Is PL8177 legal in Australia?

PL8177 in Australia at a glance

Classification and note come from the PL8177 profile, checked against Therapeutic Goods Administration (TGA) listings at the reviewed date.

What this means

• 01

  PL8177 is being studied in registered clinical trials but has not received TGA marketing approval in Australia.

• 02

  Lawful human access is limited to trial participation or a formal early-access scheme where one exists; there is no pharmacy product to prescribe.

• 03

  Vials sold online "for research use only" are not trial material, and that label does not make human use lawful.

What PL8177 is

Palatin's oral melanocortin-1 receptor agonist peptide for ulcerative colitis, with a small Phase 2 showing 33% remission versus 0% on placebo before the study was cut short for licensing.

PL8177 is a cyclic peptide agonist of MC1R designed to act in the gut and resolve inflammation rather than suppress the immune system. The Phase 2 in ulcerative colitis stopped at 12 patients when Palatin sought a partner, reporting clinical remission in 33% versus 0% and clinical response in 78% versus 33%, with no adverse events.

Mechanism: MC1R agonism on immune cells and gut epithelium promoting resolution of inflammation.

Regulatory history: Investigational; Phase 2

How TGA treats this kind of product

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 PL8177 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.

PL8177 in other countries

Frequently asked questions

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