Eplerenone
Inspra (eplerenone) is a small molecule pharmaceutical. Eplerenone was first approved as Inspra on 2002-09-27. It is used to treat hypertension and systolic heart failure in the USA. The pharmaceutical is active against mineralocorticoid receptor.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
---|---|
cardiovascular diseases | D002318 |
Trade Name
FDA
EMA
Inspra (generic drugs available since 2008-07-30)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Eplerenone
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
INSPRA | Upjohn | N-021437 RX | 2002-09-27 | 2 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
eplerenone | ANDA | 2023-06-15 |
inspra | New Drug Application | 2020-08-25 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
hypertension | EFO_0000537 | D006973 | I10 |
systolic heart failure | EFO_1001207 | D054143 | I50.20 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
103 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Hypertension | D006973 | EFO_0000537 | I10 | 4 | 4 | 2 | 12 | 2 | 24 |
Heart failure | D006333 | EFO_0003144 | I50 | 1 | 2 | 3 | 4 | 1 | 11 |
Chronic renal insufficiency | D051436 | N18 | 1 | 2 | 1 | 2 | — | 6 | |
Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | — | 1 | 4 | — | 5 |
Essential hypertension | D000075222 | I10 | — | 2 | 2 | 1 | — | 5 | |
Left ventricular hypertrophy | D017379 | EFO_0003896 | — | — | — | 3 | — | 3 | |
Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | — | 1 | 1 | — | 3 |
Myocardial infarction | D009203 | EFO_0000612 | I21 | — | 1 | — | 2 | — | 3 |
Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | 1 | 1 | 1 | 3 |
Hyperaldosteronism | D006929 | HP_0011736 | E26 | — | — | — | 2 | 1 | 3 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Central serous chorioretinopathy | D056833 | H35.71 | — | 3 | 1 | — | 2 | 5 | |
Duchenne muscular dystrophy | D020388 | — | — | 1 | — | 1 | 2 | ||
Primary hyperparathyroidism | D049950 | EFO_0008519 | E21.0 | — | 1 | 1 | — | — | 1 |
Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | 1 | — | — | 1 |
Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Diabetic nephropathies | D003928 | EFO_0000401 | 1 | 1 | — | — | — | 2 | |
Kidney transplantation | D016030 | — | 1 | — | — | — | 1 | ||
Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 1 | — | — | — | 1 |
Ascites | D001201 | HP_0001541 | R18 | — | 1 | — | — | — | 1 |
Papilledema | D010211 | EFO_1001074 | H35.81 | — | 1 | — | — | — | 1 |
Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Healthy volunteers/patients | — | 6 | — | — | — | — | 6 | ||
Fasting | D005215 | EFO_0002756 | 1 | — | — | — | — | 1 | |
Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 | ||
Aortic valve stenosis | D001024 | EFO_0000266 | Q25.1 | 1 | — | — | — | — | 1 |
Therapeutic equivalency | D013810 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Hiv | D006678 | O98.7 | — | — | — | — | 2 | 2 | |
Albuminuria | D000419 | EFO_0004285 | R80.9 | — | — | — | — | 1 | 1 |
Reperfusion injury | D015427 | — | — | — | — | 1 | 1 | ||
Renal dialysis | D006435 | EFO_0010690 | Z99.2 | — | — | — | — | 1 | 1 |
Hypoglycemia | D007003 | HP_0001943 | E16.2 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | EPLERENONE |
INN | eplerenone |
Description | Eplerenone is a steroid acid ester, a methyl ester, an oxaspiro compound, a gamma-lactone, an organic heteropentacyclic compound, a 3-oxo-Delta(4) steroid and an epoxy steroid. It has a role as an aldosterone antagonist and an antihypertensive agent. It derives from a hydride of a pregnane. |
Classification | Small molecule |
Drug class | aldosterone antagonists (spironolactone type) |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | COC(=O)[C@@H]1CC2=CC(=O)CC[C@]2(C)[C@@]23O[C@@H]2C[C@@]2(C)[C@@H](CC[C@@]24CCC(=O)O4)[C@H]13 |
Identifiers
PDB | — |
CAS-ID | 107724-20-9 |
RxCUI | 298869 |
ChEMBL ID | CHEMBL1095097 |
ChEBI ID | 31547 |
PubChem CID | 443872 |
DrugBank | DB00700 |
UNII ID | 6995V82D0B (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
No data
Variants
Clinical Variant
No data
Financial
Inspra - Pfizer
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,294 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,480 adverse events reported
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