Is Linaclotide legal in Australia?

A 14-amino-acid peptide taken orally that works without being absorbed, acting entirely on receptors in the gut lining. Approved on randomised phase 3 trials for constipation.

Linaclotide is the most interesting design on this page and the reason is counterintuitive: it is an oral peptide that works precisely because it is not absorbed. Oral peptides are normally a pharmaceutical problem, because the gut destroys them and almost nothing reaches the bloodstream.

Mechanism: A 14-amino-acid peptide agonist at guanylate cyclase-C on the apical surface of intestinal enterocytes, mimicking the endogenous peptides guanylin and uroguanylin. Activation raises intracellular and extracellular cyclic GMP, which activates the cystic fibrosis transmembrane conductance regulator chloride channel, driving chloride and bicarbonate into the lumen with sodium and water following.

Regulatory history: FDA-approved as Linzess for irritable bowel syndrome with constipation and for chronic idiopathic constipation in adults, and for functional constipation in children. Carries a boxed warning against use in children under two years because of a risk of serious dehydration.

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 Linaclotide 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.