Trial Profile

A Phase III trial of XRx-008 in autosomal dominant polycystic kidney disease patients

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 10 May 2023

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At a glance

21 Apr 2023 According to XORTX media release, company is looking forward to upcoming meeting with the FDA on May 1, 2023 to discuss our planned phase 3 clinical program for XORLO.
14 Mar 2023 According to XORTX media release, this clinical data to support a future "Accelerated Approval" new drug application (NDA) submissions to the FDA and European Medicines Agency (EMA).
14 Mar 2023 According to XORTX media release, company has announced the submission of a Type D meeting request to the USFDA for revised clinical trial protocol for this study and a response setting the date for a virtual meeting on 1st May 2023.

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