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)

Clinical Trials

Clinical Study on the Application of Lactulose Combined with Linaclotide in Bowel Preparation for Colonoscopy

Phase 4

Conditions: Lactulose
Bowel Preparation

Interventions: Drug: Lactulose+ linaclotide
Drug: Lactulose
Drug: polyethylene glycol (PEG)

First Posted Date: 2024-12-27

Last Posted Date: 2024-12-27

Lead Sponsor: Haifeng Lan

Target Recruit Count: 444

Registration Number: NCT06748638

Locations: 🇨🇳
Jinling Hospital, China, Nanjing, Jiangsu, China

A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotide

Phase 2

Active, not recruiting

Conditions: Functional Constipation

Interventions: Drug: Linaclotide
Drug: Placebo

First Posted Date: 2023-03-08

Last Posted Date: 2025-05-21

Lead Sponsor: AbbVie

Target Recruit Count: 19

Registration Number: NCT05760313

Locations: 🇺🇸
Velocity Clinical Research - Phoenix /ID# 263871, Phoenix, Arizona, United States
🇺🇸
HealthStar Research of Hot Springs PLLC /ID# 251553, Hot Springs, Arkansas, United States
🇺🇸
Advanced Research Center /ID# 248763, Anaheim, California, United States

and more 35 locations

A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation

Phase 3

Active, not recruiting

Conditions: Chronic Idiopathic Constipation (CIC)
Functional Constipation (FC)

Interventions: Drug: Placebo for Linaclotide
Drug: Linaclotide

First Posted Date: 2022-12-15

Last Posted Date: 2025-05-07

Lead Sponsor: AbbVie

Target Recruit Count: 123

Registration Number: NCT05652205

Locations: 🇺🇸
G & L Research, LLC /ID# 250658, Foley, Alabama, United States
🇺🇸
Velocity Clinical Research Phoenix /ID# 266280, Phoenix, Arizona, United States
🇺🇸
HealthStar Research of Hot Springs PLLC /ID# 249481, Hot Springs, Arkansas, United States

and more 45 locations

Effect and Safety of Polyethylene Glycol Combined With Linaclotide on Colon Cleansing for Patients With Chronic Constipation

Not Applicable

Conditions: Bowel Preparation

Interventions: Drug: Compound Polyethylene Glycol Electrolyte Powder
Drug: Linaclotide

First Posted Date: 2021-11-30

Last Posted Date: 2021-11-30

Lead Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University

Target Recruit Count: 300

Registration Number: NCT05137145

Locations: 🇨🇳
The second affiliated hospital of xi'an jiaotong university, Xi'an, Shaanxi, China

Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders

Phase 4

Conditions: Constipation-predominant Irritable Bowel Syndrome
Functional Dyspepsia

Interventions: Drug: Linaclotide
Drug: Lactulose
Drug: Omeprazol
Drug: Itopride

First Posted Date: 2021-11-26

Last Posted Date: 2021-12-13

Lead Sponsor: RenJi Hospital

Target Recruit Count: 78

Registration Number: NCT05134584

Locations: 🇨🇳
RenJiH, Shanghai, Shanghai, China

GCC Agonist Signal in the Small Intestine

Phase 1

Active, not recruiting

Conditions: Malignant Digestive System Neoplasm
Barrett Esophagus
Gastroesophageal Reflux Disease

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Esophagogastroduodenoscopy
Drug: Linaclotide
Drug: Plecanatide

First Posted Date: 2021-11-04

Last Posted Date: 2025-05-21

Lead Sponsor: University of Wisconsin, Madison

Target Recruit Count: 43

Registration Number: NCT05107219

Locations: 🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
🇺🇸
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

and more 1 locations

Evaluation of Clinical Equivalence Between Two Linaclotide Products in the Treatment of Chronic Idiopathic Constipation

Phase 3

Conditions: Chronic Idiopathic Constipation

Interventions: Drug: Placebo
Drug: LINZESS®
Drug: Linaclotide

First Posted Date: 2021-03-18

Last Posted Date: 2021-03-18

Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Target Recruit Count: 750

Registration Number: NCT04804267

Locations: 🇨🇳
Renji Hospital, Medical Collge of Shanghai Jiaotong University, Shanghai, Shanghai, China

Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation

Phase 2

Completed

Conditions: Functional Constipation

Interventions: Drug: Placebo
Drug: Linaclotide

First Posted Date: 2019-10-01

Last Posted Date: 2022-04-26

Lead Sponsor: Allergan

Target Recruit Count: 35

Registration Number: NCT04110145

Locations: 🇺🇸
HealthStar Research, Hot Springs, Arkansas, United States
🇺🇸
Foundation Pediatrics Med Clinical Research Partners, LLC, East Orange, New Jersey, United States
🇺🇸
David M. Headley, MD, P.A., Port Gibson, Mississippi, United States

and more 14 locations

Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)

Phase 3

Completed

Conditions: Functional Constipation
Irritable Bowel Syndrome With Constipation

Interventions: Drug: Placebo
Drug: Linaclotide

First Posted Date: 2019-07-19

Last Posted Date: 2024-11-26

Lead Sponsor: AbbVie

Target Recruit Count: 438

Registration Number: NCT04026113

Locations: 🇺🇸
Medclinical Research Partners LLC/ Foundation Pediatrics /ID# 232783, East Orange, New Jersey, United States
🇺🇸
University of New Mexico /ID# 233011, Albuquerque, New Mexico, United States
🇺🇸
The Children's Hospital at Montefiore /ID# 232638, Bronx, New York, United States

and more 112 locations

Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer

Phase 2

Active, not recruiting

Conditions: Stage 0 Colorectal Cancer AJCC v8
Stage I Colorectal Cancer AJCC v8
Stage IIB Colorectal Cancer AJCC v8
Stage IIIA Colorectal Cancer AJCC v8
Colorectal Adenoma
Stage II Colorectal Cancer AJCC v8
Stage IIC Colorectal Cancer AJCC v8
Stage IIIB Colorectal Cancer AJCC v8
Stage IIA Colorectal Cancer AJCC v8
Stage III Colorectal Cancer AJCC v8

Interventions: Other: Placebo
Drug: Linaclotide

First Posted Date: 2019-01-08

Last Posted Date: 2025-05-15

Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Target Recruit Count: 230

Registration Number: NCT03796884

Locations: 🇺🇸
VA Puget Sound Health Care Sysem, Seattle, Washington, United States
🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
🇺🇸
Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States

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