FDA approved Linzess (linaclotide) for IBS-C, CIC, and Pediatric Functional ConstipationFDA approved Linzess for irritable bowel syndrome and constipation in adults and children.

FDA From the archive Source published August 30, 2012 Summary added May 26, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider Linzess for IBS-C in adults and pediatric patients 7 years and older, CIC in adults, and FC in children 6 years and older.

The FDA has approved Linzess (linaclotide) for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients aged 7 years and older, chronic idiopathic constipation (CIC) in adults, and functional constipation (FC) in pediatric patients aged 6 years and older. Linzess is a guanylate cyclase-C agonist that increases intestinal fluid secretion and accelerates transit. For adults with IBS-C, the recommended dose is 290 mcg once daily; for CIC, 145 mcg or 72 mcg once daily; for pediatric IBS-C (7 years and older), 145 mcg once daily; and for pediatric FC (6 years and older), 72 mcg once daily. The drug should be taken on an empty stomach at least 30 minutes before a meal. Clinical trials in adults with IBS-C showed significant improvements in abdominal pain and complete spontaneous bowel movements compared with placebo.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Linzess (linaclotide) is a guanylate cyclase-C agonist. It binds to and activates guanylate cyclase-C on the luminal surface of intestinal epithelial cells, leading to increased intracellular cyclic guanosine monophosphate (cGMP) levels. This stimulates fluid secretion and accelerates intestinal transit.

Indication & Patient Population

Linzess is indicated for: - Irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older. - Chronic idiopathic constipation (CIC) in adults. - Functional constipation (FC) in pediatric patients 6 years of age and older.

Dosing & Administration

- IBS-C adults: 290 mcg orally once daily. - IBS-C pediatric patients 7 years and older: 145 mcg orally once daily. - CIC adults: 145 mcg orally once daily; 72 mcg once daily may be used based on individual presentation or tolerability. - FC pediatric patients 6 years and older: 72 mcg orally once daily. Take on empty stomach at least 30 minutes before a meal at approximately the same time each day. Swallow capsule whole; do not crush or chew. For patients unable to swallow, capsule may be opened and contents sprinkled on applesauce or mixed with water and administered immediately. For nasogastric or gastrostomy tube administration, mix beads with water and administer via tube.

Key Clinical Trial Data

Efficacy for IBS-C in adults was established in two double-blind, placebo-controlled trials (Trials 1 and 2). A total of 800 patients in Trial 1 and 804 patients in Trial 2 (mean age 44 years, 90% female, 77% white) received Linzess 290 mcg or placebo once daily. Patients met Rome II criteria for IBS and had mean abdominal pain score ≥3 (0-10 scale) and <3 complete spontaneous bowel movements (CSBMs) per week during baseline. Trial data for CIC and pediatric populations are not available in the label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Linzess provides a treatment option for patients with IBS-C, CIC, and pediatric functional constipation. It is a guanylate cyclase-C agonist that addresses constipation and abdominal pain. Dosing varies by indication and age. The drug should be taken on an empty stomach.

The FDA has approved a new drug called Linzess (linaclotide) for certain types of constipation and irritable bowel syndrome. Linzess works by increasing fluid in the intestines to help bowel movements happen more easily. It is approved for adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). It is also approved for children: those ages 7 and older with IBS-C, and those ages 6 and older with functional constipation.

For adults with IBS-C, the recommended dose is 290 mcg once daily. For adults with CIC, the dose is 145 mcg or 72 mcg once daily. For children, the dose depends on age and condition. The drug should be taken on an empty stomach at least 30 minutes before a meal.

This approval gives patients and doctors a new option for managing these conditions. Clinical trials showed that Linzess helped reduce abdominal pain and improve bowel movements in adults with IBS-C compared to placebo.

One important thing to know: Linzess is not a cure. If you think this drug might be right for you or your child, talk to your doctor. They can help decide if Linzess is a good choice based on your health history and symptoms.

What this means for you:

Linzess is a new FDA-approved option for certain types of constipation and IBS, but it is not a cure.

Study Details

Study typeFda approval

PublishedAug 2012

View Original Abstract ↓

1 INDICATIONS AND USAGE LINZESS is indicated for the treatment of: • irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older • chronic idiopathic constipation (CIC) in adults • functional constipation (FC) in pediatric patients 6 years of age and older LINZESS is a guanylate cyclase-C agonist indicated for treatment of: Irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older. ( 1 ) Chronic idiopathic constipation (CIC) in adults. ( 1 ) Functional constipation (FC) in pediatric patients 6 years of age and older. ( 1 )

FDA approved Linzess (linaclotide) for IBS-C, CIC, and Pediatric Functional ConstipationFDA approved Linzess for irritable bowel syndrome and constipation in adults and children.

Study Details

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FDA approved Linzess (linaclotide) for IBS-C, CIC, and Pediatric Functional ConstipationFDA approved Linzess for irritable bowel syndrome and constipation in adults and children.

Study Details

Higher TyG Index Linked to 4.36-Fold Increased Odds of NAFLD in Large Meta-Analysis

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Clinical research that matters. Delivered to your inbox.

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