Drugs / Eplerenone
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Eplerenone

Developed for
hypertensive disorder · heart failure · central serous chorioretinopathy · chronic kidney disease · essential hypertension · diastolic heart failure · metabolic syndrome X · symptomatic heart failure
+41 more · acute myocardial infarction · congestive heart failure · diabetes mellitus · end stage renal failure · HIV infectious disease · hyperaldosteronism · type 2 diabetes mellitus · abdominal aortic aneurysm · apparent mineralocorticoid excess · atrial fibrillation · autoinflammatory syndrome · cardiomyopathy · cirrhosis of liver · diabetic kidney disease · essential hypertension, genetic · fatty liver disease · Gitelman syndrome · hypertensive heart disease · hypoglycemia · intervertebral disk degenerative disorder · ischemic disease · myocardial infarction · obstructive sleep apnea syndrome · paroxysmal atrial fibrillation · primary aldosteronism · primary hyperparathyroidism · proteinuria · radiculopathy · retinal edema · systolic heart failure · tetralogy of fallot · transposition of the great arteries · triglyceride deposit cardiomyovasculopathy · univentricular heart · vitreous detachment · abdominal obesity-metabolic syndrome · aldosterone-producing adrenal cortex adenoma · Duchenne muscular dystrophy · familial dilated cardiomyopathy · myocardial ischemia · obesity disorder
Investigated by
Brigham and Women's Hospital · Viatris Inc. · Pfizer · National Heart, Lung, and Blood Institute (NHLBI) · The George Institute · Washington University School of Medicine
+70 more · Anna Stanhewicz, PhD · Assiut University · Biolab Sanus Farmaceutica · Central Hospital, Nancy, France · Centre for Chronic Disease Control, India · Göteborg University · Massachusetts General Hospital · NHS Greater Glasgow and Clyde · National Institutes of Health (NIH) · Radboud University Medical Center · Royal Brompton & Harefield NHS Foundation Trust · Sandoz · Abbott · Assistance Publique - Hôpitaux de Paris · AstraZeneca · Baker Heart and Diabetes Institute · Bayer · Bayside Health · Boehringer Ingelheim · British Heart Foundation · Canadian Cancer Society (CCS) · Canadian Institutes of Health Research (CIHR) · Emma Nilsson · French National Institute of Health and Medical Research · Imperial College London · Jichi Medical University · Karolinska Institutet · Karolinska University Hospital · Malcom Randall VA Medical Center · McMaster University · Medical University of Vienna · Montreal Heart Institute · NHS National Waiting Times Centre Board · Nanfang Li · National Center for Research Resources (NCRR) · National Institute of Allergy and Infectious Diseases (NIAID) · National Institute of Cardiology, Warsaw, Poland · North Florida Foundation for Research and Education · Northwestern University · Poznan University of Medical Sciences · Prim. Prof. Dr. Oliver Findl, MBA · Region Örebro County · Reims University Hospital · RemediumOne · RemediumOne (Pvt) Ltd. · Robert Wood Johnson Foundation · Royal Prince Alfred Hospital, Sydney, Australia · Semmelweis University · Shaare Zedek Medical Center · St Vincent's Centre for Applied Medical Research · St Vincent's University Hospital, Ireland · Tel-Aviv Sourasky Medical Center · ThromboGenics · Tufts Medical Center · University Hospital, Linkoeping · University Hospital, Umeå · University of British Columbia · University of Cincinnati · University of Erlangen-Nürnberg Medical School · University of Florida · University of Glasgow · University of Kelaniya · University of Michigan · University of Southern Denmark · Uppsala University Hospital · Vanderbilt University · Vanderbilt University Medical Center · Victor Chang Cardiac Research Institute · Wagner Macula & Retina Center · Ziekenhuis Oost-Limburg

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (2) US (FDA) INSPRA — 2003-10-07 – 2008-01-31 fda.gov ↗
Approved US (FDA) INSPRA — 2002-09-27 fda.gov ↗

Trials 75 · started per year

today
US approved 2002
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 03 trials
Phase 0 NCT07345845 Dec 2025 → Feb 2028 expected preeclampsia Anna Stanhewicz, PhD Active not recruiting No outcome recorded
Phase 0 NCT06749418 Jan 2025 → Jan 2027 expected preeclampsia Anna Stanhewicz, PhD Recruiting No outcome recorded
Phase 0 NCT03923530 Jun 2019 → Feb 2020 aortic valve stenosis, diastolic heart failure, hypertensive disorder North Florida Foundation for Research and Education Completed No outcome recorded
Phase 112 trials
Phase 1 NCT07795762 Oct 2026 → Feb 2027 expected ocular hypertension University of Florida Not yet recruiting No outcome recorded
Phase 1 NCT06831864 Feb → May 2025 symptomatic heart failure Washington University School of Medicine Completed No outcome recorded
Phase 1 NCT06556732 Aug 2024 overdue atrial fibrillation Assiut University Recruiting No outcome recorded
Phase 1 NCT03165240 Oct 2017 → Apr 2020 diabetic kidney disease Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT02957435 Jul → Dec 2017 — Biolab Sanus Farmaceutica Withdrawn No outcome recorded
Phase 1 NCT02607657 May → Oct 2016 — Biolab Sanus Farmaceutica Withdrawn No outcome recorded
Phase 1 NCT02532998 Sep → Dec 2015 — AstraZeneca Completed No outcome recorded
Phase 1 NCT01473108 Mar → Nov 2010 — Bayer Completed No outcome recorded
Phase 1 NCT00990223 Oct → Nov 2009 — Viatris Inc. Completed No outcome recorded
Phase 1 NCT00865176 Jun → Jul 2006 hypertensive disorder Sandoz Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT01146197 Feb 2010 → Dec 2012 Gitelman syndrome Assistance Publique - Hôpitaux de Paris Completed No outcome recorded
Phase 29 trials · 1 missed
Phase 2 NCT07029503 Feb 2026 → Feb 2027 expected chronic kidney disease, systolic heart failure Karolinska Institutet Recruiting No outcome recorded
Phase 2 NCT05198791 Feb 2022 → Jul 2026 overdue acute myocardial infarction NHS National Waiting Times Centre Board Recruiting No outcome recorded
Phase 2 NCT04300881 Oct 2019 → Jan 2021 retinal edema, vitreous detachment Wagner Macula & Retina Center Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT02629094 Dec 2015 → Sep 2017 fatty liver disease, triglyceride deposit cardiomyovasculopathy National Institute of Allergy and Infectious Diseases (NIAID) Terminated Missed primary
Phase 2 NCT02153125 Apr 2014 → Jun 2015 central serous chorioretinopathy Tel-Aviv Sourasky Medical Center Unknown No outcome recorded
Phase 2 NCT01822561 May 2013 → Apr 2017 central serous chorioretinopathy Tufts Medical Center Completed No outcome recorded
Phase 2 NCT01834768 Feb → Apr 2013 chronic kidney disease Reims University Hospital Unknown No outcome recorded
Phase 2 NCT01801228 Feb 2013 → Oct 2015 cirrhosis of liver Emma Nilsson Withdrawn No outcome recorded
Phase 2 NCT00649311 Apr → Sep 2003 hypertensive disorder Pfizer Terminated No outcome recorded Stop: Enrollment
Phase 2/33 trials · 1 missed
Phase 2/3 NCT02525796 Jan 2016 → Oct 2021 primary hyperparathyroidism Brigham and Women's Hospital Completed Missed primary
Phase 2/3 NCT02215330 Oct 2014 → Mar 2017 central serous chorioretinopathy Prim. Prof. Dr. Oliver Findl, MBA Unknown No outcome recorded
Phase 2/3 NCT01708798 May 2014 → Nov 2016 breast cancer University of British Columbia Terminated No outcome recorded
Phase 38 trials
Phase 3 NCT07828223 Feb 2027 → Dec 2030 expected — Central Hospital, Nancy, France Not yet recruiting No outcome recorded
Phase 3 NCT07569640 Aug 2026 → Apr 2029 expected symptomatic heart failure Washington University School of Medicine Recruiting No outcome recorded
Phase 3 NCT02490904 Oct 2016 → Nov 2021 overdue end stage renal failure Central Hospital, Nancy, France Active not recruiting No outcome recorded
Phase 3 NCT01586442 Mar 2012 → Mar 2015 glucose intolerance, heart failure, type 2 diabetes mellitus Montreal Heart Institute Completed No outcome recorded
Phase 3 NCT01319344 Sep 2010 → Dec 2012 metabolic syndrome X University of Erlangen-Nürnberg Medical School Completed No outcome recorded
Phase 3 NCT01115855 Jul 2010 → Sep 2015 heart failure Viatris Inc. Completed No outcome recorded
Phase 3 NCT00147615 Oct 2004 → Jun 2006 hypertensive disorder Viatris Inc. Completed No outcome recorded
Phase 3 NCT00147589 Sep 2004 → Jan 2007 hypertensive disorder Viatris Inc. Completed No outcome recorded
Phase 428 trials · 1 met primary · 2 missed
Phase 4 NCT07513883 Mar 2026 → Sep 2028 expected heart failure Ziekenhuis Oost-Limburg Recruiting No outcome recorded
Phase 4 NCT06168994 Feb 2024 → Sep 2026 overdue paroxysmal atrial fibrillation Assiut University Not yet recruiting No outcome recorded
Phase 4 NCT06275763 Oct 2023 → Dec 2025 hypertensive disorder National Institute of Cardiology, Warsaw, Poland Unknown No outcome recorded
Phase 4 NCT03418649 Jun 2023 → Dec 2025 intervertebral disk degenerative disorder, radiculopathy University of Cincinnati Withdrawn No outcome recorded Stop: Enrollment
Phase 4 NCT05688579 Apr 2023 → Dec 2026 expected hyperaldosteronism, hypertensive disorder Nanfang Li Enrolling by invitation No outcome recorded
Phase 4 NCT04746495 Feb → Jul 2023 essential hypertension University of Michigan Withdrawn No outcome recorded Stop: Business
Phase 4 NCT05030545 Dec 2022 → Oct 2026 expected hypertensive disorder, primary aldosteronism Brigham and Women's Hospital Recruiting No outcome recorded
Phase 4 NCT05637853 Oct 2022 → Aug 2024 overdue symptomatic heart failure Göteborg University Active not recruiting No outcome recorded
Phase 4 NCT05129722 Oct 2022 → May 2024 diastolic heart failure The George Institute Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT04840342 Feb 2022 → Sep 2025 apparent mineralocorticoid excess, essential hypertension Brigham and Women's Hospital Completed No outcome recorded
Phase not applicable11 trials · 1 met primary · 1 missed
— NCT06091475 Dec 2023 → Aug 2026 overdue dilated cardiomyopathy, heart failure Imperial College London Recruiting No outcome recorded
— NCT02740179 Jan 2017 → Mar 2022 HIV infectious disease Massachusetts General Hospital Completed Mixed
— NCT03017703 Dec 2016 → Oct 2019 — University of Southern Denmark Completed No outcome recorded
— NCT02118753 Mar 2014 → Dec 2015 ischemic disease Radboud University Medical Center Completed No outcome recorded
— NCT01650012 Mar → Dec 2013 end stage renal failure McMaster University Completed No outcome recorded
— NCT01832558 Nov 2012 → Dec 2020 chronic kidney disease Medical University of Vienna Unknown No outcome recorded
— NCT01405456 Jan 2012 → May 2017 HIV infectious disease Massachusetts General Hospital Completed Missed primary
— NCT01394627 Jan 2011 → Aug 2016 hypoglycemia Brigham and Women's Hospital Completed No outcome recorded
— NCT01786551 Mar 2010 → Jan 2013 autoinflammatory syndrome Brigham and Women's Hospital Completed No outcome recorded
— NCT00505336 Apr 2006 → Jul 2008 diastolic heart failure St Vincent's University Hospital, Ireland Completed No outcome recorded
Comparator or background therapy47 trials
Phase 1 NCT06649409 Comparator Jun 2024 — Santhera Pharmaceuticals Completed No outcome recorded
Phase 1 NCT02871648 Comparator Jan 2016 → Oct 2019 — Brigham and Women's Hospital Completed No outcome recorded
Phase 1 NCT01237899 Comparator Oct 2010 → Jan 2011 chronic kidney disease Eli Lilly and Company Completed No outcome recorded
Phase 2 NCT07238400 Comparator Mar 2026 → Mar 2029 expected hypertensive disorder Massachusetts General Hospital Recruiting No outcome recorded
Phase 2 NCT04143412 Comparator Feb 2019 → Feb 2020 diabetic kidney disease Beni-Suef University Unknown No outcome recorded

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 124 sources stand behind the page.

FieldValueCited text
Known as Eplerenone “HFrEF polypill strength 1: bisoprolol 2.5 mg + losartan 25 mg + eplerenone 25 mg + dapagliflozin 10 mg; HFrEF polypill strength 2: bisoprolol 5 mg + losartan 50 mg + eplerenone...” NCT06831864 ↗
121

“One group was treated with mineralocorticoid receptor antagonists(MRAs) (including spironolactone 20-60mg/ day, or eplerenone50-100mg/day, or finerenone 10-20mg/ day) in...” NCT05688579 ↗

“The study intervention is a HFrEF polypill consisting of bisoprolol (beta-blocker), losartan (ARB), eplerenone (MRA), and dapagliflozin (SGLT2i) manufactured using the...” NCT07569640 ↗

“Patiromer (8.4g/day to 25.2g/day) and spironolactone (up to 200mg/day) or eplerenone (up to 50mg/day if spironolactone not acceptable).” NCT04142788 ↗

“Mineralocorticoid receptor antagonist eplerenone 25 mg Sodium-glucose co-transporter 2 inhibitor (SGLT2i): empagliflozin 10mg” NCT05129722 ↗

“25 patients with type 2 diabetes mellitus and mild hypertension will be randomized to Eraloner (Eplerenone) 50 mg/ day.” NCT04143412 ↗

“MRA (Spironolactone, Eplerenone) will be introduced and up titrated in week 3 and 7 respectively.” NCT05637853 ↗

“MRA: spironolactone or eplerenone (at the maximally tolerated dose, according to the SmPC)” NCT07513883 ↗

“Withdrawal of spironolactone or eplerenone and dapagliflozin or empagliflozin” NCT06091475 ↗

“Mineralocorticoid receptor antagonist, including spironolactone or eplerenone” NCT04575675 ↗

“first spironolactone/eplerenone: per two weeks: 25 mg/d→12,5 mg/d → stop” NCT02200822 ↗

Show 111 more sources

Known as EPL “The MRB eplerenone (EPL) has been shown to reduce new onset AF and recurrent AF in HF patients (7).” NCT06168994 ↗
Known as Eplerenone (Generic) “Eplerenone (Generic)” NCT01822561 ↗
Known as Eplerenone or INSPRA “Eplerenone or INSPRA” NCT00315016 ↗
Known as Eraloner “25 patients with type 2 diabetes mellitus and mild hypertension will be randomized to Eraloner (Eplerenone) 50 mg/ day.” NCT04143412 ↗
Known as Eraloner (Eplerenone 50 mg) “Eraloner (Eplerenone 50 mg)” NCT04143412 ↗
Known as Inspra “We assessed the translatability of urinary sodium to potassium ratio (Na+/K+) and plasma aldosterone as biomarkers of MR antagonism using eplerenone (Inspra®), a commercially...” PMID 22017794 ↗ Oct 2011
7

“Treatment: Eplerenone (Inspra) All patients will receive 25mg eplerenone once a day for a week, followed by 50mg once a day, for a total of 4-12 weeks.” NCT02462499 ↗

“The subject will be started on Eplerenone (Inspra) 50-200mg daily, which he or she will continue for a period of 8 weeks.” NCT01996449 ↗

“INSPRA 25 and 50 mg tablets (MAH: Pfizer) will be used for eplerenone 25 and 50 mg tablets” NCT01955694 ↗

“Eplerenone (inspra), Bumetanide (Burinex) and Empagliflozin (jardiance)” NCT05129722 ↗

“Eplerenone (Inspra®)” NCT01473108 ↗

“Inspra (eplerenone)” NCT01807221 ↗

“Inspra /Eplerenone” NCT02629094 ↗

Action Inhibit “aldosterone antagonism with eplerenone” PMID 20299607 ↗ Mar 2010
Route Oral “50mg oral route” NCT00401856 ↗