VAFSEO (vadadustat)
Vafseo treats anemia in adults with chronic kidney disease who have been receiving dialysis for at least three months. It helps patients manage low red blood cell levels over time, though it is not used for patients who need immediate correction via transfusion. This medication is specifically used for those on long-term dialysis and is not intended for patients with kidney disease who are not on dialysis.
How VAFSEO Works
Vafseo works by reversibly inhibiting enzymes called HIF-prolyl-4-hydroxylases, which leads to the stabilization and accumulation of specific transcription factors. This process triggers the body to increase its natural production of erythropoietin.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2024-03-27
- Patent Cliff
- 2036
- Routes
- ORAL
- Dosage Forms
- TABLET
VAFSEO Approval History
What VAFSEO Treats
2 indicationsVAFSEO is approved for 2 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anemia
- Chronic Kidney Disease
VAFSEO Boxed Warning
INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, AND THROMBOSIS OF VASCULAR ACCESS VAFSEO increases the risk of thrombotic vascular events, including major adverse cardiovascular events (MACE) [see Warnings and Precautions ( 5.1 )] . Targeting a hemoglobin level greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events, as occurs with erythropoietin stimulating agents (ESAs), which also increase erythropoietin ...
WARNING: INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, AND THROMBOSIS OF VASCULAR ACCESS VAFSEO increases the risk of thrombotic vascular events, including major adverse cardiovascular events (MACE) [see Warnings and Precautions ( 5.1 )] . Targeting a hemoglobin level greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events, as occurs with erythropoietin stimulating agents (ESAs), which also increase erythropoietin levels [see Warnings and Precautions ( 5.1 )] . No trial has identified a hemoglobin target level, dose of VAFSEO, or dosing strategy that does not increase these risks [see Dosage and Administration ( 2.4 )] . Use the lowest dose of VAFSEO sufficient to reduce the need for red blood cell transfusions [ see Dosage and Administration ( 2.4 )] . WARNING: INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, and THROMBOSIS OF VASCULAR ACCESS. See full prescribing information for complete boxed warning. VAFSEO increases the risk of thrombotic vascular events, including major adverse cardiovascular events (MACE). ( 5.1 ) Targeting a hemoglobin level greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events, as occurs with erythropoietin stimulating agents (ESAs), which also increase erythropoietin levels. ( 5.1 ) No trial has identified a hemoglobin target level, dose of VAFSEO, or dosing strategy that does not increase these risks. ( 2.4 ) Use the lowest dose of VAFSEO sufficient to reduce the need for red blood cell transfusions. ( 2.4 )
VAFSEO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to VAFSEO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
26 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07537816 | 24MMHIS374e | Ph 4 | not yet recruiting | Effects of Vadadustat on Anemia, Quality of Life, and Inflammation in Dialysis Patients |
| NCT06520826 VOICE | USRC-2024-001 | Ph 3 | active not recruiting | Vafseo Outcomes In-Center Experience |
| NCT06901505 | AKB-6548-CI-0052 VOCAL | Ph 3 | active not recruiting | To Evaluate the Efficacy of Three Times Weekly (TIW) Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis |
| NCT05082571 CONVERSION | AKB-6548-CI-0041 | Ph 3 | withdrawn | Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease |
| NCT05082584 CORRECTION | AKB-6548-CI-0042 | Ph 3 | withdrawn | Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease Naive to Erythropoiesis-Stimulating Agents |
| NCT04313153 results posted | 404-201-00012 AKB-6548-CI-0036, 2019-004851-36 | Ph 3 | completed | 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) |
| NCT04478071 results posted | HSC-MS-20-0395 W81XWH-21-10032 | Ph 2 | completed | Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19) |
| NCT04707768 results posted | AKB-6548-CI-0039 | Ph 3 | completed | 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 |
| NCT03799627 FO2RWARD-2 results posted | AKB-6548-CI-0025 | Ph 2 | completed | Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa |
| NCT02865850 results posted | AKB-6548-CI-0016 2016-000838-21 | Ph 3 | completed | 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) |
| NCT02892149 results posted | AKB-6548-CI-0017 2016-001360-11 | Ph 3 | completed | Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD) |
| NCT04707573 results posted | AKB-6548-CI-0003 | Ph 2 | completed | Study to Assess the Safety and Pharmacokinetics of AKB-6548 in Participants With Chronic Kidney Disease (CKD), Stages 3 and 4 |
| NCT02648347 results posted | AKB-6548-CI-0014 2015-004265-81 | Ph 3 | completed | Study to Evaluate Vadadustat for the Correction of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease |
| NCT02680574 results posted | AKB-6548-CI-0015 2015-004774-14 | Ph 3 | completed | Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) |
| NCT03054350 results posted | AKB-6548-CI-0022 | Ph 2 | completed | Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD) |
| NCT03054337 results posted | AKB-6548-CI-0021 | Ph 2 | completed | Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Non-Dialysis Dependent Chronic Kidney Disease (NDD-CKD) |
| NCT03140722 results posted | AKB-6548-CI-0018 | Ph 2 | terminated | Study to Evaluate Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Who Are Hyporesponsive to Erythropoiesis Stimulating Agents |
| NCT04299633 | AKB-6548-CI-0037 | Ph 1 | completed | Study in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of Vadadustat |
| NCT03992066 | AKB-6548-CI-0034 | Ph 1 | completed | Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease |
| NCT03657290 | AKB-6548-CI-0028 | Ph 1 | completed | 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 |
| NCT03801733 | AKB 6548 CI 0030 | Ph 1 | completed | Drug-Drug Interaction Study of Vadadustat With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and Simvastatin |
| NCT03789032 | AKB-6548-CI-0033 | Ph 1 | completed | Study to Evaluate the Effect of Rabeprazole on the Pharmacokinetics of Vadadustat |
| NCT03799848 | AKB-6548-CI-0024 | Ph 1 | completed | A Single Dose Study of Oral Vadadustat in Subjects With Normal and Impaired Hepatic Function |
| NCT03801759 | AKB-6548-CI-0031 | Ph 1 | completed | Drug-Drug Interaction Study of Vadadustat With Digoxin, Adefovir and Furosemide |
| NCT03801746 | AKB-6548-CI-0029 | Ph 1 | completed | Drug-Drug Interaction Study of Vadadustat With Cyclosporine, Probenecid and Rifampin |
| NCT03242967 TRILOGY | AKB-6548-CI-0023 | Ph 3 | withdrawn | Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VAFSEO FDA Label Details
Indications & Usage
FDA Label (PDF)VAFSEO is indicated for the treatment of Anemia; Chronic Kidney Disease.
WARNING: INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, AND THROMBOSIS OF VASCULAR ACCESS VAFSEO increases the risk of thrombotic vascular events, including major adverse cardiovascular events (MACE) [see Warnings and Precautions ( 5.1 )] . Targeting a hemoglobin lev...
VAFSEO Patents & Exclusivity
Patents (14 active)
Exclusivity
Pro Intelligence Preview
Deep insights for VAFSEO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 126 active patents
Trial Analysis
- • 26 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment