Approved Therapeutic

Plecanatide

Trulance

Plecanatide is an approved peptide-based therapeutic or diagnostic asset. Product-specific labels define its validated uses and risks.

Compare
EvidenceTier 1
RegulatoryApproved
SafetyWell-Characterized Safety
Clinical phaseApproved
01

Overview

ClassGuanylate cyclase-C agonist peptide
Sponsor / developerBausch Health
Review statusPrimary-source check needed
Record IDPEP-012
02

Plain-language guide

What it was designed or studied for

Designed and approved for specific uses that include Chronic idiopathic constipation, IBS-C.

How it works, simply

It switches on a receptor in the intestine that increases fluid movement and helps stool pass more easily.

This simplified explanation is educational context, not a treatment recommendation or a substitute for the clinical evidence below.
03

Clinical mechanism

Activates intestinal guanylate cyclase-C in a pH-sensitive manner.

Mechanism plausibility is not the same as demonstrated clinical benefit.
04

Applications

  • Chronic idiopathic constipation
  • IBS-C
05

Human evidence

Multiple human studies and regulatory review support at least one product-specific indication.

Tier 1
06

Preclinical evidence

Mechanistic and preclinical findings are tracked separately and are not treated as proof of human clinical benefit.

06

Regulatory status

Approved. Regulatory status is product- and jurisdiction-specific and does not automatically follow from an evidence score.

07

Safety

Well-Characterized Safety

  • Adverse effects vary by product and indication
  • Contraindications and interactions require label review
08

Interactions

Review the current product label and indication-specific literature for pharmacologic and absorption interactions.

09

Treatment pattern

Treatment patterns are product-, indication- and clinician-specific; this educational profile does not provide dosing guidance.

10

Manufacturing and quality

Approved-product identity, formulation and quality controls must not be extrapolated to compounded or RUO copies.

12

Sources

  1. 01
    Primary regulatory record

    Source record prepared for primary-reference linking in the Supabase-backed editorial workflow.

  2. 02
    Clinical trial registry

    Source record prepared for primary-reference linking in the Supabase-backed editorial workflow.

  3. 03
    Peer-reviewed literature

    Source record prepared for primary-reference linking in the Supabase-backed editorial workflow.

13

Gaps and unverified claims

  • Evidence must be interpreted by indication and product label.
  • Approval does not establish safety or efficacy for off-label or compounded copies.
14

Last reviewed

August 5, 2026 · Primary-source check needed