Data updated: May 26, 2026
INSPRA (eplerenone)
Trial Activity: Declining 7 active trials
Cardiovascular
Approved 2002-09-27
Development Insights
Brigham and Women's Hospital conducting 7 trials (17%)
43 indications explored (Broad Platform)
→ hypertension (10 trials)
→ chronic kidney disease (4 trials)
→ heart failure (3 trials)
3
Indications
--
Phase 3 Trials
1
Priority Reviews
23
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2002-09-27
- Routes
- ORAL
- Dosage Forms
- TABLET
INSPRA Approval History
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
33 FDA actions from 2002 to 2025 · 2 indication expansions
Jul 2013 SUPPL
Mfg
Apr 2013 SUPPL
Mfg
What INSPRA Treats
3 FDA approvalsOriginally approved for its first indication in 2002 . Covers 3 distinct patient populations.
- Other (3)
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Clinical Trial Registry
41 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04840342 | 2021p000990 | Ph 4 | active not recruiting | MR Antagonist and LSD1 |
| NCT05593055 | 2022P002126 | Ph 4 | recruiting | Mineralocorticoid Receptor, Coronary Microvascular Function, and Cardiac Efficiency in Hypertension |
| NCT07029503 SCARF-1 | SCARF-1 2025-520550-11-00 | Ph 2 | recruiting | Swedish Cardiac And Renal Failure Study-1 |
| NCT01794091 | Fibrotic Index in Diabetics | Ph 4 | withdrawn | Detection of Diffuse Scar in Patients With Diabetes |
| NCT04519164 | 2020P002311 | Ph 4 | completed | Aldosterone, the Mineralocorticoid Receptor, and Cardiovascular Disease in Obesity |
| NCT06649409 results posted | SNT-I-VAM-026 2024-512101-60-00, N-A-PH1-23-067 | Ph 1 | completed | Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects |
| NCT05030545 | 2021P002400 | Ph 4 | recruiting | Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study |
| NCT03165240 | 1378-0008 2017-000563-32 | Ph 1 | completed | This International Study Tests BI 690517 in Patients With Diabetic Kidney Disease. The Study Tests How 3 Different Doses of BI 690517 Are Taken up in the Body and How Well They Are Tolerated |
| NCT06168994 | Eplerenone in AF | Ph 4 | not yet recruiting | Role of Eplerenone in Reducing Recurrence of Atrial Fibrillation in Patient With Structural Heart Disease |
| NCT02490904 EPURE | 2015-000956-29 | Ph 3 | active not recruiting | Eplerenone in Patients Undergoing REnal Transplant (EPURE TRANSPLANT) |
| NCT02525796 results posted | 107407 | Ph 2, Ph 3 | completed | Evaluating Alternative Medical Therapies in Primary Hyperparathyroidism |
| NCT03984591 CROWD-ASPECT | CROWD-ASPECT | Ph 4 | enrolling by invitation | A Registry-based Cluster Randomized Trial to Compare the Effect of Spironolactone vs. Eplerenone on Clinical Outcomes in Patients With Symptomatic Systolic Heart Failure |
| NCT01586442 SNOW | WS1911307 | Ph 3 | completed | Comparison of Eplerenone Versus Spironolactone in Heart Failure Patients With Glucose Intolerance or Type 2 Diabetes |
| NCT01996449 results posted | R01HL113738 | Ph 2 | completed | The Role of Aldosterone on Augmented Exercise Pressor Reflex in Hypertension |
| NCT01857856 i-PHORECAST | TCC2012007 2013-001067-23 | Ph 3 | completed | PHOspholamban RElated CArdiomyopathy STudy - Intervention |
| NCT01955694 ARTS-HF Japan | 16815 | Ph 2 | completed | Phase IIb Safety and Efficacy Study of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Moderate Chronic Kidney Disease Alone |
| NCT00758524 results posted | CLCI699A2201 | Ph 2 | completed | A Study to Evaluate Efficacy and Safety of LCI699 in Participants With Essential Hypertension |
| NCT02871648 | 2015P001664 | Ph 1 | completed | The Role of Minerelocorticoid Receptor on Modulating Aldosterone Production |
| NCT00817635 results posted | CLCI699A2216 2008-007338-23 | Ph 2 | completed | A Study to Evaluate the Efficacy and Safety of LCI699 Compared to Placebo in Participants With Resistant Hypertension |
| NCT04300881 TOTEM | WM562718 | Ph 2 | terminated | Treatment of Post-Ocriplasmin Therapy Vitreolysis Induced Subretinal Fluid With Eplerenone (Mineralocorticoid Antagonists) |
| NCT01115855 J-EMPHASIS-HF results posted | A6141114 | Ph 3 | completed | Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure |
| NCT01176968 REMINDER results posted | A6141116 2010-019844-38, REMINDER | Ph 4 | completed | Impact Of Eplerenone On Cardiovascular Outcomes In Patients Post Myocardial Infarction |
| NCT01373086 | CLFF269X2201 | Ph 2 | terminated | LFF269 Compared to Placebo After Treatment in Subjects With Essential Hypertension |
| NCT02345044 | CS3150-A-J203 | Ph 2 | completed | A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Hypertensive Subjects |
| NCT02354352 results posted | 2014H0387 | Ph 3 | completed | Therapeutic Potential for Aldosterone Inhibition in Duchenne Muscular Dystrophy |
| NCT01427972 results posted | 14350 I4M-MC-MRAC | Ph 2 | completed | A Study of LY2623091 in Male and Females With Chronic Kidney Disease |
| NCT01237899 results posted | 14121 I4M-MC-MRAB | Ph 1 | completed | Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics and Effect on Renal Potassium Clearance |
| NCT02890173 ESAX-HTN | CS3150-A-J301 | Ph 3 | completed | Study of CS-3150 in Patients With Essential Hypertension |
| NCT01887119 | 133031 | Ph 4 | terminated | Aldosterone Antagonism and Microvascular Function |
| NCT02957435 | CAEP 56.005.16 | Ph 1 | withdrawn | Pharmacokinetics Study of Eplerenone Coated Tablets |
| NCT02809963 | 2015-002519-14 | Ph 4 | completed | Mineralocorticoid Receptor Antagonists in Type 2 Diabetes |
| NCT01971593 results posted | WI170964 | Ph 4 | terminated | The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart Disease |
| NCT00703352 EVEDES | EudraCT: 2007-002605-53 | Ph 4 | completed | Eplerenone in Systemic Right Ventricle |
| NCT01708798 | H12-00185 | Ph 2, Ph 3 | terminated | Study of the Effect of Eplerenone on Heart Function in Women Receiving Anthracycline Chemotherapy for Breast Cancer |
| NCT01801228 | 2011-001264-22 2011-001264-22 | Ph 2 | withdrawn | Eplerenone Versus Spironolactone as Treatment of Ascites Due to Liver Cirrhosis; a Study of Efficacy and Side Effects |
| NCT01275352 | CLNCKA-1 | Ph 4 | withdrawn | CLCNKA (Ka Renal Chloride Channel[ClC-Ka]) Polymorphism Effects on Hypertrophy Regression |
| NCT01837108 eplerenone01 | NL43234.091.13 | Ph 4 | completed | Eplerenone and Extracellular Adenosine Formation |
| NCT01319344 MetSyn | MSyn-2010 | Ph 3 | completed | Effect of Eplerenone on Endothelial Function in Metabolic Syndrome |
| NCT01302236 | JMU-N2 | Ph 4 | withdrawn | Effect of Eplerenone in Elderly Hypertensive Early Stage Chronic Kidney Disease (CKD) Patients |
| NCT00647192 EPLERAF | EPLERAF-01 Version 09_D, EudraCT number: 2007-002119-17 | Ph 2 | terminated | EPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion |
| NCT01100203 ALBLOCK-2 | ALBLOCK-2 | Ph 3 | terminated | Aldosterone Blockade in Chronic Kidney Disease: Influence on Arterial Stiffness and Kidney Function |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
INSPRA FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment