What Happened to Psychedelics?

The trajectory of psychedelics has been marked by extreme shifts, from widespread scientific interest in the mid-20th century to decades of prohibition, and now, a powerful resurgence. Following the 1970 Controlled Substances Act, which classified most psychedelics as Schedule I drugs, research largely halted, associating these compounds with counterculture rather than medicine.

The tide began to turn in the late 20th and early 21st centuries, fueled by a growing global mental health crisis and the limitations of conventional treatments. Rigorous modern clinical trials, particularly with MDMA for Post-Traumatic Stress Disorder (PTSD) and psilocybin for treatment-resistant depression (TRD) and major depressive disorder (MDD), consistently demonstrated rapid, meaningful, and sometimes durable outcomes with low physiological toxicity and no addictive potential (except for some risk with ketamine). This evidence led the FDA to grant 'Breakthrough Therapy' designations to MDMA-assisted therapy for PTSD and psilocybin-assisted therapy for TRD and MDD, signaling their potential for major psychiatric advancements.

Key turning points have accelerated this shift. In November 2022, Colorado voters passed Proposition 122, the Natural Medicine Health Act, decriminalizing personal use of psilocybin and other natural psychedelics and establishing a regulated access framework. This followed Oregon's Measure 109, which created a regulated psilocybin services program. As of July 2026, Oregon's service centers had served approximately 16,000 clients, and Colorado had 34 licensed healing centers. Internationally, Australia notably legalized the prescribing of psilocybin for TRD and MDMA for PTSD by authorized prescribers in July 2023.

In a significant federal development, President Donald Trump issued an Executive Order on April 18, 2026, titled 'Accelerating Medical Treatments for Serious Mental Illness.' This order directed the FDA and other federal agencies to prioritize the review of psychedelic compounds, reduce research restrictions, and facilitate access pathways, including potentially through the Right to Try Act. In response, the FDA announced it was accelerating regulatory action on psychedelic-based therapies, issuing national priority vouchers for studies and releasing final guidance on clinical investigations of psychedelic drugs on August 13, 2026.

As of August 2026, the psychedelic landscape is dynamic. Resilient Pharmaceuticals (formerly MAPS PBC and Lykos Therapeutics) resubmitted its New Drug Application (NDA) for MDMA-assisted therapy for PTSD to the FDA on August 10, 2026, two years after the initial application was rejected. Compass Pathways' COMP360, a psilocybin formulation for TRD, has completed two successful Phase 3 trials, and its rolling NDA submission is underway, with potential FDA approval by late 2026 or early 2027. The U.S. Department of Veterans Affairs (VA) also launched a new clinical trial on August 5, 2026, to evaluate psilocybin for veterans with treatment-resistant depression and concurrent PTSD. The global psychedelic drugs market is projected to reach US$4.7 billion in 2026 and grow to US$11.4 billion by 2033, driven by increasing recognition of mental health disorders and ongoing clinical research.