Is PL8177 legal in the United States?

PL8177 in the United States at a glance

Classification and note come from the PL8177 profile, checked against U.S. Food and Drug Administration (FDA) listings at the reviewed date.

What this means

• 01

  PL8177 is being studied in registered clinical trials but has not received FDA marketing approval in the United States.

• 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 FDA treats this kind of product

Approves prescription drugs by indication and polices unapproved products, including peptides sold online. Compounding pharmacies may prepare some compounds under a prescription when the FDA places them on a permitted bulk-substances category.

The classification above is the The Longevity Archive reading of U.S. Food and Drug 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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