NDAORALSUSPENSION
Approved
Aug 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
14
Data completeness
6/8 — Strong
CAROSPIR (spironolactone) by R-Pharm US is aldosterone antagonists [moa]. First approved in 2017.
Drug data last refreshed Yesterday · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CAROSPIR is an oral suspension formulation of spironolactone, an aldosterone antagonist that reduces sodium reabsorption and potassium excretion in the kidney. It is used to treat conditions characterized by aldosterone excess, including heart failure, hypertension, and edema. The suspension formulation addresses the need for improved palatability and dosing flexibility compared to traditional tablet formulations.
$0.568MPart D
Peak10.4 years to LOEProduct is at peak lifecycle stage with modest Part D utilization; commercial team focus is on maintaining market position rather than growth expansion.
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 (14)
Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects (COMPARE-VS)
Started May 2026
100 enrolled
CKDCardiovascular DiseasesHeart Failure
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)
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.