Eplerenone
| Evidence Level: L5 | Predicted Indications: 5 |
Table of Contents
- Eplerenone
- Eplerenone: From Hypertension/Heart Failure to Pulmonary Hypertension Due to Lung Disease and/or Hypoxia
Eplerenone: From Hypertension/Heart Failure to Pulmonary Hypertension Due to Lung Disease and/or Hypoxia
One-Sentence Summary
Eplerenone is a selective mineralocorticoid receptor (aldosterone) antagonist generally used for hypertension and heart failure; detailed original-indication and mechanism-of-action data are not present in this evidence pack. The TxGNN model predicts potential efficacy in pulmonary hypertension due to lung disease and/or hypoxia (WHO Group 3 PH), but this is currently supported by 0 clinical trials and 20 background literature items that discuss hypoxia biology in general rather than eplerenone specifically — the evidence base for this drug–disease pair is indirect.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not provided in evidence pack (no taiwan_regulatory.licenses on file). Eplerenone is generally known as a mineralocorticoid receptor antagonist used for hypertension and post-MI heart failure — general knowledge, not sourced from this pack |
| Predicted New Indication | Pulmonary hypertension owing to lung disease and/or hypoxia |
| TxGNN Prediction Score | 99.50% |
| Evidence Level | L5 |
| UK Market Status | Not marketed |
| Number of Marketing Authorisations | 0 |
| Recommended Decision | Hold |
Why Is This Prediction Reasonable?
Currently, detailed mechanism-of-action data is not available in this evidence pack (original_moa: [Data Gap]). Based on generally known pharmacology, eplerenone is a selective mineralocorticoid receptor antagonist, mechanistically related to spironolactone but with reduced anti-androgenic activity; it is established for hypertension and chronic heart failure.
Aldosterone signalling has been implicated in vascular remodelling and fibrosis, which provides a plausible, class-level rationale for exploring mineralocorticoid receptor antagonism in pulmonary vascular disease. However, none of the 20 literature items retrieved for this prediction actually discuss eplerenone or mineralocorticoid receptor antagonists — they are general reviews and mechanistic papers on hypoxia biology (e.g. hypoxia in brain ageing, tumour biology, cognitive impairment, headache), most of which are not specific to pulmonary hypertension. The mechanistic plausibility here should therefore be treated as a hypothesis generated by the TxGNN knowledge graph, not as evidence drawn from drug-specific studies.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
None of the retrieved literature specifically studies eplerenone or mineralocorticoid receptor antagonism in pulmonary hypertension — these are general hypoxia-biology papers surfaced by keyword overlap with the predicted disease name. Listed here for transparency, not as direct supporting evidence.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 11172576 | 2000 | Review | Respiratory Care Clinics of North America | Overview of the mechanisms of hypoxaemia, including ventilation-perfusion mismatch and shunt — background respiratory physiology, not drug-specific |
| 24557798 | 2014 | Review | J Appl Physiol | General review of hypoxia physiology research |
| 27146279 | 2017 | Review | Cephalalgia | Role of hypoxia in migraine and cluster headache — mechanistic background only |
| 27423661 | 2016 | Review | Cell and Tissue Research | Hypoxia/HIF-1 signalling in tissue repair and fibrosis |
| 21328446 | 2011 | Review | J Cellular Biochemistry | General review of hypoxia-mediated cellular adaptation |
| 33862277 | 2021 | Review | Ageing Research Reviews | Hypoxia and brain ageing/neurodegeneration — neurological, not pulmonary |
| 34618295 | 2022 | Review | Metabolic Brain Disease | Cognitive impairment from acute/chronic hypoxia |
| 40347693 | 2025 | Review | Redox Biology | Hypoxia in multiple sclerosis pathology |
| 40815459 | 2025 | Review | Rev Med Inst Mex Seguro Soc | Hypobaric hypoxia and high-altitude physiology |
| 8817697 | 1996 | Review | Progress in Neurobiology | Hypoxia and brain development across the lifespan |
UK Market Information
Eplerenone currently has no UK marketing authorisation recorded in this evidence pack (0 licences on file; market status: not marketed). No product/formulation data is available to summarise.
Safety Considerations
Please refer to the SmPC and BNF for safety information. Report suspected adverse reactions via the Yellow Card Scheme.
Note: key_warnings, contraindications, and drug interaction data are all flagged as data gaps in this evidence pack, including a Blocking-severity gap on TFDA label warnings/contraindications (DG001) — this must be resolved before any safety assessment can proceed.
Conclusion and Next Steps
Decision: Hold
Rationale:
- The predicted indication has no registered clinical trials and no drug-specific literature — evidence level is L5 (model prediction only), and a Blocking-severity safety data gap (DG001: label warnings/contraindications) prevents even a preliminary safety assessment.
To proceed, the following is needed:
- Eplerenone SmPC/label data (warnings, contraindications, DDI) to close DG001
- Confirmed mechanism-of-action data from DrugBank to close DG002
- Targeted literature/trial searches specifically for eplerenone (or MRA class) in pulmonary hypertension/Group 3 PH, rather than generic hypoxia-biology hits
- UK marketing authorisation and formulation data, since the drug is currently not marketed in the UK
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.