NDAORALSUSPENSION
Approved
Aug 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
14
Data completeness
7/8 — Comprehensive
CAROSPIR (spironolactone) by R-Pharm US is aldosterone antagonists [moa]. Approved for heart failure, hypertension. First approved in 2017.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CAROSPIR is an oral suspension formulation of spironolactone, an aldosterone antagonist that blocks aldosterone-mediated sodium reabsorption in the collecting duct. It is indicated for heart failure, hypertension, atrial fibrillation, myocardial infarction, and emerging oncology indications including triple-negative breast cancer and glioblastoma. The product targets patients with volume overload, resistant hypertension, and fibrotic disease processes.
$568KPart D
Peak10.5 years to LOEProduct is at peak lifecycle with minimal Part D penetration, suggesting limited commercial scale and modest team expansion.
Mechanism of Action
Aldosterone Antagonists
Pharmacologic Class:
Aldosterone Antagonist
Indications (2)
Clinical Trials (14)
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
Started May 2026
68 enrolled
Glioblastoma (GBM)
Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects (COMPARE-VS)
Started Apr 2026
100 enrolled
CKDCardiovascular DiseasesHeart Failure
A Study to Learn How the Body Processes Spironolactone and Hydrochlorothiazide Film Coated Tablets Manufactured at Two Sites: Viatris and Neolpharma
Started Dec 2023
42 enrolled
Healthy Participants
Does Spironolactone Normalize Sleep-wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism?
Started Nov 2021
32 enrolled
HyperandrogenismPolycystic Ovary SyndromePuberty
Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients With Symptomatic HFrEF Receiving Spironolactone
Started Mar 2021
366 enrolled
HyperkalaemiaHeart Failure With Reduced Ejection Fraction
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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.