On Jan 5, 2022, NRx Pharmaceuticals announced that it had submitted an application for Emergency Use Authorization (EUA) to the US Food and Drug Administration (FDA) for the use of ZYESAMIﾮ (aviptadil) in patients with Critical COVID-19 who were at immediate risk of death from Respiratory Failure despite treatment with approved therapy including remdesivir and who are ineligible for enrollment into the ongoing ACTIV-3b NIH-sponsored trial.

In 2021, the FDA declined to issue EUA for ZYESAMI to treat patients suffering Critical COVID-19 with respiratory failure. This new EUA submission is a narrower, proposed indication for patients with no other available therapy and is supported by data requested by the FDA.