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IndexedBuilt automatically from public databases on 2026-09-30. Not yet hand-reviewed by PLOBT.How this works →

Plecanatide

FDA approved · Rx

Guanylate cyclase-C agonist

Also known as: Trulance, Trulance Immediate Release, Guanilib, plecanatida, SP-304 (SYNERGY), (3-Glutamic acid(D>E))human uroguanylin, plecanatidum

Evidence score
89/ 100
Strong evidence

Strong, human-grade evidence

  • Regulatory standing. FDA-approved prescription medicine
  • Human trials. Backed by controlled human studies
  • Registered human trials. 15 registered studies on ClinicalTrials.gov, most advanced Phase 3
  • 2 cited sources. Includes primary / regulatory sources

Computed with the same four public criteria as every profile. The human-evidence grade on an indexed profile is set automatically and may change when it is hand-reviewed. It is not a safety score, not a purity rating, and not medical advice, and not a claim that this compound treats, cures, or prevents any condition.

What it is

Plecanatide, sold as Trulance, is a synthetic peptide modeled on uroguanylin, a hormone naturally made in the gut. It activates guanylate cyclase-C receptors on the lining of the intestine, which increases fluid secretion into the gut and is thought to soften stool and speed transit. It acts locally in the gut and is minimally absorbed into the bloodstream.

What the evidence shows

Automatic summaryHuman trials

Plecanatide is FDA approved for chronic idiopathic constipation and irritable bowel syndrome with constipation in adults, supported by Phase 3 trials among about 15 registered human studies. Evidence for uses beyond these approved indications is limited.

Key facts

Molecular formula
C65H104N18O26S4
Molecular weight
1681.9 g/mol
FDA approval
Confirmed on openFDA

Registered human trials

Live from ClinicalTrials.gov, refreshed daily.

15registered studies
Phase 3most advanced phase
14completed (sample)
1recruiting (sample)

Second Plecanatide Study In Irritable Bowel Syndrome With Constipation (IBS-C)

Phase 3CompletedNCT02493452

This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC

Phase 2RecruitingNCT07723924

An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation

Phase 2CompletedNCT03120520

12-Week Study of Plecanatide for CIC (The CIC3 Study)

Phase 3CompletedNCT01982240

Published literature

Live from Europe PMC. This is how much has been published, not how much is proven in humans.

108papers referencing Plecanatide

Chronic idiopathic constipation in adults: epidemiology, pathophysiology, diagnosis and clinical management.

Med J Aust2018

Efficacy of Secretagogues in Patients With Irritable Bowel Syndrome With Constipation: Systematic Review and Network Meta-analysis.

Gastroenterology2018

Efficacy, safety, and tolerability of plecanatide in patients with irritable bowel syndrome with constipation: results of two phase 3 randomized clinical trials.

Am J Gastroenterol2018

American Gastroenterological Association-American College of Gastroenterology Clinical Practice Guideline: Pharmacological Management of Chronic Idiopathic Constipation.

Gastroenterology2023

Sources

Risks, side effects and study doses are only published on hand-reviewed profiles. Want this one reviewed, or spotted something wrong? Tell us.