FDA OKs Linaclotide in Young Children
Phase 3 data expanded use of linaclotide 72 mcg in pediatric functional constipation.
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By
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Kathryn Wighton
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May 27, 2026
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Clinical Scorecard: FDA OKs Linaclotide in Young Children
At a Glance
| Category | Detail |
|---|
| Condition | Functional Constipation |
| Key Mechanisms | Guanylate cyclase-C agonist |
| Target Population | Pediatric patients aged 2 years and older |
| Care Setting | Outpatient |
Key Highlights
- Linaclotide approved for children aged 2 to 5 years with functional constipation.
- Previously approved for patients aged 6 years and older.
- Estimated worldwide prevalence of functional constipation in preschool-aged children is approximately 3%.
- Approval supported by a 12-week phase 3 randomized placebo-controlled trial.
- Diarrhea is the most commonly reported adverse reaction.
Guideline-Based Recommendations
Diagnosis
- Functional constipation characterized by infrequent, hard, and painful bowel movements.
Management
- Linaclotide is the only FDA-approved prescription therapy for pediatric functional constipation.
Monitoring & Follow-up
- Monitor for adverse reactions, particularly diarrhea.
Risks
- Contraindicated in patients younger than 2 years due to risk of serious dehydration.
Patient & Prescribing Data
Pediatric patients aged 2 years and older with functional constipation.
Capsule contents can be mixed with applesauce or water for administration.
Clinical Best Practices
- Consider linaclotide for children aged 2-5 years who do not respond to over-the-counter therapies.
- Utilize evidence-based treatment options for managing functional constipation.
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