Is Plecanatide legal?
Written by Aaron CuhaReviewed Sep 2026
The US comes first because most people ask about it. Each country has its own page. It names the agency, the law or rule, and what the legal category means in real life.
All four countries, side by side
| What we list | United States · FDA | United Kingdom · MHRA | Australia · TGA | Canada · Health Canada |
|---|---|---|---|---|
| Status | Approved | Not approved | Not approved | Not approved |
| Legal category | FDA-approved, prescription only | Not licensed | Not registered | Not approved |
| Note | NDA 208745, approved 19 January 2017, now owned by Salix. Adults only, for long-term constipation with no known cause and for irritable bowel syndrome with constipation. Must not be used under six years of age. | We found no UK approval for sale as of this review. Linaclotide, a drug that works the same way, is the one licensed in the UK. | We found no TGA registration as of this review. | We found no Health Canada approval as of this review. |
| Agency | Check FDA directly | Check MHRA directly | Check TGA directly | Check Health Canada directly |
US FDA status: FDA-approved on 19 January 2017 under NDA 208745, sold as Trulance. It is for adults with long-term constipation that has no known cause, and for adults with irritable bowel syndrome with constipation. It must not be used in children under six, because of the risk of serious dehydration, and it is avoided in children aged six to under 18. Not approved for weight loss, for leaky gut, or for general gut health.. Reviewed Sep 2026.
Country by country
Is Plecanatide legal in the United States?
Yes. Plecanatide is an approved medicine in the United States. Its legal category is "FDA-approved, prescription only". The approval covers the use on its label. It is given out on prescription, not sold over the counter. Products labeled "research use only" are not covered by that approval, and that label does not make them legal to use in people. On the evidence, 2 completed human trials are cited on its profile.
The full United States answerIs Plecanatide legal in the United Kingdom?
No. Plecanatide is not an approved medicine in the United Kingdom. Its legal category is "Not licensed". Nothing that contains it is allowed for any use in people. Vials labeled "for research use only" get no exception: that label does not make them legal to use in people. On the evidence, 2 completed human trials are cited on its profile.
The full United Kingdom answerIs Plecanatide legal in Australia?
No. Plecanatide is not an approved medicine in Australia. Its legal category is "Not registered". Nothing that contains it is allowed for any use in people. Vials labeled "for research use only" get no exception: that label does not make them legal to use in people. On the evidence, 2 completed human trials are cited on its profile.
The full Australia answerIs Plecanatide legal in Canada?
No. Plecanatide is not an approved medicine in Canada. Its legal category is "Not approved". Nothing that contains it is allowed for any use in people. Vials labeled "for research use only" get no exception: that label does not make them legal to use in people. On the evidence, 2 completed human trials are cited on its profile.
The full Canada answerPlecanatide in sport and the military
Whether Plecanatide is banned in sport is set by the World Anti-Doping Code and by military rules, not by its legal status. Before you compete or get tested, look up Plecanatide by name on the Prohibited List, or look up a named product in Global DRO. Under the World Anti-Doping Code, category S0 bans, at all times, any drug-like substance that meets two tests. No other section of the List covers it. And no government health regulator anywhere has a current approval for it as a treatment in people. Many substances that are approved somewhere are banned by name in another section. So approval does not mean a substance is allowed in sport.
- WADA Prohibited List
- Global DRO (check a named product)
- USADA (US athletes)
- Operation Supplement Safety (US service members)
The rules you compete or serve under decide this, not this page.
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General information, current as of Sep 2026. Not legal advice. Legal status changes. For your own situation, check with the agency or a lawyer. Educational use only. This database summarizes published research and is not medical advice. Where a dose appears it is a record of what a trial or clinic ran, or what people describe doing, with its source attached. Nothing here is a recommendation for personal use. Sellers named on the price pages are ranked by certificate tier, then price, and any affiliate income is disclosed there. Naming a seller is not a recommendation to buy or use anything.