Linaclotide
Also referenced as: Linzess
A locally acting intestinal peptide used for specific constipation disorders.
- Evidence grade
- AStrong Clinical Evidence
Strong Clinical Evidence
- Regulatory status
- FDA Approved for Specific Indication
The May 2026 FDA label includes IBS-C from age 7, adult chronic idiopathic constipation, and pediatric functional constipation from age 2; contraindicated below age 2.
- Human data
- Yes
Registered clinical trials exist
- Last reviewed
- October 27, 2026
Overview
A locally acting intestinal peptide used for specific constipation disorders.
The May 2026 FDA label includes IBS-C from age 7, adult chronic idiopathic constipation, and pediatric functional constipation from age 2; contraindicated below age 2.
Pediatric age groups and diagnoses are label-specific; it is not a general gut-repair treatment.
Why It's Being Studied
- IBS with constipation
- Chronic idiopathic constipation
- Pediatric functional constipation
Mechanism of Action
Guanylate cyclase-C activation increases intestinal fluid secretion and transit, with effects on visceral pain signalling.
Guanylate cyclase-C activation increases intestinal fluid secretion and transit, with effects on visceral pain signalling. Pediatric age groups and diagnoses are label-specific; it is not a general gut-repair treatment.
From molecular target to clinical evidence
Tap each stage to see what happens.
Background: Clinical Peptide Medicines
Clinical peptide medicines include endocrine treatments, antimicrobial drugs, receptor blockers and targeted diagnostic or cancer agents. They do not share one mechanism or one set of indications.
An approval belongs to a specific medicine and indication. A diagnostic tracer, an antibiotic and a hormone are not interchangeable wellness products; read each profile's own mechanism and prescribing source.
Research Areas & Routes Studied
- IBS with constipation
- Chronic idiopathic constipation
- Pediatric functional constipation
- Oral approved capsule
Evidence Summary
Controlled human trials support bowel-response and relevant symptom outcomes in the approved populations.
Higher tiers carry more weight. Filled tiers have evidence for Linaclotide; tap to read it.
- Controlled human trials support bowel-response and relevant symptom outcomes in the approved populations.
1 cited sources.
- Prescribing label1
Human clinical evidence
- Controlled human trials support bowel-response and relevant symptom outcomes in the approved populations.
Reported Adverse Events in Research
- Severe diarrhea and dehydration can occur; use below age 2 and mechanical gastrointestinal obstruction are contraindicated.
Limitations of Current Evidence
- Pediatric age groups and diagnoses are label-specific; it is not a general gut-repair treatment.
- Findings apply to the product, route and population studied; they do not establish benefits or safety for unrelated wellness uses or research-vial products.
How to Read This Research
- Is this a single molecule or a family of medicines?
- Is the use diagnostic, therapeutic or investigational?
- Does the quoted outcome match the exact product, formulation and population?
- Use the compound-specific mechanism above; this diagram describes drug development, not a shared biological pathway.
- Historical approval, present availability and off-label use are distinct questions.
- For radiopharmaceuticals and hospital medicines, specialist handling is part of the treatment context.
- Indication
- The condition and population for which a medicine is approved.
- Antagonist
- A compound that blocks activity at a receptor.
- Radiopharmaceutical
- A medicine containing a radioactive isotope for imaging or treatment.
Compare With Other Compounds
| Linaclotide | Trofinetide | |
|---|---|---|
| Evidence grade | A — Strong Clinical Evidence | B — Moderate Human Evidence |
| Regulatory status | FDA Approved for Specific Indication | FDA Approved for Specific Indication |
| Human data | Yes | Yes |
| Clinical trials | Registered trials exist | Registered trials exist |
| Research routes | Oral approved capsule | Oral approved medicine |
| Cited sources | 1 | 2 |
Frequently Asked Questions
Research References
- Prescribing label
Linaclotide — prescribing label