Rapiblyk (landiolol) / AOP Orphan Pharma - LARVOL DELTA

PI2020_843_0057: Comparison of Landiolol versus standard of care for prevention of mortality in patients hospitalized for a septic shock with hypercontractlity: an open label prospective randomized study (clinicaltrialsregister.eu) - P2/3 | N=360 | Recruiting | Sponsor: Centre Hospitalier Universitaire Amiens Picardie | Not yet recruiting ➔ Recruiting

Enrollment open • Septic Shock

AOP Health US, LLC today announced that the first patient in the United States has been treated with Rapiblyk (landiolol) at The Valley Hospital, Paramus, NJ. (FinancialContent)

Launch US • Ventricular Tachycardia

AOP Health US LLC: RAPIBLYK (landiolol) Approved by FDA for Use in Pediatric Patients with Supraventricular Tachycardia (Businesswire) - "This approval expands the availability of RAPIBLYK beyond adults to patients of all ages in critical care settings and provides the first therapeutic option for pediatric patients with SVT in the US....The FDA’s decision is supported by data from the LANDI-PED study, which was conducted in 60 pediatric patients and showed a reduction of over 20 percent in ventricular rate from baseline in appropriate patients with SVT."

FDA approval • Ventricular Tachycardia

The effect of early Landiolol in patients with ST-elevation acute coronary syndrome undergoing primary percutaneous coronary intervention A prospective, randomized, double-blinded, placebo-controlled, phase IV pilot trial (STEMILAND-1) (clinicaltrialsregister.eu) - P4 | N=60 | Not yet recruiting | Sponsor: Medical University Of Vienna

New P4 trial • Acute Coronary Syndrome • Cardiovascular

AOP Health US, LLC has been awarded a Pharmaceutical national group purchasing agreement with Premier, Inc. Effective August 1, 2025, the agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for Rapibly (landiolol). (PharmiWeb)

Commercial • Atrial Fibrillation • Ventricular Tachycardia

LANdiolol MIcrocirculatory Effects During Septic chOc (MILANOS) (clinicaltrials.gov) - P3 | N=44 | Recruiting | Sponsor: Assistance Publique - Hôpitaux de Paris | Trial completion date: Jan 2024 ➔ Jul 2026 | Trial primary completion date: Jan 2024 ➔ Jul 2026

Trial completion date • Trial primary completion date • Septic Shock

Landiolol (Rapiblyk), A Newly Approved, Ultra-Short Acting Intravenous β1-Adrenoreceptor Blocker for the Treatment of Supraventricular Arrhythmias. (PubMed, Cardiol Rev) - "Other intravenous β-blockers approved for the same indication include esmolol (Brevibloc) and generics, and propranolol generics...Other rate-reducing treatments include intravenous nondihydropyridine calcium channel blockers such as diltiazem and verapamil. Etripamil is also being evaluated as a parenteral intranasal formulation for arrhythmia management. The clinical effectiveness, pharmacokinetic properties, and side effect profile of landiolol are reviewed in this article. At this juncture, the effectiveness of the drug in reducing the heart rate in patients with supraventricular arrhythmias, including atrial fibrillation and flutter, has been demonstrated to be as effective as generic β-blockers and calcium channel blockers."

Journal • Atrial Fibrillation • Cardiovascular • Ventricular Tachycardia

Landiolol (Rapiblyk) for short-term rate control in supraventricular tachycardia. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Atrial Fibrillation • Cardiovascular • Ventricular Tachycardia

Heart Rate Control with Landiolol Hydrochloride in Infants and Neonates During Cardiac Surgery. (PubMed, Pediatr Cardiol) - "The retrospective review included patients under 1 year of age with intraoperative tachycardia during cardiac surgery treated with landiolol hydrochloride (Rapibloc®) at the Pediatric Heart Center Giessen, Germany (June 2017-October 2022). Safety was favorable; three adverse events unrelated to landiolol were reported, and no dose interruptions occurred. Landiolol was effective and safe for HR control in neonates and infants with tachycardia during cardiac surgery, which aligns with current knowledge on its use in children."

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure • Pediatrics

RAPIBLYK (landiolol): A New Therapeutic Option for Rapid and Precise Ventricular Rate Control in the Critical Care Setting (SCCM 2025) - "Sponsored by AOP Health RAPIBLYK (landiolol) is a new FDA-approved, highly cardioselective beta antagonist indicated for short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter. Join our expert faculty member for a discussion regarding her clinical experience with this agent in the critical care setting for various patients with supraventricular arrhythmias, including atrial fibrillation/flutter."

Atrial Fibrillation • Cardiovascular • Critical care • Ventricular Tachycardia

U.S. FDA Approves AOP Health’s Rapiblyk (landiolol) for Atrial Fibrillation and Atrial Flutter in the Critical Care Setting (Businesswire) - "AOP Orphan Pharmaceuticals GmbH...announced that the U.S. Food and Drug Administration (FDA) has granted regulatory approval for Rapiblyk (landiolol) in the hospital critical care setting for the treatment of the severe heart condition supraventricular tachycardia (atrial fibrillation and atrial flutter). The approval is based on clinical studies which demonstrated that Rapiblyk (landiolol) enables rapid management of the heart rate with minimal reduction of blood pressure. The approval will provide patients in the U.S. with a new treatment option and is an important step for AOP Health in bringing its mission to help patients and make an impact on rare diseases and critical care to the United States for the first time. The approval was based on data of 5 randomized, double-blind, placebo-controlled studies."

FDA approval • Atrial Fibrillation • Cardiovascular