NDAORALTABLET
Approved
Sep 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
INSPRA (eplerenone) by Viatris (2) is aldosterone antagonists [moa]. First approved in 2002.
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
INSPRA (eplerenone) is an oral aldosterone antagonist small molecule approved in 2002 for heart failure, hypertension, chronic kidney disease, and related cardiovascular and metabolic indications. It works by blocking aldosterone receptors in the kidney and heart, reducing sodium retention, blood pressure, and cardiac remodeling. The drug addresses a broad patient population with cardiorenal disease, often used as adjunctive therapy.
$0.369MPart D
LOE ApproachingDeclining
LOE-approaching lifecycle suggests a mature product with limited growth; commercial teams are likely focused on lifecycle management and generic transition planning.
Mechanism of Action
Aldosterone Antagonists
Pharmacologic Class:
Aldosterone Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Stratified Medicine of Eplerenone in Acute Myocardial Infarction or Injury and no Obstructive Coronary Arteries.
Started Feb 2022
400 enrolled
Myocardial Infarction, AcuteMyocardial Infarction With Nonobstructive Coronary ArteriesMyocardial Injury
Pharmacokinetics Study of Eplerenone Coated Tablets
Started Jul 2017
0PharmacokineticsHealthy SubjectsFasting
Pharmacokinetics of Eplerenone Tablet
Started May 2016
0Healthy Volunteers
Cardiometabolic Effects of Eplerenone in HIV Infection
Started Dec 2015
5 enrolled
Cardiac SteatosisHepatic Steatosis
Study of the Effect of Eplerenone on Heart Function in Women Receiving Anthracycline Chemotherapy for Breast Cancer
Started May 2014
44 enrolled
Breast Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.