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
+67 more · Anna Stanhewicz, PhD · Assiut University · Biolab Sanus Farmaceutica · 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 · RemediumOne · 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) · Central Hospital, Nancy, France · 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 · 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 Glasgow · 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 73 · started per year

today
US approved 2002
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2001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
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 111 trials
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 NCT00865618 Jun → Jul 2006 hypertensive disorder Sandoz 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
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
Phase 2 NCT02629094 Dec 2015 → Sep 2017 fatty liver disease, triglyceride deposit cardiomyovasculopathy National Institute of Allergy and Infectious Diseases (NIAID) Terminated No outcome recorded
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 NCT01801228 Feb 2013 → Oct 2015 cirrhosis of liver Emma Nilsson Withdrawn No outcome recorded
Phase 2 NCT01834768 Feb → Apr 2013 chronic kidney disease Reims University Hospital Unknown No outcome recorded
Phase 2 NCT00649311 Apr → Sep 2003 hypertensive disorder Pfizer Terminated No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT02525796 Jan 2016 → Oct 2021 primary hyperparathyroidism Brigham and Women's Hospital Completed No outcome recorded
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 37 trials
Phase 3 NCT07569640 Jun 2026 → Dec 2028 expected symptomatic heart failure Washington University School of Medicine Not yet 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
Phase 4 NCT07513883 Mar 2026 → Sep 2028 expected heart failure Ziekenhuis Oost-Limburg Recruiting No outcome recorded
Phase 4 NCT06168994 Feb 2024 → Sep 2026 expected 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
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
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
Phase 4 NCT04840342 Feb 2022 → Sep 2025 overdue apparent mineralocorticoid excess, essential hypertension Brigham and Women's Hospital Active not recruiting No outcome recorded
Phase not applicable11 trials
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 No outcome recorded
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 No outcome recorded
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
Also used as a comparator or background therapy in 47 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 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 212 trials
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
Phase 2 NCT02345044 Comparator Jan → Aug 2015 essential hypertension Daiichi Sankyo Completed No outcome recorded
Phase 2 NCT01955694 Comparator Nov 2013 → Jan 2015 heart failure Bayer Completed No outcome recorded
Phase 2 NCT01996449 Comparator Jul 2013 → Apr 2021 hypertensive disorder University of Texas Southwestern Medical Center Completed No outcome recorded
Phase 37 trials
Phase 3 NCT04450953 Comparator Oct 2021 → Nov 2025 overdue Central Hospital, Nancy, France Recruiting No outcome recorded
Phase 3 NCT02890173 Comparator Sep 2016 → Jul 2017 essential hypertension Daiichi Sankyo Completed No outcome recorded
Phase 3 NCT02354352 Comparator Mar 2015 → May 2018 Duchenne muscular dystrophy Ohio State University Completed No outcome recorded
Phase 3 NCT01857856 Comparator May 2013 → Oct 2021 familial dilated cardiomyopathy M.p. van den Berg, MD, PhD, professor in Cardiology Completed No outcome recorded
Phase 3 NCT01100203 Comparator Apr 2010 → Jan 2012 chronic kidney disease Lene Boesby Terminated No outcome recorded
Phase 417 trials
Phase 4 NCT05593055 Comparator Aug 2023 → Apr 2027 expected hypertensive disorder Brigham and Women's Hospital Recruiting No outcome recorded
Phase 4 NCT03984591 Comparator Nov 2020 → Dec 2028 expected systolic heart failure Bispebjerg Hospital Enrolling by invitation No outcome recorded
Phase 4 NCT04575675 Background May → Nov 2020 heart failure, hypotensive disorder Cheng-Hsin General Hospital Completed No outcome recorded
Phase 4 NCT03476616 Comparator Sep 2018 → Jun 2025 essential hypertension, obesity disorder Hippocration General Hospital Completed No outcome recorded
Phase 4 NCT03079141 Comparator Feb 2017 → Aug 2019 central serous chorioretinopathy Leiden University Medical Center Unknown No outcome recorded
Phase not applicable8 trials
NCT07335900 Background Dec 2025 → Dec 2026 expected aortic valve stenosis RenJi Hospital Recruiting No outcome recorded
NCT06208072 Comparator Sep 2023 → Dec 2024 essential hypertension, obesity disorder Hippocration General Hospital Unknown No outcome recorded
NCT05797558 Comparator Apr 2023 → May 2028 expected aldosterone-producing adrenal cortex adenoma Göteborg University Recruiting No outcome recorded
NCT01990677 Comparator Oct 2013 → Mar 2015 central serous chorioretinopathy Wills Eye Completed No outcome recorded
NCT01521546 Comparator Feb 2012 → Jun 2016 Duchenne muscular dystrophy Ohio State University Completed No outcome recorded

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 122 sources stand behind the page.

FieldValueCited text
Known as Eplerenone “The study intervention will be a heart failure with reduced ejection fraction (HFrEF) polypill consisting of bisoprolol (beta-blocker), losartan (ARB), eplerenone (MRA), and...” NCT07569640
119

“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

“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

“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

“Mineralocorticoid receptor antagonist, including spironolactone or eplerenoneNCT04575675

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

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

“triamterene, eplerenone, spironolactone, atenolol, betaxolol” NCT00684489

“representative drugs spironolactone and eplerenoneNCT07335900

Eplerenone 25 mg daily will be given” NCT06556732

“50-150 mg /day eplerenone (Inspra ®)” NCT01146197

NCT00147589

NCT01427972

NCT01373086

NCT00082589

NCT03923530

NCT00232180

NCT01586442

NCT00223717

NCT03476616

NCT00315016

NCT01176968

NCT02629094

NCT01302236

NCT00515021

NCT06208072

NCT01893788

NCT00865176

NCT07345845

NCT05198791

NCT00147563

NCT02153125

NCT01473108

NCT01857856

NCT02532998

NCT06649409

NCT00108251

NCT00703352

NCT02354352

NCT01990677

NCT05030545

NCT00138944

NCT03079141

NCT04840342

NCT00430924

NCT03418649

NCT02871648

NCT00649311

NCT03165240

NCT01955694

NCT00990223

NCT01822561

NCT00293150

NCT02118753

NCT01837108

NCT02957435

NCT00825188

NCT00401856

NCT01786551

NCT01394627

NCT04746495

NCT03683069

NCT04519164

NCT04697485

NCT02345590

NCT01319344

NCT02345044

NCT00132093

NCT02215330

NCT01801228

NCT01971593

NCT01521546

NCT00980031

NCT02490904

NCT00187889

NCT04300881

NCT01405456

NCT03984591

NCT01115855

NCT04450953

NCT00817635

NCT02607657

NCT00608465

NCT01237899

NCT01275352

NCT05797558

NCT00758524

NCT07029503

NCT01832558

NCT05593055

NCT06275763

NCT01834768

NCT02740179

NCT01807221

NCT01100203

NCT07238400

NCT00553722

NCT06749418

NCT02890173

NCT01650012

NCT03017703

NCT00505336

NCT03186742

NCT02462499

NCT02525796

NCT00391846

NCT06168994

NCT00147615

NCT01794091

NCT01887119

NCT01996449

NCT00647192

NCT02809963

NCT01708798

NCT00865618

NCT00214825

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 INSPRANCT00315016
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