NDAORALTABLETPriority Review
Approved
Jan 1960
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
14
Data completeness
5/8 — Partial
Priority Review
ALDACTONE (spironolactone) by Pfizer is aldosterone antagonists [moa]. First approved in 1960.
Drug data last refreshed 12h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALDACTONE (spironolactone) is an oral aldosterone antagonist used primarily to treat heart failure, hypertension, and edema in patients with cirrhosis or nephrotic syndrome. It works by blocking aldosterone receptors in the collecting duct, reducing sodium reabsorption and increasing potassium retention. The drug has been a cornerstone therapy for over 60 years in managing fluid overload and blood pressure in complex patient populations.
$0.546MPart D
LOE ApproachingProduct is in late-stage lifecycle with modest Part D utilization; commercial teams should prepare for generic erosion and focus on clinical differentiation and patient loyalty programs.
Mechanism of Action
Aldosterone Antagonists
Pharmacologic Class:
Aldosterone Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (14)
Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects (COMPARE-VS)
Started May 2026
100 enrolled
CKDCardiovascular DiseasesHeart Failure
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)
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.