XYRA Doses First European Patient in Budiodarone Trial

BASEL, Switzerland, Aug. 31, 2026

HARBOR-AF Trial Expands Into Europe

The HARBOR-AF Phase 2/3 trial is evaluating the safety and effectiveness of budiodarone in adults with symptomatic paroxysmal or persistent atrial fibrillation. The study is designed to generate clinical evidence supporting the candidate’s potential use in patients who require pharmacological rhythm control. Atrial fibrillation is the most common sustained cardiac arrhythmia and occurs when the heart’s upper chambers beat irregularly. The condition can cause symptoms such as palpitations, fatigue, shortness of breath and reduced exercise tolerance and is associated with an increased risk of stroke and other cardiovascular complications. Although multiple treatments are available, selecting an appropriate antiarrhythmic medicine can be challenging because of differences in efficacy, tolerability and safety among existing therapies. The enrollment of the first European participant broadens the geographic reach of HARBOR-AF and supports continued recruitment across international clinical sites. The company expects the global study to provide additional information on the candidate’s therapeutic potential in patients with different forms of atrial fibrillation.

Budiodarone Targets Rhythm Control

Budiodarone is an investigational antiarrhythmic drug being developed by XYRA for the treatment of atrial fibrillation. The compound is being evaluated for its ability to maintain normal heart rhythm and reduce the burden of abnormal atrial activity. The development program focuses on patients with paroxysmal AF, in which episodes begin and end spontaneously, as well as persistent AF, in which episodes last longer and typically require intervention to restore normal rhythm. Evaluating both populations may provide a broader understanding of how budiodarone performs across clinically important forms of the disease. The Phase 2/3 design is intended to combine information about safety, tolerability and preliminary efficacy with data needed to support later-stage development. As with any investigational medicine, the candidate’s benefits and risks must be established through controlled clinical research before regulatory authorities can determine whether it should be approved. The European first-patient milestone therefore represents progress in clinical development rather than evidence that budiodarone has been proven effective or safe for routine patient treatment.

Clinical Program Addresses AF Treatment Needs

The expansion of HARBOR-AF comes amid continued efforts to improve treatment options for patients with atrial fibrillation, a condition affecting millions of people worldwide. Rhythm-control strategies can be particularly important for patients who experience significant symptoms despite rate-control approaches or who require restoration and maintenance of normal sinus rhythm. Existing antiarrhythmic medicines can be effective, but their use may be limited by safety considerations, drug interactions and patient-specific contraindications. New therapies that can provide effective rhythm control with an improved therapeutic profile could therefore address an important unmet medical need. XYRA’s decision to advance budiodarone through a Phase 2/3 program reflects the company’s goal of efficiently generating clinical evidence that could support future regulatory submissions. The HARBOR-AF study is expected to provide data on the candidate’s performance across relevant patient populations and help define its potential role in the management of atrial fibrillation. The first European patient dosing also marks a significant operational milestone for XYRA as the company expands the clinical footprint of its budiodarone development program. Further enrollment and follow-up will be necessary to determine whether the investigational therapy can demonstrate clinically meaningful benefits while maintaining an acceptable safety profile. If successful, the HARBOR-AF program could support future discussions with regulatory agencies regarding the development and potential approval of budiodarone. For now, the therapy remains investigational and is not approved for the treatment of atrial fibrillation.

Source: XYRA press release