Overview
Spironolactone is a potassium-sparing diuretic. It binds to mineralocorticoid receptors and functions as aldosterone antagonists. It promotes sodium and water excretion and potassium retention. Spironolactone was originally developed purely for this ability before other pharmacodynamic properties of the drug were discovered. It is indicated to treat several conditions, including heart failure, edema, hyperaldosteronism, and hypertension. Off-label uses of spironolactone include hirsutism, female pattern hair loss, and adult acne vulgaris. Spironolactone was developed in 1957, marketed in 1959, and approved by the FDA on January 21, 1960.
Indication
Spironolactone is indicated for the treatment of the following conditions: As spironolactone has antiandrogenic activity, its off-label uses include the treatment of hirsutism, female pattern hair loss, and adult acne vulgaris.
Associated Conditions
- Edema
- Hypertension
- Primary Aldosteronism
- Primary Hyperaldosteronism
- Secondary hyperaldosteronism
- Chronic heart failure with reduced ejection fraction (NYHA Class III)
- Chronic heart failure with reduced ejection fraction (NYHA Class IV)
- Idiopathic hyperaldosteronism
- Refractory Edema
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/27 | Not Applicable | Not yet recruiting | |||
2025/06/13 | Not Applicable | Recruiting | |||
2024/10/15 | N/A | Completed | Ahmad Abdullah Salawi | ||
2024/08/30 | Phase 1 | Completed | |||
2024/06/13 | Phase 4 | Recruiting | Qifu Li | ||
2024/05/14 | Phase 3 | Completed | Ospedale San Raffaele | ||
2024/02/23 | Phase 4 | Recruiting | National Institute of Cardiology, Warsaw, Poland | ||
2024/01/12 | Phase 3 | Not yet recruiting | |||
2023/12/11 | Phase 4 | Not yet recruiting | Shanghai Jiao Tong University School of Medicine | ||
2023/09/15 | N/A | Recruiting | China National Center for Cardiovascular Diseases |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| NuCare Pharmaceuticals,Inc. | 68071-2977 | ORAL | 100 mg in 1 1 | 4/17/2023 | |
| Direct_Rx | 72189-497 | ORAL | 25 mg in 1 1 | 7/6/2023 | |
| Aidarex Pharmaceuticals LLC | 33261-895 | ORAL | 50 mg in 1 1 | 2/2/2014 | |
| Preferred Pharmaceuticals Inc. | 68788-8452 | ORAL | 50 mg in 1 1 | 5/30/2023 | |
| REMEDYREPACK INC. | 70518-3625 | ORAL | 25 mg in 1 1 | 3/26/2024 | |
| NorthStar Rx LLC | 72603-136 | ORAL | 100 mg in 1 1 | 9/27/2023 | |
| NorthStar RxLLC | 16714-639 | ORAL | 100 mg in 1 1 | 11/25/2022 | |
| Denton Pharma, Inc. DBA Northwind Pharmaceuticals | 70934-368 | ORAL | 50 mg in 1 1 | 6/3/2020 | |
| Padagis US LLC | 0574-1133 | ORAL | 25 mg in 5 mL | 8/31/2023 | |
| NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8178 | ORAL | 25 mg in 1 1 | 1/25/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 5/26/2023 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| SPIRIDON TABLETS 50MG | SIN16710P | TABLET | 50.0mg | 2/23/2023 | |
| URACTONUM TABLET 25 mg | SIN00664P | TABLET | 25 mg | 5/3/1988 | |
| SPIRIDON TABLETS 25MG | SIN16711P | TABLET | 25.0mg | 2/23/2023 | |
| SPIROLON 100 TABLET 100 mg | SIN02168P | TABLET, FILM COATED | 100 mg | 6/27/1988 | |
| SPIRIDON TABLETS 100MG | SIN16709P | TABLET | 100.0mg | 2/23/2023 | |
| SPIROLON 25 TABLET 25 mg | SIN02153P | TABLET, FILM COATED | 25 mg | 6/27/1988 | |
| ALDACTONE TABLET 25 mg | SIN02222P | TABLET | 25 mg | 6/29/1988 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Spironolactone Capsules | 国药准字H42021717 | 化学药品 | 胶囊剂 | 9/17/2020 | |
| Spironolactone Capsules | 国药准字H50020400 | 化学药品 | 胶囊剂 | 8/17/2020 | |
| Spironolactone Capsules | 国药准字H32020049 | 化学药品 | 胶囊剂 | 9/9/2020 | |
| Spironolactone Tablets | 国药准字H20227135 | 化学药品 | 片剂 | 10/18/2022 | |
| Spironolactone Tablets | 国药准字H23020207 | 化学药品 | 片剂 | 6/1/2020 | |
| Spironolactone Tablets | 国药准字H21021804 | 化学药品 | 片剂 | 5/12/2020 | |
| Spironolactone Tablets | 国药准字H21021273 | 化学药品 | 片剂 | 7/13/2020 | |
| Spironolactone Tablets | 国药准字H32023932 | 化学药品 | 片剂 | 6/15/2020 | |
| Spironolactone Tablets | 国药准字H41024151 | 化学药品 | 片剂 | 8/14/2020 | |
| Spironolactone Tablets | 国药准字H44020863 | 化学药品 | 片剂 | 1/17/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Aldactone 25mg tablet blister pack | 68953 | Medicine | A | 5/28/1999 | |
| Spironolactone and Hydrochlorothiazide Tablets USP 25 mg / 25 mg Bottle | 401190 | Medicine | A | 12/18/2022 | |
| Spironolactone Tablets USP 25mg | 400797 | Medicine | A | 12/8/2022 | |
| Aldazide tablets | 33606 | Proqualix Pty Ltd - in Administration | Medicine | A | 11/7/1991 |
| SPIRONOLACTONE VIATRIS 25 spironolactone 25 mg tablet bottle | 338091 | Medicine | A | 8/19/2020 | |
| ALDACTONE TABLETS | 24273 | Proqualix Pty Ltd - in Administration | Medicine | A | 10/9/1991 |
| SPIRONOLACTONE VIATRIS 100 spironolactone100 mg tablet bottle | 338092 | Medicine | A | 8/19/2020 | |
| Aldactone 100mg tablet blister pack | 68954 | Medicine | A | 5/28/1999 | |
| SPIRACTIN 100 spironolactone 100mg tablets | 46691 | Medicine | A | 10/14/1993 | |
| SPIRACTIN 25 spironolactone 25mg tablets | 46689 | Medicine | A | 10/14/1993 |
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