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Gut & neuroendocrine

Plecanatide

A 16-amino-acid oral peptide modelled on the natural gut hormone uroguanylin, approved for chronic constipation and IBS-C in adults.

L5Practice-changingApproved medicineApprovedHigh confidenceLast reviewed 2026-08-23
Oral

Also known as: Trulance

Evidence passport

Last reviewed 2026-08-23

Evidence level
L5Practice-changing
Confidence
High confidence
Human efficacy
78/100
Human safety
75/100
Regulatory status
Approved medicine
Development
Approved
Routes
Oral
Evidence base
Includes human data
Furthest stage
Approved
Source curation
Sources fully curated
Clinical maturity
Established oral gut peptide

Overview

Human evidence78/100
Preclinical evidence68/100
Human safety evidence75/100

Clinical maturity: Established oral gut peptide

Routes & formulations

Studied / approved routes

Oral

An oral tablet acting locally in the gut with minimal systemic exposure.

Route availability is not evidence of efficacy, and evidence from one route does not transfer to another. The Registry never provides dosing or sourcing information.

Peptide lifecycle

  1. Discovery

  2. Preclinical

  3. Phase I

  4. Phase II

  5. Phase III

  6. Approved

Approved

What it is

A synthetic uroguanylin analogue that activates guanylate cyclase-C in the intestine to increase fluid secretion.

What people claim

  • Relieves chronic idiopathic constipation and IBS-C in adults

What the evidence actually says

Pivotal randomised trials supported its adult constipation indications; like linaclotide it demonstrates that oral peptide delivery is viable when the target is the gut itself.

Human evidence

  • Pivotal randomised placebo-controlled trials in CIC and IBS-C.

Preclinical evidence

  • GC-C pharmacology and uroguanylin-pathway characterisation.

Animal and cell findings are Level 1–2 evidence.

Mechanism and pathways

  • GC-C agonism raises epithelial cGMP, increasing intestinal fluid secretion and transit.

Safety and unknowns

  • Diarrhoea is the most common labelled adverse effect.
  • Labelled paediatric restrictions reflect juvenile animal findings; adult use only under the current label.

Cancer relevance

No concern identified

No established human cancer signal within approved use.

Regulatory status

FDA-approved (Trulance) for chronic idiopathic constipation and irritable bowel syndrome with constipation in adults under its current label.

Evidence grade

L5Practice-changingHigh confidence

Replicated large randomised trials, pivotal Phase 3 programmes, or a major regulatory decision.

What would change our rating?

  • Not applicable at this evidence tier.

References and sources

Sources fully curated

Source hierarchy: regulatory documents and trial registries first, peer-reviewed work next, sponsor material flagged as non-independent. We never use supplier or clinic marketing as evidence, and where a verified source has not yet been curated we say so rather than inventing one.

Evidence change history

No recorded changes yet. Baseline position set on 2026-08-23.