Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients With Lower Risk Myelodysplastic Syndrome (MDS) With Low Red Blood Cell (RBC) Transfusion Burden (LTB)

Status: Discontinued

Phase of Trial: Phase III

Latest Information Update: 08 Oct 2025

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At a glance

06 Aug 2025 According to a FibroGen media release, the company plans to submit the Phase 3 trial protocol to the FDA in the fourth quarter of this year.
12 May 2025 According to a FibroGen media release, company filed Type-C meeting request with FDA for roxadustat in anemia associated with lower-risk myelodysplastic syndromes (LR-MDS) and expect feedback on potential path forward in 3Q 2025
01 Sep 2024 Results published in the American Journal of Hematology

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