Amlodipine
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Amlodipine: From Hypertension to Brain Stem Infarction
One-Sentence Summary
Amlodipine is an oral blood-pressure-lowering drug, originally used for hypertension, with listed uses in stroke and cerebrovascular disorders and in Prinzmetal angina. The TxGNN model predicts it may be effective for brain stem infarction, but no clinical trials and no publications specific to this condition were found, so the prediction currently rests on the model score alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Hypertension (also stroke and cerebrovascular disorders, Prinzmetal angina, per the knowledge graph; Singapore label wording is not available in the compiled data) |
| Predicted New Indication | Brain stem infarction |
| TxGNN Prediction Score | 99.94% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, amlodipine is a blood-pressure-lowering drug with established efficacy in hypertension. Its effect on blood pressure is the most plausible route to a benefit in stroke.
Brain stem infarction is a type of ischaemic stroke. Amlodipine is already linked to stroke, cerebral infarction and cerebrovascular disorders in the knowledge graph, so a link through secondary stroke prevention is reasonable. This also means the high score probably reflects overlap with existing indications rather than a new repurposing signal. No data specific to brain stem infarction were found to test this.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Singapore Market Information
Amlodipine has 20 valid single-ingredient tablet registrations in Singapore, and none are cancelled. The registration records do not include approved-indication text. Five of them are listed below.
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| SIN05277P | Norvasc Tablet 5 mg | Tablet | Viatris Pharmaceuticals LLC / Pfizer Manufacturing Deutschland GmbH |
| SIN14756P | Amlodipine Sandoz Tablets 5 mg | Tablet | Novartis Pharmaceutical Manufacturing LLC / Sandoz (Gebze 2) |
| SIN14159P | Apo-Amlodipine Tablet 5 mg | Tablet | Apotex Inc. |
| SIN14548P | Tenox Tablets 5 mg | Tablet | Krka, d.d., Novo mesto |
| SIN14529P | Amcad 5 Tablet 5 mg | Tablet | Cadila Pharmaceuticals Limited |
Safety Considerations
Contraindication-related conditions (from the knowledge graph, not label text): The knowledge graph links amlodipine to the following conditions. These should be checked against the Singapore package insert.
- Liver and biliary: liver failure, liver disease, gallbladder disease, pancreatitis
- Kidney and urinary: kidney disease, pyoureter
- Cardiovascular: hypotensive disorder
- Endocrine and metabolic: hypothyroidism (including myxedema and congenital hypothyroidism), diabetes mellitus, diabetic ketoacidosis, hyperuricemia, hyperparathyroidism, osteitis fibrosa, potassium deficiency
- Angioedema (several forms, including hereditary and renin-angiotensin-aldosterone system-blocker-induced)
- Autoimmune and haematological: systemic lupus erythematosus (including paediatric), neutropenia, agranulocytosis
- Neuromuscular: myopathy, muscular and skeletal muscle disease, familial periodic paralysis
Drug interactions: The interaction screen returned 100 interacting drugs. The 20 shown in the compiled data are all rated Moderate:
- Corticosteroids: hydrocortisone, betamethasone, budesonide, dexamethasone
- Calcium salts: acetate, carbonate, chloride, citrate, gluconate, lactate and others
- Others: aprepitant, aspirin, bupropion, canagliflozin, dapagliflozin, clarithromycin, clotrimazole
The full interaction list and the package insert warnings should be reviewed before any new use is considered.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction for brain stem infarction has a very high model score but no supporting trials or literature (L5). It also largely overlaps with amlodipine's existing stroke and cerebrovascular indications, so it adds little as a new repurposing opportunity.
To proceed, the following is needed:
- Disease-specific evidence, such as trials or observational studies in brain stem or posterior circulation infarction
- Singapore package insert warnings and contraindications, and approved-indication text
- Mechanism of action data
- Clarification of whether this prediction adds anything beyond existing stroke prevention use
Note on other predictions in the data: Two other predicted indications have more support than brain stem infarction.
- Intracerebral haemorrhage (secondary prevention): This has the strongest evidence, at L2. It includes the completed Phase 3 TRIDENT trial (NCT02699645, N=1671) and a 2026 NEJM publication (PMID 42019018). Amlodipine was tested only as one part of a three-drug low-dose pill, so its own contribution cannot be isolated. The data compiled for this report did not include outcome results, and these should be checked before upgrading the evidence level.
- Cerebral artery occlusion: This rests mainly on animal studies (L3). The human trials found were terminated with very small enrolment.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.