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A phase II study of Budiodarone

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Trial Profile

A phase II study of Budiodarone

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 04 Mar 2024

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At a glance

  • Drugs Budiodarone (Primary)
  • Indications Atrial fibrillation
  • Focus Therapeutic Use

    • Most Recent Events

    • 26 Feb 2024 According to According to an XYRA media release, if the drug continues to be safe and effective in the agreed AF pivotal studies above and a short-term study of ventricular tachycardia (VT) subjects with an implantable cardiac defibrillator (ICD), then approval may be possible within International Conference on Harmonization (ICH) guidance.
    • 26 Feb 2024 According to an XYRA media release, the company announced the successful completion of End of phase II meeting with the US FDA for the agreement of endpoint of the trial which will support the approval of Budiodarone for the treatment of symptomatic atrial fibrillation.
    • 15 Feb 2017 New trial record

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