Aldactazide, Qaialdo(spironolactone)
Aldactazide, Aldactone, Carospir, Qaialdo, Spironolactone (spironolactone) is a small molecule pharmaceutical. Spironolactone was first approved as Spironolactone and hydrochlorothiazide on 1982-01-01. It is used to treat ascites, edema, heart failure, hirsutism, and hyperaldosteronism amongst others in the USA. It has been approved in Europe to treat ascites, edema, essential hypertension, heart failure, and hyperaldosteronism amongst others. The pharmaceutical is active against mineralocorticoid receptor.
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Commercial
Trade Name
FDA
EMA
Aldactone, Carospir, Spironolactone (discontinued: Spironolactone)
CombinationsAldactazide, Spironolactone hydrochlorothiazide (discontinued: Aldactazide, Spironolactone hydrochlorothiazide, Spironolactone w/ hydrochlorothiazide)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 011054 niacinamide 4% / spironolactone 5% | unapproved drug other | 2020-07-02 |
| 011218 niacinamide 2% / spironolactone 5% / tretinoin 0.025% | unapproved drug other | 2020-07-02 |
| 011220 niacinamide 2% / spironolactone 5% / tretinoin 0.05% | unapproved drug other | 2020-07-02 |
| 011503 dapsone 6% / niacinamide 2% / spironolactone 5% | unapproved drug other | 2020-07-02 |
| aldactazide | New Drug Application | 2024-04-02 |
| aldactone | New Drug Application | 2023-12-11 |
| benzoyl peroxide 5% / clindamycin 1% / niacinamide 2% / spironolactone 2% | unapproved drug other | 2019-05-10 |
| benzoyl peroxide 5% / clindamycin 1% / niacinamide 2% / spironolactone 2% / tretinoin 0.025% | unapproved drug other | 2019-05-03 |
| benzoyl peroxide 5% / clindamycin 1% / niacinamide 2% / spironolactone 2% / tretinoin 0.05% | unapproved drug other | 2019-05-02 |
| carospir | New Drug Application | 2024-04-12 |
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Indications
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Agency Specific
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HCPCS
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Clinical
Clinical Trials
294 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart failure | D006333 | HP_0001635 | I50 | 4 | 9 | 13 | 23 | 20 | 66 |
| Hypertension | D006973 | EFO_0000537 | I10 | 3 | 10 | 6 | 22 | 17 | 58 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | 12 | 3 | 5 | 4 | 23 |
| Fibrosis | D005355 | — | — | — | 3 | 3 | 8 | 6 | 19 |
| Hyperaldosteronism | D006929 | HP_0011736 | E26 | — | — | 1 | 6 | 11 | 18 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.9 | — | 3 | 3 | 6 | 1 | 13 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | 1 | 2 | 1 | 6 | 2 | 12 |
| Chronic renal insufficiency | D051436 | — | N18 | — | 6 | — | 2 | 3 | 11 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 2 | 1 | 4 | 5 | 11 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | 1 | 4 | 2 | 3 | 2 | 10 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 2 | 3 | — | 3 | 7 |
| Essential hypertension | D000075222 | — | I10 | — | 3 | 1 | — | 2 | 6 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | 3 | — | 1 | 4 |
| Infarction | D007238 | EFO_0009463 | — | — | — | 3 | — | 1 | 4 |
| Inflammation | D007249 | MP_0001845 | — | — | 1 | 1 | — | 3 | 4 |
| Acute kidney injury | D058186 | HP_0001919 | N17 | — | 1 | 2 | — | 1 | 4 |
| Wounds and injuries | D014947 | — | T14.8 | — | 1 | 1 | — | 2 | 4 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | — | 2 | — | 1 | 3 |
| Proteinuria | D011507 | HP_0000093 | R80 | — | 1 | 1 | — | 2 | 3 |
| St elevation myocardial infarction | D000072657 | — | — | — | — | 2 | — | 1 | 3 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 4 | 2 | — | — | 3 | 9 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | 1 | — | — | 2 | 3 |
| Gender identity | D005783 | — | — | 1 | 1 | — | — | 2 | 3 |
| Fatty liver | D005234 | EFO_0003934 | — | 1 | 3 | — | — | — | 3 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 2 | 1 | — | — | — | 2 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 2 | 2 | — | — | — | 2 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 1 | 2 | — | — | — | 2 |
| Univentricular heart | D000080039 | — | Q20.4 | 1 | 1 | — | — | 1 | 2 |
| Arrhythmogenic right ventricular dysplasia | D019571 | Orphanet_247 | I42.8 | — | 1 | — | — | — | 1 |
| Wet macular degeneration | D057135 | EFO_0004683 | — | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperandrogenism | D017588 | — | — | 3 | — | — | — | 1 | 4 |
| Gender dysphoria | D000068116 | — | — | 1 | — | — | — | 2 | 3 |
| Puberty | D011627 | EFO_0001382 | — | 2 | — | — | — | — | 2 |
| Alcohol drinking | D000428 | EFO_0004329 | — | 1 | — | — | — | 1 | 2 |
| Glucose metabolism disorders | D044882 | — | — | 1 | — | — | — | — | 1 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | 1 | — | — | — | — | 1 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | 1 | — | — | — | — | 1 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | 1 | — | — | — | — | 1 |
| Disorders of sex development | D012734 | HP_0000062 | Q56.3 | 1 | — | — | — | — | 1 |
| Melanosis | D008548 | HP_0001480 | L81.1 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mitral valve insufficiency | D008944 | HP_0001653 | — | — | — | — | — | 4 | 4 |
| Hypokalemia | D007008 | HP_0002900 | E87.6 | — | — | — | — | 3 | 3 |
| Transgenes | D019076 | — | — | — | — | — | — | 3 | 3 |
| Adenoma | D000236 | — | — | — | — | — | — | 3 | 3 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 2 | 2 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | — | — | 2 | 2 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | — | — | 2 | 2 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 2 | 2 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | — | — | — | 2 | 2 |
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | — | — | — | — | 2 | 2 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Spironolactone |
| INN | spironolactone |
| Description | Spironolactone is a steroid lactone that is 17alpha-pregn-4-ene-21,17-carbolactone substituted by an oxo group at position 3 and an alpha-acetylsulfanyl group at position 7. It has a role as a diuretic, an aldosterone antagonist, an antihypertensive agent, an environmental contaminant and a xenobiotic. It is a steroid lactone, an oxaspiro compound, a thioester and a 3-oxo-Delta(4) steroid. |
| Classification | Small molecule |
| Drug class | Antimineralocorticoid; Steroidal antiandrogen |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(=O)S[C@@H]1CC2=CC(=O)CC[C@]2(C)[C@H]2CC[C@@]3(C)[C@@H](CC[C@@]34CCC(=O)O4)[C@@H]21 |
Identifiers
| PDB | — |
| CAS-ID | 52-01-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1393 |
| ChEBI ID | 9241 |
| PubChem CID | 5833 |
| DrugBank | DB00421 |
| UNII ID | 27O7W4T232 (ChemIDplus, GSRS) |
Target
Agency Approved
NR3C2
NR3C2
Organism
Homo sapiens
Gene name
NR3C2
Gene synonyms
MCR, MLR
NCBI Gene ID
Protein name
mineralocorticoid receptor
Protein synonyms
aldosterone receptor, mineralocorticoid receptor 1, mineralocorticoid receptor 2, mineralocorticoid receptor delta, Nuclear receptor subfamily 3 group C member 2
Uniprot ID
Mouse ortholog
Nr3c2 (110784)
mineralocorticoid receptor (Q8VII8)
Alternate
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Variants
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Financial
Revenue by drug
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Estimated US medical usage
Spironolactone
+
Hydrochlorothiazide
Total medical expenditures per year (USD, in millions)
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Spironolactone
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Safety
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Adverse Events
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27,832 adverse events reported
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