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Vadadustat FDA Approval Status

Last updated by Judith Stewart, BPharm on March 31, 2021.

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, 2022Akebia Therapeutics Receives Complete Response Letter from the FDA for Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients
Jun  1, 2021Akebia and Otsuka Announce FDA Acceptance for Filing of New Drug Application for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis and Not on Dialysis
Apr 28, 2021New England Journal of Medicine Publishes Results of Global Phase 3 Clinical Program of Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease
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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