Eplerenone

Overview

Eplerenone, an aldosterone receptor antagonist similar to spironolactone, has been shown to produce sustained increases in plasma renin and serum aldosterone, consistent with inhibition of the negative regulatory feedback of aldosterone on renin secretion. The resulting increased plasma renin activity and aldosterone circulating levels do not overcome the effects of eplerenone. Eplerenone selectively binds to recombinant human mineralocorticoid receptors relative to its binding to recombinant human glucocorticoid, progesterone and androgen receptors.

Indication

For improvement of survival of stable patients with left ventricular systolic dysfunction (ejection fraction <40%) and clinical evidence of congestive heart failure after an acute myocardial infarction.

Associated Conditions

Hypertension
LVEF <40% Congestive heart failure
Chronic heart failure with reduced ejection fraction (NYHA Class II)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Swedish Cardiac And Renal Failure Study-1	2025/06/19	NCT07029503	Phase 2	Not yet recruiting	Karolinska Institutet
Vascular Effects of High-Salt After Preeclampsia	2024/12/27	NCT06749418	Early Phase 1	Recruiting	Anna Stanhewicz, PhD
Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects	2024/10/18	NCT06649409	Phase 1	Completed	Santhera Pharmaceuticals
Optimal Medical Treatment of Difficult-to-treat Hypertension	2024/02/23	NCT06275763	Phase 4	Recruiting	National Institute of Cardiology, Warsaw, Poland
The Predictive Role of Urinary Proteomics in Blood Pressure Response of Obese Hypertensive Treated With Irbesartan or Eplerenone.	2024/01/17	NCT06208072	Not Applicable	Recruiting	Hippocration General Hospital
Role of Eplerenone in Reducing Recurrence of Atrial Fibrillation in Patient With Structural Heart Disease	2023/12/13	NCT06168994	Phase 4	Not yet recruiting	Assiut University
Bioequivalence Study of Test and Reference 50 mg Eplerenone Film-coated Tablets in Healthy Volunteers	2022/12/23	NCT05663372	Phase 1	Completed	Darnitsa Pharmaceutical Company
Mineralocorticoid Receptor, Coronary Microvascular Function, and Cardiac Efficiency in Hypertension	2022/10/25	NCT05593055	Phase 4	Recruiting	Brigham and Women's Hospital
Eplerenone Versus PDT: Comparative Study by OCTA	2021/11/02	NCT05104138	N/A	Completed	Federico II University
Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study	2021/09/01	NCT05030545	Phase 4	Recruiting	Brigham and Women's Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
eplerenone	Slate Run Pharmaceuticals, LLC	70436-099	ORAL	50 mg in 1 1	8/19/2020
Inspra	Viatris Specialty LLC	58151-142	ORAL	25 mg in 1 1	6/23/2025
EPLERENONE	Breckenridge Pharmaceutical, Inc.	51991-877	ORAL	25 mg in 1 1	8/19/2025
EPLERENONE	Camber Pharmaceuticals, Inc.	31722-049	ORAL	25 mg in 1 1	6/15/2023
Eplerenone	Eon Labs, Inc.	0185-5368	ORAL	25 mg in 1 1	9/10/2020
Eplerenone	Greenstone LLC	59762-1720	ORAL	50 mg in 1 1	8/27/2020
Eplerenone	Mylan Pharmaceuticals Inc.	59762-1720	ORAL	50 mg in 1 1	8/27/2020
Inspra	Rebel Distributors Corp	21695-797	ORAL	25 mg in 1 1	8/10/2009
eplerenone	Slate Run Pharmaceuticals, LLC	70436-098	ORAL	25 mg in 1 1	8/19/2020
Inspra	Pfizer Laboratories Div Pfizer Inc	0025-1710	ORAL	25 mg in 1 1	10/1/2021

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
INSPRA TABLETS 50mg	Pfizer Pharmaceuticals LLC – Vega Baja	SIN13049P	TABLET, COATED	50 mg	2/17/2005
EPLERENONE MEVON FILM-COATED TABLETS 25 MG	Pharmathen S.A.	SIN16941P	TABLET, FILM COATED	25.000 mg	2/6/2024
EPLERENONE MEVON FILM-COATED TABLETS 50 MG	Pharmathen S.A.	SIN16940P	TABLET, FILM COATED	50.000 mg	2/6/2024
INSPRA TABLETS 25mg	Pfizer Pharmaceuticals LLC – Vega Baja	SIN13048P	TABLET, COATED	25 mg	2/17/2005

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
EPLERENONE TABLETS 50MG	N/A	HONG KONG MEDICAL SUPPLIES LIMITED	N/A	N/A	1/12/2023

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
EPLERENONE SP eplerenone 50 mg tablet blister pack	231445	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	10/21/2015
EPLERENONE SP eplerenone 25 mg tablet blister pack	231442	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	10/21/2015
EPLERENONE APOTEX eplerenone 50 mg tablet blister pack	295706	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/8/2018
EPLERENONE-DWRN eplerenone 50 mg tablet blister pack	427186	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	3/15/2024
EPLERENONE-RJIC eplerenone 50 mg tablet blister pack	427188	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	3/15/2024
APO-EPLERENONE eplerenone 25 mg tablet blister pack	295709	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/8/2018
EPLERENONE-RJIC eplerenone 25 mg tablet blister pack	427187	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	3/15/2024
EPLERENONE-DWRN eplerenone 25 mg tablet blister pack	427185	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	3/15/2024
INPLER eplerenone 50 mg tablet blister pack	231453	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	10/21/2015
EPLERENONE GPPL eplerenone 25 mg tablet blister pack	231456	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	10/21/2015

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
INSPRA	BGP Pharma ULC	02323052	Tablet - Oral	25 MG	5/8/2009
MINT-EPLERENONE	mint pharmaceuticals inc	02471442	Tablet - Oral	25 MG	4/9/2018
APO-EPLERENONE	Apotex Inc	02465019	Tablet - Oral	25 MG	N/A
JAMP EPLERENONE	Jamp Pharma Corporation	02543389	Tablet - Oral	25 MG	6/18/2024
INSPRA	BGP Pharma ULC	02323060	Tablet - Oral	50 MG	5/5/2009
JAMP EPLERENONE	Jamp Pharma Corporation	02543397	Tablet - Oral	50 MG	6/18/2024
GD-EPLERENONE	genmed a division of pfizer canada ulc	02441578	Tablet - Oral	50 MG	N/A
APO-EPLERENONE	Apotex Inc	02465027	Tablet - Oral	50 MG	N/A
GD-EPLERENONE	genmed a division of pfizer canada ulc	02441543	Tablet - Oral	25 MG	N/A
MINT-EPLERENONE	mint pharmaceuticals inc	02471450	Tablet - Oral	50 MG	4/9/2018

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
EPLERENONA AUROVITAS SPAIN 25 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Aurovitas Spain, S.A.U.	75754	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
EPLERENONA STADA 50 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorio Stada S.L.	76183	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
EPLERENONA NORMON 25 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorios Normon S.A.	75983	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
INSPRA 25 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Viatris Healthcare Limited	66356	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
EPLERENONA TARBIS 25 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Tarbis Farma S.L.	76363	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
EPLERENONA VIATRIS 50 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Viatris Limited	78658	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
EPLERENONA STADA 25 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorio Stada S.L.	76182	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
ELECOR 50 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Almirall S.A.	66757	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
EPLERENONA VIR 25 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Industria Quimica Y Farmaceutica Vir S.A.	75724	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
EPLERENONA TARBIS FARMA 25 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG	Tarbis Farma S.L.	89225	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

Researchers Challenge Standard Diagnostic Test for Primary Aldosteronism, Call for Paradigm Shift in Hypertension Care

4 months ago

A new study published in Annals of Internal Medicine found that the seated saline suppression test (SSST) commonly used to confirm primary aldosteronism is often inaccurate and may prevent patients from receiving effective treatment.

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