As of September 2026, plecanatide is an approved medicine in the US for chronic idiopathic constipation and IBS-C. No EU marketing authorisation was found. Its evidence comes from published Phase 3 trials, most of them against placebo, run on the way to approving Trulance. A vial sold as plecanatide outside a pharmacy was not in those trials, and you cannot confirm by looking what it holds.
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What is plecanatide?
Plecanatide is a lab-made chain of 16 amino acids, almost identical to uroguanylin, a natural gut hormone. Synergy Pharmaceuticals developed it, and Bausch Health took it on later. The FDA approved it in January 2017 as Trulance for chronic idiopathic constipation, and widened the label to IBS-C in 2018.
Does plecanatide work?
For chronic idiopathic constipation and for IBS-C, the FDA reviewed the trials and approved it. Most of the evidence is placebo-controlled, and direct trials against linaclotide, its closest competitor in the same class, are lacking.
What we found. 4+ completed randomized trials counted on the record. 2 human study rows listed below, so the number shows with a plus sign until every trial is listed. 1 animal row sits under them.
| Study | Tested in | Status | What it shows |
|---|---|---|---|
| Main Phase 3 trials in chronic idiopathic constipation, or CIC (AJG 2017) | People | Completed. The key trials for FDA approval | The number of complete spontaneous bowel movements rose against placebo. The trials supported the January 2017 approval |
| Main Phase 3 trials in IBS-C | People | Completed, randomized. Approval followed | Belly pain and bowel symptom scores improved against placebo |
| Toxicity studies in young animals | Animals | Completed | Young mice faced a risk of fatal dehydration. The finding informed the limit on use in children under 6 |
Is plecanatide safe?
The main concern on the record is diarrhea. Trulance carries a warning against use in children under 6. In animals, studies in young mice found a risk of fatal dehydration, and that finding is the reason for the age limit. The record adds roughly a decade of use since approval. Those facts are about Trulance. A vial sold under the same name somewhere else is a separate matter, and the vial section covers it.
Is plecanatide legal?
- United States
- Approved by the FDA in January 2017 as Trulance, for chronic idiopathic constipation. IBS-C was added in January 2018.
- European Union
- No EU marketing authorisation found.
- Sport
- Not named on WADA's list. That is not clearance.
Not medical advice. Approval and sport status as of . Medical disclaimer
What is in a vial sold as plecanatide?
The Phase 3 trials above supported the approval of Trulance. The record carries no sign of plecanatide being sold outside pharmacies. If a vial sold as plecanatide reached you another way, those trials did not test it, and the checklist lists what to ask the seller.
What don't we know?
- Whether it differs from linaclotide in effect or in tolerability. Direct trials are lacking.
- Whether an EU marketing authorisation exists. The record identified none.
- Whether a vial sold as plecanatide outside a pharmacy holds what its label says.
The other side
Trulance is prescribed, and a doctor's care comes with it. Its published Phase 3 trials supported two FDA approvals, and the record counts roughly a decade of use since the first. What is lacking is a direct trial against linaclotide, its closest competitor.
What would change this record?
- A head-to-head randomized trial against linaclotide. It would clarify any difference in effect or in tolerability.
Three questions to ask next
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Ask better questions.
More questions about plecanatide
What is plecanatide used for?
- Chronic idiopathic constipation and IBS-C. The FDA approved the first use in January 2017 and the second in January 2018.
Is plecanatide the same as Trulance?
- Trulance is the brand name for plecanatide.
Is plecanatide approved in Europe?
- No EU marketing authorisation found. The record reports that none was identified. It does not report a refusal.
Is plecanatide the same as linaclotide?
- No. They are two medicines in the same class, and the record says both act on the same receptor in the gut lining. Direct trials between them are lacking.
Is plecanatide banned in sport?
- It is not named on WADA's list. That is not clearance, and this record holds no sport source. If you compete, check the current List.
Record checked on . Each source shows the date it was checked.
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