TheraRadar
Data updated: May 26, 2026

CAROSPIR (spironolactone)

Aldosterone Antagonists Trial Activity: Declining 15 active trials
Cardiovascular Approved 2017-08-04

Carospir helps patients with advanced heart failure manage fluid buildup and improve their chances of survival while reducing the need for hospital visits. It is also used as an additional therapy for people with high blood pressure to help lower their risk of serious cardiovascular events like strokes and heart attacks. Furthermore, it treats swelling in adults with liver cirrhosis when dietary restrictions on salt and fluids are not effective.

Source: FDA Label • CMP DEV LLC • Aldosterone Antagonist
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How CAROSPIR Works

This medication works by blocking aldosterone from binding to specific receptors in the kidneys' distal tubules. This action causes the body to excrete more sodium and water while retaining potassium, which allows the drug to function as both a diuretic and a blood pressure-lowering agent.

Source: FDA Label

Development Insights

Relypsa, Inc. conducting 3 trials (4%)
97 indications explored (Broad Platform)
→ heart failure (8 trials)
→ hypertension (5 trials)
→ healthy (4 trials)
1
Indication
--
Phase 3 Trials
8
Years on Market

Details

Status
Prescription
First Approved
2017-08-04
Patent Cliff
2036

Pro Metrics

Patent cliff and revenue data

Unlock with Pro
Routes
ORAL
Dosage Forms
SUSPENSION

Companies

CMP DEV LLC
Active Ingredient: SPIRONOLACTONE

CAROSPIR Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2017 to 2023
Aug 2023 SUPPL
Label · Labeling
FDA Letter Label
Jul 2021 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label
Jun 2021 SUPPL
Label · Labeling
FDA Letter Label

What CAROSPIR Treats

3 indications

CAROSPIR is approved for 3 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Heart Failure
  • Hypertension
  • Edema
Source: FDA Label

CAROSPIR Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

JAVADIN
AZURITY
2025 3 indic.
LASIX ONYU
SQ INNOVATION
2025 2 indic.
Unlock 8 more competitors across all three rings.
Upgrade to Pro

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to CAROSPIR

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ALDACTONE
SPIRONOLACTONE
3 shared
Pfizer
Shared indications:
Heart FailureHypertensionEdema
THALITONE
CHLORTHALIDONE
3 shared
CASPER PHARMA LLC
Shared indications:
HypertensionEdemaHeart Failure
ATACAND
CANDESARTAN CILEXETIL
2 shared
ANI PHARMS
Shared indications:
HypertensionHeart Failure
View all 20 similar drugs Pro
📋

Clinical Trial Registry

71 trials
Trial Sponsor ID Phase Status Title
NCT03344159 STAR-HF 20170694 Ph 4 completed Spironolactone Therapy in Chronic Stable Right HF Trial
NCT01712620 120211 12-CC-0211 Ph 2 recruiting Spironolactone for Pulmonary Arterial Hypertension
NCT05807139 10001546 001546-DA Ph 1 recruiting Spironolactone in Alcohol Use Disorder (SAUD)
NCT06004830 HARP 2000033919_a 1P01AA029545-01 Ph 2 active not recruiting Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 1
NCT07483177 25-014938 Ph 1, Ph 2 not yet recruiting HEART: Pilot Randomized Controlled Trial
NCT04582383 SD-ACNE R34AR074733-01A1 Ph 4 active not recruiting Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne
NCT03593317 BRAVE 69HCL18_0038 2023-505048-20-00 Ph 2 recruiting Blockade of the Renin-angiotensin-aldosterone System in Patients With ARVD
NCT03429946 HypoANS-B 2004P001233-B R01HL109634, K24HL103845 Ph 4 completed Hypoglycemia and Autonomic Nervous System Function-B
NCT04522739 STAND STUDY00000124 Ph 4 completed Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Dementia
NCT05754684 HKCH-REC-2021-007 Ph 2 recruiting Quadruple Immunotherapy for Neuroblastoma
NCT01552044 C11-21 2011-003046-40 Ph 1, Ph 2 completed Effect of Spironolactone in Treating Chronic Non-resolutive Central Serous Chorioretinitis
NCT04901975 20-017716 1R01HL149139-01A1 Ph 1, Ph 2 recruiting Fibrosis and the Fontan
NCT05092984 ALDORA 8154 2021-003958-23 Ph 3 recruiting Evaluation of Spironolactone Efficacy in Patient with Rheumatoid Arthritis (RA)
NCT05010707 TREAT results posted 202104092 Ph 2 completed Transgender Estradiol Affirming Therapy
NCT02901184 SPIRRIT U-2015-030 U01HL134679-01, U01HL134694-02 Ph 3 recruiting Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction
NCT03048825 CLEAR SYNERGY CLSYN.1702 OASIS-9 Ph 3 completed Colchicine and Spironolactone in Patients with MI / SYNERGY Stent Registry
NCT04331691 4-2019-1334 Ph 4 completed Comparison of Spironolactone and Amiloride on Home Blood Pressure in Resistant Hypertension
NCT01294319 results posted 110078 11-CH-0078 Ph 2 completed Evaluation of Cortisol Resistance in Young Sedentary and Endurance-Trained Men
NCT06413082 ALTUM ALTUM Ph 3 completed Pharmacogenetics of Torasemide and Spironolactone in Hypertension Treatment
NCT06204640 SPONSoR SPONSoR Ph 3 not yet recruiting SPironolactONe for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation
NCT03777319 results posted IRB17-00240 Ph 1 terminated Spironolactone Versus Prednisolone in DMD
NCT01848639 ALCHEMIST ALCHEMIST RB 12-079 Ph 3 completed ALdosterone Antagonist Chronic HEModialysis Interventional Survival Trial
NCT02169089 results posted 57047 Ph 4 completed Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Trial
NCT02575963 API-01 Ph 1, Ph 2 completed Lintuzumab-Ac225 in Older Acute Myeloid Leukemia (AML) Patients
NCT03334682 FASCE RC16_0467 Ph 3 completed Randomized Double-blind Study on the Benefit of Spironolactone for Treating Acne of Adult Woman.
NCT04190433 19-007547 NCI-2021-13928 Ph 2 withdrawn Autophagy Activation for the Alleviation of Cardiomyopathy Symptoms After Anthracycline Treatment, ATACAR Trial
NCT03984591 CROWD-ASPECT CROWD-ASPECT Ph 4 enrolling by invitation A Registry-based Cluster Randomized Trial to Compare the Effect of Spironolactone vs. Eplerenone on Clinical Outcomes in Patients With Symptomatic Systolic Heart Failure
NCT02497300 VEMAKD results posted F140508008 Ph 2 completed Vascular Effects of Mineralocorticoid Receptor Antagonism in Kidney Disease
NCT02230891 results posted CLNB-009-13F Ph 2 completed Biomarker Guided Therapies in Stage A/B Heart Failure
NCT01586442 SNOW WS1911307 Ph 3 completed Comparison of Eplerenone Versus Spironolactone in Heart Failure Patients With Glucose Intolerance or Type 2 Diabetes
NCT03597035 MAGMAAddOn results posted 02-17-16 Ph 4 terminated Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Add-On
NCT02883400 results posted 12-14-03A Ph 4 completed Spironolactone After Liver Transplant
NCT04205136 HUM00147375 Ph 4 withdrawn Spironolactone to Improve Apnea and Cardiovascular Markers in Obstructive Sleep Apnea Patients
NCT01345656 ARTS 14563 2011-000301-45 Ph 2 completed BAY94-8862 Dose Finding Trial in Subjects With Chronic Heart Failure and Mild (Part A) or Moderate (Part B) Chronic Kidney Disease
NCT01602861 SPIREN Eudra CT: 2011-002243-98 Ph 4 completed The Effects of Spironolactone on Calcineurin Inhibitor Induced Nephrotoxicity
NCT01371747 AMETHYST-DN results posted RLY5016-205 2011-000165-12 Ph 2 completed Patiromer in the Treatment of Hyperkalemia in Patients With Hypertension and Diabetic Nephropathy (AMETHYST-DN)
NCT03071263 AMBER results posted RLY5016-207 2016-002657-38 Ph 2 completed Spironolactone With Patiromer in the Treatment of Resistant Hypertension in Chronic Kidney Disease
NCT01130597 results posted RLY5016-204 Ph 2 completed Evaluation of Patiromer Titration in Heart Failure Patients With Chronic Kidney Disease
NCT00328809 1045057 Ph 4 withdrawn Spironolactone Safety in Dialysis Patients
NCT04393493 results posted 112/17 Ph 2 completed The Effect in Renal Function on Patients With Type 1 Cardiorenal Syndrome Treated With Two Strategies of Furosemide.
NCT02194465 results posted 15525 I7T-MC-RMAH Ph 2 completed A Study of LY2623091 in Participants With High Blood Pressure
NCT03682497 D6401C00004 Ph 1 terminated Study in HFpEF Patients to Compare the Effect of AZD9977 and Spironolactone on Serum Potassium
NCT01867294 results posted RC09C8 NCI-2012-01275, RC09C8 Ph 2 completed Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab
NCT02046668 SPIR-OA 13/WS/0232 2013-002638-19 Ph 4 completed The Effect of Spironolactone on Pain in Older People With Osteoarthritis
NCT02354352 results posted 2014H0387 Ph 3 completed Therapeutic Potential for Aldosterone Inhibition in Duchenne Muscular Dystrophy
NCT01853553 results posted 13-1440 R01DK097081 Ph 3 completed Mineralocorticoid Antagonism and Endothelial Dysfunction in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
NCT01691053 MiREnDa MN0511_1 2011-003179-12, 01KG1202 Ph 2 completed Mineralocorticoid Receptor Antagonists in End Stage Renal Disease
NCT02285920 SPin-D results posted 821193 Ph 2 completed Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent ESRD Trial
NCT02236520 results posted 141382 Ph 2 completed Tissue Sodium in Pre-hypertensive Patients
NCT02832973 ResHypOT SaoJoseRPU Ph 4 completed Sequential Nephron Blockade vs. Dual Blockade Renin-angiotensin System + Bisoprolol in Resistant Arterial Hypertension

Showing 50 of 71 trials

🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CAROSPIR FDA Label Details

Indications & Usage

FDA Label (PDF)

CAROSPIR is indicated for the treatment of Heart Failure; Hypertension; Edema.

View full patent landscape →
8 OB patents · 2 families · 22 international docs across 5 countries

CAROSPIR Patents & Exclusivity

Latest Patent: Oct 2036

Patents (8 active)

US9757394 Expires Oct 28, 2036
US11395828 Expires Oct 28, 2036
US10888570 Expires Oct 28, 2036
US11389461 Expires Oct 28, 2036
US10660907 Expires Oct 28, 2036
US10624906 Expires Oct 28, 2036
US10493083 Expires Oct 28, 2036
US11491166 Expires Oct 28, 2036
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for CAROSPIR

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2036
  • • 10 active patents

Trial Analysis

  • • 78 total trials
  • • Stage: Declining

Competitive Landscape

  • • 20 similar drugs
  • • Same target/indication analysis
Unlock Full Intelligence

Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA209478 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment