The U.S. Food and Drug Administration granted Breakthrough Therapy Designation for Usona Institute‘s psilocybin for the treatment of major depressive disorder (MDD), the organization announced today.

According to a release, the designation bolsters Usona’s mission to advance psilocybin as a treatment paradigm toward new drug approval.

“The results from previous studies clearly demonstrate the remarkable potential for psilocybin as a treatment in MDD patients, which Usona is now seeking to confirm in its own clinical trials,” Usona Director of Clinical and Translational Research Charles Raison, MD, said in a statement.

Usona also announced that the launch of its phase 2 clinical trial, which will include approximately 80 participants at seven study sites around the country

Promega CEO Bill Linton co-founded Usona Institute, which is dedicated to supporting and conducting pre-clinical and clinical research to further the understanding of the therapeutic effects of psilocybin and other consciousness-expanding medicines.