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Vadadustat

Alternative Names: vadadustat, akb-6548, akb6548, akb 6548
Clinical Status: Active
Latest Update: 2025-10-28
Latest Update Note: News Article

Product Description

Vadadustat is an oral hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor, a class of drugs that stabilize HIF and stimulate erythropoietin and red-cell production. (Sourced from: https://www.nejm.org/doi/full/10.1056/NEJMoa2035938)

Mechanisms of Action: HIF Inhibitor

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: *

Approval Status: Approved

Approved Countries: Belgium | Croatia | European Medicines Agency | Finland | Iceland | Japan | Korea | Lithuania | Poland | Portugal | Slovakia | Sweden

Approved Indications: None

Known Adverse Events: None

Company: Akebia
Company Location: CAMBRIDGE MA 02142
Company CEO: John P. Butler
Additional Commercial Interests: Otsuka

Clinical Description

Map of Global Clinical Trials for Vadadustat

Countries in Clinic: United States

Active Clinical Trial Count: 4

Recent & Upcoming Milestones

  • Clinical Outcomes Reported - Akebia presented P3 Kidney Diseases results on 2025-11-06 for Vadadustat
  • Clinical Outcomes Reported - Akebia presented P3 Kidney Diseases results on 2025-06-04 for Vadadustat
  • Clinical Outcomes Reported - Akebia presented P3 Anemia results on 2025-04-10 for Vadadustat

Highest Development Phases

Phase 3: Acute Lung Injury|Acute Respiratory Distress Syndrome|Anemia|Kidney Failure, Chronic|Respiratory Distress Syndrome, Newborn

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated
HSC-MS-22-0260

P3

Not yet recruiting

Respiratory Distress Syndrome, Newborn|Acute Lung Injury|Acute Respiratory Distress Syndrome

2026-07-01

2025-07-26

Primary Endpoints
AKB-6548-CI-0052

P3

Recruiting

Kidney Failure, Chronic|Anemia

2026-06-01

23%

2025-08-21

Patient Enrollment|Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status
VOICE

P3

Recruiting

Kidney Failure, Chronic|Anemia

2026-06-30

38%

2024-12-13

Primary Endpoints|Start Date|Treatments|Trial Status
AKB-6548-CI-0039

P3

Completed

Kidney Failure, Chronic|Anemia

2023-01-06

17%

2025-01-16

Primary Endpoints

Recent News Events

Date

Type

Title

11/06/2025

News Article

 Vafseo® (vadadustat) Dialysis Dependent Patient Post Hoc Data Analysis: Composite of All-Cause Mortality and Hospitalization Outcomes Statistically More Favorable for Patients Receiving Vadadustat vs. ESAs

10/28/2025

News Article

 Akebia Therapeutics Provides Update on Vafseo for Non-Dialysis Patients

10/20/2025

News Article

 Akebia Therapeutics Announces Five Presentations at ASN Kidney Week 2025

08/21/2025

News Article

 Akebia Therapeutics and Innovative Renal Care Announce Nationwide Availability of Vafseo® (vadadustat) Across All IRC Dialysis Clinics

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