Spironolactone

Generic Name: Spironolactone

Brand Names: Aldactazide, Aldactone, Carospir, Qaialdo

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₃₂O_₄S

CAS Number: 52-01-7

Unique Ingredient Identifier: 27O7W4T232

Background: Spironolactone is a potassium-sparing diuretic. It binds to mineralocorticoid receptors and functions as aldosterone antagonists. It promotes sodium and water excretion and potassium retention. Spironolactone was originally developed purely for this ability before other pharmacodynamic properties of the drug were discovered. It is indicated to treat several conditions, including heart failure, edema, hyperaldosteronism, and hypertension. Off-label uses of spironolactone include hirsutism, female pattern hair loss, and adult acne vulgaris.

Spironolactone was developed in 1957, marketed in 1959, and approved by the FDA on January 21, 1960.

Indication: Spironolactone is indicated for the treatment of the following conditions:

As spironolactone has antiandrogenic activity, its off-label uses include the treatment of hirsutism, female pattern hair loss, and adult acne vulgaris.

Associated Conditions: Edema, Hypertension, Primary Aldosteronism, Primary Hyperaldosteronism, Secondary hyperaldosteronism, Chronic heart failure with reduced ejection fraction (NYHA Class III), Chronic heart failure with reduced ejection fraction (NYHA Class IV), Idiopathic hyperaldosteronism, Refractory Edema

Associated Therapies: Perioperative drug treatment, Maintenance therapy

Clinical Trials

Determination of Drug Levels for Pharmacotherapy of Heart Failure

Phase 4

Not yet recruiting

Conditions: Cardiovascular Diseases
Heart Failure With Reduced Ejection Fraction

Interventions: Drug: Nebivolol
Drug: Valsartan and Sacubitril
Drug: Carvedilol
Drug: Bisoprolol
Drug: Metoprolol
Drug: Spironolactone

First Posted Date: 2023-09-13

Last Posted Date: 2024-01-18

Lead Sponsor: University Hospital Ostrava

Target Recruit Count: 100

Registration Number: NCT06035978

Locations: 🇨🇿
University Hospital Ostrava, Ostrava, Czech Republic, Czechia

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

Phase 4

Not yet recruiting

Conditions: Edema Due to Heart Failure or Cirrhosis

Interventions: Drug: Spironolactone Oral Suspension

First Posted Date: 2023-09-01

Last Posted Date: 2023-09-28

Lead Sponsor: CMP Development, LLC

Target Recruit Count: 96

Registration Number: NCT06021860

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

Phase 4

Not yet recruiting

Conditions: Cardiotoxicity
Chemotherapy Effect
Neoplasms
Heart Failure

Interventions: Drug: Spironolactone
Drug: Placebo

First Posted Date: 2023-08-22

Last Posted Date: 2023-08-22

Lead Sponsor: University of Sao Paulo

Target Recruit Count: 264

Registration Number: NCT06005259

Locations: 🇧🇷
Instituto do Coração, São Paulo, Brazil

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

Phase 2

Recruiting

Conditions: Alcohol Use Disorder
Hiv

Interventions: Drug: Spironolactone

First Posted Date: 2023-08-22

Last Posted Date: 2025-05-21

Lead Sponsor: Yale University

Target Recruit Count: 30

Registration Number: NCT06004830

Locations: 🇺🇸
Atlanta VA Medical Center, Decatur, Georgia, United States

The Effects and Safety of Topical Spironolactone Ophthalmic Solution, 0.005 mg/cc in Subjects With Dry Eye Disease

Early Phase 1

Not yet recruiting

Conditions: Dry Eye Disease

Interventions: Drug: Placebo
Drug: Topical spironolactone ophthalmic solution, 0.005 mg/cc

First Posted Date: 2023-08-16

Last Posted Date: 2023-08-21

Lead Sponsor: Richard W Yee, MD

Target Recruit Count: 30

Registration Number: NCT05995392

Locations: 🇺🇸
Richard W Yee, MD PLLC, Bellaire, Texas, United States

Study of LP-184 in Patients with Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Advanced Solid Tumor
Metastatic Solid Tumor
GBM
TNBC - Triple-Negative Breast Cancer
DDR Gene Mutation
NSCLC
Pancreatic Adenocarcinoma

Interventions: Drug: LP-184
Drug: Spironolactone
Drug: Olaparib

First Posted Date: 2023-07-06

Last Posted Date: 2025-03-06

Lead Sponsor: Lantern Pharma Inc.

Target Recruit Count: 175

Registration Number: NCT05933265

Locations: 🇺🇸
Highlands Oncology Group, Springdale, Arkansas, United States
🇺🇸
Cancer and Blood Specialty Clinic, Los Alamitos, California, United States
🇺🇸
Northwest Oncology & Hematology, Rolling Meadows, Illinois, United States

and more 6 locations