Product Description
Spironolactone is a potassium-sparing diuretic (water pill). It prevents your body from absorbing too much salt and keeps your potassium levels from getting too low. This medicine is also used to treat or prevent hypokalemia (low potassium levels in the blood). (Sourced from: https://www.mayoclinic.org/drugs-supplements/spironolactone-oral-route/description/drg-20071534)
Mechanisms of Action: Mineralocorticoid Receptor Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Heart Failure | Heart Failure, Chronic | Heart Failure, Systolic | Myocardial Infarction | Hypertension | Stroke | Edema
Known Adverse Events: Gynecomastia
Company: AstraZeneca
Company Location: CAMBRIDGE X0 CB2 0AA
Company CEO: Pascal Soriot
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Austria, Canada, China, Czech Republic, Denmark, Egypt, France, Hungary, Italy, Nepal, Netherlands, North Macedonia, Norway, Serbia, Spain, Switzerland, United Kingdom, United States
Active Clinical Trial Count: 6
Highest Development Phases
Phase 3: Acne Vulgaris|Heart Failure, Chronic|Heart Failure, Systolic|Non-ST Elevated Myocardial Infarction|ST Elevation Myocardial Infarction
Phase 2: Polycystic Ovary Syndrome
Phase 1: Healthy Volunteers
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| SPIOMET4HEALTH | P2 |
Unknown Status |
Polycystic Ovary Syndrome |
2026-02-25 |
|
| CLEAR SYNERGY | P3 |
Completed |
ST Elevation Myocardial Infarction|Non-ST Elevated Myocardial Infarction |
2024-08-09 |
|
| Viatris and Neolpharma | P1 |
Completed |
Healthy Volunteers |
2024-03-01 |
28% |
| Viatris and Neolpharma | P1 |
Completed |
Healthy Volunteers |
2024-03-01 |
28% |
| CRC-C2009 | P1 |
Completed |
Healthy Volunteers |
2023-05-05 |