Last reviewed 2026-04-20 · How we verify

VADADUSTAT

At a glance

Approved indications

No approved indications tracked.

Boxed warnings

• 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 )

Common side effects

• Hypertension
• Diarrhea
• Headache
• Nausea
• Fatigue
• Abdominal pain
• Vomiting
• Gastrointestinal erosion
• Dizziness
• Dyspnea

Serious adverse events

• Thrombotic vascular events
• Death
• Myocardial infarction
• Stroke
• Venous thromboembolism
• Thrombosis of vascular access
• Hepatotoxicity
• Seizures
• Permanent treatment discontinuation due to adverse reaction

Key clinical trials

• Vafseo Outcomes In-Center Experience (PHASE3)
• 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 (PHASE3)
• Efficacy and Safety Study to Evaluate MT-6548 in Peritoneal Dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan (PHASE3)
• Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Not Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan (PHASE3)
• Efficacy and Safety Study to Evaluate MT-6548 in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan (PHASE3)
• Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Currently Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan (PHASE3)
• Effects of Iron Supplements on the Pharmacokinetics of MT-6548 (PHASE3)
• Vadadustat for the Treatment of Nonintubated Acute Respiratory Distress Syndrome Due to Pathogen-Associated Lung Injury (PHASE2, PHASE3)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• VADADUSTAT CI brief — competitive landscape report
• VADADUSTAT updates RSS · CI watch RSS