The End Wise Initiative: TGA Application for Existential Distress

End Wise is seeking TGA approval to allow psilocybin-assisted therapy for people with a life-limiting illness experiencing existential distress: profound suffering that can include fear of death, loss of meaning, hopelessness and diminished dignity, often unresolved by current palliative care modalities. 

Treatment would be delivered entirely within the existing safeguards of Australia's Authorised Prescriber Scheme, and is supported by a growing body of evidence, including an Australian Phase 2b trial at St Vincent's Hospital Melbourne showing significant, sustained reductions in depression, anxiety and fear of death in people with advanced illness. 

Eligibility is grounded in the same functional test already used in Australia's Voluntary Assisted Dying legislation: an incurable, advanced and progressive illness expected to cause death. Existential distress itself is then confirmed separately by a psychiatrist using validated clinical tools, so access is offered only where a measurable level of distress is present. 

End Wise remains committed to advocating for safe, evidence-based and compassionate access to psychedelic-assisted therapy at the end of life. We believe every person deserves the opportunity to approach death with dignity, meaning, connection and peace. 

Current Status The TGA released an Interim Decision in June 2026 declining the proposed amendment. On 31 July 2026, End Wise submitted a detailed response addressing the Committee's concerns, proposing a refined clinical framework built on Australia's existing VAD and Authorised Prescriber frameworks. A Final Decision is expected in Q4 2026. 

To learn more, visit the TGA Consultation Hub.

Below you can read the End Wise Initiative resubmission to the TGA and follow the progress of the regulatory process.