Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
vadadustat · 1 trial · 2 indications
National Institute of Allergy and Infectious Disease Ordinal Scale (NIAID-OS): 8 - Death 7 - Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 6 - Hospitalized, on non-invasive ventilation or high flow oxygen devices 5 - Hospitalized, requiring supplemental oxygen 4 - Hospitalized, not requiring supplemental oxygen - requiring ongoing care (COVID-19 related or otherwise) 3 - Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 2 - Not hospitalized, limitation on activities and/or requiring home oxygen 1 - Not hospitalized, no limitations on activities
| Arm | Type | Description |
|---|---|---|
| vadadustat | EXPERIMENTAL | - |
| placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| vadadustat | DRUG | Participants will receive vadadustat once daily for 14 days. |
| placebo | DRUG | Participants will receive matching placebo once daily for 14 days. |
Inclusion Criteria: * Laboratory-confirmed diagnosis of COVID-19 by detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA by Reverse transcription polymerase chain reaction (RT-PCR) from any specimen respiratory * Admitted to the hospital within 36 hours * Oxygen saturation ...
Vadadustat is an investigational small molecule being studied for the prevention and treatment of Acute Respiratory Distress Syndrome (ARDS) in hospitalized patients with COVID-19. It is in Phase 2 clinical development and is not approved by the FDA. The completed trial enrolled 448 participants in the United States.
Vadadustat is a small molecule that targets hypoxia-inducible factor prolyl hydroxylase, an enzyme involved in cellular oxygen sensing. By inhibiting this target, it stabilizes hypoxia-inducible factor, which may help regulate inflammatory and protective pathways relevant to ARDS. This mechanism is being evaluated in the context of COVID-19-related lung injury.
Vadadustat is being developed by United Therapeutics Corporation, a biopharmaceutical company listed on NASDAQ under the ticker UTHR. The company is conducting clinical research to evaluate the drug's potential in Acute Respiratory Distress Syndrome associated with COVID-19.
Vadadustat is in Phase 2 clinical development for Acute Respiratory Distress Syndrome. It is an investigational drug and has not been approved by the FDA. One Phase 2 trial has been completed, and the drug is not currently in active clinical trials for this indication.
Vadadustat has one completed clinical trial, NCT04478071, titled 'Vadadustat for the Prevention and Treatment of Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19)'. This Phase 2, randomized, double-blind, placebo-controlled study enrolled 448 participants in the United States.
Vadadustat is also known by the brand name Vafseo, which is approved in some regions for anemia due to chronic kidney disease. However, for the Acute Respiratory Distress Syndrome indication, it remains investigational and is being studied under the name vadadustat.