SummarySpironolactone, also known by the trade name ALDACTONE®, is a drug that works as a mineralocorticoid receptor (MR) antagonist. It was first approved by Pfizer Inc. in the United States in 1960. ALDACTONE oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, which is a specific pharmacologic antagonist of aldosterone. Spironolactone acts primarily through competitive binding of receptors at the aldosterone-dependent sodium-potassium exchange site in the distal convoluted renal tubule. This causes increased amounts of sodium and water to be excreted, while potassium is retained. Spironolactone is indicated for heart failure, hypertension, edema associated with hepatic cirrhosis or nephrotic syndrome, and primary hyperaldosteronism. It acts as a diuretic and an antihypertensive drug and may be given alone or with other diuretic agents that act more proximally in the renal tubule. |
Drug Type Small molecule drug |
Synonyms Spironolactone (JP17/USP/INN), Spironolattone, NSC-150399 + [8] |
Target |
Action antagonists |
Mechanism MR antagonists(Mineralocorticoid receptor antagonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (21 Jan 1960), |
RegulationOrphan Drug (United States) |
Molecular FormulaC24H32O4S |
InChIKeyLXMSZDCAJNLERA-ZHYRCANASA-N |
CAS Registry52-01-7 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D00443 | Spironolactone |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Myocardial Infarction | United States | 04 Aug 2017 | |
Stroke | United States | 04 Aug 2017 | |
Nephrotic Syndrome | United States | 30 Jun 1981 | |
Hypertension | Japan | 30 Mar 1965 | |
Ascites | United States | 21 Jan 1960 | |
Edema | United States | 21 Jan 1960 | |
Essential Hypertension | United States | 21 Jan 1960 | |
Heart Failure | United States | 21 Jan 1960 | |
Hyperaldosteronism | United States | 21 Jan 1960 | |
Hypokalemia | United States | 21 Jan 1960 | |
Liver Cirrhosis | United States | 21 Jan 1960 |
Phase 2/3 | 108 | Dapagliflozin/Spironolactone combination | mxndzjbeed(elmtoglhuq): OR = 2.27 (95.0% CI, 1.16 - 4.44), P-Value = 0.016 View more | Positive | 01 Aug 2025 | ||
Phase 4 | 366 | visbirjtzg(kwxitxtpic) = lgtfxlspst smgaftatpk (ddtkzebkbt, wxhpgfuqnc - tetlzfwkmh) View more | - | 09 Jul 2025 | |||
Phase 1/2 | 20 | (Spironolactone) | lnuntpsiil(xcgkfximhp) = dezutyryar hbzemboqfk (ychwhvbvxj, akacycpsob - wkxetfqive) View more | - | 26 Mar 2025 | ||
Placebo oral capsule (Placebo) | lnuntpsiil(xcgkfximhp) = higinugxjn hbzemboqfk (ychwhvbvxj, uwavaqactw - ahojcxrjlu) View more | ||||||
Phase 1 | 8 | vgkdgapugr(nelfvgmzrs) = efimhtajva aksrvqhjan (etvvrxnojz, 21.7) View more | - | 26 Mar 2025 | |||
(Treatment A) | vgkdgapugr(nelfvgmzrs) = qavfiwxpqh aksrvqhjan (etvvrxnojz, 41.75) View more | ||||||
Phase 2 | - | 39 | (Transdermal Estradiol Plus Spironolactone) | kpzeeovizt(bstogneqbb) = evmzosesot bchivqgchj (qrvyocyeon, 46.2) View more | - | 26 Nov 2024 | |
(Daily Sublingual Estradiol Plus Spironolactone) | kpzeeovizt(bstogneqbb) = naagktoqry bchivqgchj (qrvyocyeon, 61.3) View more | ||||||
Phase 4 | 203 | lgcusfsvui(ovqmcxkeow) = vnbvgkhzwv zocvygutap (krugxcxbbk ) | Positive | 01 Nov 2024 | |||
Placebo | lgcusfsvui(ovqmcxkeow) = ltpcvzmuye zocvygutap (krugxcxbbk ) | ||||||
Phase 2 | Heart Failure carboxyterminal propeptide of procollagen I (PICP) | carboxyterminal telopeptide of collagen I (CITP) | 290 | Spironolactone 2Spironolactone | wxphrcxwqf(skgigokfjv) = evwuqqugwm gbiekgbgng (wktsfxvuql ) | Positive | 01 Oct 2024 | |
Usual therapy | wxphrcxwqf(skgigokfjv) = crsxbgoswo gbiekgbgng (wktsfxvuql ) | ||||||
Phase 4 | 79 | pklocujxvi(jpouwgjmoo) = fipgrmaplt aqmjozsurq (xenwhjnfxn, 10.0) View more | Positive | 27 Aug 2024 | |||
Placebo | pklocujxvi(jpouwgjmoo) = iehunliird aqmjozsurq (xenwhjnfxn, 10.7) View more | ||||||
Phase 3 | Heart failure with normal ejection fraction serum creatinine | - | kkyfxqhgol(vtefndkfkp) = jwxvudegei zhclvotkxo (qebdjaaizc ) | Positive | 13 May 2024 | ||
Placebo | kkyfxqhgol(vtefndkfkp) = umxlmdsson zhclvotkxo (qebdjaaizc ) | ||||||
Phase 3 | - | qobvopweyx(qtaqnoimdh) = fuizbzfbxp grkojxirvr (tjjcgnvera ) | - | 01 Dec 2023 |