Specialty & Research

Linaclotide

Guanylate cyclase-C agonist

A guanylate cyclase-C agonist peptide studied in gastrointestinal research, including chronic constipation trials.

Compiled by PeptiDexProfile review date 2026-09-201 linked reference How to read the evidence ↗

Overview

Two placebo-controlled phase 3 trials evaluated linaclotide in adults with chronic constipation. The studies assessed bowel symptoms and tolerability over 12 weeks, with a withdrawal period in one trial.

At a glance

ClassGuanylate cyclase-C agonist

CategorySpecialty & Research

Page purposeResearch and educational reference

Regulatory statusThis page summarizes the cited research. Regulatory authorization is specific to a product, indication and jurisdiction; consult the relevant regulator for current labeling.

Selected evidence, in context

A closer reading of selected linked publications. This is not a systematic review, an evidence grade or a complete account of safety and effectiveness.

Two randomized, double-blind, placebo-controlled phase 3 trials

Two randomized trials of linaclotide for chronic constipation

Population or model: 1,276 people with chronic constipation; 12 weeks
Research question: Did linaclotide improve a prespecified complete spontaneous bowel-movement endpoint?
Reported finding: More participants receiving linaclotide met the combined bowel-frequency and improvement endpoint than those receiving placebo. Diarrhea caused 4.2% of linaclotide recipients to discontinue treatment.
What this cannot establish: The trials evaluated chronic constipation over 12 weeks. They do not establish long-term outcomes or results for every gastrointestinal condition.

Reading note checked 2026-09-20 · PMID 21830967 · citation and indexing details

Mechanism of action

Linaclotide is a guanylate cyclase-C agonist studied for local intestinal effects.

Mechanistic description reflects published research-literature understanding. Much peptide research is preclinical (in-vitro or animal-model); mechanism in humans may differ and is not established for many compounds.

What it's studied for

Research contexts in which Linaclotide appears in the literature. Listing a research area is not a claim of efficacy or a therapeutic indication.

Key characteristics

Diarrhea was a relevant adverse event in these studies. Trial findings apply to the studied formulation and population, not to unrelated gastrointestinal claims.

How it compares

Diarrhea was a relevant adverse event in these studies. Trial findings apply to the studied formulation and population, not to unrelated gastrointestinal claims.

Handling & Stability

Lyophilized peptides are stored cold, protected from light, and reconstituted only at the time of intended in-vitro work.

Avoid repeated freeze-thaw cycles
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Follow institutional lab-safety protocols

Analytical & COA Concepts

Reputable research suppliers publish a third-party Certificate of Analysis per batch. Key analytical concepts referenced in COAs include:

Category Context

Linaclotide sits in the Specialty & Research area of the PeptiDex library.

Research reference

No supplier listing is attached to this profile. The cited study describes its own formulation and population.

Read the evidence guide →

Frequently asked questions

What is the evidence context for Linaclotide?

Diarrhea was a relevant adverse event in these studies. Trial findings apply to the studied formulation and population, not to unrelated gastrointestinal claims.

Does this reference establish that a supplier product is equivalent?

No. A study of a defined pharmaceutical formulation does not verify the identity, purity, sterility or clinical suitability of any separately sold material.

Answers are educational summaries of research-literature context and do not constitute medical advice. See the Research Library, COA guide, and Storage & Handling guide for more.

References

Publications indexed in PubMed and linked to this profile, including original studies and reviews. Publication labels reflect PubMed indexing, not evidence strength. Listing a study records that it exists and is indexed — it is not a claim of efficacy, a therapeutic indication, or an endorsement of its conclusions. Much of this literature is preclinical (in-vitro or animal-model).

Two randomized trials of linaclotide for chronic constipation N Engl J Med, 2011. PubMed 21830967
Randomized controlled trial · Citation and indexing details

Bibliographic metadata refreshed from PubMed on 2026-09-20. This checks the record identity and metadata; it is not a new review of every scientific claim. A reference may concern a related molecule or formulation: read its methods and the context above. See the editorial policy.