Is Plecanatide legal in Canada?

An oral 16-amino-acid uroguanylin analogue approved in 2017 for chronic idiopathic constipation and irritable bowel syndrome with constipation. In its pivotal phase 3, 20.1 percent of patients on 3 mg were durable responders versus 12.8 percent on placebo, a 7.3 point absolute difference. Its claimed tolerability advantage over linaclotide has never been tested head to head.

Plecanatide is a 16-amino-acid peptide that differs from human uroguanylin, the body's own guanylate cyclase-C ligand, by a single amino acid. The FDA approved it on 19 January 2017 under NDA 208745 for chronic idiopathic constipation in adults, and later for irritable bowel syndrome with constipation.

Mechanism: Agonism at guanylate cyclase-C on the luminal surface of intestinal epithelial cells. Receptor activation raises intracellular cyclic GMP, which activates the cystic fibrosis transmembrane conductance regulator and drives chloride and bicarbonate into the gut lumen, pulling water with them.

Regulatory history: FDA-approved on 19 January 2017 under NDA 208745, marketed as Trulance, for chronic idiopathic constipation and for irritable bowel syndrome with constipation in adults. Contraindicated in patients under six years of age because of the risk of serious dehydration, and its use is avoided in children aged six to under 18. Not approved for weight loss, for gut permeability or leaky gut, or for any general digestive health use.

Authorises drugs for sale through a Notice of Compliance and Drug Identification Number. A compound that is not authorised for sale cannot lawfully be sold for human use, and personal importation of prescription drugs is limited.

The classification above is the The Longevity Archive reading of Health Canada, Health Products and Food Branch listings for Plecanatide 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.