How many Australians have been prescribed psilocybin?

Every authorised prescriber (opens in new tab) reports patient numbers to the Therapeutic Goods Administration (TGA) every six months. Through 30 June 2025 those reports (opens in new tab) record 47 new psilocybin patients, and the scheme’s first six months produced three reports and no patients.

As of 28 November 2025, 36 of 40 applications to prescribe psilocybin stood approved. A later TGA summary (opens in new tab), released in February 2026, counts 40 prescribers and 65 patients: a different measure over a different window, aggregated by a method the release does not state, so the two cannot be subtracted.

In May 2026 the ABC reported (opens in new tab) that about 74 patients had received psilocybin therapy outside clinical trials, beside a TGA spokesperson’s figure of 40 psychiatrists holding approvals for both MDMA and psilocybin. The report does not say how the 74 was counted, so it sits beside the figures above as a separate measure.

The TGA’s medicinal cannabis dashboard, built from the same six-monthly return, explains how one patient can be counted more than once:

No adverse events linked to psilocybin prescribed under the scheme were reported to the TGA from July 2023 to the end of December 2025. That zero describes the reporting channel, and these files do not say whether anything happened.

The patient numbers above came out through the TGA’s freedom-of-information disclosure log (opens in new tab), and the TGA publishes no psilocybin patient figures of its own. Its Performance Report 2023-24 (opens in new tab) counts prescribers only: by 30 June 2024, 12 authorised applications allowed nine psychiatrists to prescribe MDMA, psilocybin or both. For medicinal cannabis, the TGA runs an interactive public dashboard (opens in new tab).

With numbers this small, per-approval publication could identify individual prescribers, and small-cell suppression is ordinary statistical practice, so there is a fair case for the silence. The TGA has not made that argument, or given any other reason why psilocybin has no dashboard.

Since 1 July 2023 (opens in new tab) a specialist psychiatrist in Australia can prescribe psilocybin (opens in new tab) for treatment-resistant depression and nothing else, on an approval personal to the doctor that no clinic or profession can hold.

No psilocybine product is on the Australian Register of Therapeutic Goods (opens in new tab), as of the August 2026 review of Australia’s entry in the register, so every prescription is for an unapproved good. That good can be imported, under an Office of Drug Control (opens in new tab) licence and a permit for each consignment, or made in Australia (opens in new tab) on a site holding a TGA manufacturing licence, where state or territory law also allows it. The ABC reported in May 2026 that Breathe Life Sciences manufactures psilocybin in Brisbane.

In May 2026 the TGA changed some of the scheme’s requirements (opens in new tab), covering psychiatrist competency, the therapy team, prescriber oversight and treatment sites. Its prescriber guidance (opens in new tab), updated on 22 June 2026, requires a therapy team of at least two, one of them registered as a clinical psychologist, doctor, mental-health nurse or occupational therapist.

The approval is an authority under subsection 19(5) of the Therapeutic Goods Act 1989 (opens in new tab). In the Poisons Standard (opens in new tab), Schedule 8 (opens in new tab) admits psilocybine for that condition alone, and Appendix D clause 9 limits supply to those prescribers and to a clinical trial approved by or notified to the Secretary; everything else stays in Schedule 9.

Five of the 324 records in our trials corpus have an Australian site, as of 25 August 2026. None is in treatment-resistant depression.

The corpus also does not hold a completed phase 2b randomised controlled trial at St Vincent’s Hospital Melbourne, which is registered on the Australian New Zealand Clinical Trials Registry (opens in new tab) and described in detail in the 2026 decision.

In 2025 an applicant the TGA records only as private asked for a second Schedule 8 indication: existential distress towards the end of life, prescribed by palliative-care specialists, a class the committee found was not clearly defined. After the committee recommended no change, a TGA delegate issued an interim decision (opens in new tab) on 29 May 2026 that the current scheduling of psilocybine remains appropriate.

The delegate agreed the evidence base was not sufficient, the committee found the supporting trials small and short of the methodological rigour it expected, and there was no clear pathway to implementation. Existential distress is not a recognised diagnostic category in DSM-5-TR (opens in new tab), though the decision notes that treatment-resistant depression is not a standalone DSM-5 diagnosis either, and that there is high international agreement on it.

Of 595 submissions to the consultation before the committee met, 590 were in support, though only 321 included any written component. In opposition, Palliative Care Australia raised concerns that the research remains experimental and currently insufficient to support routine use, the decision records (opens in new tab).

The reasons also record that scheduling may be revisited as evidence and diagnostic criteria mature, and that peak professional bodies not yet heard would be asked before any final decision. As of 23 September 2026 none has been published, and no statutory deadline governs when one must come. We check again on 30 November 2026.