Is OSK Partial Reprogramming legal in Australia?

Three of the four Yamanaka factors, switched on briefly to reset epigenetic marks without erasing cell identity. Every efficacy result is in mice. One phase 1 safety trial is recruiting, in 18 people, in one eye.

Partial reprogramming is the idea that ageing cells keep a readable record of their younger epigenetic state, and that turning on a subset of the Yamanaka factors for a short period can recover it. OSK is that subset: Oct4, Sox2 and Klf4, with c-Myc deliberately left out because c-Myc is an oncogene.

Mechanism: Established in mice. OSK expression drives partial erasure and rewriting of DNA methylation marks, moving the methylation profile of a cell toward a younger pattern without progressing to pluripotency.

Regulatory history: Not approved in any country for any indication. No reprogramming therapy has ever been approved. One investigational product, Life Biosciences ER-100, is in a recruiting phase 1 safety study (NCT07290244).

Registers or lists therapeutic goods on the ARTG and schedules substances in the Poisons Standard. Many peptides are Schedule 4 (prescription only), so possession without a prescription and personal importation are restricted even when no product is registered.

The classification above is the The Longevity Archive reading of Therapeutic Goods Administration listings for OSK Partial Reprogramming at the reviewed date, not a legal opinion. Rules change, and importing, prescribing and possessing a compound can each be treated differently. Check the regulator directly before acting on anything here.