Vafseo

(Vadadustat)

ApprovedSmall molecule

Vadadustat is used to treat anemia (low red blood cell count) in patients with chronic kidney disease by helping their kidneys produce more of a hormone that stimulates red blood cell production.[2] Vafseo is currently approved and in use across 4 indications[4].[1]

Vafseo is one of 102 small molecule programs targeting Anemia (phenotype). It is currently in Approved.

Indications

Total Trials

Active Trials

101

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Anemia (phenotype)Active, not recruiting

Liver DiseaseApproved

Acute Respiratory Distress Syndrome (ARDS)Recruiting

OutcomeActive, not recruiting

Anemia (phenotype)Approved

Active, not recruiting

Liver DiseaseApproved

Approved

Acute Respiratory Distress Syndrome (ARDS)Preclinical

Recruiting

OutcomePhase 3

Active, not recruiting

Competition

Competitive Landscape

100 competitors in Liver Disease

#DrugCompanyPhaseTrials

Vafseo

AAkebia Therapeutics

Approved

27 2

Elunate

Mektovi

Exjade

Alecensa

Calciferol

Resotran

Lorbrena

Lumakras

Brintellix

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2031

PreclinicalRecruiting

Acute Respiratory Distress Syndrome (ARDS)

NCT07086755

Clinical

Trials by Indication[1]

Chronic Kidney Disease12 trials

Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease

Completed·AAkebia Therapeutics·Phase 1·NCT03992066·46 enrolled

Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD)

Completed·AAkebia Therapeutics·Phase 2·NCT03054350·60 enrolled

Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD)

Withdrawn·AAkebia Therapeutics·Phase 3·NCT03242967

Show 9 more trials

Study to Assess the Safety and Pharmacokinetics of AKB-6548 in Participants With Chronic Kidney Disease (CKD), Stages 3 and 4

Completed·AAkebia Therapeutics·Phase 2·NCT04707573·22 enrolled

Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)

Completed·AAkebia Therapeutics·Phase 3·NCT02680574·1,725 enrolled

Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD)

Completed·AAkebia Therapeutics·Phase 3·NCT02892149·3,554 enrolled

Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease

Withdrawn·AAkebia Therapeutics·Phase 3·NCT05082571

Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD)

Completed·AAkebia Therapeutics·Phase 2·NCT03054337·51 enrolled

Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents

Terminated·AAkebia Therapeutics·Phase 2·NCT03140722·2 enrolled

Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Participants With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD)

Completed·AAkebia Therapeutics·Phase 3·NCT02865850·369 enrolled

Study to Evaluate Vadadustat for the Correction of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease

Completed·AAkebia Therapeutics·Phase 3·NCT02648347·1,751 enrolled

Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease Naive to Erythropoiesis-Stimulating Agents

Withdrawn·AAkebia Therapeutics·Phase 3·NCT05082584

Anemia3 trials

Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects

Completed·AAkebia Therapeutics·Phase 3·NCT04707768·456 enrolled

Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa

Completed·AAkebia Therapeutics·Phase 2·NCT03799627·175 enrolled

Trial Evaluating the Efficacy and Safety of Oral Vadadustat Once Daily (QD) and Three Times Weekly (TIW) for the Maintenance Treatment of Anemia in Hemodialysis Subjects Converting From Erythropoiesis-Stimulating Agents (ESAs)

Completed·AAkebia Therapeutics·Phase 3·NCT04313153·319 enrolled

Interaction2 trials

Drug-Drug Interaction Study of Vadadustat With Digoxin, Adefovir and Furosemide

Completed·AAkebia Therapeutics·Phase 1·NCT03801759·62 enrolled

Drug-Drug Interaction Study of Vadadustat With Cyclosporine, Probenecid and Rifampin

Completed·AAkebia Therapeutics·Phase 1·NCT03801746·40 enrolled

Atorvastatin1 trial

Drug-Drug Interaction Study of Vadadustat With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and Simvastatin

Completed·AAkebia Therapeutics·Phase 1·NCT03801733·134 enrolled

Adult1 trial

A Study in Evaluating Bioequivalence Between Test and Reference Formulations of Vadadustat Tablets in Healthy Adults

Completed·AAkebia Therapeutics·Phase 1·NCT03639155·50 enrolled

8 more indications

Acute Respiratory Distress Syndrome1 trial

Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19)

Completed·TThe University of Texas Health Science Center, Houston·Phase 2·NCT04478071·448 enrolled

Outcome1 trial

Vafseo Outcomes In-Center Experience

Active, not recruiting·UUSRC Kidney Research·Phase 3·NCT06520826·2,200 enrolled

Adult Subject1 trial

Study in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of Vadadustat

Completed·AAkebia Therapeutics·Phase 1·NCT04299633·54 enrolled

Hepatic Function1 trial

A Single Dose Study of Oral Vadadustat in Subjects With Normal and Impaired Hepatic Function

Completed·AAkebia Therapeutics·Phase 1·NCT03799848·24 enrolled

Tics1 trial

Study to Evaluate the Effect of Rabeprazole on the Pharmacokinetics of Vadadustat

Completed·AAkebia Therapeutics·Phase 1·NCT03789032·20 enrolled

Anemia of Chronic Kidney Disease1 trial

A Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy of Three Times Weekly Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis

Completed·AAkebia Therapeutics·Phase 3·NCT06901505·353 enrolled

Acute Respiratory Distress Syndrome (ARDS)1 trial

Vadadustat for the Treatment of Nonintubated Acute Respiratory Distress Syndrome Due to Pathogen-Associated Lung Injury

Recruiting·PPaul Potnuru·Preclinical·NCT07086755·1,100 enrolled

Unspecified1 trial

A Study in Evaluating Bioequivalence of Test and Reference Vadadustat 450 MG and 150 MG Tablets and to Determine Food Effect on the 450 MG Tablet

Completed·AAkebia Therapeutics·Phase 1·NCT03657290·54 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 27, 2024

VAFSEO

NDA NDA215192

Sources

References

[1]
ClinicalTrials.gov — 27 trial records for Vadadustat. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Vafseo drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Vadadustat compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Vadadustat. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA215192). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Vafseo. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Akebia Therapeutics company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Egl Nine Homolog 1 Inhibitor; Hypoxia-Inducible Factor Prolyl Hydroxylase 1 Inhibitor; Egl Nine Homolog 3 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AAkebia Therapeutics

Patent Landscape[6]

Patent Cliff

Jun 26, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8598210Jun 26, 2027

RE47437Jun 26, 2027

8940773Jun 26, 2027

8343952Aug 14, 2027

7811595Mar 13, 2028

9 more patents

8323671Apr 3, 2028

12569474Jun 4, 2034

11857543Jun 9, 2034

11065237Nov 14, 2034

9701636Nov 14, 2034

9987262Nov 14, 2034

10149842Nov 14, 2034

11844756Mar 31, 2036

11324734Mar 31, 2036

Vafseo

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2031

Trials by Indication[1]

Chronic Kidney Disease12 trials

Anemia3 trials

Interaction2 trials

Atorvastatin1 trial

Adult1 trial

Acute Respiratory Distress Syndrome1 trial

Outcome1 trial

Adult Subject1 trial

Hepatic Function1 trial

Tics1 trial

Anemia of Chronic Kidney Disease1 trial

Acute Respiratory Distress Syndrome (ARDS)1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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