Wednesday, July 8, 2026

Drug profile · INN

spironolactone

spironolactone (ALDACTONE) is a mineralocorticoid receptor antagonist. Associated with Pfizer Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Cardiovascular system (C03) C03DA01
US status approved
Patents linked 0
Pipeline programs 3
News articles 0
Drug details — spironolactone
US status
approved
Class
Cardiovascular system (C03)
Route
ORAL
Patents
0
Programs
3
Data quality
0.89

Quick answer

spironolactone (ALDACTONE) is a mineralocorticoid receptor antagonist. Associated with Pfizer Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN spironolactone
Brand ALDACTONE
Mechanism Mineralocorticoid receptor antagonist
Target Mineralocorticoid receptor
Therapeutic class Cardiovascular system (C03)
Route ORAL
Formulation SUSPENSION
ATC code C03DA01

Mechanism of action

Mineralocorticoid receptor antagonist

Primary target: Mineralocorticoid receptor

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. Spironolactone Phase 3 · Takeda · Atrial Fibrillation
  2. Spironolactone 25mg Phase 2 · Hospital Authority · Atrial Fibrillation
  3. Spironolactone Phase 1 · BRIGHT MINDS BIOSCIENCES · Alcohol Use Disorder

Related & competitor drugs

  1. alirocumab Cardiovascular system (C10)
  2. aliskiren Cardiovascular system (C09)
  3. azilsartan medoxomil Cardiovascular system (C09)
  4. bempedoic acid Cardiovascular system (C10)
  5. bosentan Cardiovascular system (C02)
  6. dofetilide Cardiovascular system (C01)

Frequently asked questions

What is spironolactone?

spironolactone (ALDACTONE) is a mineralocorticoid receptor antagonist. Associated with Pfizer Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for spironolactone?

ALDACTONE is a marketed brand name for spironolactone. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of spironolactone?

spironolactone has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.