What the studies show
A separate licensed indication with its own phase 3 trials at lower doses; the label carries both, and a paediatric functional-constipation indication was added later.
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.
- 1Linzess (linaclotide) prescribing information.DailyMed, read 29 Oct 2026Oral route, negligible systemic availability, indications and the contraindication under 2 years of age.
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 chronic idiopathic constipation?
What studies are behind the grade?
Is Linaclotide approved for this?
Other outcomes for Linaclotide
- AIrritable bowel syndrome with constipation1 phase 3 RCT (n=804, 26 wk)
- ADiarrhoeaadverse1 phase 3 RCT (n=804); approval programme
- ASystemic effectsLabel pharmacokinetics
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 →