On Jun. 7, 2022, Veru announced that is had submitted an emergency use authorization (EUA) application to the U.S. Food and Drug Administration for its sabizabulin oral 9mg treatment of moderate to severe hospitalized COVID-19 patients at high risk for developing Acute Respiratory Distress Syndrome (ARDS).

The EUA submission to the FDA is based on the positive results from the double-blind, randomized, multicenter placebo-controlled Phase 3 COVID-19 clinical trial .