Linaclotide

(Linzess®)

Linaclotide

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Drug updated on 4/15/2024

Dosage FormCapsule (oral; 72 mcg, 145 mcg, 290 mcg)
Drug ClassGuanylate cyclase-C agonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults.
  • Indicated for the treatment of chronic idiopathic constipation (CIC) in adults.
  • Indicated for the treatment of functional constipation (FC) in pediatric patients 6 to 17 years of age.

Summary
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  • Linaclotide (Linzess) is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C), chronic idiopathic constipation (CIC) in adults, and functional constipation (FC) in pediatric patients aged 6 to 17 years. It demonstrates substantial efficacy across these conditions, particularly notable for its effectiveness at relieving abdominal bloating among FDA-licensed drugs for IBS-C.
  • Information was derived from a total of eight systematic reviews and meta-analyses that compared linaclotide's safety and effectiveness against other treatments such as lubiprostone, elobixibat, and various laxatives.
  • In terms of safety profiles when treating CC and IBS-C, linaclotide is primarily associated with diarrhea as the main adverse reaction. This differs from other treatments like lubiprostone or elobixibat which may have different side effects.
  • A study focusing on Japanese patients revealed potential variability in response across different ethnicities; while linaclotide showed equal efficacy to new medications overall, elobixibat and lubiprostone might be more effective at increasing spontaneous bowel movements within this population group.
  • Linaclotide has been found effective not only for specific symptoms but also forms part of broader assessments related to increasing spontaneous bowel movements - an important factor in managing chronic constipation conditions.
  • While being versatile enough to treat a range of constipation-related disorders across age groups including adults with IBS-C or CIC or children aged between 6 to 17 years suffering from FC; considering individual variability in response, particularly based on ethnicity observed in studies, remains crucial.

Product Monograph / Prescribing Information

Document TitleYearSource
Linzess (linaclotide) Prescribing Information.2023AbbVie, Inc. North Chicago, IL and Ironwood Pharmaceuticals, Inc. Boston, MA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines