Cybin has announced that it has received a “may proceed letter” and Investigational New Drug Application clearance from the U.S. FDA for its Phase I/IIa first-in-human clinical trial evaluating CYB003. CYB003 is a proprietary deuterated psilocybin analogue that is being developed for the potential treatment of major depressive disorder. This milestone marks the industry’s first-ever novel psilocybin analogue to enter clinical development.
Cybin is a for-profit company that aims to deliver psychedelics (psilocybin) via a sublingual delivery mechanism. The company aims to start clinical trials within the year (2021). It has raised $98 million US.