ALDACTONE

LOE Approaching

spironolactone

Pfizer

NDAORALTABLETPriority Review

Approved

Jan 1960

Lifecycle

LOE Approaching

Competitive Pressure

30/100

Clinical Trials

Mechanism of Action

Aldosterone Antagonists

Pharmacologic Class:

Aldosterone Antagonist

Indications (19)

NYHA Class III–IV heart failure reduced ejection fraction to increase survival manage edema reduce the need for hospitalization for heart failure edema in the following settings: • Cirrhosis of the liver sodium restriction to reduce the need for hospitalization for heart failure ()edema in adult patients sodium restrictions the setting of nephrotic syndrome restriction of fluid sodium intake the use of other diuretics produce an inadequate response ()primary hyperaldosternism for: () o Short-term preoperative treatment o Long-term maintenance for patients with discrete aldosterone-producing adrenal adenomas macronodular adrenal hyperplasia 1 the following settings: • Short-term preoperative treatment of patients with primary hyperaldosteronism heart failure hypertension need for hospitalization for heart failure

Clinical Trials (5)

NCT07431216Phase 1/2Not Yet Recruiting

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

Started Apr 2026

68 enrolled

Histopathology Confirmed Supratentorial GBM at First RecurrenceIDHwt GBMIDHm Grade 4 Astrocytoma

NCT07304817Phase 2Not Yet Recruiting

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

Started Feb 2026

100 enrolled

CKDCardiovascular DiseasesHeart Failure

NCT06205407Phase 1Completed

A Study to Learn How the Body Processes Spironolactone and Hydrochlorothiazide Film Coated Tablets Manufactured at Two Sites: Viatris and Neolpharma

Started Dec 2023

42 enrolled

Healthy Participants

NCT04676646Phase 4Completed

Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients With Symptomatic HFrEF Receiving Spironolactone

Started Mar 2021

366 enrolled

HyperkalaemiaHeart Failure With Reduced Ejection Fraction

NCT03682497Phase 1Terminated

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

Started Nov 2018

68 enrolled

Heart Failure

Company

External Resources

Full prescribing information

FDA Drugs@FDA

FDA approval history

RxNorm

Drug nomenclature & identifiers