On May 8, 2020, RedHill Biopharma announced the U.S. Food and Drug Administration (FDA) had approved its Investigational New Drug application for a Phase 2a clinical study evaluating its investigational drug, opaganib (Yelivaﾮ, ABC294640)1, in patients with confirmed moderate-to-severe SARS-CoV-2 infection.

The randomized, double-blind, placebo-controlled Phase 2a study aims to enroll up to 40 patients with moderate-to-severe SARS-CoV-2 infection and pneumonia requiring hospitalization and supplemental oxygenation.