Aldactone

(Spironolactone)

ApprovedSmall molecule

Spironolactone is used to treat high blood pressure and fluid buildup in the body caused by heart, kidney, or liver problems. It's also used to treat a hormonal condition called hyperaldosteronism and can help reduce acne and excess hair growth in women.[2] Aldactone is currently approved and in use across 78 indications[4].[1]

Aldactone is one of 1453 small molecule programs targeting Single ventricle. It is currently in Approved.

Indications

181

Total Trials

Active Trials

1,452

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Single VentricleApproved

CalcificationActive, not recruiting

Metabolic SyndromeActive, not recruiting

Cirrhosis of LiverActive, not recruiting

Ischemic CardiomyopathyActive, not recruiting

Adult Acute Respiratory Distress SyndromeActive, not recruiting

AscitesActive, not recruiting

Cardiovascular DiseaseActive, not recruiting

Left Ventricular HypertrophyActive, not recruiting

Mitral RegurgitationActive, not recruiting

Single VentricleApproved

Approved

CalcificationPhase 3

Active, not recruiting

Metabolic SyndromePhase 1

Active, not recruiting

Cirrhosis of LiverApproved

Active, not recruiting

Ischemic CardiomyopathyPreclinical

Active, not recruiting

Adult Acute Respiratory Distress SyndromePreclinical

Active, not recruiting

AscitesApproved

Active, not recruiting

Cardiovascular DiseasePhase 2

Active, not recruiting

Left Ventricular HypertrophyApproved

Active, not recruiting

Mitral RegurgitationPreclinical

Active, not recruiting

Showing 10 of 76 indications

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

Aldactone

Pfizer

Approved

1 2

Bnt162b2

BioNTech

Preclinical

29 3

Biaxin

AbbVie

Preclinical

2 4

Singulair

AstraZeneca

Preclinical

1 5

Angiomax

BBaxter Healthcare Corporation

Preclinical

2 6

Nitrostat

VViatris Specialty LLC

Preclinical

1 7

Low-Molecular-Weight Heparin

Daiichi Sankyo

Preclinical

3 8

Piperacillin/tazobactam

Pfizer

Preclinical

1 9

Glucocorticoid

AbbVie

Preclinical

1 10

Nadroparin

GSK

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Post-ApprovalActive, not recruiting

Spironolactone

NCT04582383

Q4 2026

Phase 3Recruiting

Heart Failure

NCT02901184

Recruiting

Endothelial Function

NCT05561361

Phase 2Recruiting

Pulmonary Arterial Hypertension

NCT01712620

Q1 2027

Phase 2Recruiting

Alcohol Use Disorder

NCT06004830

Q2 2027

Phase 1Recruiting

Alcohol Use Disorder

NCT05807139

Clinical

Trials by Indication[1]

Spironolactone25 trials

Spironolactone Versus Prednisolone in DMD

Terminated·KKevin Flanigan·Phase 1·NCT03777319·2 enrolled

Spironolactone in CKD Enabled by Chlorthalidone: PILOT

Unknown status·IIndiana Institute for Medical Research·Phase 2·NCT05222191·24 enrolled

Randomized Double-blind Study on the Benefit of Spironolactone for Treating Acne of Adult Woman.

Completed·NNantes University Hospital·Phase 3·NCT03334682·158 enrolled

Show 22 more trials

Colchicine and Spironolactone in Patients with MI / SYNERGY Stent Registry

Completed·PPopulation Health Research Institute·Phase 3·NCT03048825·7,264 enrolled

Using the Drug Spironolactone to Test If It Reduces Protein Leakage From the Kidney

Completed·MMelbourne Health·Phase 2/3·NCT00106561·60 enrolled

Pharmacokinetic Study of Spironolactone 25 mg, 50 mg and 100 mg Tablets

Completed· Orion Corporation, Orion Pharma logo

Orion Corporation, Orion Pharma·Phase 1·NCT01083290·14 enrolled

Does Treatment of Androgen Excess Using Spironolactone Improve Ovulatory Rates in Girls With Androgen Excess?

Unknown status·UUniversity of Virginia·Phase 1·NCT04075149·24 enrolled

Comparing the Effects of Spironolactone With Chlortalidone on LV Mass in Patients With CKD

Unknown status·UUniversity Hospital Birmingham·Phase 4·NCT02502981·154 enrolled

Spironolactone Improved Children With Gene Mutations Related to NCOR

Completed·QQilu Hospital of Shandong University·Phase 2/3·NCT06678685·2 enrolled

Antiarrhythmic Effects of Spironolactone in Patients With ICDs

Completed·VVA Office of Research and Development·Phase 4·NCT04495712·90 enrolled

Spironolactone Versus Indapamide in Obese and Hypertensive Patients

Unknown status·PPeking University Third Hospital·N/A·NCT03626506·400 enrolled

Spironolactone Therapy in Chronic Stable Right HF Trial

Completed·OOttawa Heart Institute Research Corporation·Phase 4·NCT03344159·15 enrolled

Spironolactone to Decrease Potassium Wasting in Hypercalciurics on Thiazides Diuretics

Completed·IIndiana University School of Medicine·N/A·NCT00276289·10 enrolled

Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne

Active, not recruiting·UUniversity of Pennsylvania·Phase 4·NCT04582383·350 enrolled

Clinical Trial Studying the Effects of Spironolactone on Heart and Skeletal Muscle Function in Chronic Alcoholics

Suspended·UUniversity of Aarhus·Phase 4·NCT00226109·40 enrolled

Spironolactone for the Treatment of Melasma

Withdrawn·MMedical University of South Carolina·Phase 1·NCT03953209

Spironolactone Therapy In Young Women With NASH

Completed·UUniversity of California, San Francisco·Phase 1/2·NCT03576755·20 enrolled

Spironolactone and XPB-1 Integrity in the TFIIH Complex

Enrolling by invitation·UUniversity of Sao Paulo General Hospital·N/A·NCT07415811·12 enrolled

Bioequivalence Study of Spironolactone Tablets in Healthy Subjects

Completed·SSPH Sine Pharmaceutical Laboratories Co., Ltd.·Phase 1·NCT06579053·64 enrolled

Use of Spironolactone for the Prevention of Electrolyte Abnormalities in Patients Treated With Amphotericin B

Terminated·IInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran·Phase 4·NCT01843309·36 enrolled

Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects (COMPARE-VS)

Not yet recruiting·UUniversity Medical Center Groningen·Phase 2·NCT07304817·100 enrolled

Study in HFpEF Patients to Compare the Effect of AZD9977 and Spironolactone on Serum Potassium

Terminated· AstraZeneca logo

AstraZeneca·Phase 1·NCT03682497·68 enrolled

L-Arginine and Spironolactone Trial in Dialysis-Dependent ESRD

Withdrawn·—·Phase 4·NCT01855334

The Effect of Amiloride and Spironolactone in Healthy Persons

Completed·RRegional Hospital Holstebro·Phase 1·NCT00857909·30 enrolled

Effects of Spironolactone in Dialysis

Unknown status·UUPECLIN HC FM Botucatu Unesp·Phase 4·NCT01128101·60 enrolled

Heart Failure17 trials

Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function

Completed·CCarelon Research·Phase 3·NCT00094302·3,445 enrolled

Biomarker Guided Therapies in Stage A/B Heart Failure

Completed·VVA Office of Research and Development·Phase 2·NCT02230891·58 enrolled

Early Aldosterone Blockade in Acute Heart Failure: An Exploratory Safety Study

Withdrawn·IIndiana University·Phase 2·NCT02299726

Show 14 more trials

Aldosterone Blockade in Heart Failure

Completed·JJustin Ezekowitz·Phase 3·NCT00523757·8 enrolled

Effect of Aldosterone on Energy Starvation in Heart Failure

Completed·VVanderbilt University·Phase 4·NCT00574119·16 enrolled

SCREEN-HFI (SCReening Evaluation of the Evolution of New Heart Failure Intervention Study)

Completed·MMonash University·Phase 3·NCT00604006·20 enrolled

Evaluation of Heart Failure Treatment Guided by N-terminal Pro B-type Natriuretic Peptide (NTproBNP) vs Clinical Symptoms and Signs Alone

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00391846·252 enrolled

Determination of Drug Levels for Pharmacotherapy of Heart Failure

Not yet recruiting·UUniversity Hospital Ostrava·Phase 4·NCT06035978·100 enrolled

The Comparison Between Spironolactone and Indapamide Monotherapy or in Combination With Amlodipine to Reduce the Risk of Heart Failure

Unknown status·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT04455178·200 enrolled

High-Dose Aldactone for Treatment of Diuretic Resistant Heart Failure

Withdrawn·TThe University of Texas Health Science Center at San Antonio·Phase 4·NCT02429388

Hemodynamic Effects of Spironolactone in Patients With Heart Failure

Completed·UUniversity of Toledo Health Science Campus·N/A·NCT00860340·18 enrolled

Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction

Recruiting·UUppsala University·Phase 3·NCT02901184·2,000 enrolled

Mineralocorticoid Receptor Antagonists (MRA) in Heart Failure (HF) and Loop Diuretic Resistance

Completed·—·Phase 2/3·NCT02585843·20 enrolled

Study of Drug Therapy for Pediatric Heart Failure

Unknown status·CChina National Center for Cardiovascular Diseases··NCT06039540·200 enrolled

Gender-Based Differences in Heart Failure Hospitalizations Among Patients With Heart Failure Treated With Spironolactone

Completed·AAhmad Abdullah Salawi··NCT06641284·509 enrolled

Diuretic and Natriuretic Effect of High-dose Spironolactone in Patients With Acute Heart Failure

Unknown status·LLaikο General Hospital, Athens·Phase 4·NCT04618601·50 enrolled

Study of High-dose Spironolactone vs. Placebo Therapy in Acute Heart Failure

Completed·—·Phase 2·NCT02235077·360 enrolled

Hypertension12 trials

Spironolactone Versus Amiloride as an Add on Agent in Resistant Hypertension

Withdrawn·VVA Salt Lake City Health Care System·N/A·NCT00709137

Resistant Hypertension Optimal Treatment

Unknown status·IInstituto do Coracao·Phase 4·NCT01643434·2,000 enrolled

Comparison of Spironolactone and Amiloride on Home Blood Pressure in Resistant Hypertension

Completed·YYonsei University·Phase 4·NCT04331691·118 enrolled

Show 9 more trials

The Effect of Spironolactone on Blood Pressure in Type-2 Diabetics With Resistant Hypertension

Completed·IIb Abildgaard Jacobsen·Phase 3·NCT01062763·119 enrolled

Optimum Treatment for Drug-Resistant Hypertension

Unknown status·UUniversity of Cambridge·Phase 4·NCT02369081·348 enrolled

Addition of Spironolactone in Patients With Resistant Arterial Hypertension

Unknown status·JJan Vaclavík·Phase 4·NCT00524615·160 enrolled

The Efficacy of Spironolactone in Patients With Resistant Hypertension

Terminated·SSheffield Teaching Hospitals NHS Foundation Trust·Phase 2·NCT00430794·40 enrolled

Spironolactone to Improve Pregnancy-Associated Hypertension Trajectories

Recruiting·MMassachusetts General Hospital·Phase 2·NCT07041281·204 enrolled

The Effect of Amiloride and Spironolactone in Patients With Hypertension

Completed·EErling Bjerregaard Pedersen·Phase 4·NCT01388088·23 enrolled

Pharmacogenetics of Torasemide and Spironolactone in Hypertension Treatment

Completed·OOspedale San Raffaele·Phase 3·NCT06413082·38 enrolled

Sequential Nephron Blockade vs. Dual Blockade Renin-angiotensin System + Bisoprolol in Resistant Arterial Hypertension

Completed·SSao Jose do Rio Preto Medical School·Phase 4·NCT02832973·72 enrolled

SPIRO-First: A Pragmatic Primary Care-Embedded Pilot Trial of Renin-Guided First-Line Antihypertensive Therapy

Not yet recruiting·OOttawa Hospital Research Institute·Approved·NCT07687160·30 enrolled

Atrial Fibrillation6 trials

Spironolactone in Atrial Fibrillation

Unknown status·UUniversity of Birmingham·Phase 4·NCT02673463·250 enrolled

Efficacy of Aldosterone Antagonist Therapy for Prevention of New Atrial Fibrillation

Active, not recruiting·PPiedmont Healthcare·Phase 1·NCT03929718·50 enrolled

Spironolactone and Perioperative Atrial Fibrillation Occurrence in Cardiac Surgery Patients.

Unknown status·UUniversity Hospital, Caen·Phase 3·NCT03551548·1,500 enrolled

Show 3 more trials

Inhibition of Aldosterone to Reduce Myocardial Diffuse Fibrosis in Patients With Paroxysmal and Persistent Atrial Fibrillation in Preventing Recurrent Episodes of Atrial Fibrillation

Unknown status·—·Phase 3·NCT02764619·125 enrolled

Mineralocorticoid Antagonism to Stop Progression of Atrial Fibrillation (MONITOR-AF) Study

Unknown status·NNational University Hospital, Singapore·Phase 2·NCT04327232·184 enrolled

SPironolactONe for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation

Not yet recruiting·UUniversity Hospital, Caen·Phase 3·NCT06204640·580 enrolled

Diabetic Nephropathy6 trials

Spironolactone in Diabetic Nephropathy

Completed·SSteno Diabetes Center Copenhagen·Phase 4·NCT00317954·48 enrolled

Spironolactone for Reducing Proteinuria in Diabetic Nephropathy

Completed·UUS Department of Veterans Affairs·N/A·NCT00498537·30 enrolled

Aldosterone in Diabetic Nephropathy

Unknown status·UUniversidad de los Andes, Chile·Phase 4·NCT00870402·160 enrolled

Show 3 more trials

Patiromer in the Treatment of Hyperkalemia in Patients With Hypertension and Diabetic Nephropathy (AMETHYST-DN)

Completed·RRelypsa, Inc.·Phase 2·NCT01371747·324 enrolled

A Study To Evaluate The Safety And Tolerability Of PF-03882845 In Patients With Type 2 Diabetic Nephropathy

Terminated· Pfizer logo

Pfizer·Phase 1·NCT01488877·6 enrolled

Proteomic Prediction and Renin Angiotensin Aldosterone System Inhibition Prevention Of Early Diabetic nephRopathy In TYpe 2 Diabetic Patients With Normoalbuminuria

Completed·PPeter Rossing·Phase 2/3·NCT02040441·1,777 enrolled

88 more indications

Chronic Kidney Disease5 trials

The Role of Skin Sodium Accumulation in Chronic Kidney Disease

Recruiting·—·N/A·NCT07020104·60 enrolled

Evaluation of CLP With and Without Spironolactone in Heart Failure Patients With Chronic Kidney Disease

Completed·SSorbent Therapeutics·Phase 1·NCT01598740·18 enrolled

Spironolactone With Patiromer in the Treatment of Resistant Hypertension in Chronic Kidney Disease

Completed·RRelypsa, Inc.·Phase 2·NCT03071263·295 enrolled

Show 2 more trials

BAY94-8862 Dose Finding Trial in Subjects With Chronic Heart Failure and Mild (Part A) or Moderate (Part B) Chronic Kidney Disease

Completed· Bayer logo

Bayer·Phase 2·NCT01345656·457 enrolled

Evaluation of Patiromer Titration in Heart Failure Patients With Chronic Kidney Disease

Completed·RRelypsa, Inc.·Phase 2·NCT01130597·63 enrolled

Primary Aldosteronism4 trials

Efficacy and Safety of Finerenone vs. Spironolactone in Patients With Primary Aldosteronism

Unknown status·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT06164379·150 enrolled

Comparing the Efficacy and Safety of Finerenone and Spironolactone in the Treatment of Primary Aldosteronism

Not yet recruiting·TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School·Phase 4·NCT05814770·96 enrolled

Efficacy of Spironolactone Combined With Antihypertensive Drugs in Patients With Primary Aldosteronism

Recruiting·TThird Military Medical University··NCT07137364·350 enrolled

Show 1 more trial

Finerenone for Patients With Primary Aldosteronism (FAIRY)

Recruiting·QQifu Li·Phase 4·NCT06457074·306 enrolled

Cardiovascular3 trials

The Effects of Amiloride and Spironolactone on Renophysiological and Cardiovascular Variables

Completed·RRegional Hospital Holstebro·N/A·NCT01195805·25 enrolled

Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent ESRD Trial

Completed·UUniversity of Pennsylvania·Phase 2·NCT02285920·129 enrolled

Cardiovascular Protective Effect of Spironolactone in Hemodialysis

Unknown status·UUniversidad de los Andes, Chile·Phase 4·NCT00277693

Acute Kidney Injury3 trials

The Effect of Spironolactone on Acute Kidney Injury in Patients Undergoing Coronary Angiography

Completed·AAlhasan Mujtaba Abdul-Wahid·Phase 2·NCT03329443·490 enrolled

Short Term Spironolactone for Prevention of Acute Kidney Injury After Cardiac Surgery

Unknown status·IInstituto Nacional de Cardiologia Ignacio Chavez·N/A·NCT02417896·150 enrolled

Spironolactone on Acute Kidney Injury in Critically Ill Patients

Unknown status·IInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran·Phase 3·NCT03206658·90 enrolled

Cardiomyopathy2 trials

Spironolactone Against Anthracycline-induced Cardiomyopathy

Completed·TTC Erciyes University·Phase 4·NCT02053974·90 enrolled

Autophagy Activation for the Alleviation of Cardiomyopathy Symptoms After Anthracycline Treatment, ATACAR Trial

Withdrawn·MMayo Clinic·Phase 2·NCT04190433

Type 1 Diabetes2 trials

Autoregulation of Glomerular Filtration Rate in Patients With Type 1 Diabetes During Spironolactone Therapy

Completed·SSteno Diabetes Center Copenhagen·Phase 4·NCT00335413·17 enrolled

The Impact of Fitness and Mineralocorticoid Receptor Blockade on Vascular Dysfunction in Adults With Type 1 Diabetes

Completed·UUniversity of Virginia·N/A·NCT03174288·32 enrolled

Atherosclerosis2 trials

Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Trial

Completed·UUniversity Hospitals Cleveland Medical Center·Phase 4·NCT02169089·79 enrolled

Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Add-On

Terminated·UUniversity Hospitals Cleveland Medical Center·Phase 4·NCT03597035·8 enrolled

Alcohol Use Disorder2 trials

Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 1

Recruiting·YYale University·Phase 2·NCT06004830·30 enrolled

Spironolactone in Alcohol Use Disorder (SAUD): A Double-Blind, Placebo-Controlled, Ascending Dose, Phase 1b Study

Recruiting·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT05807139·20 enrolled

Hyperaldosteronism2 trials

Superselective Adrenal Arterial Embolization Versus Oral Spironolactone for Treatment of Idiopathic Hyperaldosteronism

Recruiting·—·N/A·NCT07328230·172 enrolled

Etiology of Sleep Apnea-related Hyperaldosteronism - BP Treatment

Completed·UUniversity of Alabama at Birmingham·N/A·NCT01897727·41 enrolled

Hypertrophic Cardiomyopathy2 trials

Clinical and Therapeutic Implications of Fibrosis in Hypertrophic Cardiomyopathy

Completed·TTufts Medical Center·Phase 4·NCT00879060·53 enrolled

Evaluating the Effect of Spironolactone on Hypertrophic Cardiomyopathy

Unknown status·XXinhua Hospital, Shanghai Jiao Tong University School of Medicine·Phase 4·NCT02948998·260 enrolled

Mitral regurgitation2 trials

Impact of Medical and Surgical Therapy on Functional Mitral Regurgitation

Completed·—·N/A·NCT00224809·250 enrolled

Study of Innovative Drug Treatment Therapy for Pediatric Mitral Regurgitation

Unknown status·CChina National Center for Cardiovascular Diseases··NCT06037434·122 enrolled

ALD2 trials

Blockade of the Renin-angiotensin-aldosterone System in Patients With ARVD

Recruiting·HHospices Civils de Lyon·Phase 2·NCT03593317·120 enrolled

Unmitigated Aldosterone Signaling During Standard Clinical MRA Dosing

Recruiting·YYale University·Phase 4·NCT07281014·20 enrolled

Pulmonary Arterial Hypertension2 trials

Effects of Spironolactone on Collagen Metabolism in Patients With Pulmonary Arterial Hypertension

Unknown status·—·Phase 4·NCT01468571·50 enrolled

A Pilot Study of the Effect of Spironolactone Therapy on Exercise Capacity and Endothelial Dysfunction in Pulmonary Arterial Hypertension

Recruiting·NNational Institutes of Health Clinical Center (CC)·Phase 2·NCT01712620·70 enrolled

Cardiovascular Disease2 trials

Is Spironolactone Safe and Effective in the Treatment of Cardiovascular Disease in Mild Chronic Renal Failure?

Completed·UUniversity Hospital Birmingham·Phase 2·NCT00291720·120 enrolled

Role of Mineralocorticoid Receptor in Diabetic Cardiovascular Disease

Completed·—·N/A·NCT00865124·69 enrolled

Kidney Disease2 trials

Improving Outcomes in Patients With Kidney Disease Due to Diabetes

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT00381134·92 enrolled

Vascular Effects of Mineralocorticoid Receptor Antagonism in Kidney Disease

Completed·UUniversity of Alabama at Birmingham·Phase 2·NCT02497300·21 enrolled

Single ventricle2 trials

Spironolactone in Patients With Single Ventricle Heart

Completed·EEmory University·N/A·NCT00211081·12 enrolled

Acute Imposition of Fontan Physiology in The Single Ventricle Patient: Effects on Fibrosis, Function and Drug Intervention

Completed·CChildren's Hospital of Philadelphia·Preclinical·NCT04901975·98 enrolled

End-Stage Renal Disease2 trials

Aldosterone bloCkade for Health Improvement EValuation in End-stage Renal Disease

Completed·PPopulation Health Research Institute·Phase 3·NCT03020303·2,538 enrolled

Mineralocorticoid Receptor Antagonists in End Stage Renal Disease

Completed·WWuerzburg University Hospital·Phase 2·NCT01691053·118 enrolled

Withdrawn·UUniversity of Michigan·Phase 4·NCT04205136

Glucose intolerance1 trial

Comparison of Eplerenone Versus Spironolactone in Heart Failure Patients With Glucose Intolerance or Type 2 Diabetes

Completed·MMontreal Heart Institute·Phase 3·NCT01586442·62 enrolled

Fibrosis1 trial

Spironolactone and Prevention of Peritoneal Fibrosis in Peritoneal Dialysis

Completed·IInstituto Nacional de Cardiologia Ignacio Chavez·Phase 3·NCT00865449·20 enrolled

Diastolic Heart Failure1 trial

Novel Treatment for Diastolic Heart Failure in Women

Completed·—·Phase 4·NCT00206232·48 enrolled

Hypertensive1 trial

Tissue Sodium in Pre-hypertensive Patients

Completed·VVanderbilt University·Phase 2·NCT02236520·71 enrolled

Cognitive impairment1 trial

Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Dementia

Completed·EEmory University·Phase 4·NCT04522739·25 enrolled

Acute Myeloid Leukemia1 trial

Lintuzumab-Ac225 in Older Acute Myeloid Leukemia (AML) Patients

Completed·AActinium Pharmaceuticals·Phase 1/2·NCT02575963·40 enrolled

Severe Depression1 trial

Mineralocorticoid Receptor in the Treatment of Severe Depression

Completed·UUniversitätsklinikum Hamburg-Eppendorf·N/A·NCT00295347·65 enrolled

Advanced Cancer1 trial

Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab

Completed·—·Phase 2·NCT01867294·19 enrolled

Rheumatoid Arthritis1 trial

Evaluation of Spironolactone Efficacy in Patient with Rheumatoid Arthritis (RA)

Recruiting·UUniversity Hospital, Strasbourg, France·Phase 3·NCT05092984·154 enrolled

Acute Myocardial Infarction1 trial

Aldosterone Blockade Early After Acute Myocardial Infarction

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT01059136·1,603 enrolled

Resistance1 trial

Evaluation of Cortisol Resistance in Young Sedentary and Endurance-Trained Men

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT01294319·51 enrolled

Elderly1 trial

PIE II: Pharmacological Intervention in the Elderly II

Completed·WWake Forest University·Phase 3·NCT00123955·80 enrolled

High Blood Pressure1 trial

A Study of LY2623091 in Participants With High Blood Pressure

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT02194465·304 enrolled

Post-Operative Atrial Fibrillation1 trial

Renin-angiotensin-aldosterone System (RAAS), Inflammation, and Post-Operative Atrial Fibrillation (AF)

Completed·VVanderbilt University·Phase 2/3·NCT00141778·455 enrolled

Patients With Advanced Solid Tumors1 trial

Study of LP-184 in Patients With Advanced Solid Tumors

Recruiting·LLantern Pharma Inc.·Phase 1/2·NCT05933265·175 enrolled

Left Ventricular Hypertrophy1 trial

Left Ventricular Hypertrophy and Spironolactone in End Stage Renal Disease

Withdrawn·DDawnmarie DeFazio·Phase 4·NCT00548912

Oral1 trial

A Study of LY3045697 After Multiple Oral Dosing in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01821703·24 enrolled

Cardiotoxicity1 trial

Effect of Spironolactone in the Prevention of Anthracycline-induced Cardiotoxicity (SPIROTOX)

Unknown status·UUniversity of Sao Paulo·Phase 4·NCT06005259·264 enrolled

Mortality1 trial

Effects of Spironolactone on Cardio- and Cerebrovascular Morbidity and Mortality in Hemodialysis Patients

Completed·DDialysis Outcomes Heart Failure Aldactone Study Group·Phase 4·NCT01687699·157 enrolled

Function1 trial

The Effect in Renal Function on Patients With Type 1 Cardiorenal Syndrome Treated With Two Strategies of Furosemide.

Completed·HHospital Civil de Guadalajara·Phase 2·NCT04393493·80 enrolled

Autosomal Dominant Polycystic Kidney Disease1 trial

Mineralocorticoid Antagonism and Endothelial Dysfunction in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Completed·UUniversity of Colorado, Denver·Phase 3·NCT01853553·61 enrolled

Duchenne Muscular Dystrophy1 trial

Therapeutic Potential for Aldosterone Inhibition in Duchenne Muscular Dystrophy

Completed·OOhio State University·Phase 3·NCT02354352·52 enrolled

Chronic Lung Disease1 trial

Determining the Effect of Spironolactone on Electrolyte Supplementation in Preterm Infants With Chronic Lung Disease

Unknown status·—·Phase 2/3·NCT01721655·40 enrolled

Female Pattern Hair Loss1 trial

Efficacy of Therapy With the Spironolactone Pills Compared to Minoxidil Lotion in Female Pattern Hair Loss

Completed·UUniversity of British Columbia·Phase 2·NCT00175617·40 enrolled

Peritoneal Dialysis1 trial

Effect of Add-on Spironolactone to Losartan Versus Losartan Alone on Peritoneal Membrane Among Peritoneal Dialysis Patients

Unknown status·—·Phase 4·NCT03953950·84 enrolled

Systolic Heart Failure1 trial

A Registry-based Cluster Randomized Trial to Compare the Effect of Spironolactone vs. Eplerenone on Clinical Outcomes in Patients With Symptomatic Systolic Heart Failure

Enrolling by invitation·—·Phase 4·NCT03984591·7,200 enrolled

ART1 trial

Effect of Aldosterone Blockade on Arterial Compliance

Completed·WWolfson Medical Center·Phase 4·NCT01089309·51 enrolled

Precocious Puberty1 trial

Treatment of Boys With Precocious Puberty

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 2·NCT00001202·80 enrolled

Cirrhosis1 trial

Effect of Betablocker or Aldosterone Antagonist Therapy on Patients With Liver Cirrhosis

Unknown status·HHvidovre University Hospital·Phase 4·NCT00332904·22 enrolled

Hemodialysis1 trial

ALdosterone Antagonist Chronic HEModialysis Interventional Survival Trial

Completed·UUniversity Hospital, Brest·Phase 3·NCT01848639·823 enrolled

Osteoarthritis1 trial

The Effect of Spironolactone on Pain in Older People With Osteoarthritis

Completed·UUniversity of Dundee·Phase 4·NCT02046668·86 enrolled

Kidney Injury1 trial

Spironolactone Administration to Prevent Ischemic Kidney Injury in Critically Ill Cancer Patients

Unknown status·IInstituto Nacional de Cancerologia de Mexico·Phase 2/3·NCT02531412·24 enrolled

Hypoglycemia1 trial

Hypoglycemia and Autonomic Nervous System Function-B

Completed·—·Phase 4·NCT03429946·28 enrolled

Biomarkers1 trial

Search of Biomarkers of Mineralocorticoid Receiver Activity : the Value of Neutrophil Gelatinase Associated Lipocalin (NGAL)in Serum or Urine in Human

Completed·—·N/A·NCT02129621·42 enrolled

Pediatric Patients1 trial

A Phase IV, Two-part, Open-label Study Assessing the Pharmacokinetics, Safety and Pharmacodynamics of Spironolactone Oral Suspension in Pediatric Patients

Unknown status·CCMP Development, LLC·Phase 4·NCT06021860·96 enrolled

Metabolic Syndrome1 trial

Aldosterone and the Metabolic Syndrome

Completed·VVanderbilt University Medical Center·Phase 1·NCT01103245·69 enrolled

Myocardial fibrosis1 trial

Effect of Antifibrotic Therapy on Regression of Myocardial Fibrosis After Transcatheter Aortic Valve Implantation (TAVI) in Aortic Stenosis Patients With High Fibrotic Burden

Recruiting·UUniversity Medical Center Goettingen·Phase 3·NCT05230901·300 enrolled

Age-Related Macular Degeneration1 trial

Adjuvant Anti-Mineralocorticoid-Receptor Treatment in Anti-VEGF Refractory Neovascular Age-Related Macular Degeneration

Completed·DDr Irmela MANTEL·Phase 2·NCT03744767·20 enrolled

COVID-191 trial

Spironolactone in Covid-19 Induced ARDS

Completed·IIstanbul University - Cerrahpasa··NCT04345887·60 enrolled

Age1 trial

Optimalization of Nephroprotection Using Agents Inhibiting Renin-Angiotensin-Aldosterone System

Completed·MMedical University of Gdansk·N/A·NCT00528385

Diabetic Macular Edema1 trial

Non-Responsive Diabetic Macular Edema and Spironolactone

Withdrawn·WWake Forest University Health Sciences·Phase 4·NCT04853355

Androgenetic Alopecia1 trial

The Use of 5mg Finasteride Versus 200mg Spironolactone and Topical 5% Minoxidil in Treating Postmenopausal Female Androgenetic Alopecia

Withdrawn·UUniversity of Florida·Phase 4·NCT02483195

Drug Interactions1 trial

Evaluating Drug Interactions Between Doravirine With Estradiol and Spironolactone in Healthy Transgender Women

Completed·TThomas Jefferson University·Phase 1·NCT04283656·8 enrolled

Glioblastoma1 trial

A Phase 1b/2a Study to Evaluate the Safety, Pharmacokinetics, and Objective Response of STAR-001 (LP-184) in Combination With Spironolactone in Supratentorial Glioblastoma at First Progression

Not yet recruiting·LLantern Pharma Inc.·Phase 1/2·NCT07431216·68 enrolled

Ventricular Function1 trial

Study of Innovative Drug Strategies in Improving Left Ventricular Function After Mitral Repair

Unknown status·CChina National Center for Cardiovascular Diseases··NCT06039592·164 enrolled

Hidradenitis Suppurativa1 trial

Spironolactone for Hidradenitis Suppurativa

Withdrawn·MMedical University of South Carolina·Phase 4·NCT04100083

Calcification1 trial

Prevention of the Progression of Coronary Calcification With Use of Spironolactone in Peritoneal Dialysis Patients

Completed·PProfessor Fernando Figueira Integral Medicine Institute·Phase 3·NCT03314493·33 enrolled

Congenital Heart Disease1 trial

Spironolactone in Adult Congenital Heart Disease

Completed·OOregon Health and Science University·Phase 2·NCT01069510·40 enrolled

Hyperandrogenism1 trial

Does Spironolactone Normalize Sleep-wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism?

Recruiting·UUniversity of Virginia·Phase 1·NCT04723862·32 enrolled

Single Dose1 trial

A Single Dose Study Of Antimineralocorticoid Activity Of PF-03882845 In Healthy Volunteers

Completed· Pfizer logo

Pfizer·Phase 1·NCT01314898·12 enrolled

Complication1 trial

Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications

Completed·—·N/A·NCT01406015·38 enrolled

Paroxysmal atrial fibrillation1 trial

Spironolactone for Paroxysmal Atrial Fibrillation

Unknown status·TTaichung Veterans General Hospital·N/A·NCT00689598·30 enrolled

Liver Transplant1 trial

Spironolactone After Liver Transplant

Completed·WWake Forest University Health Sciences·Phase 4·NCT02883400·30 enrolled

Heart Disease1 trial

Importance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease

Completed·UUniversity of Erlangen-Nürnberg Medical School·Phase 3·NCT00865501·50 enrolled

Allograft1 trial

Mineralocorticoid Receptor Antagonist and Kidney Allograft Histology

Unknown status·—·Phase 4·NCT01510795·40 enrolled

Tics1 trial

Examining the Effect of Different Diuretics on Fluid Retention in Diabetics Treated With Rosiglitazone.

Completed· GSK logo

GSK·Phase 4·NCT00306696·388 enrolled

Polycystic Ovary Syndrome1 trial

A Clinical Trial to Evaluate the Efficacy, Tolerability, and Safety of a Fixed Dose Combination of Spironolactone, Pioglitazone & Metformin (SPIOMET) in Polycystic Ovary Syndrome (PCOS)

Recruiting·FFundació Sant Joan de Déu·Phase 2·NCT05394142·364 enrolled

Chorioretinitis1 trial

Effect of Spironolactone in Treating Chronic Non-resolutive Central Serous Chorioretinitis

Completed·IInstitut National de la Santé Et de la Recherche Médicale, France·Phase 1/2·NCT01552044·17 enrolled

Randomized Controlled Trial1 trial

HEART: Pilot Randomized Controlled Trial

Not yet recruiting·MMayo Clinic·Phase 1/2·NCT07483177·50 enrolled

Toxicity1 trial

The Effects of Spironolactone on Calcineurin Inhibitor Induced Nephrotoxicity

Completed·OOdense University Hospital·Phase 4·NCT01602861·188 enrolled

AML1 trial

Venetoclax and Lintuzumab-Ac225 in AML Patients

Unknown status·AActinium Pharmaceuticals·Phase 1/2·NCT03867682·38 enrolled

Overweight1 trial

Effect of Spironolactone on Adrenal or Ovarian Androgen Production in Overweight Pubertal Girls With Androgen Excess

Unknown status·UUniversity of Virginia·N/A·NCT01422759·20 enrolled

Ischemic Cardiomyopathy1 trial

Larger Dose of Spironolactone for the Treatment of Patients With Nonischemic Cardiomyopathy

Terminated·HHebei Medical University·N/A·NCT00125437·200 enrolled

Acanthosis Nigricans1 trial

Phase II Study of the Effect of Leuprolide Acetate and Spironolactone on Insulin Resistance in Hyperandrogenic Women With Polycystic Ovarian Disease or Hyperandrogenism Insulin Resistance Acanthosis Nigricans Syndrome

Completed·NNational Center for Research Resources (NCRR)·Phase 2·NCT00004311

Kidney Transplant1 trial

Spironolactone and Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients

Suspended·IInstituto Nacional de Cardiologia Ignacio Chavez·Phase 2·NCT01021943·40 enrolled

Neuroblastoma1 trial

Quadruple Immunotherapy for Neuroblastoma

Recruiting·HHong Kong Children's Hospital·Phase 2·NCT05754684·29 enrolled

Aortic Stenosis1 trial

Regression in Left Ventricular Hypertrophy and Fibrosis in Aortic Stenosis - a Randomised Controlled Trial

Not yet recruiting·UUniversity College, London·Phase 2·NCT07539259·445 enrolled

Unspecified4 trials

Exploring Mechanisms and Morphology of QT Interval Prolongation

Completed·HHerlev and Gentofte Hospital·N/A·NCT03291145·28 enrolled

Hyperandrogenemia and Altered Day-night LH Pulse Patterns

Recruiting·UUniversity of Virginia·Phase 1·NCT03068910·32 enrolled

The Effect of SAAE on Ventricular Remodeling in PA Patients

Recruiting·SSecond Affiliated Hospital of Nanchang University·N/A·NCT05501080·112 enrolled

Show 1 more trial

Transgender Estradiol Affirming Therapy

Completed·WWashington University School of Medicine·Phase 2·NCT05010707·39 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 30, 1983

ALDACTONE

NDA NDA012151

Aug 4, 2017

CAROSPIR

NDA NDA209478

Sources

References

[1]
ClinicalTrials.gov — 181 trial records for Spironolactone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Aldactone drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Spironolactone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Spironolactone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA209478). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Aldactone. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Mineralocorticoid Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Pfizer

Patent Landscape[6]

Patent Cliff

Oct 28, 2036

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9757394Oct 28, 2036

11395828Oct 28, 2036

10888570Oct 28, 2036

11389461Oct 28, 2036

10660907Oct 28, 2036

3 more patents

10624906Oct 28, 2036

10493083Oct 28, 2036

11491166Oct 28, 2036

Aldactone

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Spironolactone25 trials

Heart Failure17 trials

Hypertension12 trials

Atrial Fibrillation6 trials

Diabetic Nephropathy6 trials

Chronic Kidney Disease5 trials

Primary Aldosteronism4 trials

Cardiovascular3 trials

Acute Kidney Injury3 trials

Cardiomyopathy2 trials

Type 1 Diabetes2 trials

Atherosclerosis2 trials

Alcohol Use Disorder2 trials

Hyperaldosteronism2 trials

Hypertrophic Cardiomyopathy2 trials

Mitral regurgitation2 trials

ALD2 trials

Pulmonary Arterial Hypertension2 trials

Cardiovascular Disease2 trials

Kidney Disease2 trials

Single ventricle2 trials

End-Stage Renal Disease2 trials

Dialysis Patients1 trial

Endothelial Function1 trial

Obstructive Sleep Apnea1 trial

Glucose intolerance1 trial

Fibrosis1 trial

Diastolic Heart Failure1 trial

Hypertensive1 trial

Cognitive impairment1 trial

Acute Myeloid Leukemia1 trial

Severe Depression1 trial

Advanced Cancer1 trial

Rheumatoid Arthritis1 trial

Acute Myocardial Infarction1 trial

Resistance1 trial

Elderly1 trial

High Blood Pressure1 trial

Post-Operative Atrial Fibrillation1 trial

Patients With Advanced Solid Tumors1 trial

Left Ventricular Hypertrophy1 trial

Oral1 trial

Cardiotoxicity1 trial

Mortality1 trial

Function1 trial

Autosomal Dominant Polycystic Kidney Disease1 trial

Duchenne Muscular Dystrophy1 trial

Chronic Lung Disease1 trial

Female Pattern Hair Loss1 trial

Peritoneal Dialysis1 trial

Systolic Heart Failure1 trial

ART1 trial

Precocious Puberty1 trial

Cirrhosis1 trial

Hemodialysis1 trial

Osteoarthritis1 trial

Kidney Injury1 trial

Hypoglycemia1 trial

Biomarkers1 trial

Pediatric Patients1 trial

Metabolic Syndrome1 trial

Myocardial fibrosis1 trial

Age-Related Macular Degeneration1 trial

COVID-191 trial

Age1 trial

Diabetic Macular Edema1 trial

Androgenetic Alopecia1 trial

Drug Interactions1 trial

Glioblastoma1 trial

Ventricular Function1 trial

Hidradenitis Suppurativa1 trial