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Drug

Spironolactone

Approved · EMA
ClassMineralocorticoid receptor antagonistEmerging researchLate-stage developmentCooling momentum
Also known as Aldactazide, Aldactone, Cardalis, CaroSpir+6 more

Aldactazide, Aldactone, Cardalis, CaroSpir, Espironolactona, Hydrochlorothiazide-Spironolactone, Spironol, Spironolactone Plus, Spironolattone, Spironolactonum.

8
Research papers
25
Active clinical trials
Mineralocorticoid receptor
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Guidelines of care for the management of acne vulgaris.

Research2024-01-30Journal of the American Academy of Dermatology

Approval: Qaialdo (EMA)

Regulatory2023-05-26EMA

Spironolactone for heart failure with preserved ejection fraction.

Research2014-04-01The New England journal of medicine

Evidence confidence

1 claim

How strongly the incorporated evidence supports specific clinical claims about this treatment. A confidence figure is a current summary of evidence strength, not a permanent verdict.

Lowers systolic blood pressure in hypertension
65%Moderate confidence
Uncertainty ±16%Evidence coverage: PartialUpdated 1 March 2026

High point estimate, but substantial uncertainty remains.

Confidence has a moderate point estimate but a wide uncertainty band — the evidence base is still thin.

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Spironolactone
Aliases & brands
AldactazideAldactoneCardalisCaroSpirEspironolactonaHydrochlorothiazide-SpironolactoneSpironolSpironolactone PlusSpironolattoneSpironolactonum
RxNorm CUI
9997
ChEMBL ID
CHEMBL1393
ATC codes
C03DA01
UNII
27O7W4T232
Primary mechanism
Mineralocorticoid receptor antagonist
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

ANTAGONISTMineralocorticoid receptor antagonist

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2023-05-26
Latest approval
2023-05-26
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2023-05-26Approval
Approval: Qaialdo (EMA)
Indication: In the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis andShow full indication

In the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension. Neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5.1 and 5.2).

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

175 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
175
registered trials across all phases
LATEST COMPLETION 2026
25
Active studies
23
Recruiting
116
Late-stage (III+)
95
Completed
55
Discontinued
PHASE DISTRIBUTIONn = 175
Early Phase 14Phase 113Phase 1 / 27Phase 235Phase 2 / 36Phase 325Phase 460Phase N / A25

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

8 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
19992024
Most influential
Recent papers
Major research themes8
Acne Vulgaris1Anti-Bacterial Agents1Benzoyl Peroxide1Defibrillators, Implantable1Dermatologic Agents1Dicarboxylic Acids1Doxycycline1Echocardiography1
Journals, researchers & institutions
Top journals
  • Circulation. Heart failure3
  • The New England journal of medicine2
  • Circulation1
  • Circulation. Arrhythmia and electrophysiology1
  • Journal of the American Academy of Dermatology1
Leading researchers
  • Pitt B6
  • Anand IS5
  • Heitner JF5
  • O'Meara E5
  • Pfeffer MA5
  • Shah SJ5
  • Solomon SD5
  • Sweitzer NK5
Leading institutions
free-text, unnormalised
  • Brigham and Women's Hospital4
  • American Academy of Dermatology1
  • Beth Israel Deaconess Medical Center1
  • Emory University School of Medicine1
  • From the University of Michigan School of Medicine1
  • Massachusetts General Hospital1

Related diseases

1 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Active research areas

Related drugs

8 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Studied across the same disease area as Spironolactone in the shared literature.

1 shared disease1 shared paper

Studied across the same disease area as Spironolactone in the shared literature.

1 shared disease1 shared paper

Studied across the same disease area as Spironolactone in the shared literature.

1 shared disease1 shared paper

Studied across the same disease area as Spironolactone in the shared literature.

1 shared disease1 shared paper

Studied across the same disease area as Spironolactone in the shared literature.

1 shared disease1 shared paper

Studied across the same disease area as Spironolactone in the shared literature.

1 shared disease1 shared paper

Studied across the same disease area as Spironolactone in the shared literature.

1 shared disease1 shared paper

Studied across the same disease area as Spironolactone in the shared literature.

1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.