Amlodipine Besilate

證據等級: L5

預測適應症: 0 個

Amlodipine Besilate: From Hypertension / Angina — No TxGNN Prediction Available

One-Sentence Summary

Amlodipine Besilate is a well-established dihydropyridine calcium channel blocker widely used for hypertension and angina pectoris, with 76 registered products currently marketed in Malaysia. The current Evidence Pack contains no TxGNN model predictions for new indications — this may reflect that the prediction pipeline has not yet been run, or that results were not included in this submission. A full repurposing evaluation cannot proceed until prediction outputs, MOA data, and product-level registration details are obtained.

Quick Overview

Item	Content
Original Indication	Hypertension / Angina pectoris (based on drug class knowledge; no approved indication text provided in Evidence Pack)
Predicted New Indication	— (Not available)
TxGNN Prediction Score	— (Not available)
Evidence Level	— (Not determinable)
Malaysia Market Status	✓ Marketed
Number of Registrations	76
Recommended Decision	Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available in this Evidence Pack (flagged as Data Gap DG002). Based on established pharmacological knowledge, Amlodipine Besilate is a third-generation dihydropyridine calcium channel blocker. It selectively inhibits the influx of calcium ions through L-type voltage-gated channels in vascular smooth muscle cells and cardiac myocytes, resulting in peripheral vasodilation, reduction of systemic vascular resistance, and decreased myocardial oxygen demand — making it effective for both hypertension and stable/vasospastic angina.

Because no predicted new indication has been generated by TxGNN for this drug in the current Evidence Pack, it is not possible to assess the mechanistic bridge between the original indication and any repurposing target at this time.

Clinical Trial Evidence

Currently no related clinical trials registered — no predicted indication is available in this Evidence Pack to anchor a clinical trial search.

Literature Evidence

Currently no related literature available — no predicted indication is available in this Evidence Pack to anchor a literature search.

Malaysia Market Information

The Evidence Pack confirms 76 registered products for Amlodipine Besilate in Malaysia with a current market status of Marketed. However, the detailed product-level fields (authorization numbers, product names, dosage forms, and approved indication texts) were not populated in this submission.

Authorization Number	Product Name	Dosage Form	Approved Indication
—	—	—	Detailed records not provided in this Evidence Pack

⚠️ Product-level data for all 76 registrations should be retrieved from the NPRA database to complete this section.

Safety Considerations

Please refer to the package insert for safety information.

⚠️ Blocking Data Gap (DG001): TFDA/NPRA package insert warnings and contraindications have not been retrieved. This gap is classified as Blocking and prevents entry into the S1 safety pre-assessment stage. Remediation: download and parse the package insert PDF from the official regulatory authority website.

Conclusion and Next Steps

Decision: Hold

Rationale: This Evidence Pack is incomplete — no TxGNN prediction output is present, MOA data is missing, all product-level registration details are unpopulated, and safety warnings are blocked by a critical data gap. There is currently no repurposing candidate to evaluate.

To proceed, the following is needed:

[Critical] Run the TxGNN prediction pipeline and include predicted_indications output in the Evidence Pack
[Blocking] Retrieve NPRA/TFDA package insert (DG001) to populate safety warnings, contraindications, and dosage form details
[High] Obtain MOA data from DrugBank API (DG002) to enable mechanistic plausibility analysis
[Required] Populate all 76 license records with authorization numbers, product names, dosage forms, and approved indication texts from the NPRA database
Once the above are available, re-run Evidence Pack generation and re-submit for full evaluation
Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.