Last reviewed · How we verify
Phase C: Spironolactone
Phase C: Spironolactone is a Potassium-sparing diuretic; Aldosterone antagonist Small molecule drug developed by National Institute of Cardiology, Warsaw, Poland. It is currently FDA-approved for Heart failure with reduced ejection fraction, Hypertension, Primary hyperaldosteronism. Also known as: Spironolactone.
Spironolactone blocks aldosterone receptors in the kidney to reduce sodium reabsorption and potassium excretion, lowering blood pressure and reducing fluid retention.
Spironolactone blocks aldosterone receptors in the kidney to reduce sodium reabsorption and potassium excretion, lowering blood pressure and reducing fluid retention. Used for Heart failure with reduced ejection fraction, Hypertension, Primary hyperaldosteronism.
At a glance
| Generic name | Phase C: Spironolactone |
|---|---|
| Also known as | Spironolactone |
| Sponsor | National Institute of Cardiology, Warsaw, Poland |
| Drug class | Potassium-sparing diuretic; Aldosterone antagonist |
| Target | Mineralocorticoid receptor (MR) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Spironolactone is a potassium-sparing diuretic and aldosterone antagonist that binds to mineralocorticoid receptors in the collecting duct of the nephron. By blocking aldosterone signaling, it prevents sodium reabsorption and potassium loss, leading to increased sodium and water excretion while retaining potassium. This dual action makes it particularly useful in heart failure and hypertension, especially in patients at risk of hypokalemia.
Approved indications
- Heart failure with reduced ejection fraction
- Hypertension
- Primary hyperaldosteronism
- Edema associated with cirrhosis or nephrotic syndrome
Common side effects
- Hyperkalemia
- Gynecomastia
- Menstrual irregularities
- Headache
- Dizziness
- Gastrointestinal upset
Key clinical trials
- An Observational Study to Learn More About the Real-world Outcomes in Patients With Heart Failure Who Initiate Treatment With Vericiguat in Japan
- Study of LP-184 in Patients With Advanced Solid Tumors (PHASE1, PHASE2)
- Optimal Medical Treatment of Difficult-to-treat Hypertension (PHASE4)
- Lintuzumab-Ac225 in Older Acute Myeloid Leukemia (AML) Patients (PHASE1, PHASE2)
- Treatment of Intermediate-stage Hepatocellular Carcinoma (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Phase C: Spironolactone CI brief — competitive landscape report
- Phase C: Spironolactone updates RSS · CI watch RSS
- National Institute of Cardiology, Warsaw, Poland portfolio CI
Frequently asked questions about Phase C: Spironolactone
What is Phase C: Spironolactone?
How does Phase C: Spironolactone work?
What is Phase C: Spironolactone used for?
Who makes Phase C: Spironolactone?
Is Phase C: Spironolactone also known as anything else?
What drug class is Phase C: Spironolactone in?
What development phase is Phase C: Spironolactone in?
What are the side effects of Phase C: Spironolactone?
What does Phase C: Spironolactone target?
Related
- Drug class: All Potassium-sparing diuretic; Aldosterone antagonist drugs
- Target: All drugs targeting Mineralocorticoid receptor (MR)
- Manufacturer: National Institute of Cardiology, Warsaw, Poland — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Heart failure with reduced ejection fraction
- Indication: Drugs for Hypertension
- Indication: Drugs for Primary hyperaldosteronism
- Also known as: Spironolactone
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing