On Mar. 2, 2022, Sorrento Therapeutics announced that it had received clearance from the FDA for its investigational new drug application (IND) for intranasal (IN) STI-9199 (COVISHIELD) to study the safety and pharmacokinetics in healthy volunteers.

The Phase 1 study was at a single clinical site in San Diego and followed by multinational (USA, UK and Mexico) Phase 2/3 trials. Sorrento plans to discuss with the FDA the most appropriate end-points for the pivotal study that could result in an Emergency Use Authorization, if the trials met the efficacy end-points of the pivotal study.