Therapeutic Goods Administration (TGA), Australian Government Department of Health, Disability and Ageing
Is Elamipretide (SS-31) legal in Australia?
Not approvedNo elamipretide product is on the ARTG and none appears on the TGA's evaluation list.
Not approved as a medicine here.
A keyword search of the ARTG on 29 September 2026 returned no elamipretide product, and the TGA list of prescription medicines under evaluation (updated 21 September 2026) shows no elamipretide application. It is an unapproved therapeutic good in Australia; access for an individual patient would need a route such as the Special Access Scheme.
Last verified 2026-09-29 · how we verify
Elamipretide (SS-31) elsewhere
Sources (3)
- 01ARTG keyword search for 'elamipretide' (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