Authors
Donatella Marazziti, Matteo Gambini, Riccardo Gurrieri, Gerardo Russomanno, Giorgia Sità, Elena Pescini, Francesca Rita Digiuseppe, Federico Mucci
Published in
Expert opinion on pharmacotherapy. Apr 07, 2026. Epub Apr 07, 2026.
Abstract
After decades of regulatory marginalization, psychedelic compounds have reemerged as promising therapeutic tools in psychiatry, driven by unmet clinical needs in treatment-resistant mental disorders and by growing evidence of rapid and sustained effects on mood, cognition, and behavior.
This narrative review critically examined the current clinical and regulatory landscape of psychedelic-assisted therapies in psychiatry. We synthesize evidence from phase II - III clinical trials, regulatory agency documents, and international drug policy frameworks, focusing on ketamine/esketamine, MDMA, psilocybin, LSD, DMT/5-MeO-DMT, and ibogaine across major depressive disorder, treatment-resistant depression, PTSD, anxiety disorders, and substance use disorders. Particular attention will be given to regulatory pathways, scheduling constraints, access mechanisms, and compound-specific approval trajectories in the United States, European Union, and selected international jurisdictions.
Psychedelic-assisted therapies are unlikely to follow a conventional prescription model and instead require specialist-delivered, psychotherapy-integrated care under appropriate regulatory and ethical safeguards. While late-stage trials support their potential in high-need populations, unresolved challenges, including long-term safety, scalability, workforce training, equity of access, and medico-legal accountability, must be addressed before broader clinical implementation.
PMID:
41944071
Bibliographic data and abstract were imported from PubMed on 07 Apr 2026.
Read full publication at:
Please sign in
to see all details.
Advertisement
Stats
- Recommendations n/a n/a positive of 0 vote(s)
- Views 62
- Comments 0