Trial Profile

A phase III trial of sparsentan for Alport Syndrome

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 27 Nov 2025

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At a glance

27 Nov 2025 New trial record
24 Oct 2025 According to Renalys Pharma media release, Chugai will acquire Renalys and will align development with PMDA expectations, also gaining exclusive rights to develop and commercialize sparsentan in Japan, South Korea, and Taiwan.
17 Oct 2025 According to Renalys Pharma media release, company announced that it has reached an agreement with the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan regarding development plans for Phase III clinical trial of sparsentan in Japan (development code: RE-021) investigating the use of sparsentan in Alport Syndrome. Preparations are currently underway for the submission of Clinical Trial Notifications to the PMDA.

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