it may be effective for active peptic ulcer disease, but this is essentially a restatement of an existing use rather than a new one. Evidence is limited to 0 clinical trials and 2 publications for this exact indication, and the publications are old or only loosely relevant.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Peptic ulcer disease, gastroesophageal reflux disease, esophagitis, dyspepsia (the registration records compiled for this report contain no approved indication text) |
| Predicted New Indication | Active peptic ulcer disease |
| TxGNN Prediction Score | 99.86% |
| Evidence Level | L3 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 9 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available. Based on known information, magnesium trisilicate is a non-systemic antacid. It neutralizes gastric acid and can adsorb pepsin, so it may relieve symptoms of acid-related disease.
The predicted indication, active peptic ulcer disease, is very close to the drug's original indications (peptic ulcer disease, reflux disease, dyspepsia). It is effectively an on-label use, not true repurposing. The high TxGNN score probably reflects this closeness in the knowledge graph.
Other predictions from the model are less convincing. Peptic ulcer perforation and duodenal obstruction are surgical or mechanical problems that an antacid would not treat. Gastroparesis is a delayed-emptying disorder that antacids do not address. For these, the score appears to reflect only graph proximity to ulcer disease.
Clinical Trial Evidence
Currently no related clinical trials registered for active peptic ulcer disease.
For the broader category "stomach disease", two completed trials tested a combination product that contains magnesium trisilicate. They are listed here as context only, because the effect of magnesium trisilicate cannot be isolated:
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT03883074 | N/A | Completed | 21 | Double-blind crossover study of an oral hyaluronic acid, chondroitin sulphate and magnesium trisilicate formulation on mucosal integrity and reflux exposure in GERD patients not on a PPI |
| NCT04202692 | N/A | Completed | 40 | Double-blind crossover study of the same type of combination (GERDOff Plus) added to PPI treatment in GERD patients not fully satisfied with their PPI |
Literature Evidence
Publications retrieved for active peptic ulcer disease, plus the most relevant items for related ulcer conditions:
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 4909818 | 1970 | Clinical study (double-blind) | Gut | Duogastrone (a different drug) controlled duodenal ulcer symptoms and appeared to hasten healing. The control group received a magnesium trisilicate placebo |
| 14248445 | 1965 | RCT | British Medical Journal | Double-blind trial of bismuth aluminate and magnesium trisilicate in peptic ulceration, with simultaneous gastric analysis (combination product) |
| 6328685 | 1984 | Comparative trial | S Afr Med J | In 88 patients, 4-week duodenal ulcer healing was 74% with ranitidine and 63% with an aluminium hydroxide and magnesium trisilicate antacid (Gelusil) |
| 6368445 | 1983 | Controlled trial | Int J Tissue React | De-Nol compared with an antacid mixture that includes magnesium trisilicate in 40 gastric ulcer outpatients over 4 weeks |
| 15425465 | 1950 | Case series | Am J Dig Dis | Aluminium hydroxide and magnesium trisilicate plus mucin in 125 peptic ulcer patients |
| 6547921 | 1984 | Physiological study | Fortschr Med | Local effects of sucralfate, aluminium hydroxide and magnesium trisilicate on transmural potential difference in gastric ulcer (6 patients per group) |
| 20321118 | 1938 | Clinical report | Can Med Assoc J | Magnesium trisilicate in the treatment of peptic ulcer |
| 9789728 | 1998 | Review | Drugs Aging | Mechanisms of drug-induced diarrhoea in the elderly (safety context) |
| 15688172 | 2005 | Review / case-based | Urologe A | Silica-containing urinary stones (safety signal) |
Two retrieved papers on norethisterone and phenytoin availability concern drug interactions, not efficacy. Most of the evidence is decades old, involves combination products and does not isolate magnesium trisilicate.
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN03314P | SEMOR STOMACH TABLET | Tablet | Not stated in the compiled records |
| SIN06599P | MAGNESIUM TRISILICATE COMPOUND TABLET BP | Tablet | Not stated in the compiled records |
| SIN03159P | ALUMAG TABLETS | Tablet | Not stated in the compiled records |
| SIN05336P | WELUSIL TABLET | Tablet | Not stated in the compiled records |
| SIN08786P | MAGTASIL ANTACID MIXTURE | Suspension | Not stated in the compiled records |
A further 4 valid licences exist (9 in total, all single-ingredient and valid, none cancelled).
Safety Considerations
The data compiled for this report do not include package insert warnings or contraindications. The knowledge graph links the drug to possible contraindications in the following conditions:
- Possible contraindicated conditions (knowledge graph, not label text): kidney disease, congestive heart failure, diarrhoeal disease (acute and chronic), constipation, intestinal impaction, hypophosphatemia, haemorrhoids, pyoureter.
- Literature safety signals: drug-induced diarrhoea in the elderly, and silica-containing urinary stones.
- Absorption interactions: antacids containing magnesium trisilicate reduced the availability of norethisterone acetate in vitro, and the effect on phenytoin bioavailability has been studied. Dosing should be separated from other oral drugs.
No drug interaction records were found in the database queried. Please refer to the package insert for full safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The predicted indication is essentially already covered by the drug's existing use, so it is not a true repurposing opportunity. Supporting evidence is old, mostly uncontrolled, and based on combination products, with no modern controlled trial. Other high-scoring predictions (perforation, obstruction, gastroparesis) are mechanistically implausible.
To proceed, the following is needed:
- Package insert warnings and contraindications from the HSA (currently a blocking gap for safety screening)
- Approved indication text for the Singapore licences
- Detailed mechanism of action data
- Modern controlled evidence for magnesium trisilicate alone, if a formal claim is desired
- A review of renal function and magnesium accumulation risk in vulnerable patients
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.