Approved Therapeutic

Linaclotide

Linzess · Constella

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

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EvidenceTier 1
RegulatoryApproved
SafetyWell-Characterized Safety
Clinical phaseApproved
01

Overview

ClassGuanylate cyclase-C agonist peptide
Sponsor / developerAbbVie / Ironwood
Review statusReviewed
Record IDPEP-011
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Plain-language guide

What it was designed or studied for

Designed and approved for specific uses that include Irritable bowel syndrome with constipation, Chronic idiopathic constipation.

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.
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Clinical mechanism

Activates intestinal guanylate cyclase-C to increase fluid secretion and transit.

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

  • Irritable bowel syndrome with constipation
  • Chronic idiopathic constipation
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Human evidence

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

Tier 1
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Preclinical evidence

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

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Regulatory status

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

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Safety

Well-Characterized Safety

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

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

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Treatment pattern

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

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Manufacturing and quality

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

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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.

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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.
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Last reviewed

August 5, 2026 · Reviewed