AOP Orphan Pharmaceuticals GmbH (AOP Health) today announced that Rapiblyk™ (landiolol), an ultra-short-acting, selective beta-1 adrenergic receptor blocker, is now commercially available in the United States and can be ordered through Cencora. This follows the U.S. Food and Drug Administration’s (FDA) approval of Rapiblyk™ for the short-term reduction of ventricular rate in adults with supraventricular tachycardia (SVT), or an irregularly rapid heart rate, including atrial fibrillation and atrial flutter, in critical care settings.
AOP Health Announces U.S. Availability of Rapiblyk™ (landiolol) for Critical Care Use
July 21st 2025
Rapiblyk™ now available for order by healthcare providers in the U.S. Cencora
John Kimmet
The U.S. availability of Rapiblyk represents a meaningful advancement for patients experiencing acute cardiac arrhythmias in critical care. We’re proud to expand access to this proven therapy, already well- established across Europe, to U.S. healthcare providers who need to provide rapid, potentially life-saving, heart rate reduction.
Rapiblyk™ delivers rapid, targeted heart rate control with a low risk of hypotension, making it well-suited for use in intensive care units, emergency departments, and perioperative environments. Its clinical efficacy and safety were demonstrated across five randomized, double-blind, placebo-controlled studies. The trials showed 40-90% of patients achieved meaningful heart rate reductions within 10 minutes of administration, compared to 0–11% in the placebo group. Adverse events were observed in 9.9% of landiolol-treated patients (mainly hypotension) compared to 1% in placebo, and were [generally manageable]. Risk for SVT, including atrial fibrillation and atrial flutter, increases with age, and can occur spontaneously, requiring timely and effective intervention in acute care settings.
Ordering Information
Healthcare professionals can order Rapiblyk™ via Cencora using its established ordering platforms:
- Rapiblyk™ Item Number: 10301954
- Cencora Contact Information:
- Phone Number: +1 800 746 6273
- Email: service[at]asdhealthcare.com
Prescribing information can be found at www.rapiblyk.com
Study Design
The FDA approval of Rapiblyk was based on results from five randomized, double-blind, placebo-controlled studies conducted to test landiolol’s efficacy and safety in patients (n=317) with supraventricular tachycardia (including atrial fibrillation and atrial flutter). Adult patients (≥18 years) receiving landiolol achieved heart rate reduction of 40–90%, versus 0–11% in the placebo group. Heart rate decrease was defined as a >20% reduction, HR<100 bpm, or intermittent arrhythmia cessation. Dosing, administered via intravenous infusion in a monitored setting, ranged from 9.3 to 74.6 mcg/kg/min. Adverse events were observed in 9.9% of landiolol-treated patients (mainly hypotension), compared to 1% in placebo.
About Supraventricular Tachycardias
Supraventricular tachycardias (SVTs), including atrial fibrillation and flutter, are characterized by abnormally rapid heartbeats. They can affect individuals with or without structural heart disease and require immediate medical attention due to the risk of acute cardiovascular complications.
About Rapiblyk™ (landiolol)
Rapiblyk™ is a short-acting beta-1 selective adrenergic receptor antagonist, with a beta-1/beta-2 selectivity ratio of 255. It enables rapid heart rate control without significant blood pressure reduction. It is intended for use in intensive care, perioperative, emergency, and cardio-thoracic units. It is not indicated for chronic arrhythmia management.
INDICATION
Rapiblyk™ is indicated for the short-term reduction of ventricular rate in adults with supraventricular tachycardia, including atrial fibrillation and atrial flutter.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Rapiblyk™ is contraindicated in patients with:
- Severe sinus bradycardia, sick sinus syndrome, or >1st-degree AV block
- Decompensated heart failure
- Cardiogenic shock
- Pulmonary hypertension
- Known hypersensitivity to landiolol or formulation components
WARNINGS AND PRECAUTIONS
Includes risk of hypotension, bradycardia, cardiac failure, bronchospasm, masking of hypoglycemia symptoms, infusion site reactions, worsening of Prinzmetal’s angina, complications in pheochromocytoma, peripheral vascular disease, abrupt withdrawal effects, hyperkalemia, metabolic acidosis, and unresponsiveness to epinephrine in hypersensitivity reactions.
ADVERSE REACTIONS
Most common adverse event: Hypotension (9.9% vs. 1% in placebo).
Please consult the full Prescribing Information for Rapiblyk™: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217202s000lbl.pdf
About AOP Health
AOP Health is a global enterprise group with roots in Austria, where the headquarters of AOP Orphan Pharmaceuticals GmbH ("AOP Health") is located. Since 1996, the AOP Health Group has been dedicated to developing innovative solutions to address unmet medical needs, particularly in the fields of rare diseases and intensive care medicine. The group has established itself internationally as a pioneer in integrated therapy solutions and operates worldwide through subsidiaries, representations, and a strong network of partners. With the "Needs. Science. Trust." the AOP Health Group emphasizes its commitment to research and development, as well as the importance of building relationships with physicians and patient advocacy groups to ensure that the needs of these stakeholders are reflected in all aspects of the company’s actions.
Further inquiries:
Mag. Nina Roth, MAS
Director Corporate Communications
nina.roth[at]aop-health.com
011-43-676-3131509