CaroSpir (spironolactone oral suspension) / CMP Pharma - LARVOL DELTA

Comparison chart: Some drugs for HFrEF. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure

Drugs for chronic heart failure. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure

Evaluating dosing accuracy and galenic dispersion quality in Hospital-Based pediatric spironolactone oral suspension. (PubMed, Eur J Pharm Biopharm) - "After educational intervention from the pharmacy teams, in 2022 improvements were observed, but underdosing and variability remained significant, reflecting ongoing challenges in suspension homogeneity. These findings highlight the need for a more stable pediatric formulation to enhance patient safety and treatment effectiveness."

Journal • Critical care • Pediatrics

Drugs for hypertension. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Review • Cardiovascular • Hypertension

A Phase IV, Two-part, Open-label Study Assessing the Pharmacokinetics, Safety and Pharmacodynamics of Spironolactone Oral Suspension in Pediatric Patients (clinicaltrials.gov) - P4 | N=96 | Not yet recruiting | Sponsor: CMP Development, LLC | Trial completion date: Dec 2021 ➔ Mar 2025 | Initiation date: Mar 2021 ➔ Jun 2024 | Trial primary completion date: Dec 2021 ➔ Mar 2025

Trial completion date • Trial initiation date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Fibrosis • Heart Failure • Hepatology • Immunology • Pediatrics • CST3

A Phase IV, Two-part, Open-label Study Assessing the Pharmacokinetics, Safety and Pharmacodynamics of Spironolactone Oral Suspension in Pediatric Patients (clinicaltrials.gov) - P4 | N=96 | Completed | Sponsor: CMP Development, LLC

New P4 trial • Cardiovascular • Congestive Heart Failure • Fibrosis • Heart Failure • Hepatology • Immunology • Pediatrics • CST3

AuTophagy Activation for Cardiomyopathy Due to Anthracycline tReatment (ATACAR)Trial (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Mayo Clinic | Trial completion date: Dec 2022 ➔ Dec 2024 | Trial primary completion date: Jun 2022 ➔ Jun 2023

Trial completion date • Trial primary completion date • Cardiomyopathy • Cardiovascular • Hematological Malignancies • Lymphoma • Oncology

Model-Informed Optimization of a Pediatric Clinical Pharmacokinetic Trial of a New Spironolactone Liquid Formulation. (PubMed, Pharmaceutics) - "Herein, we demonstrate the application of a model-based approach to select doses and pharmacokinetic sampling scenarios for the clinical evaluation of a novel oral suspension of spironolactone in pediatric patients with edema...Doses of 0.5 and 1.5 mg/kg led to target exposures (i.e., similar to 25 and 100 mg of the reference product in adults) in all the reference pediatric ages (i.e., 2, 6, 12 and 17 years). Additionally, two different sampling scenarios were delineated to accommodate patients into sparse sampling schemes informative to characterize drug pharmacokinetics while minimizing phlebotomy and burden to participating children."

Clinical • Journal • PK/PD data • Pediatrics

AuTophagy Activation for Cardiomyopathy Due to Anthracycline tReatment (ATACAR)Trial (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: Mayo Clinic; Not yet recruiting ➔ Recruiting

Enrollment open • Cardiomyopathy • Cardiovascular • Hematological Malignancies • Lymphoma • Oncology

Drugs for hypertension. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hypertension

Spotlight on Spironolactone Oral Suspension for the Treatment of Heart Failure: Focus on Patient Selection and Perspectives. (PubMed, Vasc Health Risk Manag) - "The new drug formulation comes as a banana-flavored oral suspension that contains 25 mg/5 mL of spironolactone, supplied in 4-ounce (118 mL) and 16-ounce (473 mL) bottles. The details of this drug formulation development and the benefits of spironolactone use in patients with heart failure with a focus on patient selection are herein reviewed."

Clinical • Journal • Review

AuTophagy Activation for Cardiomyopathy Due to Anthracycline tReatment (ATACAR)Trial (clinicaltrials.gov) - P2; N=40; Not yet recruiting; Sponsor: Mayo Clinic

New P2 trial

Drug-drug Interaction (DDI) Study of Spironolactone (Perpetrator) and Digoxin (Substrate Drug) (clinicaltrials.gov) - P1; N=28; Completed; Sponsor: CMP Development, LLC; Active, not recruiting ➔ Completed

Clinical • Trial completion

Drug-drug Interaction (DDI) Study of Spironolactone (Perpetrator) and Digoxin (Substrate Drug) (clinicaltrials.gov) - P1; N=28; Active, not recruiting; Sponsor: CMP Development, LLC

Clinical • New P1 trial