Psilocybin therapy is making history: Compass Pathways will launch the world’s first Phase 3 trial for treatment-resistant depression by the end of 2022, enrolling nearly 1,000 participants across two pivotal studies. This is the threshold every promising drug must cross to become an approved medicine, and no psychedelic compound has crossed it before. For the roughly 100 million people worldwide whose depression doesn’t respond to standard treatments, the stakes are real — current options are few, often invasive, and inconsistently helpful. A single guided dose, if the evidence holds, could reshape what care looks like. Beyond depression, this moment signals that a long-stigmatized class of medicines is finally being tested with the rigor patients deserve.