Esketamine (Spravato)
Approved + off-label ketamineEsketamine is approved and used alongside off-label ketamine in clinics.
Last updated 18 August 2026
Psychedelic Therapy Legal Landscape
Esketamine is approved and used alongside off-label ketamine in clinics.
Off-label medical use plus esketamine.
Since 1 July 2023, TGA-authorised psychiatrists can prescribe psilocybin for treatment-resistant depression (Schedule 8 for this use). Honest picture three years in: it works but remains expensive — often tens of thousands of dollars per course — with limited authorised psychiatrists. Legal does not yet mean accessible.
Same decision: MDMA prescribable by TGA-authorised psychiatrists for PTSD since 1 July 2023 — the only standing national MDMA pathway in the world.
Via TGA Special Access / Authorised Prescriber pathways since 2016.
Active trials alongside the authorised-prescriber pathway — university centers in Melbourne and Sydney. Participation is free; screening is strict; never pay for “trial access”.