LOS ALTOS, Calif. — March 4, 2026 — Leads & Copy — XYRA LLC has been granted U.S. Patent No. 12,551,706 by the U.S. Patent and Trademark Office (USPTO). The patent protects the use of dose adjusted budiodarone for treating atrial fibrillation (AF), with monitoring to reduce or delay the risk of stroke and/or congestive heart failure.
Atrial fibrillation can cause or worsen existing heart failure, and heart failure often leads to AF. Treating the combination of these two conditions can be difficult and may lead to poor outcomes. Loss of atrial contraction in AF reduces cardiac output, resulting in a five-fold increase in the risk of heart failure, stroke, and death.
Up to 40% of hospitalized AF subjects were also determined to have heart failure in one recent study. Many current approved drug therapies to treat AF also depress ventricular function, which can precipitate or exacerbate heart failure. Therefore, such therapies cannot be used to manage AF in patients with or at risk of heart failure.
There is a need for new AF rhythm control agents that are safe, effective, and well-tolerated in patients with current heart failure and that can reduce the risk of heart failure development. Heart failure develops in 7-10% of AF subjects each year.
Reducing AF burden, eliminating long episodes of AF, and restoring normal sinus rhythm have improved symptoms and lessened heart failure progression. Wearable AF monitoring devices can now identify subjects with high AFB, LEAF, and symptoms. These patients are at high risk of complications, including stroke, heart failure, and progression to permanent AF.
Budiodarone has reduced the number and duration of AF episodes, restoring atrial contraction and normal sinus rhythm. It also does not depress ventricular function and is well-tolerated in AF subjects with heart failure. Dose adjusted budiodarone may provide a new treatment option in AF patients to inhibit development of or treat heart failure in a personalized manner with patient monitoring.
According to Peter Milner, MD, FACC, and managing member of XYRA, there has been a marked growth in both atrial fibrillation and heart failure in recent years. He also stated that many of the drugs used to treat atrial fibrillation are contraindicated in patients with heart failure.
Milner added that the company plans to investigate the use of monitored, dose-adjusted budiodarone in Phase 3 clinical trials as an effective, safe, and well-tolerated treatment option for AF rhythm control in patients including those who have heart failure, and as a treatment to reduce the development of heart failure in at-risk AF patients.
Budiodarone is currently in Phase 3 studies and is a potentially first-in-class mixed ion channel blocker with esterase metabolism, with a shorter half-life than amiodarone and no evidence of tissue accumulation in human or animal studies. Budiodarone has been shown to treat AF by controlling symptoms, eliminating LEAF, reducing AF burden, and maintaining normal sinus rhythm.
Atrial Fibrillation is the most common sustained arrhythmia in adults, with approximately 44 million individuals estimated to have AF worldwide. It is associated with thromboembolic risk, impairment in cardiac performance, and other morbidities. The management of AF has evolved over time from ventricular rate control to therapies that seek to restore and maintain normal sinus rhythm.
XYRA LLC is a private biopharmaceutical company committed to developing innovative therapies for cardiac rhythm disorders with high unmet need. Xyra’s mission is to make AF management comparable to that of other common cardiac conditions like hypertension and hypercholesterolemia.
Source: XYRA LLC
