Signal Eight psychedelic candidates hold FDA breakthrough therapy designation

Summary

The Psychedelics and Healing Initiative counts eight psychedelic drug candidates that have received breakthrough therapy designation from the US FDA. This status speeds up regulatory review for promising treatments. The listed programmes include psilocybin from Compass and from Usona, a psilocybin analogue from Cybin, now called Helus, and an LSD-based compound from MindMed, now Definium. They also include MDMA from Lykos, now Resilient Therapeutics, intranasal 5-MeO-DMT from AtaiBeckley, methylone from Transcend Therapeutics and a subcutaneous candidate from Reunion. The Initiative uses the count to argue that the FDA is receptive to novel psychedelic compounds. It adds that the esketamine therapy Spravato earlier received the same designation.