Summary
Eplerenone has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Hypertension would be drug repurposing rather than first-in-human development. This does not mean it is approved for Hypertension. ClinicalTrials.gov lists 8 registered trials linking Eplerenone to Hypertension: 5 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT03186742). The largest enrolment is 1001 participants (NCT02890173). Registration activity spans 2007 to 2023. The literature layer holds 12 publications for this pair: 3 Cochrane reviews, 2 meta-analyses, 2 systematic reviews and 5 clinical trial publications. Publication years run from 2014 to 2025. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Essential Hypertension ranks 376 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Not well-characterized as population baseline; routinely framed as irreversible in clinical culture despite contrary trial evidence.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 73.5 (trials 23.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 5 completed, 3 other |
| Linked publications | 12 (5 clinical trial publications, 3 Cochrane reviews, 2 meta-analyses, 2 systematic reviews) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT03186742 | Reduction of Left Ventricular Hypertrophy After Eplerenone Therapy 2014 | completed | Phase 4 | 125 |
| NCT02890173 | Study of CS-3150 in Patients With Essential Hypertension 2016 | completed | Phase 3 | 1,001 |
| NCT00138944 | Effectiveness of Eplerenone to Improve Target Organ Damage in Patients With Resistant Arterial Hypertension 2007 | completed | Phase 3 | 85 |
| NCT00758524 | A Study to Evaluate Efficacy and Safety of LCI699 in Participants With Essential Hypertension 2008 | completed | Phase 2 | 628 |
| NCT02345044 | A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Hypertensive Subjects 2015 | completed | Phase 2 | 426 |
| NCT01373086 | LFF269 Compared to Placebo After Treatment in Subjects With Essential Hypertension 2011 | terminated | Phase 2 | 19 |
| NCT00980031 | Aldosterone Blockade to Prevent Myocardial Remodeling In Patients With Controlled Essential Hypertension 2007 | terminated | Not applicable | 20 |
| NCT06208072 | The Predictive Role of Urinary Proteomics in Blood Pressure Response of Obese Hypertensive Treated With Irbesartan or Eplerenone. 2023 | status unknown | Not applicable | 50 |
Published literature
- Systematic review A Systematic Review Supporting the Endocrine Society Clinical Practice Guideline on Management of Primary AldosteronismFarah MH, Hegazi M, Firwana M et al. · The Journal of clinical endocrinology and metabolism · 2025 · PMID 40658500
- Cochrane review Efficacy and safety of esaxerenone (CS-3150) in primary hypertension: a meta-analysisSun R, Li Y, Lv L et al. · Journal of human hypertension · 2024 · PMID 38177694
- Clinical trial publication Differential effects of eplerenone versus amlodipine on muscle metaboreflex function in hypertensive humansPeri-Okonny PA, Velasco A, Lodhi H et al. · Journal of clinical hypertension (Greenwich, Conn.) · 2021 · PMID 34432358
- Clinical trial publication Effect of the Nonsteroidal Mineralocorticoid Receptor Blocker, Esaxerenone, on Nocturnal Hypertension: A Post Hoc Analysis of the ESAX-HTN StudyKario K, Ito S, Itoh H et al. · American journal of hypertension · 2021 · PMID 33165570
- Clinical trial publication Double-Blind Randomized Phase 3 Study Comparing Esaxerenone (CS-3150) and Eplerenone in Patients With Essential Hypertension (ESAX-HTN Study)Ito S, Itoh H, Rakugi H et al. · Hypertension (Dallas, Tex. : 1979) · 2020 · PMID 31786983
- Clinical trial publication Efficacy and safety of esaxerenone (CS-3150) for the treatment of essential hypertension: a phase 2 randomized, placebo-controlled, double-blind studyIto S, Itoh H, Rakugi H et al. · Journal of human hypertension · 2019 · PMID 31113987
- Clinical trial publication Effects of eplerenone on blood pressure and glucose metabolism in Japanese hypertensives with overweight or obesityAdachi H, Kakuma T, Kawaguchi M et al. · Medicine · 2019 · PMID 30985644
- Meta-analysis Pharmacological Treatment of Arterial Hypertension in Children and Adolescents: A Network Meta-AnalysisBurrello J, Erhardt EM, Saint-Hilary G et al. · Hypertension (Dallas, Tex. : 1979) · 2018 · PMID 29967035
- Cochrane review Eplerenone for hypertensionTam TS, Wu MH, Masson SC et al. · The Cochrane database of systematic reviews · 2017 · PMID 28245343
- Meta-analysis The Effects of Aldosterone Antagonists in Patients With Resistant Hypertension: A Meta-Analysis of Randomized and Nonrandomized StudiesDahal K, Kunwar S, Rijal J et al. · American journal of hypertension · 2015 · PMID 25801902
- Systematic review [Hypertension in the course of primary aldosteronism during pregnancy]Wyskida M, Wyskida K, Olszanecka-Glinianowicz M et al. · Postepy higieny i medycyny doswiadczalnej (Online) · 2015 · PMID 25720606
- Cochrane review Efficacy and safety of eplerenone in the management of mild to moderate arterial hypertension: systematic review and meta-analysisPelliccia F, Patti G, Rosano G et al. · International journal of cardiology · 2014 · PMID 25499383
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Eplerenone approved for Hypertension?
Eplerenone has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Hypertension would be drug repurposing rather than first-in-human development. This does not mean it is approved for Hypertension. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Eplerenone in clinical trials for Hypertension?
ClinicalTrials.gov lists 8 registered trials linking Eplerenone to Hypertension: 5 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT03186742). The largest enrolment is 1001 participants (NCT02890173). Registration activity spans 2007 to 2023.
What does the evidence show for Eplerenone in Hypertension?
Eplerenone has both completed registered trials and synthesis-level publications linked to Hypertension. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.