Plecanatide

Plecanatide

Evidence & Status

  • FDA Approved
  • Strong Human Evidence
  • Established

FDA Approval Scope

U.S. approval: treatment of chronic idiopathic constipation or irritable bowel syndrome with constipation in adults.

At a Glance

An FDA-approved oral peptide for adults with chronic idiopathic constipation or IBS with constipation. Its label carries a boxed warning about serious dehydration risk in children.

Plain English

Plecanatide, sold as Trulance, acts in the intestine to help with constipation. Adult trials support its approved uses. Diarrhea is its most common side effect, and the medicine must be kept away from children.

Overview

Plecanatide is a 16-amino-acid peptide and guanylate cyclase-C agonist that acts locally in the intestine. Trulance is approved in the United States for adults with chronic idiopathic constipation (CIC) or irritable bowel syndrome with constipation (IBS-C).

Research Summary

Randomized Phase 3 trials support both adult indications. In one 1,394-person CIC trial, 21.0% receiving the studied 3 mg dose met its durable bowel-movement response definition versus 10.2% receiving placebo. Two IBS-C trials randomized 2,189 adults altogether; their respective 3 mg response rates were 30.2% versus 17.8% and 21.5% versus 14.2%. The conditions and response definitions differ; these percentages must not be compared as though they measure the same outcome.

Research Areas

  • Chronic idiopathic constipation
  • IBS-C
  • Gastrointestinal motility

Safety & Risks

Serious Risks

  • The label warns of serious dehydration risk in children: Trulance is contraindicated under age 6 and should be avoided from ages 6 through 17.
  • Severe diarrhea can occur.
  • Trulance is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.

Reported Side Effects

  • Diarrhea
United States
FDA-approved as Trulance for adults with CIC or IBS-C.
United Kingdom
Current authorization status not established in this record.
Australia
Current authorization status not established in this record.
Canada
Trulance is authorized for adults with IBS-C and CIC.

Citations & Sources