Trial Profile

Phase III trial of budiodarone for the treatment of symptomatic atrial fibrillation.

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 18 Oct 2024

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At a glance

16 Oct 2024 According to According to an XYRA media release, the FDA has reached agreement regarding clinical trial endpoints and potential approval pathway for multiple active doses of budiodarone in the management of non-permanent AF, XYRA sought and received guidance from the FDA on a prospective label for budiodarone use post-approval.
16 Oct 2024 According to According to an XYRA media release, the FDA has agreed on the use of AF monitoring devices in clinical trials for budiodarone approval. The FDA has also issued guidance on the steps required to incorporate wearable AF monitoring devices into a drug label.
04 Mar 2024 New trial record

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