NDAORALTABLETPriority Review
Approved
Jan 1960
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
14
Data completeness
6/8 — Strong
Priority Review
ALDACTONE (spironolactone) by Pfizer is aldosterone antagonists [moa]. Approved for heart failure, hypertension. First approved in 1960.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALDACTONE (spironolactone) is an oral aldosterone antagonist small molecule approved in 1960 for heart failure, hypertension, and related cardiovascular and renal conditions. It works by blocking aldosterone receptors in the distal tubule, reducing sodium reabsorption and lowering blood pressure and fluid retention. The drug has expanded into oncology, endocrinology, and rare disease indications based on mechanistic rationale.
$0.546MPart D
LOE ApproachingStable
Mature product in LOE phase with modest Part D utilization; commercial teams are likely focused on line extension, indication expansion, and generic defense strategies.
Mechanism of Action
Aldosterone Antagonists
Pharmacologic Class:
Aldosterone Antagonist
Indications (2)
Clinical Trials (14)
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 May 2026
68 enrolled
Glioblastoma (GBM)
Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects (COMPARE-VS)
Started Apr 2026
100 enrolled
CKDCardiovascular DiseasesHeart Failure
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
Does Spironolactone Normalize Sleep-wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism?
Started Nov 2021
32 enrolled
HyperandrogenismPolycystic Ovary SyndromePuberty
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
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.