Therapeutic Goods Administration (TGA), Australian Government Department of Health, Disability and Ageing
Is Setmelanotide legal in Australia?
Not approvedNo setmelanotide product is on the ARTG and none appears on the TGA's evaluation list. Access would need an unapproved-medicine pathway.
Not approved as a medicine here.
A keyword search of the ARTG on 29 September 2026 found no setmelanotide product, including under the brand Imcivree, and the TGA list of prescription medicines under evaluation (updated 21 September 2026) shows no application. Registered doctors can apply to the TGA for access to an unapproved medicine for an individual patient through the Special Access Scheme.
Last verified 2026-09-29 · how we verify
Setmelanotide elsewhere
Sources (3)
- 01ARTG keyword search for 'setmelanotide' (no matching results)Therapeutic Goods Administration (TGA) · 2026-09-29 · accessed 2026-09-29
- 02Prescription medicines under evaluation (last updated 21 September 2026)Therapeutic Goods Administration (TGA) · 2026-09-21 · accessed 2026-09-29
- 03Access to unapproved therapeutic goods for individual patients (Special Access Scheme)Therapeutic Goods Administration (TGA) · 2025-12-03 · accessed 2026-09-29