Psychedelic-assisted pharmacotherapy: clinical applications and regulatory considerations
Expert Opinion on Pharmacotherapy March 24, 2026 Donatella Marazziti, Matteo Gambini, Riccardo Gurrieri et al.
After decades of limited use, psychedelic compounds are reemerging as potential treatments for mental disorders that do not respond to existing therapies. This narrative review examines the current clinical and regulatory landscape of psychedelic-assisted therapies, covering ketamine, esketamine, MDMA, psilocybin, LSD, DMT, 5-MeO-DMT, and ibogaine for conditions like major depressive disorder, PTSD, and substance use disorders. The authors argue that these therapies will not follow standard prescription models but require specialist-delivered, psychotherapy-integrated care. Late-stage trials show promise for high-need populations, but unresolved challenges around long-term safety, scalability, workforce training, equity of access, and legal accountability remain.