Treats hypertension. Sold as Inspra. Every FDA application for this active ingredient: 1 branded and 9 generic.
As of Nov 13, 2026, FDA lists 10 applications for Eplerenone (sold as Inspra), first approved Sep 27, 2002, with 2 new uses approved and 0 published complete response letters.
| Eplerenone | Part D | $28.9M | +6% | 102,233 |
| Inspra | Part D | $320K | -8% | 80 |
| Early Mineralocorticoid Receptor Antagonist Therapy for Low-Renin Essential HypertensionHypertension (HTN), Low-Renin Essential Hypertension · China National Center for Cardiovascular Diseases | Phase 4 | Not yet recruiting | Nov 12, 2026 |
| AIM2-NLRP3 Inflammasome Dual Inhibitor on hsCRPCoronary Heart Disease, Inflammation · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not applicable | Not yet recruiting | Nov 12, 2026 |
| Reducing Arterial Inflammation Using Eplerenone and Statins in HIVHIV (Human Immunodeficiency Virus), Cardiovascular Diseases (CVD) · Massachusetts General Hospital | Phase 2 / Phase 3 | Not yet recruiting | Oct 23, 2026 |
| Cardiac Improvement by Eplerenone Among Patients Under Cyclosporine or Tacrolimus for Kidney Transplantation.Kidney Transplantation · Central Hospital, Nancy, France | Phase 3 | Not yet recruiting | Sep 18, 2026 |
| Eplerenone and IOP in Healthy AdultsIntraocular Pressure (IOP), Healthy Adult · University of Florida | Phase 1 | Not yet recruiting | Aug 31, 2026 |
| Early Aldo Blockade in Subclinical PASubclinical Primary Aldosteronism · Xinjiang Medical University | Phase 2 / Phase 3 | Not yet recruiting | Jul 27, 2026 |
| HFrEF Polypill in Sri Lanka RCTHeart Failure With Reduced Ejection Fraction · Washington University School of Medicine | Phase 3 | Recruiting | May 6, 2026 |
| The Assessment of Partial Guideline-Directed Medical Therapy Down Titration in Heart Failure in Remission.Heart Failure · Ziekenhuis Oost-Limburg | Phase 4 | Recruiting | Apr 7, 2026 |
| Sep 27, 2002 | InspraNDA 21437 · New molecular entity | Upjohn | 10 | Marketed |
| Jul 30, 2008 | EplerenoneANDA 78482 | Chartwell Rx | 2 | Marketed |
| Aug 1, 2008 | EplerenoneANDA 78510 | Sandoz | 8 | Marketed |
| Feb 2, 2017 | EplerenoneANDA 203896 | Andas 5 Holding | 2 | Discontinued |
| Jul 13, 2017 | EplerenoneANDA 206922 | Accord Hlthcare | 3 | Marketed |
| Sep 14, 2018 | EplerenoneANDA 208283 | Breckenridge | 1 | Marketed |
| Aug 10, 2020 | EplerenoneANDA 212765 | Pharmazone | 0 | Marketed |
| Oct 25, 2021 | EplerenoneANDA 207842 | Everest Lifesciences | 0 | Marketed |
| Mar 23, 2022 | EplerenoneANDA 214663 | Rising | 1 | Marketed |
| Jun 2, 2023 | EplerenoneANDA 213812 | Annora Pharma | 1 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Sandoz
Accord Hlthcare