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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 diseasesD002318
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
INSPRAUpjohnN-021437 RX2002-09-27
2 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
eplerenone ANDA2023-06-15
inspraNew Drug Application2020-08-25
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hypertensionEFO_0000537D006973I10
systolic heart failureEFO_1001207D054143I50.20
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
C: Cardiovascular system drugs
— C03: Diuretics
— C03D: Aldosterone antagonists and other potassium-sparing agents
— C03DA: Aldosterone antagonists
— C03DA04: Eplerenone
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
HypertensionD006973EFO_0000537I1044212224
Heart failureD006333EFO_0003144I501234111
Chronic renal insufficiencyD051436N181212—6
Metabolic syndromeD024821EFO_0000195E88.81——14—5
Essential hypertensionD000075222I10—221—5
Left ventricular hypertrophyD017379EFO_0003896———3—3
Type 2 diabetes mellitusD003924EFO_0001360E111—11—3
Myocardial infarctionD009203EFO_0000612I21—1—2—3
Chronic kidney failureD007676EFO_0003884N18.6——1113
HyperaldosteronismD006929HP_0011736E26———213
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Central serous chorioretinopathyD056833H35.71—31—25
Duchenne muscular dystrophyD020388——1—12
Primary hyperparathyroidismD049950EFO_0008519E21.0—11——1
Breast neoplasmsD001943EFO_0003869C50—11——1
Glucose intoleranceD018149HP_0000833R73.03——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Diabetic nephropathiesD003928EFO_000040111———2
Kidney transplantationD016030—1———1
Liver cirrhosisD008103EFO_0001422K74.0—1———1
AscitesD001201HP_0001541R18—1———1
PapilledemaD010211EFO_1001074H35.81—1———1
Atrial fibrillationD001281EFO_0000275I48.0—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
FastingD005215EFO_00027561————1
PharmacokineticsD0105991————1
Aortic valve stenosisD001024EFO_0000266Q25.11————1
Therapeutic equivalencyD0138101————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HivD006678O98.7————22
AlbuminuriaD000419EFO_0004285R80.9————11
Reperfusion injuryD015427————11
Renal dialysisD006435EFO_0010690Z99.2————11
HypoglycemiaD007003HP_0001943E16.2————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEPLERENONE
INNeplerenone
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 classaldosterone 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-ID107724-20-9
RxCUI298869
ChEMBL IDCHEMBL1095097
ChEBI ID31547
PubChem CID443872
DrugBankDB00700
UNII ID6995V82D0B (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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Tabular view
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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