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Vadadustat - Akebia Therapeutics

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Drug Profile

Vadadustat - Akebia Therapeutics

Alternative Names: AKB-6548; MT 6548; PG 1016548; VAFSEO; Vafseo

Latest Information Update: 05 Nov 2025

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At a glance

  • Originator Procter & Gamble
  • Developer Akebia Therapeutics; MEDICE; Otsuka Pharmaceutical; Tanabe Pharma Corporation
  • Class Acetic acids; Amides; Antianaemics; Antivirals; Chlorobenzenes; Chlorophenols; Pyridines; Small molecules; Urologics
  • Mechanism of Action Hypoxia-inducible factor-proline dioxygenase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Anaemia
  • Phase II Renal failure; SARS-CoV-2 acute respiratory disease

Most Recent Events

  • 28 Oct 2025 US FDA do not come to alignment for design of VALOR trial of vadadustat in Anaemia
  • 26 Sep 2025 Akebia Therapeutics withdrew phase III clinical trials in Anaemia (In adolescents, In children, In infants) in Spain, Hungary, France, Poland and US(PO), due to sponsor decision (EudraCT2021-004022-30) (NCT05082571)
  • 07 Aug 2025 Akebia Therapeutics completes enrollment in phase III VOICE trial for Anaemia in the US (PO, Tablet) (NCT06520826)

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