Pursuing a new standard of care for patients with anemia associated with chronic kidney disease (CKD)
Vadadustat is an investigational drug being studied for the treatment of anemia associated with chronic kidney disease. Anemia is common in patients with CKD, and its prevalence increases as CKD progresses.
Anemia is a condition characterized by abnormally low levels of hemoglobin. Hemoglobin is the part of red blood cells that carries oxygen. If there are too few red blood cells or if hemoglobin levels are low, the cells in the body will not get enough oxygen. In patients with CKD, anemia results from inadequate erythropoietin levels, which negatively affect red blood cell production. In addition, iron, which is essential to red blood cell production, may be deficient in patients with CKD. Left untreated, anemia significantly accelerates overall deterioration of patient health with increased morbidity and mortality.
Designed to Mimic the Physiological Effects of Altitude
Vadadustat is a Hypoxia Inducible Factor Prolyl Hydroxylase (HIF-PH) inhibitor. Vadadustat is an investigational drug that relies on the HIF pathway – the same pathway used by the body to adapt to lower oxygen availability, such as that experienced with a moderate increase in altitude. At higher altitudes, the body responds to lower oxygen levels by increasing the availability of HIF, which coordinates the interdependent processes of iron utilization and erythropoietin production to increase red blood cell production and, ultimately, improve oxygen delivery.
Vadadustat Clinical Trial Program
Vadadustat is currently in Phase 3 clinical trials in patients with anemia associated with chronic kidney disease, including the PRO2TECT studies for non-dialysis-dependent (NDD) patients and the INNO2VATE studies for dialysis-dependent (DD) patients. In addition, the Phase 2 FO2RWARD study has been initiated in dialysis-dependent patients who are hyporesponsive to erythropoiesis-stimulating agents (ESAs), and the Phase 3 TRILO2GY study will assess the safety and efficacy of vadadustat three times per week versus an active comparator in dialysis-dependent patients with CKD.
Vadadustat is an investigational drug and has not yet been approved by the US Food and Drug Administration (FDA) or any regulatory authority.