Ambrisentan
| 證據等級: L5 | 預測適應症: 10 個 |
目錄
Ambrisentan: Drug Repurposing Evaluation Report
One-Sentence Summary
Ambrisentan (DrugBank: DB06403) is a selective endothelin type-A (ETA) receptor antagonist, primarily indicated for the treatment of pulmonary arterial hypertension (PAH). The TxGNN model has not generated any predicted new indications for this drug at this time, and the evidence pack contains significant data gaps that prevent a full evaluation.
Quick Overview
| Item | Content |
|---|---|
| Drug (INN) | Ambrisentan |
| DrugBank ID | DB06403 |
| Original Indication | Not listed in evidence pack (known use: Pulmonary Arterial Hypertension) |
| Predicted New Indication | — None predicted — |
| TxGNN Prediction Score | N/A |
| Evidence Level | L5 (No predictions or supporting studies available) |
| Taiwan Market Status | 未上市 (Not marketed) |
| Number of Authorizations | 0 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data was not available in the evidence pack. Based on publicly known information, Ambrisentan is a selective endothelin type-A (ETA) receptor antagonist. Endothelin-1 (ET-1) is a potent vasoconstrictor and smooth muscle mitogen, and by selectively blocking the ETA receptor, Ambrisentan promotes vasodilation and reduces pulmonary vascular resistance. It is approved in multiple markets (e.g., US as Letairis®, EU as Volibris®) for WHO Group 1 pulmonary arterial hypertension (PAH).
Since no predicted indications were generated by the TxGNN model, there is currently no mechanistic bridging analysis to perform. This may be due to the drug's absence from the Taiwan market and limited representation in the knowledge graph used by the model. Further data enrichment — including MOA details, complete safety profiles, and broader indication mapping — would be required before the model can generate actionable predictions.
Clinical Trial Evidence
Currently no predicted indication available — clinical trial search was not performed.
Literature Evidence
Currently no predicted indication available — literature search was not performed.
Taiwan Market Information
Ambrisentan is not currently marketed in Taiwan (未上市). No TFDA authorizations were found.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| — | — | — | No authorizations on record |
Safety Considerations
Please refer to the package insert for safety information.
Note: No TFDA package insert warnings, contraindications, or drug-drug interaction data were available in the evidence pack. For reference, internationally known safety concerns for Ambrisentan include:
- Hepatotoxicity risk (requires liver function monitoring)
- Teratogenicity (Pregnancy Category X — strictly contraindicated in pregnancy; requires pregnancy testing and contraception in females of reproductive potential)
- Fluid retention and peripheral oedema
- Decreased haemoglobin / haematocrit
Prescribers should consult the approved product labelling in the relevant jurisdiction (e.g., US FDA Letairis® PI, EMA Volibris® SmPC).
Conclusion and Next Steps
Decision: Hold
Rationale: The TxGNN model did not generate any predicted new indications for Ambrisentan. Additionally, the drug is not marketed in Taiwan, and the evidence pack has critical data gaps (MOA, safety warnings, contraindications). Without a predicted indication, no repurposing evaluation can proceed.
To proceed, the following is needed:
- Resolve Blocking Data Gap (DG001): Obtain TFDA package insert warnings and contraindications (or equivalent international labelling) to enable Stage 1 safety screening.
- Resolve High-Priority Data Gap (DG002): Retrieve detailed mechanism of action data from DrugBank API to support mechanistic bridging analysis.
- Knowledge Graph Enrichment: Ensure Ambrisentan and its endothelin receptor antagonist class are adequately represented in the TxGNN knowledge graph, then re-run predictions.
- Re-evaluate: Once data gaps are filled and predictions are available, regenerate the evidence pack and reassess.
| *Report generated: 2026-04-03 | Evidence Pack version: v4 | Candidate ID: TW-DB06403-multi* |
⚠️ This report is for research purposes only and does not constitute medical advice. Any drug repurposing candidates require clinical validation before application.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.