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Roxadustat FDA Approval Status

Last updated by Judith Stewart, BPharm on Jan 21, 2020.

FDA Approved: No
Generic name: roxadustat
Company: FibroGen, Inc.
Treatment for: Anemia Due to Chronic Kidney Disease

Roxadustat (FG-4592) is a first-in-class, orally administered small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor in development for the treatment of anemia of chronic kidney disease (CKD).

Development timeline for roxadustat

DateArticle
May  5, 2023FibroGen Announces Results for MATTERHORN, a Phase 3 Clinical Study of Roxadustat for the Treatment of Anemia in Patients with Myelodysplastic Syndromes (MDS)
Aug 11, 2021FibroGen Receives Complete Response Letter from the FDA for Roxadustat for Anemia of Chronic Kidney Disease
Jul 16, 2021Status on FDA Advisory Committee Vote on Roxadustat in Anemia of Chronic Kidney Disease
Apr  6, 2021FibroGen Announces FDA Advisory Committee to Review Roxadustat New Drug Application Tentatively Scheduled for July 15, 2021
Mar  1, 2021Further Update on US Regulatory Review of Roxadustat in Anemia of Chronic Kidney Disease
Mar  1, 2021FibroGen Provides Regulatory Update on Roxadustat
Dec 18, 2020Update on US Regulatory Review of Roxadustat in Anemia of Chronic Kidney Disease
Feb 11, 2020FibroGen Announces U.S. FDA Acceptance of New Drug Application for Roxadustat for the Treatment of Anemia of Chronic Kidney Disease
Dec 23, 2019FibroGen Submits New Drug Application to the U.S. FDA for Roxadustat in Patients With Anemia of Chronic Kidney Disease
Nov  7, 2019Roxadustat Significantly Increased Hemoglobin Levels for Chronic Kidney Disease Patients with Anemia in Phase III OLYMPUS and ROCKIES Trials
Sep 26, 2019FibroGen Announces Initiation of Phase 2 Clinical Trial of Roxadustat for the Treatment of Anemia in Cancer Patients Receiving Chemotherapy
May 14, 2019Pooled Analyses of the Roxadustat Global Phase III Programme Confirmed Cardiovascular Safety
Dec 20, 2018Phase III OLYMPUS and ROCKIES Trials for Roxadustat Met Their Primary Endpoints in Chronic Kidney Disease Patients with Anemia

Further information

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