The End Wise Initiative: TGA Application for Existential Distress

In March 2025, End Wise, with the support of Mind Medicine Australia, submitted an application to the Therapeutic Goods Administration (TGA) seeking to allow authorised psychiatrists to prescribe psilocybin-assisted therapy for people living with a terminal illness who are experiencing existential distress.

Existential distress is a profound form of suffering that can arise when confronting a terminal diagnosis. It may include overwhelming fear of death, loss of meaning and purpose, hopelessness, isolation, anxiety, depression and a diminished sense of dignity. While physical symptoms can often be managed through palliative care, existential distress remains one of the most challenging aspects of the end-of-life experience for patients and their families.

The End Wise Initiative submission was supported by a growing body of international and Australian clinical evidence demonstrating that psilocybin-assisted therapy can significantly reduce end-of-life anxiety and depression, alleviate fear of death, enhance spiritual wellbeing and improve quality of life for people facing a terminal illness.

The application seeks to expand access to a promising therapeutic option for people whose suffering cannot be adequately addressed through existing treatments, while maintaining the rigorous clinical safeguards that underpin Australia's Authorised Prescriber framework.

End Wise remains committed to advocating for safe, evidence-based and compassionate access to psychedelic-assisted therapy for people experiencing existential distress associated with terminal illness. We believe every person deserves the opportunity to approach the end of life with dignity, meaning, connection and peace.

Current Status

Following an initial public consultation, the TGA released an Interim Decision in June 2026 declining the proposed amendment to the Poisons Standard.

While the Interim Decision did not support the proposed amendment, the process is not yet complete. A further public consultation period is now underway before the Delegate makes a Final Decision.

To learn more about the consultation process, visit the TGA Consultation Hub. To support the work of End Wise, visit our Support Us page.

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