Drugs / Spironolactone
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Spironolactone

Small molecule targets NR3C2, RXRG via inhibition / activation

Developed for
heart failure · hypertensive disorder · atrial fibrillation · chronic kidney disease · polycystic ovary syndrome · congestive heart failure · diabetic kidney disease · essential hypertension
+87 more · type 2 diabetes mellitus · end stage renal failure · HIV infectious disease · resistant hypertension · acne · acute kidney injury · COVID-19 · diastolic heart failure · proteinuria · symptomatic heart failure · alcohol-related disorders · cardio-renal syndrome · diabetes mellitus · dilated cardiomyopathy · hypertrophic cardiomyopathy · metabolic dysfunction-associated steatohepatitis · pulmonary arterial hypertension · pulmonary hypertension · acanthosis nigricans · acute respiratory distress syndrome · alcoholic liver cirrhosis · Alport syndrome · Alzheimer disease · androgenetic alopecia · anemia · anovulation · aortic valve stenosis · arrhythmogenic right ventricular cardiomyopathy · arteriosclerosis disorder · atherosclerosis · autosomal dominant polycystic kidney disease · calcinosis · cancer · cardiovascular disorder · central serous chorioretinopathy · chronic renal failure syndrome · cognitive impairment with or without cerebellar ataxia · congenital heart disease · congenital heart malformation · coronary artery disorder · diabetic macular edema · disease related to solid organ transplantation · dry eye syndrome · Duchenne muscular dystrophy · endomyocardial fibrosis · fungal infectious disease · glomerulonephritis · hyperaldosteronism · hyperpigmentation of the skin · idiopathic hypercalciuria · intracerebral hemorrhage · ischemic stroke · kidney failure · liver disorder · long QT syndrome · major depressive disorder · myocardial infarction · neuroblastoma · obesity disorder · obstructive sleep apnea syndrome · potassium deficiency disease · precocious puberty · preeclampsia · primary aldosteronism · rheumatoid arthritis · skin atrophy · stroke disorder · thoracic aortic aneurysm · toxic dermatosis · type 1 diabetes mellitus · univentricular heart · vascular disorder · viral pneumonia · wet macular degeneration · alcohol dependence · alcoholic cardiomyopathy · bronchopulmonary dysplasia · cardiac rhythm disease · cardiomyopathy due to anthracyclines · cirrhosis of liver · hidradenitis suppurativa · metabolic dysfunction-associated steatotic liver disease · osteoarthritis, knee · poisoning · portal hypertension · ST-elevation myocardial infarction · systolic heart failure
Investigated by
National Heart, Lung, and Blood Institute (NHLBI) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · University of Virginia · Assistance Publique - Hôpitaux de Paris · Brigham and Women's Hospital · National Institute of Medical Sciences and Nutrition Salvador Zubiran
+184 more · Vanderbilt University · Baylor College of Medicine · CMP Development, LLC · Chiang Mai University · Emory University · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · French National Institute of Health and Medical Research · Hebei Medical University · Indiana University · Massachusetts General Hospital · Mayo Clinic · Ministry of Health, France · National Cancer Institute (NCI) · National Institutes of Health (NIH) · Steno Diabetes Center Copenhagen · Tottori University Hospital · Universidad de los Andes, Chile · University Hospital, Caen · University Hospitals Cleveland Medical Center · University of Cambridge · University of Colorado, Denver · University of Michigan · University of Pennsylvania · University of Sao Paulo · Wake Forest University Health Sciences · Yale University · Ziekenhuis Oost-Limburg · ACS Biomarker · Academic Medical Center - University of Amsterdam · Academic and Community Cancer Research United · Ain Shams University · Alzheimer's Association · American Heart Association · Aristotle University Of Thessaloniki · Asociación Civil Impacta Salud y Educación, Peru · Assistance Publique Hopitaux De Marseille · Assiut University · Baxter Healthcare Corporation · Beth Israel Deaconess Medical Center · Biomedis International Ltd. · British Heart Foundation · Carelon Research · Carol Davila University of Medicine and Pharmacy · Central Hospital, Nancy, France · Centro Hospitalar De São João, E.P.E. · Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. · Charite University, Berlin, Germany · Children's Hospital of Philadelphia · Children's Mercy Hospital Kansas City · Chita State Regional Clinical Hospital Number 1 · Columbia University · Coordinating Centre for Clinical Trials, Charité · Dawnmarie DeFazio · Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) · Dialysis Outcomes Heart Failure Aldactone Study Group · Dr Irmela MANTEL · Dutch Kidney Foundation · Echo Core Lab Berlin · Epicentro · Federal University of São Paulo · Fredericia Hosptial · Fundació Sant Joan de Déu · GlaxoSmithKline · Göteborg University · Hasselt University · Herlev and Gentofte Hospital · Hong Kong Children's Hospital · Hospices Civils de Lyon · Hospital Civil de Guadalajara · Ib Abildgaard Jacobsen · Imperial College London · Indiana Institute for Medical Research · Institute for Cardiovascular Computer-assisted Medicine, Charité · Instituto Nacional de Cardiologia Ignacio Chavez · all 190 on the full record

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Qaialdo — 2023-05-26 europa.eu ↗
Label expansion US (FDA) ALDACTONE — 1981-06-30 fda.gov ↗
Approved US (FDA) ALDACTONE — 1960-01-21 fda.gov ↗

Trials 151 · started per year

today
US approved 1960
EU approved 2023
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 04 trials
Phase 0 NCT05995392 Aug 2023 → Feb 2024 dry eye syndrome Richard W Yee, MD Unknown No outcome recorded
Phase 0 NCT04723862 Nov 2021 → Oct 2025 overdue polycystic ovary syndrome University of Virginia Recruiting No outcome recorded
Phase 0 NCT04075149 Dec 2019 → Sep 2024 anovulation, polycystic ovary syndrome University of Virginia Unknown No outcome recorded
Phase 0 NCT03929718 Apr 2019 → Sep 2025 overdue atrial fibrillation Piedmont Healthcare Active not recruiting No outcome recorded
Phase 19 trials · 2 missed
Phase 1 NCT05807139 Jul 2023 → Dec 2026 expected alcohol-related disorders National Institute on Drug Abuse (NIDA) Recruiting No outcome recorded
Phase 1 NCT04283656 Jan → Oct 2022 HIV infectious disease Thomas Jefferson University Completed Missed primary
Phase 1 NCT03953209 Mar 2020 → Jan 2021 hyperpigmentation of the skin Medical University of South Carolina Withdrawn No outcome recorded Stop: Business
Phase 1 NCT03909529 Mar → Apr 2019 — CMP Development, LLC Completed No outcome recorded
Phase 1 NCT03777319 Dec 2018 → Sep 2021 Duchenne muscular dystrophy Kevin Flanigan Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT01598740 Jun → Sep 2012 heart failure Sorbent Therapeutics Completed Missed primary
Phase 1 NCT01314898 Mar → Jun 2011 — Pfizer Completed No outcome recorded
Phase 1 NCT01083290 Apr 2010 — Orion Corporation, Orion Pharma Completed No outcome recorded
Phase 1 NCT00240656 Oct 2005 → May 2006 pulmonary arterial hypertension Hebei Medical University Completed No outcome recorded
Phase 1/24 trials · 1 met primary
Phase 1/2 NCT07483177 May 2026 → May 2028 expected thoracic aortic aneurysm Mayo Clinic Recruiting No outcome recorded
Phase 1/2 NCT04901975 Feb 2021 → Jun 2026 univentricular heart Children's Hospital of Philadelphia Completed No outcome recorded
Phase 1/2 NCT03576755 Jan 2019 → Jul 2023 metabolic dysfunction-associated steatohepatitis University of California, San Francisco Completed No outcome recorded
Phase 1/2 NCT01552044 Jan 2012 → Jan 2013 central serous chorioretinopathy French National Institute of Health and Medical Research Completed Met primary
Phase 231 trials · 1 met primary · 2 missed
Phase 2 NCT07715318 Dec 2026 → Dec 2027 expected anemia Ain Shams University Not yet recruiting No outcome recorded
Phase 2 NCT07645300 Oct 2026 → Mar 2032 expected chronic kidney disease VA Office of Research and Development Not yet recruiting No outcome recorded
Phase 2 NCT07473895 Apr → Oct 2026 expected acne Assiut University Not yet recruiting No outcome recorded
Phase 2 NCT07041281 Oct 2025 → Dec 2027 expected preeclampsia Massachusetts General Hospital Recruiting No outcome recorded
Phase 2 NCT03593317 Dec 2024 → Dec 2027 expected arrhythmogenic right ventricular cardiomyopathy Hospices Civils de Lyon Recruiting No outcome recorded
Phase 2 NCT06004830 Nov 2023 → Jan 2026 HIV infectious disease, alcohol-related disorders Yale University Completed No outcome recorded
Phase 2 NCT05394142 May 2022 → Apr 2025 polycystic ovary syndrome Fundació Sant Joan de Déu Unknown No outcome recorded
Phase 2 NCT05222191 Feb 2022 → Dec 2023 chronic kidney disease, hypertensive disorder Indiana Institute for Medical Research Unknown No outcome recorded
Phase 2 NCT05754684 Jan 2022 → Dec 2025 overdue neuroblastoma Hong Kong Children's Hospital Recruiting No outcome recorded
Phase 2 NCT04633005 Nov 2021 → Oct 2025 heart failure University of Texas Southwestern Medical Center Completed Met primary
Phase 2/37 trials · 1 met primary · 1 missed
Phase 2/3 NCT06678685 Oct 2024 → Dec 2026 expected — Qilu Hospital of Shandong University Recruiting No outcome recorded
Phase 2/3 NCT05676684 Sep 2022 → Nov 2024 diastolic heart failure University of Porto Completed Met primary
Phase 2/3 NCT03981861 Jul 2016 → Jul 2018 polycystic ovary syndrome Children's Mercy Hospital Kansas City Completed No outcome recorded
Phase 2/3 NCT02585843 Nov 2015 → Mar 2017 heart failure Columbia University Completed No outcome recorded
Phase 2/3 NCT02531412 Oct 2015 → Aug 2017 cancer National Cancer Institute of Mexico Unknown No outcome recorded
Phase 2/3 NCT00141778 Apr 2005 → Jul 2010 atrial fibrillation Vanderbilt University Completed Missed primary
Phase 2/3 NCT00106561 Jan 2002 → Sep 2004 diabetic kidney disease, glomerulonephritis, proteinuria Melbourne Health Completed No outcome recorded
Phase 322 trials · 3 missed
Phase 3 NCT07043634 Jun → Dec 2025 — Sarfez Pharmaceuticals, Inc. Completed No outcome recorded
Phase 3 NCT06204640 Mar 2024 → Jan 2028 expected atrial fibrillation University Hospital, Caen Not yet recruiting No outcome recorded
Phase 3 NCT05092984 Jun 2022 → Mar 2026 overdue rheumatoid arthritis University Hospital, Strasbourg, France Recruiting No outcome recorded
Phase 3 NCT05230901 Feb 2022 → Jun 2025 aortic valve stenosis University Medical Center Goettingen Unknown No outcome recorded
Phase 3 NCT04980716 Jun 2021 → Jan 2026 overdue non-small cell lung carcinoma Sun Yat-sen University Recruiting No outcome recorded
Phase 3 NCT04826822 Feb → Jul 2021 COVID-19, viral pneumonia Chita State Regional Clinical Hospital Number 1 Unknown No outcome recorded
Phase 3 NCT06413082 Feb 2021 → Jul 2023 essential hypertension Ospedale San Raffaele Completed No outcome recorded
Phase 3 NCT04465123 Aug 2020 → Jul 2022 acute kidney injury, heart failure Chiang Mai University Unknown No outcome recorded
Phase 3 NCT04424134 May → Jul 2020 COVID-19 Lomonosov Moscow State University Medical Research and Educational Center Unknown No outcome recorded
Phase 3 NCT03551548 Feb 2019 → Jul 2021 atrial fibrillation University Hospital, Caen Unknown No outcome recorded
Phase 451 trials · 4 met primary · 5 missed
Phase 4 NCT07687160 Sep 2026 → Feb 2028 expected hypertensive disorder Ottawa Hospital Research Institute Not yet recruiting No outcome recorded
Phase 4 NCT07513883 Mar 2026 → Sep 2028 expected heart failure Ziekenhuis Oost-Limburg Recruiting No outcome recorded
Phase 4 NCT06523465 Sep 2024 → Dec 2025 overdue hypertensive disorder, primary aldosteronism Third Military Medical University Recruiting No outcome recorded
Phase 4 NCT06021860 Jun 2024 → Mar 2025 — CMP Development, LLC Unknown No outcome recorded
Phase 4 NCT06035978 Mar 2024 → Apr 2026 symptomatic heart failure University Hospital Ostrava Unknown No outcome recorded
Phase 4 NCT06499948 Feb 2024 → Nov 2025 Alport syndrome Stefan Lujinschi Completed No outcome recorded
Phase 4 NCT06275763 Oct 2023 → Dec 2025 hypertensive disorder National Institute of Cardiology, Warsaw, Poland Unknown No outcome recorded
Phase 4 NCT06005259 Oct 2023 → Oct 2025 chemotherapy-induced toxicity, heart failure, neoplasm University of Sao Paulo Unknown No outcome recorded
Phase 4 NCT05688579 Apr 2023 → Dec 2026 expected hyperaldosteronism, hypertensive disorder Nanfang Li Enrolling by invitation No outcome recorded
Phase 4 NCT05637853 Oct 2022 → Aug 2024 overdue symptomatic heart failure Göteborg University Active not recruiting No outcome recorded
Phase not applicable23 trials · 1 met primary
— NCT07020104 Jan 2025 → Dec 2039 expected chronic kidney disease Academic Medical Center - University of Amsterdam Recruiting No outcome recorded
— NCT07415811 Jul → Dec 2024 overdue HIV infectious disease University of Sao Paulo General Hospital Enrolling by invitation No outcome recorded
— NCT06091475 Dec 2023 → Aug 2026 overdue dilated cardiomyopathy, heart failure Imperial College London Recruiting No outcome recorded
— NCT03626506 Feb 2019 → Aug 2020 hypertensive disorder Peking University Third Hospital Unknown No outcome recorded
— NCT03291145 Jun 2017 → Jun 2018 long QT syndrome, sudden arrhythmia death syndrome Herlev and Gentofte Hospital Completed No outcome recorded
— NCT01422759 Dec 2016 → Dec 2024 obesity disorder, polycystic ovary syndrome University of Virginia Unknown No outcome recorded
— NCT03174288 Aug 2015 → May 2019 type 1 diabetes mellitus University of Virginia Completed No outcome recorded
— NCT02047422 Jan 2014 → Feb 2016 congestive heart failure Yonsei University Withdrawn No outcome recorded
— NCT02190318 Nov 2013 → Dec 2015 chronic kidney disease Second Xiangya Hospital of Central South University Unknown No outcome recorded
— NCT02417896 Apr 2013 → Jul 2015 acute kidney injury Instituto Nacional de Cardiologia Ignacio Chavez Unknown No outcome recorded
Comparator or background therapy103 trials
Phase 0 NCT02689843 Comparator Feb → Nov 2018 polycystic ovary syndrome Shiraz University of Medical Sciences Completed No outcome recorded
Phase 0 NCT03068910 Comparator Jul 2016 → Oct 2025 overdue polycystic ovary syndrome University of Virginia Recruiting No outcome recorded
Phase 1 NCT06205407 Comparator Dec 2023 → Mar 2024 — Pfizer Completed No outcome recorded
Phase 1 NCT03682497 Comparator Nov 2018 → Mar 2020 heart failure AstraZeneca Terminated No outcome recorded
Phase 1 NCT02941315 Comparator Dec 2016 → Oct 2021 idiopathic cardiomyopathy RenJi Hospital Completed No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2018-07-20 Zydus Lifesciences Limited Regulatory Zydus receives final approval from the USFDA for Spironolactone Tablets USP zyduslife.com ↗

All press releases naming this drug 1 release

DateIssuerRelease

Evidence & citations 32 cited values

Every value below carries the sentence it was read from. 257 sources stand behind the page.

FieldValueCited text
Known as Spironolactone “The pharmacological treatment intended to enhance reverse remodeling includes 4 drugs initiated immediately after weaning of inotropic support once achieving adequate end-organ...” NCT01774656 ↗
252

“Standard medical therapy for heart failure, including spironolactone (20 mg once daily), metoprolol succinate (25 mg twice daily), and sacubitril/valsartan (50 mg twice daily)....” NCT07130175 ↗

“One group was treated with mineralocorticoid receptor antagonists(MRAs) (including spironolactone 20-60mg/ day, or eplerenone50-100mg/day, or finerenone 10-20mg/ day) in...” NCT05688579 ↗

“1st dose (day 0) given i.v. (potassium-canrenoate), before primary PCI day 1 - 12 weeks: spironolactone 25mg daily, which is uptitrated to 50mg daily after 2 weeks, if possible” NCT01882179 ↗

“Unless serum potassium value is higher than 5 mmol/L, oral spironolactone or potassium canrenoate will be added; dose will be established based on serum creatinine value.” NCT04062760 ↗

“The investigators hypothesize that the mineralocorticoid receptor antagonist (MRA), spironolactone, may prevent HF by acting on extracellular matrix remodelling” NCT02556450 ↗

“Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated” NCT01953874 ↗

“Patiromer (8.4g/day to 25.2g/day) and spironolactone (up to 200mg/day) or eplerenone (up to 50mg/day if spironolactone not acceptable).” NCT04142788 ↗

“Oral standard diuretics therapy (furosemide 40 mg tablet plus spironolactone 100 mg tablet with a dose increase in 40 mg:100 mg ratio)” NCT04785755 ↗

“Antiandrogen therapy with spironolactone started at a dose of 50 mg daily and increased every 4 weeks to 200 mg daily” NCT03757117 ↗

“Patients will be randomized (1:1) to renal sympathetic denervation treatment or spironolactone (50mg)” NCT02039492 ↗

Show 242 more sources

Known as Abbolactone ChEMBL registry synonym — accepted as the source's own label CHEMBL1393 ↗
Known as Aldactone “Spironolactone (Aldactone) is an antiandrogen that also reduced testosterone synthesis by inhibiting the enzyme 17-hydroxylase.” NCT00001202 ↗
4

“Diuretics will be continued with an maximum dose of furosemide (160mg) and Aldactone 400 mg.” NCT03645642 ↗

“100 mg tablet of Spironolactone (Aldactone) by mouth with half a glass of water.” NCT00860340 ↗

“Ramipril Tritace®, Carvedilol Carvid®,and Spironolactone Aldactone®” NCT05849766 ↗

“Aldactone” NCT02417896 ↗

Known as Carospir “Spironolactone Oral Suspension 100 mg (perpetrator, Carospir® Oral Suspension 20 mL of 25 mg / 5 mL)” NCT03909529 ↗
Known as Diatensec ChEMBL registry synonym — accepted as the source's own label CHEMBL1393 ↗
Known as Espironolactona ChEMBL registry synonym — accepted as the source's own label CHEMBL1393 ↗
Known as Gx spironol ChEMBL registry synonym — accepted as the source's own label CHEMBL1393 ↗
Known as Laractone ChEMBL registry synonym — accepted as the source's own label CHEMBL1393 ↗
Known as NSC-150399 ChEMBL registry synonym — accepted as the source's own label CHEMBL1393 ↗
Known as Qaialdo ChEMBL registry synonym — accepted as the source's own label CHEMBL1393 ↗
Known as SC-9420 ChEMBL registry synonym — accepted as the source's own label CHEMBL1393 ↗
Known as Spiretic ChEMBL registry synonym — accepted as the source's own label CHEMBL1393 ↗
Known as spiro “before and after spironolactone (Spiro).” PMID 20550533 ↗ Nov 2010
1

“spironolactone (spiro)/empa” NCT07857772 ↗

Known as Spiroctan 100 ChEMBL registry synonym — accepted as the source's own label CHEMBL1393 ↗
Known as Spiroctan 25 ChEMBL registry synonym — accepted as the source's own label CHEMBL1393 ↗
Known as Spiroctan 50 ChEMBL registry synonym — accepted as the source's own label CHEMBL1393 ↗
Known as Spironol “Spironolactone (Spironol) 25 mg” NCT00528385 ↗
Known as Spironolactone ARROW “Spironolactone ARROW ® 75 mg, 150mg, orally, once a day during all the trial” NCT03334682 ↗
Known as Spironolactone ceva ChEMBL registry synonym — accepted as the source's own label CHEMBL1393 ↗
Known as Spironolactone component of aldactazide ChEMBL registry synonym — accepted as the source's own label CHEMBL1393 ↗
Known as Spironolactone component of cardalis ChEMBL registry synonym — accepted as the source's own label CHEMBL1393 ↗
Known as Spironolactonum ChEMBL registry synonym — accepted as the source's own label CHEMBL1393 ↗
Known as Spirospare 100 ChEMBL registry synonym — accepted as the source's own label CHEMBL1393 ↗
Known as Spirospare 25 ChEMBL registry synonym — accepted as the source's own label CHEMBL1393 ↗
Known as SPL “The SPin-D Trial is a phase II randomized, double-blind, placebo-controlled, multi-center study of spironolactone (SPL) for patients with hemodialysis-dependent end-stage renal disease.” NCT02285920 ↗
1

“Spironolactone (SPL), a mineralocorticoid receptor antagonist” NCT05222191 ↗