Linaclotide

Overview

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

Title	Posted	Study ID	Phase	Status	Sponsor
Effect to Linaclotide on Colonic Motility	2025/05/25	NCT06989268	Phase 4	Completed	Universitaire Ziekenhuizen KU Leuven
Clinical Study on the Application of Lactulose Combined with Linaclotide in Bowel Preparation for Colonoscopy	2024/12/27	NCT06748638	Phase 4	ENROLLING_BY_INVITATION	Haifeng Lan
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	2023/03/08	NCT05760313	Phase 2	Completed	AbbVie
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	2022/12/15	NCT05652205	Phase 3	Active, not recruiting	AbbVie
Effect and Safety of Polyethylene Glycol Combined With Linaclotide on Colon Cleansing for Patients With Chronic Constipation	2021/11/30	NCT05137145	Not Applicable	UNKNOWN	Second Affiliated Hospital of Xi'an Jiaotong University
Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders	2021/11/26	NCT05134584	Phase 4	UNKNOWN	RenJi Hospital
GCC Agonist Signal in the Small Intestine	2021/11/04	NCT05107219	Phase 1	Active, not recruiting	University of Wisconsin, Madison
Evaluation of Clinical Equivalence Between Two Linaclotide Products in the Treatment of Chronic Idiopathic Constipation	2021/03/18	NCT04804267	Phase 3	UNKNOWN	Jiangsu Hansoh Pharmaceutical Co., Ltd.
Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation	2019/10/01	NCT04110145	Phase 2	Completed	Allergan
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)	2019/07/19	NCT04026113	Phase 3	Completed	AbbVie

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Linzess	Allergan, Inc.	0456-1202	ORAL	290 ug in 1 1	9/20/2023
Linzess	Allergan, Inc.	0456-1203	ORAL	72 ug in 1 1	9/20/2023
Linzess	Allergan, Inc.	0456-1201	ORAL	145 ug in 1 1	9/20/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Constella	AbbVie Deutschland GmbH & Co. KG,Knollstrasse,67061 Ludwigshafen,Germany	Authorised	11/26/2012

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
CONSTELLA linaclotide 145 microgram hard capsule bottle	297703	AbbVie Pty Ltd	Medicine	A	6/18/2019
CONSTELLA linaclotide 72 microgram hard capsule bottle	297705	AbbVie Pty Ltd	Medicine	A	6/18/2019
CONSTELLA linaclotide 290 microgram hard capsule bottle	297704	AbbVie Pty Ltd	Medicine	A	6/18/2019

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
CONSTELLA	Abbvie Corporation	02417170	Capsule - Oral	290 MCG	12/17/2014
CONSTELLA	Abbvie Corporation	02469510	Capsule - Oral	72 MCG	4/2/2018
CONSTELLA	Abbvie Corporation	02417162	Capsule - Oral	145 MCG	4/29/2014

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
Constella 290 microgramos capsulas duras	Abbvie Deutschland Gmbh & Co. Kg	112801002	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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