Cybin Receives FDA IND Clearance for its Phase 1/2a Clinical Trial Evaluating CYB003 for the Potential Treatment of Major Depressive Disorder

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.

Category Press Release
Published in Businesswire

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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.