Claimed effect · Linaclotide

Does Linaclotide help with irritable bowel syndrome with constipation?

A
Grade A — established in humans1 phase 3 RCT (n=804, 26 wk) · effect size: moderate
Short answerEstablished in humans. 1 phase 3 RCT (n=804, 26 wk) point the same way: a moderate effect. A 26-week randomised placebo-controlled trial in 804 patients with IBS-C: a third met the composite FDA responder endpoint for abdominal pain and bowel movements, against a seventh on placebo — a number needed to treat of about five.

What the studies show

A 26-week randomised placebo-controlled trial in 804 patients with IBS-C: a third met the composite FDA responder endpoint for abdominal pain and bowel movements, against a seventh on placebo — a number needed to treat of about five.

“In all, 804 patients (mean age = 44 years, female = 90 % , white = 78 % ) were evaluated; 33.7 % of linaclotide-treated patients were FDA end point responders, vs. 13.9 % of placebo-treated patients ( P < 0.0001) (number needed to treat = 5.1, 95 % confidence interval (CI): 3.9, 7.1).”

Verbatim, from the abstractChey WD, Lembo AJ, Lavins BJ, et al. Linaclotide for irritable bowel syndrome with constipation: a 26-week, randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety. Am J Gastroenterol, 2012;107:1702–1712

Several well-run randomised trials in people, pointing the same way. You can plan around this. It still says nothing about whether the effect is worth the side effects for you.

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In context

Linaclotide is a 14-amino-acid peptide with three disulfide bonds, approved since 2012 as Linzess and Constella for irritable bowel syndrome with constipation and for chronic idiopathic constipation. It is taken as a capsule and is minimally absorbed — it acts on guanylate cyclase-C receptors on the luminal surface of the intestine. In a 26-week phase 3 trial, 33.7% of treated patients met the FDA responder endpoint against 13.9% on placebo. Diarrhoea is the dose-limiting effect.

Linaclotide is approved (rx). Legal status differs by country — see the regulation section or the jurisdiction pages.

Questions

Is Linaclotide proven to help with irritable bowel syndrome with constipation?
Yes, as far as human trials can show it: 1 phase 3 RCT (n=804, 26 wk). LYO grades this outcome A.
What studies are behind the grade?
A 26-week randomised placebo-controlled trial in 804 patients with IBS-C: a third met the composite FDA responder endpoint for abdominal pain and bowel movements, against a seventh on placebo — a number needed to treat of about five.
Is Linaclotide approved for this?
Linaclotide is an approved medicine (Approved (Rx)); whether this particular outcome is a licensed indication is stated on the compound page's regulation section.

Other outcomes for Linaclotide

Written and maintained by LYO Research — how pages are written and checked. Reviewed 29 October 2026. Grades count human evidence only; see how LYO grades. Not medical advice. Correct this page →