Linaclotide

Generic Name: Linaclotide

Brand Names: Constella, Linzess

Drug Type: Small Molecule

Chemical Formula: C_₅₉H_₇₉N_₁₅O_₂₁S_₆

CAS Number: 851199-59-2

Unique Ingredient Identifier: N0TXR0XR5X

Background: Linaclotide is a synthetic 14-amino acid cyclic peptide and first-in-class guanylate cyclase-C (G-CC) agonist. Linaclotide is structurally related to human guanylin and uroguanylin, paracrine peptide hormones that are endogenous activators of GC-C. It is also a homolog of a heat-stable enterotoxin derived from Escherichia coli, the first natural ligand that activates GC-C.

Linaclotide is used for the treatment of various types of constipation, including irritable bowel syndrome with constipation. Linaclotide was first approved by the FDA on August 30, 2012. It gained EMA and Health Canada approval on November 26, 2012 and December 3, 2013, respectively. Linaclotide works to improve the symptoms of constipation and gastrointestinal symptoms of conditions involving constipation.

Indication: Linaclotide is indicated for the treatment of irritable bowel syndrome with constipation in adults. This indication is approved in the US, Canada, and Europe.

In the US and Canada, it is also indicated for the treatment of chronic idiopathic constipation in adults.

In the US, it is also indicated for the treatment of functional constipation in pediatric patients 6 to 17 years of age.

Associated Conditions: Functional Constipation (FC), Irritable Bowel Syndrome With Constipation (IBS-C), Chronic idiopathic constipation (CIC)

Associated Therapies: -

Clinical Trials

A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically

Phase 1

Completed

Conditions: Breast Feeding
Constipation
Irritable Bowel Syndrome

Interventions: Drug: linaclotide

First Posted Date: 2014-08-19

Last Posted Date: 2020-12-19

Lead Sponsor: Forest Laboratories

Target Recruit Count: 7

Registration Number: NCT02220348

Locations: 🇺🇸
University of Iowa, Iowa City, Iowa, United States
🇺🇸
Digestive Disease Specialists Inc (DDSI), Oklahoma City, Oklahoma, United States

Investigation of Linaclotide's Effect on the Bi-directional Brain and Gut Axis in IBS-C Patients

Not Applicable

Completed

Conditions: Irritable Bowel Syndrome With Constipation (IBS-C)

Interventions: Drug: Placebo
Drug: Linaclotide

First Posted Date: 2014-03-05

Last Posted Date: 2018-07-23

Lead Sponsor: Augusta University

Target Recruit Count: 39

Registration Number: NCT02078323

Locations: 🇺🇸
Augusta University, Augusta, Georgia, United States

A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Phase 3

Completed

Conditions: Irritable Bowel Syndrome With Constipation (IBS-C)

Interventions: Drug: Placebo
Drug: Linaclotide

First Posted Date: 2013-06-19

Last Posted Date: 2016-09-27

Lead Sponsor: AstraZeneca

Target Recruit Count: 1722

Registration Number: NCT01880424

Locations: 🇳🇿
Research Site, Wellington, New Zealand

A Study to Evaluate the Effect of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome

Phase 2

Completed

Conditions: Constipation-predominant Irritable Bowel Syndrome (IBS-C)

Interventions: Drug: placebo
Drug: linaclotide

First Posted Date: 2012-10-26

Last Posted Date: 2024-10-18

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 559

Registration Number: NCT01714843

An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

Phase 3

Completed

Conditions: Chronic Constipation
Irritable Bowel Syndrome With Constipation

Interventions: Drug: Linaclotide

First Posted Date: 2008-10-03

Last Posted Date: 2019-02-15

Lead Sponsor: Forest Laboratories

Target Recruit Count: 1559

Registration Number: NCT00765999

Locations: 🇺🇸
Clinical Trials Management of Boca Raton, Inc., Boca Raton, Florida, United States
🇺🇸
Gastrointestinal Specialists of Georgia, PC, Marietta, Georgia, United States
🇺🇸
Atlanta Gastroenterology Associates, LLC, Marietta, Georgia, United States

and more 106 locations