Legal status by country
Is Linaclotide legal?
Written by Aaron CuhaReviewed Sep 2026
How Linaclotide 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 | Approved | Approved | Approved |
| Classification | FDA-approved, prescription only | Licensed, prescription only (MHRA) | TGA-registered, prescription only | Health Canada approved, prescription only |
| Note | Approved for irritable bowel syndrome with constipation and chronic idiopathic constipation. Boxed warning contraindicating use in children under two years due to risk of serious dehydration. | None recorded | None recorded | None recorded |
US FDA status: 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.. Reviewed Sep 2026.
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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.