Aluminum Hydroxide
| Evidence Level: L3 | Predicted Indications: 10 |
Table of Contents
- Aluminum Hydroxide
- Aluminum Hydroxide: From Peptic Ulcer and Acid Reflux Disease to Active Peptic Ulcer Disease
Aluminum Hydroxide: From Peptic Ulcer and Acid Reflux Disease to Active Peptic Ulcer Disease
One-Sentence Summary
Aluminum hydroxide is an antacid originally used for gastric ulcer, duodenal ulcer, peptic ulcer disease, gastroesophageal reflux disease, esophagitis and dyspepsia. The TxGNN model predicts it may be effective for active peptic ulcer disease, but this is essentially an on-label or near-label use rather than true repurposing. Evidence is limited: 0 registered clinical trials and 9 publications (mostly older reviews, mechanistic studies and historical reports) support this direction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Gastric ulcer, peptic ulcer disease, gastroesophageal reflux disease, esophagitis, dyspepsia, duodenal ulcer (from the knowledge graph; the approved indication text in the Singapore licences is blank) |
| Predicted New Indication | Active peptic ulcer disease |
| TxGNN Prediction Score | 99.64% |
| Evidence Level | L3 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 14 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, aluminum hydroxide is an acid-neutralizing antacid. It reduces gastric acidity and peptic (pepsin) activity, which is the basis of its existing peptic ulcer indication. Mechanistically it may be applicable to active peptic ulcer disease.
The predicted indication is very close to the original ones, so this is not a true change of disease area. The high score likely reflects the proximity of "active peptic ulcer disease" to "peptic ulcer disease" in the knowledge graph. The retrieved literature supports the plausibility of acid neutralization and mucosal protection. However, much of it concerns sucralfate (an aluminum-containing agent), antacid neutralizing-capacity testing, or a nizatidine trial, all of which relate only indirectly to aluminum hydroxide itself.
Other predictions on the list follow the same pattern. Gastroduodenitis and gastrojejunal ulcer are plausible because they are acid-related, but no study addresses them specifically. Peptic ulcer perforation, achlorhydria, pylorospasm, gastric dilatation, Dieulafoy lesion and cascade stomach have no supporting evidence. Several are mechanistically implausible. For example, achlorhydria is the absence of acid, and aluminum antacids can slow gastric emptying, which could worsen gastric dilatation.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 3018068 | 1986 | Clinical physiology study | J Clin Gastroenterol | Compared the postprandial buffering of sodium bicarbonate with aluminum-magnesium hydroxide in duodenal ulcer patients |
| 1526089 | 1992 | RCT (different drug, nizatidine) | Clin Pharmacol Ther | 8-week placebo-controlled trial of nizatidine in benign gastric ulcer; not about aluminum hydroxide |
| 3929601 | 1985 | In vitro/mechanistic | Am J Med | Sucralfate, which contains aluminum hydroxide moieties, inhibits pepsin activity by raising pH and adsorbing pepsin |
| 9334882 | 1997 | Animal study | Jpn J Pharmacol | Aluminum hydroxide prevented acid- and pepsin-induced damage to rat gastric epithelial cells |
| 3104655 | 1986 | Review | Klin Wochenschr | Aluminum-containing antacids protect the gastric mucosa against aspirin- and ethanol-induced necrosis and haemorrhage |
| 6798099 | 1981 | Review (sucralfate) | J Clin Gastroenterol | Development of sucralfate to counteract acid and pepsin activity |
| 35720246 | 2022 | In vitro antacid comparison | Med Pharm Rep | Evaluated the acid-neutralizing capacity of antacids marketed in Morocco |
| 7190055 | 1980 | Review | Brain Res Bull | Restraint-induced ulcers in animals respond to known therapeutic agents, including cimetidine and aluminum hydroxide |
Related evidence from a closely linked prediction: a controlled trial of aluminum hydroxide gel in duodenal ulcer pain (PMID 324863, 1977, Gastroenterology) found complete relief in 79% with the gel versus 45% with a dummy gel in one set of trials, but the difference was not significant in a replicate set.
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN02930P | ALU-TAB TABLET 600 mg | Film-coated tablet | Not stated in the data compiled for this report |
| SIN03159P | ALUMAG TABLETS | Tablet | Not stated in the data compiled for this report |
| SIN09499P | ALLUMAG M TABLET | Tablet | Not stated in the data compiled for this report |
| SIN06592P | AXCEL EVILINE TABLET | Tablet | Not stated in the data compiled for this report |
| SIN03406P | POLYSILIC III SUSPENSION | Suspension | Not stated in the data compiled for this report |
There are 14 valid single-ingredient registrations in total. Dosage forms include tablets, film-coated tablets, suspensions and granules.
Safety Considerations
- Drug Interactions: 100 interactions were found; the list reviewed includes the following.
- Major: Dolutegravir, sodium citrate
- Moderate: Acalabrutinib, doxycycline, alendronic acid, risedronic acid, allopurinol, amphetamine, ascorbic acid, acetylsalicylic acid, atazanavir, proguanil
- Minor: Famotidine, ranitidine, and others
- Safety signals from the literature: Long-term or excessive use of aluminum-containing antacids has been linked to phosphate depletion, osteomalacia and bone demineralization (PMIDs 7431592, 2257522, 6293043). Aluminum antacids may also slow gastric emptying and cause constipation.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The predicted indication is essentially the same as the drug's existing use, so it does not add new therapeutic value. No clinical trials are registered, and the literature consists mainly of older studies, mechanistic work and studies of related drugs. The package insert warnings and contraindications are not yet available, so safety screening cannot be completed.
To proceed, the following is needed:
- Package insert warnings and contraindications from the HSA website (blocking item)
- Mechanism of action data from DrugBank
- Approved indication text for the Singapore licences, to confirm whether peptic ulcer is already on-label
- A decision on whether to pursue the other predictions, which have little or no supporting evidence, or to drop them
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.