ZYESAMI® (AVIPTADIL®) ZYESAMI® (Aviptadil acetate), a synthetic form of human Vasoactive Intestinal Peptide (VIP), is a substance produced by the body, that amongst other functions, helps protect cells against inflammatory conditions. VIP has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients suffering from Critical COVID-19 with respiratory failure, and is now in clinical trials.
The FDA has also provided an Expanded Access Protocol for ZYESAMI®, a destination that an investigational medicine is intended to treat serious or life-threatening diseases or conditions, and has shown potential to address unmet medical needs. Emerging data indicates that VIP binds uniquely to receptors on Alveolar Type II cells in the lung, the same cells that bind the SARS-CoV-2 virus. VIP is believed to protect those cells and the surrounding pulmonary epithelium by blocking cytokines, preventing cytopathy (cell death), and upregulating the production of surfactant, the loss of which is increasingly implicated in COVID-19 respiratory failure.
Ongoing trials show VIP may also inhibit the replication of the SARS-CoV2 virus. In the most recent Phase 3 trial for ZYESAMI®, data showed ZYESAMI® was more effective than placebo in treating patients suffering from Critical COVID-19 with respiratory failure, reducing their hospital stay, and increasing their likelihood of survival. The most common adverse event noted in the data was diarrhea.