VSTAT-2 is a Phase IIb/III adaptive seamless randomized controlled trial evaluating vadadustat — an FDA-approved oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) — in adults hospitalized with pathogen-associated nonintubated ARDS (acute respiratory distress syndrome). The trial builds on the completed Phase 2 VSTAT-1 study (JCI Insight 2025), which established the safety and efficacy of vadadustat in a similar patient population with viral pneumonia and severe hypoxia.

The VSTAT-2 Trial is designed to determine whether vadadustat, by activating the body's natural oxygen-sensing pathway, can improve outcomes in patients experiencing serious, infection-driven breathing failure. Evidence from several groups suggests that activating these pathways can enhance pathogen clearance and promote lung repair to improve outcomes in acute lung injury.

7000 Fannin St, Houston, TX 77030 | UTHealth Houston | Phone: (315) 6-VSTAT2