Spironolactone
Highest phase reached
Approved
Drug type
Small molecule
First approval year
1960
- First approval year
- 1960
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Spironolactone
- Molecular weight
- 416.58
- Structure (SMILES)
- 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]12
- abbolactone
- Abbolactone
- aldactone
- Aldactone
- carospir
- Carospir
- diatensec
- Diatensec
- gx spironol
- Gx spironol
- laractone
- Laractone
- qaialdo
- Qaialdo
- spiretic
- Spiretic
- spiroctan 100
- Spiroctan 100
- spiroctan 25
- Spiroctan 25
- spiroctan 50
- Spiroctan 50
- spironolactone
- Spironolactone
- spironolactone ceva
And 9 more, listed on the interactive page.
- .spironolactone
- 17 hydroxy 7α mercapto 3 oxo 17α pregn 4 ene 21 carboxylic acid γ lactone acetate
- 17-Hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid, γ-lactone acetate
- 200mg spironolactone
- 200mg Spironolactone
- 25 mg Aldactone (Spironolactone) tablet
- aldactazide component spironolactone
- ALDACTAZIDE COMPONENT SPIRONOLACTONE
- aldactone
- cardalis component spironolactone
- CARDALIS COMPONENT SPIRONOLACTONE
- espironolactona
- Espironolactona
- nsc 150399
- NSC-150399
- pregn 4 ene 21 carboxylic acid 7 acetylthio 17 hydroxy 3 oxo gamma lactone 7 alpha 17 alpha
- PREGN-4-ENE-21-CARBOXYLIC ACID, 7-(ACETYLTHIO)-17-HYDROXY-3-OXO-,.GAMMA.-LACTONE, (7.ALPHA.,17.ALPHA.)-
- sc 9420
- SC-9420
- spironolactone
- Spironolactone
- Spironolactone (drug)
- Spironolactone (Spironol) 25 mg
- Spironolactone (SPL 25)
- SPIRONOLACTONE [EMA EPAR VETERINARY]
And 54 more, listed on the interactive page.
- ATC classification codes
- C03DA01
Sources for recorded values
- CAS registry numbers
- 52-01-7
- ChEMBL ID
- CHEMBL1393
- InChIKey
- LXMSZDCAJNLERA-ZHYRCANASA-N
- PubChem compound IDs
- 5833
- RxNorm IDs (RxCUI)
- 9997
- FDA ingredient codes (UNII)
- 27O7W4T232
- Applicant
- PFIZER
- Approval date
- 21 Jan 1960
- Application number
- NDA012151
- Status
- Authorised
- Status date
- 26 May 2023
- Authorisation date
- 26 May 2023
- Approved indications
- In the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension. Neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5.1 and 5.2).
- Product number
- EMEA/H/C/005535
- Authorisation holder
- Lipomed GmbH
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Ascites
- Edema
- Essential Hypertension
- Heart Failure
- Hyperaldosteronism
- Liver Cirrhosis
- Nephrotic Syndrome
European medicines record
- Patents
- 8
- Designations
- 1
- Earliest recorded loss of exclusivity
- 28 Oct 2036
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- spironolactone
- Type
- Synthetic organic
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Action
- Antagonist
- Action type
- Antagonist
- Target
- Mineralocorticoid receptor
- Gene symbol
- NR3C2
- Protein identifier
- P08235
- Median affinity
- 8.63
- Affinity units
- pKi
- Primary target
- Yes
- Mechanism
- Mineralocorticoid receptor antagonist
- Action type
- Antagonist
- Target
- Mineralocorticoid receptor
- Protein identifier
- P08235
Open Targets mechanisms
- Mechanism
- Mineralocorticoid receptor antagonist
- Action type
- Antagonist
- Target
- Mineralocorticoid receptor
DrugCentral mechanisms
- Action type
- Antagonist
- Gene symbol
- NR3C2
- Protein identifier
- P08235
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- Leukemia, Myeloid, Acute
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000222
- Subject identifier
- D015470
- Condition
- Aortic Valve Stenosis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000266
- Subject identifier
- D001024
- Condition
- Atrial Fibrillation
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000275
- Subject identifier
- D001281
- Condition
- Cardiomyopathies
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000318
- Subject identifier
- D009202
- Condition
- Cardiovascular Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000319
- Subject identifier
- D002318
- Condition
- Heart Failure
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000373
- Subject identifier
- D006333
- Condition
- Diabetes Mellitus
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000400
- Subject identifier
- D003920
- Condition
- Diabetic Nephropathies
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000401
- Subject identifier
- D003928
- Condition
- Hypertension
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000537
- Subject identifier
- D006973
- Condition
- Leukemia
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000565
- Subject identifier
- D007938
- Condition
- Myocardial Infarction
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000612
- Subject identifier
- D009203
- Condition
- Neuroblastoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000621
- Subject identifier
- D009447
- Condition
- Polycystic Ovary Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000660
- Subject identifier
- D011085
- Condition
- Toxemia
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000668
- Subject identifier
- D014115
- Condition
- Arthritis, Rheumatoid
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000685
- Subject identifier
- D001172
- Condition
- Hypertension, Pulmonary
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001361
- Subject identifier
- D006976
- Condition
- Macular Degeneration
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001365
- Subject identifier
- D008268
- Condition
- Fibrosis
- Highest recorded phase
- 4
- Condition identifier
- EFO:0001422
- Subject identifier
- D005355
- Condition
- Heart Failure
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003144
- Subject identifier
- D006333
- Condition
- Renal Insufficiency, Chronic
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003884
- Subject identifier
- D051436
- Condition
- Acne Vulgaris
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003894
- Subject identifier
- D000152
- Condition
- Melanosis
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003963
- Subject identifier
- D008548
- Condition
- Nephrotic Syndrome
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004255
- Subject identifier
- D009404
- Condition
- Cerebral Hemorrhage
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005669
- Subject identifier
- D002543
- Condition
- ST Elevation Myocardial Infarction
- Highest recorded phase
- 3
- Condition identifier
- EFO:0008585
- Subject identifier
- D000072657
And 19 more, listed on the interactive page.
- Condition identifier
- EFO_0000195
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000266
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000266
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000275
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000319
- Condition identifier
- EFO_0000373
- Condition identifier
- EFO_0000401
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000537
- Condition identifier
- EFO_0000612
- Condition identifier
- EFO_0000660
- Condition identifier
- EFO_0000668
- Condition identifier
- EFO_0000685
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001361
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001365
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001422
- Condition identifier
- EFO_0001425
- Condition identifier
- EFO_0003144
- Condition identifier
- EFO_0003884
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003894
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003963
- Highest recorded phase
- 1
- Condition identifier
- EFO_0004255
- Condition identifier
- EFO_0004285
- Highest recorded phase
- 1
- Condition identifier
- EFO_0009006
- Highest recorded phase
- 1
- Condition identifier
- EFO_0009373
- Condition identifier
- EFO_0009373
- Highest recorded phase
- 4
And 85 more, listed on the interactive page.
Warnings
- Warning
- Black Box Warning
- Effect
- carcinogenicity
Open Targets warnings
- Warning
- Black Box Warning
- Effect
- carcinogenicity
- Country
- United States
- Event
- acute kidney injury
- Reports
- 1,671
- Reporting signal score
- 3,016.53
- Event
- blood creatinine increased
- Reports
- 335
- Reporting signal score
- 330.214
- Event
- blood potassium increased
- Reports
- 199
- Reporting signal score
- 392.14
- Event
- blood urea increased
- Reports
- 135
- Reporting signal score
- 177.127
- Event
- bradycardia
- Reports
- 471
- Reporting signal score
- 556.681
- Event
- cardiac failure
- Reports
- 347
- Reporting signal score
- 407.01
- Event
- cardiac failure chronic
- Reports
- 72
- Reporting signal score
- 169.992
- Event
- dehydration
- Reports
- 698
- Reporting signal score
- 807.016
- Event
- drug interaction
- Reports
- 702
- Reporting signal score
- 542.414
- Event
- electrolyte imbalance
- Reports
- 101
- Reporting signal score
- 148.113
- Event
- fall
- Reports
- 550
- Reporting signal score
- 195.851
- Event
- general physical health deterioration
- Reports
- 318
- Reporting signal score
- 291.049
- Event
- gynaecomastia
- Reports
- 170
- Reporting signal score
- 394.641
- Event
- hepatic encephalopathy
- Reports
- 146
- Reporting signal score
- 287.7
- Event
- hyperkalaemia
- Reports
- 2,140
- Reporting signal score
- 6,993.16
- Event
- hypokalaemia
- Reports
- 242
- Reporting signal score
- 223.84
- Event
- hyponatraemia
- Reports
- 938
- Reporting signal score
- 1,746.84
- Event
- hypotension
- Reports
- 802
- Reporting signal score
- 649.892
- Event
- hypovolaemia
- Reports
- 89
- Reporting signal score
- 161.247
- Event
- injection site pain
- Reports
- 2
- Reporting signal score
- 138.45
- Event
- metabolic acidosis
- Reports
- 195
- Reporting signal score
- 228.564
- Event
- orthostatic hypotension
- Reports
- 228
- Reporting signal score
- 353.333
- Event
- pemphigoid
- Reports
- 91
- Reporting signal score
- 146.264
- Event
- renal failure
- Reports
- 423
- Reporting signal score
- 403.393
- Event
- renal failure acute
- Reports
- 702
- Reporting signal score
- 1,180.58
And 2 more, listed on the interactive page.
- NCT00001202
- NCT00094302
- NCT00123955
- NCT00141778
- NCT02764619
- NCT03551548
- NCT03929718
- NCT04327232
- NCT06204640
- NCT00240656
- NCT01712620
- NCT00335413
- NCT00353652
- NCT00430794
- NCT00524615
- NCT00857909
- NCT01388088
- NCT01643434
- NCT02236520
- NCT02369081
- NCT02832973
- NCT04331691
- NCT04455178
- NCT00523757
- NCT00604006
And 54 more, listed on the interactive page.
- Dose
- 25-100mg
- Route
- Oral
- How often
- Once daily
- Take consistently with respect to food
- Take with or without food
- Hydrogen bond acceptors
- 5
- Hydrogen bond donors
- 0
- Polar surface area
- 60.44
- Calculated partition coefficient (ALogP)
- 4.85
- Calculated partition coefficient (XLogP)
- 2.9
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 1
- Heavy atoms
- 29
- Molecular formula
- C24H32O4S
- Monoisotopic mass
- 416.20213067
- Natural product
- Yes
- 0025-1001
- 0025-1031
- 0025-1041
- 0378-0243
- 0378-0403
- 0378-0437
- 0378-2146
- 0574-1133
- 0615-8451
- 0615-8452
- 0904-6927
- 16729-225
- 16729-226
- 16729-227
- 17089-260
- 31722-094
- 31722-095
- 31722-096
- 31722-691
- 42292-017
- 42708-101
- 42708-126
- 43063-832
- 43063-835
- 43063-974
And 164 more, listed on the interactive page.
- Recorded assays
- 2,127
- Active assays
- 145
- Confirmatory
- Other
- Screening
- Summary
- Mineralocorticoid Receptor Antagonists
- Diuretics
These details could not be displayed.
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- A Clinical Trial to Evaluate the Efficacy, Tolerability, and Safety of a Fixed Dose Combination of Spironolactone, Pioglitazone & Metformin (SPIOMET) in Polycystic Ovary Syndrome (PCOS)
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- A Phase 1b/2a Study to Evaluate the Safety, Pharmacokinetics, and Objective Response of STAR-001 (LP-184) in Combination With Spironolactone in Supratentorial Glioblastoma at First Progression
- A Phase IV, Two-part, Open-label Study Assessing the Pharmacokinetics, Safety and Pharmacodynamics of Spironolactone Oral Suspension in Pediatric Patients
- A Prospective, Single-center, Open-label, Pilot Study to Compare the Effectiveness and Safety of Diuretics Add-On Strategy in Chronic Heart Failure Patients (DIOS 1)
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- A Registry-based Cluster Randomized Trial to Compare the Effect of Spironolactone vs. Eplerenone on Clinical Outcomes in Patients With Symptomatic Systolic Heart Failure
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Approved for (10)
- Cardiovascular disorder
- Cirrhosis of liver
- Congestive heart failure
- Essential hypertension
- Heart failure
- Hypertensive disorder
- Myocardial infarction
- Nephrotic syndrome
- Preeclampsia
- Primary aldosteronism
In development for (29)
- Acne Phase 3
- Acute kidney injury Phase 3
- Acute myeloid leukemia Phase 1
- Age-related macular degeneration Phase 2
- Alcohol dependence Phase 1
- Aortic valve stenosis Phase 3
- Arrhythmogenic right ventricular cardiomyopathy Phase 2
- Atrial fibrillation Phase 3
- Autosomal dominant polycystic kidney disease Phase 3
- Cancer Phase 2
- Cardiomyopathy Phase 2
- Chorioretinitis Phase 1
- Chronic kidney disease Phase 3
- COVID-19 Phase 2
- Diabetes mellitus Phase 1
- Diabetic kidney disease Phase 1
- Diastolic heart failure Phase 3
- Dry eye syndrome Early phase 1
- Duchenne muscular dystrophy Phase 3
- Fatty liver disease Phase 2
Other linked conditions (3)
- Adult acute respiratory distress syndrome
- Hyperaldosteronism
- Type 1 diabetes mellitus
Targets (1)
- NR3C2 Mineralocorticoid receptor antagonist