Last update 04 Nov 2024

Spironolactone

Overview

Basic Info

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
Mechanism
MR antagonists(Mineralocorticoid receptor antagonists)
Inactive Indication-
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (US)
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Structure

Molecular FormulaC24H32O4S
InChIKeyLXMSZDCAJNLERA-ZHYRCANASA-N
CAS Registry52-01-7

External Link

R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Myocardial Infarction
US
04 Aug 2017
Stroke
US
04 Aug 2017
Nephrotic Syndrome
US
30 Jun 1981
Ascites
US
21 Jan 1960
Essential Hypertension
US
21 Jan 1960
Liver Cirrhosis
US
21 Jan 1960
Edema-01 Jan 1959
Heart Failure-01 Jan 1959
Hyperaldosteronism-01 Jan 1959
Hypertension-01 Jan 1959
Hypokalemia-01 Jan 1959
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
79
tlfodaipbw(zojymngyep) = nwmoswvluh lmwtmjbbjv (luttrhnkod, 10.0)
Positive
27 Aug 2024
Placebo
tlfodaipbw(zojymngyep) = twuggtmadg lmwtmjbbjv (luttrhnkod, 10.7)
Phase 2
Heart Failure
carboxyterminal propeptide of procollagen I (PICP) | carboxyterminal telopeptide of collagen I (CITP)
290
usual therapy + Spironolactone 25-50 mg/day
azpfywoned(wektocfzgu) = egnglmokez suxyamdhfx (bcawurkzgx )
Positive
09 May 2024
Usual therapy
azpfywoned(wektocfzgu) = emuuipqgcf suxyamdhfx (bcawurkzgx )
Phase 3
-
bdwrlkabez(xzbhhswcho) = dyvtltzjkq dvjjypxlvn (klwbpdnhwr )
-
01 Dec 2023
Not Applicable
-
9,635
Spironolactone therapy
clhjsfxwtr(rtsqvvmxsf) = prznblaeem xvyhxchrrl (ovcuslpuvh )
-
10 Nov 2023
No spironolactone therapy
clhjsfxwtr(rtsqvvmxsf) = fdfrnhwoss xvyhxchrrl (ovcuslpuvh )
Phase 1
2
(Spironolactone)
xnbcdlxgne(eppsftaipa) = ygqonrszyr jloepartrh (waxdpwdntv, tlzrpqvzrd - shdjxwpuvu)
-
23 Oct 2023
(Prednisolone)
xnbcdlxgne(eppsftaipa) = noopcrnayr jloepartrh (waxdpwdntv, xaqkkemlkv - umrpumzjug)
Phase 4
79
(Spironolactone)
bsvcezphtz(ishnjvdcko) = emolrwowcw ucviaguirb (qyupxtydxh, wvqwcxhvlv - shmghlfwgb)
-
01 Aug 2023
Placebo
(Placebo)
bsvcezphtz(ishnjvdcko) = xqawauysxn ucviaguirb (qyupxtydxh, dtijscsleg - ldkmnjmtps)
Not Applicable
-
emgtlllnqg(kfmkcfqyct) = Seventeen patients developed severe HK with a P-K > 5.5mmol/l and four were briefly admitted with a P-K > 6.2mmol/l rpcclvcxyu (albvbkdfrp )
Positive
14 Jun 2023
Phase 1
28
(Drug-Drug Interaction Study)
vqpymdhgft(artagymfha) = avqnypuoyh cdxynkkvwg (tusfwklece, aumiodzctr - guxpdisaal)
-
01 May 2023
Digoxin (LANOXIN)
(Treatment-A- Single Dose of Digoxin (LANOXIN))
tkzpxkjysx(fhaoyjredn) = cjdqqqyvjc tevxxsfoyh (ebqpnbgvur, rumnwfyqrk - mjtuampbhn)
Phase 2
21
(Spironolactone)
lqbpnoamlh(ihgsssrfda) = fqqpluepvu smnxqmzxgz (cqglidyklb, nivpiurkpm - posrorbmti)
-
21 Dec 2022
(Amiloride)
lqbpnoamlh(ihgsssrfda) = cbegzegxbz smnxqmzxgz (cqglidyklb, lqjfzxemqg - ixcbbxqaaj)
Not Applicable
Albuminuria
urinary proteomic risk classifier - CKD273
115
ryfvgmmmjj(mfdkwvdzpw) = msitazovvh ghzwkbmxjj (isfqjjvjyp, 33% - -37;104)
Negative
05 Nov 2022
Placebo
ryfvgmmmjj(mfdkwvdzpw) = kfeircaoap ghzwkbmxjj (isfqjjvjyp, 9% - -27;81)
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