CAROSPIR

Peak

spironolactone

NDAORALSUSPENSION
Approved
Aug 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
9

Mechanism of Action

Aldosterone Antagonists

Pharmacologic Class:

Aldosterone Antagonist

Indications (12)

NYHA Class III-IV heart failurereduced ejection fraction in adult patients to increase survivalmanage edemato reduce the need for hospitalization for heart failureedema in adult cirrhotic patientssodium restrictionreduced ejection fraction to increase survivalto reduce the need for hospitalization for heart failure ()sodium restrictions () 1heart failurehypertensionneed for hospitalization for heart failure

Clinical Trials (5)

NCT07431216Phase 1/2Not Yet Recruiting

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 Apr 2026
68 enrolled
Histopathology Confirmed Supratentorial GBM at First RecurrenceIDHwt GBMIDHm Grade 4 Astrocytoma
NCT07304817Phase 2Not Yet Recruiting

Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects (COMPARE-VS)

Started Feb 2026
100 enrolled
CKDCardiovascular DiseasesHeart Failure
NCT06205407Phase 1Completed

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
NCT04676646Phase 4Completed

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
NCT03682497Phase 1Terminated

Study in HFpEF Patients to Compare the Effect of AZD9977 and Spironolactone on Serum Potassium

Started Nov 2018
68 enrolled
Heart Failure

Loss of Exclusivity

LOE Date
Oct 28, 2036
129 months away
Patent Expiry
Oct 28, 2036

Patent Records (5)

Patent #ExpiryTypeUse Code
10493083
Oct 28, 2036
Product
—
10624906
Oct 28, 2036
Product
—
10660907
Oct 28, 2036
Product
—
10888570
Oct 28, 2036
Product
—
11389461
Oct 28, 2036
Product
—
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers