Signal Seven psychedelic candidates have reached FDA Phase 3 trials

Summary

The Psychedelics and Healing Initiative lists seven psychedelic candidate drugs that have reached Phase 3 trials under the FDA, the last stage before a decision on approval. They include Compass's psilocybin for treatment-resistant depression and Usona's psilocybin for major depressive disorder. A psilocin analogue from Cybin, now Helus, also targets major depression. MindMed, now Definium, has an LSD-based compound in Phase 3 for both generalized anxiety disorder and major depression. The list is completed by MDMA from Lykos, now Resilient Therapeutics, for PTSD and a ketamine candidate from Solvonis Therapeutics for severe alcohol use disorder. The Initiative presents this pipeline as evidence that regulated approval is becoming the field's main route to patients.