Legal status by country
Is Plecanatide legal?
Written by Aaron CuhaReviewed Sep 2026
How Plecanatide is classified in the United States, United Kingdom, Australia and Canada, side by side. Each country has its own page with a direct answer, the regulator's approval status and what the classification means in practice.
All four countries, side by side
| Attribute | United States · FDA | United Kingdom · MHRA | Australia · TGA | Canada · Health Canada |
|---|---|---|---|---|
| Status | Approved | Not approved | Not approved | Not approved |
| Classification | FDA-approved, prescription only | Not licensed | Not registered | Not approved |
| Note | NDA 208745, approved 19 January 2017, now Salix. Adults only, for chronic idiopathic constipation and irritable bowel syndrome with constipation. Contraindicated under six years of age. | No UK marketing authorisation identified as of this review. Linaclotide is the guanylate cyclase-C agonist licensed in this market. | No TGA registration identified as of this review. | No Health Canada authorisation identified as of this review. |
US FDA status: 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.. Reviewed Sep 2026.
Related compounds
General information current as of Sep 2026, not legal advice. Classifications change; confirm with the regulator or a lawyer for a specific situation. Educational use only. This database summarizes published research. It is not medical advice and contains no dosing protocols or recommendations for personal use. The Longevity Archive has no vendor relationships.