TheraRadar
Data updated: May 26, 2026

SPIRONOLACTONE

Aldosterone Antagonists
Cardiovascular Approved 1980-05-07

Spironolactone is an aldosterone antagonist indicated for: The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure . Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions .

Source: FDA Label • Sun Pharma
Jump to: Indications Approvals Trials Competitors Safety Patents
19
Indications
--
Phase 3 Trials
46
Years on Market

Details

Status
Prescription
First Approved
1980-05-07
Routes
ORAL
Dosage Forms
TABLET, SUSPENSION

Companies

Sun Pharma Aurobindo Pharma WATSON LABS JUBILANT GENERICS ASCOT HETERO LABS LTD III Viatris CHARTWELL RX UPSHER SMITH WARNER CHILCOTT ANNORA PHARMA Teva LEDERLE VANGARD PUREPAC PHARM IVAX PHARMS ACCORD HLTHCARE PHARMOBEDIENT AMNEAL AMNEAL PHARMS OXFORD PHARMS MUTUAL PHARM SUPERPHARM ZYDUS PHARMS GRAVITI PHARMS
Active Ingredient: SPIRONOLACTONE

SPIRONOLACTONE Approval History

1981
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2026
Original
New Indication
New Form
Label Update
382 FDA actions from 1980 to 2026
May 2026 SUPPL
Label · Labeling
Jul 2025 ORIGINAL
Update
Jun 2025 SUPPL
Label · Labeling

What SPIRONOLACTONE Treats

19 FDA approvals

Originally approved for its first indication in 1980 . Covers 19 distinct patient populations.

  • Other (19)
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Clinical Trial Registry

71 trials
Trial Sponsor ID Phase Status Title
NCT03344159 STAR-HF 20170694 Ph 4 completed Spironolactone Therapy in Chronic Stable Right HF Trial
NCT01712620 120211 12-CC-0211 Ph 2 recruiting Spironolactone for Pulmonary Arterial Hypertension
NCT05807139 10001546 001546-DA Ph 1 recruiting Spironolactone in Alcohol Use Disorder (SAUD)
NCT06004830 HARP 2000033919_a 1P01AA029545-01 Ph 2 active not recruiting Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 1
NCT07483177 25-014938 Ph 1, Ph 2 not yet recruiting HEART: Pilot Randomized Controlled Trial
NCT04582383 SD-ACNE R34AR074733-01A1 Ph 4 active not recruiting Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne
NCT03593317 BRAVE 69HCL18_0038 2023-505048-20-00 Ph 2 recruiting Blockade of the Renin-angiotensin-aldosterone System in Patients With ARVD
NCT03429946 HypoANS-B 2004P001233-B R01HL109634, K24HL103845 Ph 4 completed Hypoglycemia and Autonomic Nervous System Function-B
NCT04522739 STAND STUDY00000124 Ph 4 completed Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Dementia
NCT05754684 HKCH-REC-2021-007 Ph 2 recruiting Quadruple Immunotherapy for Neuroblastoma
NCT01552044 C11-21 2011-003046-40 Ph 1, Ph 2 completed Effect of Spironolactone in Treating Chronic Non-resolutive Central Serous Chorioretinitis
NCT04901975 20-017716 1R01HL149139-01A1 Ph 1, Ph 2 recruiting Fibrosis and the Fontan
NCT05092984 ALDORA 8154 2021-003958-23 Ph 3 recruiting Evaluation of Spironolactone Efficacy in Patient with Rheumatoid Arthritis (RA)
NCT05010707 TREAT results posted 202104092 Ph 2 completed Transgender Estradiol Affirming Therapy
NCT02901184 SPIRRIT U-2015-030 U01HL134679-01, U01HL134694-02 Ph 3 recruiting Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction
NCT03048825 CLEAR SYNERGY CLSYN.1702 OASIS-9 Ph 3 completed Colchicine and Spironolactone in Patients with MI / SYNERGY Stent Registry
NCT04331691 4-2019-1334 Ph 4 completed Comparison of Spironolactone and Amiloride on Home Blood Pressure in Resistant Hypertension
NCT01294319 results posted 110078 11-CH-0078 Ph 2 completed Evaluation of Cortisol Resistance in Young Sedentary and Endurance-Trained Men
NCT06413082 ALTUM ALTUM Ph 3 completed Pharmacogenetics of Torasemide and Spironolactone in Hypertension Treatment
NCT06204640 SPONSoR SPONSoR Ph 3 not yet recruiting SPironolactONe for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation
NCT03777319 results posted IRB17-00240 Ph 1 terminated Spironolactone Versus Prednisolone in DMD
NCT01848639 ALCHEMIST ALCHEMIST RB 12-079 Ph 3 completed ALdosterone Antagonist Chronic HEModialysis Interventional Survival Trial
NCT02169089 results posted 57047 Ph 4 completed Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Trial
NCT02575963 API-01 Ph 1, Ph 2 completed Lintuzumab-Ac225 in Older Acute Myeloid Leukemia (AML) Patients
NCT03334682 FASCE RC16_0467 Ph 3 completed Randomized Double-blind Study on the Benefit of Spironolactone for Treating Acne of Adult Woman.
NCT04190433 19-007547 NCI-2021-13928 Ph 2 withdrawn Autophagy Activation for the Alleviation of Cardiomyopathy Symptoms After Anthracycline Treatment, ATACAR Trial
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
NCT02497300 VEMAKD results posted F140508008 Ph 2 completed Vascular Effects of Mineralocorticoid Receptor Antagonism in Kidney Disease
NCT02230891 results posted CLNB-009-13F Ph 2 completed Biomarker Guided Therapies in Stage A/B Heart Failure
NCT01586442 SNOW WS1911307 Ph 3 completed Comparison of Eplerenone Versus Spironolactone in Heart Failure Patients With Glucose Intolerance or Type 2 Diabetes
NCT03597035 MAGMAAddOn results posted 02-17-16 Ph 4 terminated Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Add-On
NCT02883400 results posted 12-14-03A Ph 4 completed Spironolactone After Liver Transplant
NCT04205136 HUM00147375 Ph 4 withdrawn Spironolactone to Improve Apnea and Cardiovascular Markers in Obstructive Sleep Apnea Patients
NCT01345656 ARTS 14563 2011-000301-45 Ph 2 completed BAY94-8862 Dose Finding Trial in Subjects With Chronic Heart Failure and Mild (Part A) or Moderate (Part B) Chronic Kidney Disease
NCT01602861 SPIREN Eudra CT: 2011-002243-98 Ph 4 completed The Effects of Spironolactone on Calcineurin Inhibitor Induced Nephrotoxicity
NCT01371747 AMETHYST-DN results posted RLY5016-205 2011-000165-12 Ph 2 completed Patiromer in the Treatment of Hyperkalemia in Patients With Hypertension and Diabetic Nephropathy (AMETHYST-DN)
NCT03071263 AMBER results posted RLY5016-207 2016-002657-38 Ph 2 completed Spironolactone With Patiromer in the Treatment of Resistant Hypertension in Chronic Kidney Disease
NCT01130597 results posted RLY5016-204 Ph 2 completed Evaluation of Patiromer Titration in Heart Failure Patients With Chronic Kidney Disease
NCT00328809 1045057 Ph 4 withdrawn Spironolactone Safety in Dialysis Patients
NCT04393493 results posted 112/17 Ph 2 completed The Effect in Renal Function on Patients With Type 1 Cardiorenal Syndrome Treated With Two Strategies of Furosemide.
NCT02194465 results posted 15525 I7T-MC-RMAH Ph 2 completed A Study of LY2623091 in Participants With High Blood Pressure
NCT03682497 D6401C00004 Ph 1 terminated Study in HFpEF Patients to Compare the Effect of AZD9977 and Spironolactone on Serum Potassium
NCT01867294 results posted RC09C8 NCI-2012-01275, RC09C8 Ph 2 completed Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab
NCT02046668 SPIR-OA 13/WS/0232 2013-002638-19 Ph 4 completed The Effect of Spironolactone on Pain in Older People With Osteoarthritis
NCT02354352 results posted 2014H0387 Ph 3 completed Therapeutic Potential for Aldosterone Inhibition in Duchenne Muscular Dystrophy
NCT01853553 results posted 13-1440 R01DK097081 Ph 3 completed Mineralocorticoid Antagonism and Endothelial Dysfunction in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
NCT01691053 MiREnDa MN0511_1 2011-003179-12, 01KG1202 Ph 2 completed Mineralocorticoid Receptor Antagonists in End Stage Renal Disease
NCT02285920 SPin-D results posted 821193 Ph 2 completed Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent ESRD Trial
NCT02236520 results posted 141382 Ph 2 completed Tissue Sodium in Pre-hypertensive Patients
NCT02832973 ResHypOT SaoJoseRPU Ph 4 completed Sequential Nephron Blockade vs. Dual Blockade Renin-angiotensin System + Bisoprolol in Resistant Arterial Hypertension

Showing 50 of 71 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

SPIRONOLACTONE FDA Label Details

Indications & Usage

FDA Label (PDF)

Spironolactone is an aldosterone antagonist indicated for: The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure . Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions . The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of n...

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Data Sources

FDA Approval: ANDA089424 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.