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

Linaclotide

FDA approved · Rx

Guanylate cyclase-C agonist

Also known as: Linzess, Constella, Linaclotida, ASP0456, MD-1100, ASP-0456, MD-7246 (DELAYED RELEASE FORMULATION)

Evidence score
95/ 100
Strong evidence

Strong, human-grade evidence

  • Regulatory standing. FDA-approved prescription medicine
  • Human trials. Backed by controlled human studies
  • Registered human trials. 60 registered studies on ClinicalTrials.gov, most advanced Phase 4
  • 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

Linaclotide is a synthetic 14 amino acid peptide sold under the brand name Linzess. It acts locally in the gut by activating guanylate cyclase-C receptors on intestinal cells, which increases fluid secretion into the intestine and is thought to reduce pain signaling from the bowel. It is minimally absorbed into the bloodstream.

What the evidence shows

Automatic summaryHuman trials

Linaclotide is FDA approved for irritable bowel syndrome with constipation and chronic idiopathic constipation in adults, and for functional constipation in some pediatric patients, supported by around 60 registered human trials reaching Phase 4. Uses outside these approved indications are not established.

Key facts

Molecular formula
C59H79N15O21S6
Molecular weight
1526.8 g/mol
FDA approval
Confirmed on openFDA

Registered human trials

Live from ClinicalTrials.gov, refreshed daily.

60registered studies
Phase 4most advanced phase
41completed (sample)
3recruiting (sample)

Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation

Phase 3CompletedNCT00765882

A Study to Evaluate Safety of Multiple Dose of ASP0456 in Healthy Subjects

Phase 1CompletedNCT01427387

Efficacy of Linaclotide to Senna for CIC

TerminatedNCT02239510

A Study of Virtual Reality and Linaclotide for IBS-C

RecruitingNCT05796388

Published literature

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

471papers referencing Linaclotide

Linaclotide for irritable bowel syndrome with constipation: a 26-week, randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety.

Am J Gastroenterol2012

A 12-week, randomized, controlled trial with a 4-week randomized withdrawal period to evaluate the efficacy and safety of linaclotide in irritable bowel syndrome with constipation.

Am J Gastroenterol2012

Two randomized trials of linaclotide for chronic constipation.

N Engl J Med2011

Diagnosis and management of chronic constipation in adults.

Nat Rev Gastroenterol Hepatol2016

Sources

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