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Vadadustat FDA Approval Status

FDA Approved: No
Generic name: vadadustat
Company: Akebia Therapeutics, Inc.
Treatment for: Anemia Associated with Chronic Renal Failure

Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor in development for the treatment of anemia due to chronic kidney disease (CKD) in adults.

Development Timeline for vadadustat

DateArticle
Mar 30, 2021Akebia Submits New Drug Application (NDA) to the FDA for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis and Not on Dialysis
May  5, 2020Akebia Therapeutics Announces Positive Top-Line Results from Global Phase 3 Program of Vadadustat for Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis
Nov  9, 2019Akebia Announces Positive 52-week Efficacy and Safety Data for Vadadustat from Two Pivotal Phase 3 Studies in Japanese Patients with Anemia Due to Chronic Kidney Disease

Further information

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