Trial Profile

A phase 3 trial of roxadustat in anemia associated with lower-risk Myelodysplastic Syndromes (MDS)

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 27 Oct 2025

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At a glance

27 Oct 2025 New trial record
02 Sep 2025 According to FibroGen media release, a after a positive meeting with the USFDA, the Company intends to file the pivotal Phase 3 clinical trial protocol for roxadustat for the treatment of anemia in patients with LR-MDS and high transfusion burden in Q4 2025.
11 Aug 2025 According to FibroGen media release, company reached agreement with the U.S. Food and Drug Administration (FDA) on important design elements for a pivotal Phase 3 trial for roxadustat for the treatment of anemia in patients with lower-risk myelodysplastic syndromes (LR-MDS) and high red blood cell (RBC) transfusion burden

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