Treats anemia due to chronic kidney disease (CKD). Sold as Vafseo. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Vadadustat (sold as Vafseo), first approved Mar 27, 2024, with 0 new uses approved and 1 published complete response letter.
| Safety and Efficacy of a Phased Transition From Epogen to Three Times Weekly Oral Vadadustat for the Treatment of Anemia in Subjects Receiving In-Center HemodialysisAnemia Associated With Chronic Kidney Disease · Geoff Block | Phase 3 | Not yet recruiting | May 4, 2026 |
| Effects of Vadadustat on Anemia, Quality of Life, and Inflammation in Dialysis PatientsRenal Anemia · Mackay Memorial Hospital | Phase 4 | Not yet recruiting | Apr 17, 2026 |
| Vadadustat for the Treatment of Nonintubated Acute Respiratory Distress Syndrome Due to Pathogen-Associated Lung InjuryNonintubated Acute Respiratory Distress Syndrome (ARDS), Pathogen-associated Lung Injury · Paul Potnuru | Phase 2 / Phase 3 | Recruiting | Jul 25, 2025 |
| Letter | Product | Now |
|---|---|---|
| Mar 29, 2022 | VadadustatClinical And Statistical | Approved |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
