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Gastrointestinal

Plecanatide

Also called Trulance

Plecanatide (brand name Trulance) is a prescription tablet for long-term constipation in adults. It is a small man-made copy of uroguanylin, a hormone-like peptide the gut makes, and it works inside the intestine to draw water into the bowel. It is FDA-approved for chronic idiopathic constipation (2017) and irritable bowel syndrome with constipation (2018), and it must not be used in young children.

FDA-approvedApproved by the FDA for at least one use after large human trials.

New · under editorial review. Added October 30, 2026 by our automated research, with every claim sourced. A person has not checked this page yet; treat it with extra care. How we research

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Illustrative chain. The exact sequence has not been published in a source we could verify.

Overview

Plecanatide (brand name Trulance) is a prescription tablet for long-term constipation in adults. It is a small man-made copy of uroguanylin, a hormone-like peptide the gut makes, and it works inside the intestine to draw water into the bowel. It is FDA-approved for chronic idiopathic constipation (2017) and irritable bowel syndrome with constipation (2018), and it must not be used in young children.

How it works

Established: plecanatide switches on guanylate cyclase-C (GC-C), a receptor on the inner lining of the intestine. This raises cyclic GMP inside and outside the cells, which drives chloride and bicarbonate out through the CFTR channel. Water follows, so stools get softer and move faster 1. It acts locally: at the approved dose it is almost never measurable in the blood 16. Proposed: a computer-modeling study suggests plecanatide keeps uroguanylin's pH-sensitive shape and is most active at about pH 5, which the authors link to the upper small intestine; linaclotide, by contrast, was rigid and resembled a bacterial toxin peptide 7. This pH idea comes from modeling, not human studies.

What research shows

  • Phase 3 CIC trial (human RCT, n=1,394, 12 weeks): 21.0% on 3 mg and 19.5% on 6 mg were durable responders (better bowel movements most weeks) vs 10.2% on placebo 4.
  • FDA label CIC data (two human RCTs, 905 and 870 randomized): responder rates on 3 mg were 21% vs 10% and 21% vs 13% on placebo 1.
  • Two phase 3 IBS-C trials (human RCTs, 2,189 randomized, 12 weeks): overall responders (less belly pain plus more complete bowel movements) were 30.2% and 21.5% on 3 mg vs 17.8% and 14.2% on placebo 5.
  • Phase 3 trial in China (human RCT, n=648, functional constipation, 12 weeks): durable responders 23.5% on 3 mg vs 10.2% on placebo 8.
  • Phase 1 single-dose study (healthy volunteers, n=72): no measurable absorption into the blood at 0.1–48.6 mg; side-effect rates similar to placebo 6.
  • The label states that a 6 mg dose did not add benefit over 3 mg and caused more side effects 1.

Doses studied in people

Study or labelDose usedSource
FDA label (adults with CIC or IBS-C)3 mg by mouth once daily1
Phase 3 RCT in CIC (n=1,394, 12 weeks)3 mg or 6 mg by mouth once daily vs placebo4
Two phase 3 RCTs in IBS-C (n=2,189, 12 weeks)3 mg or 6 mg by mouth once daily vs placebo5
Phase 3 RCT in functional constipation, China (n=648, 12 weeks)3 mg by mouth once daily vs placebo8
Phase 1 single-dose study in healthy volunteers (n=72)Single oral doses from 0.1 mg to 48.6 mg6

Doses shown are from the FDA label and published trials only; they are reported, not recommended.

Read this first: these are the amounts given to participants in published studies or written on official prescribing labels, reported for reference. They are not recommendations. Trial doses were chosen for specific patients under medical supervision, and a dose that is safe in one person can be harmful in another.

Safety

  • Boxed warning (label): risk of serious dehydration in children. It is contraindicated under age 6 because single doses killed young juvenile mice through dehydration, and use from 6 to under 18 should be avoided 1.
  • Diarrhea is the most common side effect (label): 5% vs 1% on placebo in CIC trials and 4.3% vs 1% in IBS-C trials; severe diarrhea occurred in 0.6% (CIC) and 1% (IBS-C) 1.
  • Stopping treatment because of side effects (label): 4% vs 2% on placebo in CIC and 2.5% vs 0.4% in IBS-C 1.
  • Contraindicated in people with known or suspected mechanical bowel blockage 1.
  • Reported after approval (label): allergic-type reactions such as itching, hives and rash, and vomiting 1.
  • Safety and effectiveness in people under 18 have not been established 1.

Report side effects of any drug or product to the FDA through MedWatch. For a possible poisoning in the US, call Poison Control at 1-800-222-1222.

Storage and stability

Label: store at room temperature (20–25°C), keep dry in the original bottle with its desiccant 1.

General lab handling, not instructions for personal use. See Storage and stability.

History

Developed by Synergy Pharmaceuticals 46. In a 2013 first-in-human study, single doses up to 48.6 mg in healthy volunteers produced no measurable blood levels 6. The FDA approved Trulance as a new molecular entity for chronic idiopathic constipation on January 19, 2017, and on January 24, 2018 approved a supplement (S-001) that added irritable bowel syndrome with constipation 23. The application is now held by Salix 2. A phase 3 trial in Chinese adults with functional constipation was published in 2025 8.

Common questions

Is plecanatide FDA-approved?

Yes. It is approved as Trulance for adults with chronic idiopathic constipation (2017) and irritable bowel syndrome with constipation (2018) 12.

How is plecanatide different from linaclotide?

Both turn on the same gut receptor, GC-C 1. Plecanatide is modeled on the body's own uroguanylin, and a computer study suggests it is pH-sensitive like uroguanylin, while linaclotide is more rigid and resembles a bacterial toxin peptide 7.

How well does it work?

In 12-week trials, about 21–30% of adults on 3 mg met the strict responder goals, compared with about 10–18% on placebo 45.

What are the main risks?

Diarrhea is the most common side effect, at about 4–5% vs 1% on placebo 1. The label has a boxed warning about serious dehydration in children; it must not be used under age 6 1.

Does plecanatide get into the bloodstream?

Very little. At the approved dose it was below measurable levels in most blood samples, and single doses up to 48.6 mg in volunteers showed no measurable absorption 16.

Is plecanatide banned in sport?

It is not named on the 2026 WADA Prohibited List 12.

Related compounds

GastrointestinalFDA-approvedFlashcard

Linaclotide

Linzess · Constella

Linaclotide is a small peptide pill that works inside the gut to treat chronic constipation and constipation-type irritable bowel syndrome.

GastrointestinalLate-stage trialsFlashcard

Larazotide

larazotide acetate · AT-1001

Larazotide is a small, swallowed peptide designed to tighten the seals between cells lining the gut.

GastrointestinalFDA-approvedFlashcard

Teduglutide

Gattex · Revestive

Teduglutide is a longer-lasting version of GLP-2, a gut hormone that helps the intestine grow and absorb nutrients.

Sources

  1. Trulance (plecanatide) tablets Prescribing Information, revised 3/2024 (DailyMed) FDA label
  2. Drugs@FDA: NDA 208745 Trulance (plecanatide) approval history Regulatory
  3. Bausch Health correspondence to FDA on NDA 208745 (Dec 2024), confirming Supplement S-001 added the IBS-C indication (hosted on fda.gov) Regulatory
  4. Miner PB Jr et al. A randomized phase III clinical trial of plecanatide in chronic idiopathic constipation. Am J Gastroenterol 2017 (PMID 28169285) Journal
  5. Brenner DM et al. Efficacy, safety, and tolerability of plecanatide in IBS-C: results of two phase 3 trials. Am J Gastroenterol 2018 (PMID 29545635) Journal
  6. Shailubhai K et al. Plecanatide, an oral guanylate cyclase C agonist acting locally in the GI tract, is safe and well-tolerated in single doses. Dig Dis Sci 2013 (PMID 23625291) Journal
  7. Brancale A et al. Therapeutically targeting guanylate cyclase-C: computational modeling of plecanatide, a uroguanylin analog. Pharmacol Res Perspect 2017 (PMID 28357122) Journal
  8. Bai T et al. Efficacy and safety of plecanatide in Chinese patients with functional constipation: a phase III RCT. Drugs 2025 (PMID 40571893) Journal
  9. PubChem CID 70693500: plecanatide computed properties Regulatory
  10. PubChem CID 70693500: plecanatide sequence (biologic line notation) Regulatory
  11. PubChem CID 70693500: plecanatide CAS registry number Regulatory
  12. WADA World Anti-Doping Code International Standard: Prohibited List 2026 (full list, Asia Rugby mirror) Regulatory

Curious how a compound like this one becomes an approved medicine? The Academy track How a peptide becomes a medicine walks through it. You can try the Academy free first.

Last reviewed 2026-10-30 · How we research · Found an error? See our corrections policy.