Interested in the development and regulatory approval of psychedelic drugs for medicinal use? Read our latest review ‘Mind the gap! Addressing unresolved aspects of abuse potential evaluation and scheduling of classic and novel psychedelic drugs’ in a Special Issue of Journal of Psychopharmacology in tribute to Roland Griffiths in recognition of his important contribution to psychedelic research.
We set out clear proposals for categorizing psychedelic drug-candidates into ‘classical’ psychedelics (well-known compounds eg psilocybin, DMT, LSD), ‘novel’ psychedelics (eg analogues of known psychedelics) and ‘grey area’ psychedelics (located between classical and novel psychedelics, eg non-hallucinogenic 5-HT2A agonists).
We describe the development pathway and abuse/dependence testing procedures for each category and give our perspective on how these drugs will be evaluated and scheduled by the regulatory authorities, using the US Controlled Substances Act as example (although many of the principles discussed can be applied to the regulatory requirements of other countries).
You can read the full article here
Heal DJ, Gosden J, Smith SL. Mind the gap! Addressing unresolved aspects of abuse potential evaluation and scheduling of classic and novel psychedelic drugs. J Psychopharm, 2025; doi.org/10.1177/02698811251382147. Epub 2025 Oct 16.
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