In short
Budiodarone tartrate is an investigational antiarrhythmic substance related to amiodarone, being studied for the treatment of non-permanent atrial fibrillation. One Phase 4 clinical trial with 600 participants is currently authorised to evaluate its safety, tolerability, and efficacy. The substance is given as a capsule for oral use and has no marketing authorisation in the product records.
Key points
- Budiodarone tartrate is a chemically synthesised antiarrhythmic related to amiodarone.
- It is being studied in non-permanent atrial fibrillation.
- One Phase 4 trial is authorised, with 600 participants planned.
- The trial is open-label and evaluates safety, tolerability, and efficacy.
- The substance is given as a capsule for oral use.
- Budiodarone tartrate has no marketing authorisation and remains investigational.
What is budiodarone tartrate?
Budiodarone tartrate is an investigational antiarrhythmic substance related to amiodarone, a medicine used for heart rhythm disorders. It is a chemically synthesised small molecule with the development code ATI-2042. The substance has no marketing authorisation in the product records and is supplied by XYRA, LLC. Budiodarone tartrate is being investigated for use in arrhythmia and atrial fibrillation.
How does budiodarone tartrate work?
Budiodarone is an antiarrhythmic related to amiodarone. Antiarrhythmic substances act on the electrical system of the heart to help restore or maintain a normal heart rhythm. The trial record describes evaluating the efficacy of budiodarone to prevent LEAF in subjects with non-permanent atrial fibrillation. LEAF refers to low-energy atrial fibrillation, a form of atrial fibrillation that can occur after cardioversion or ablation procedures.
Which conditions is it studied for?
- Non-permanent atrial fibrillation — a heart rhythm disorder where the upper chambers of the heart beat irregularly, but the condition is not permanent and may come and go.
The substance data places budiodarone tartrate in the therapeutic area of cardiovascular diseases. DrugBank lists arrhythmia and atrial fibrillation as the investigated indications.
How is budiodarone tartrate given?
Budiodarone tartrate is given as a capsule for oral use. The trial is described as an open-label, dose escalation study, meaning that participants receive different increasing doses during the study.
What do the clinical trials show?
One clinical trial of budiodarone tartrate is registered in the EU Clinical Trials Information System. The trial is a Phase 4, open-label, dose escalation study. It is authorised, meaning that it has received regulatory approval to begin but may not yet have started recruiting participants.
What is the trial measuring?
The trial evaluates the safety and tolerability of budiodarone by recording treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs), including major adverse cardiac events (MACE). It also measures the efficacy of budiodarone in preventing LEAF in people with non-permanent atrial fibrillation.
Who can take part?
The trial is designed for subjects with non-permanent atrial fibrillation. The planned enrollment is 600 participants. The study is open-label, meaning that both participants and researchers know which treatment is being given.
What side effects are known?
The trial record lists the types of side effects that will be monitored: treatment-emergent adverse events, serious adverse events, and adverse events of special interest, including major adverse cardiac events. No specific side effects of budiodarone tartrate are described in the available supplementary sources. Because budiodarone is related to amiodarone, side effects associated with amiodarone may be of interest, but this is not stated in the provided data.