Linaclotide
- Generic Name
- Linaclotide
- Brand Names
- Constella, Linzess
- Drug Type
- Small Molecule
- Chemical Formula
- C59H79N15O21S6
- 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...
- 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.
...
- Associated Conditions
- Functional Constipation (FC), Irritable Bowel Syndrome With Constipation (IBS-C), Chronic idiopathic constipation (CIC)
- Associated Therapies
- -
Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)
- First Posted Date
- 2018-03-21
- Last Posted Date
- 2024-10-18
- Lead Sponsor
- Astellas Pharma Inc
- Target Recruit Count
- 2475
- Registration Number
- NCT03471728
- Locations
- 🇯🇵
Site JP00003, Iwate, Japan
🇯🇵Site JP00039, Kochi, Japan
🇯🇵Site JP00028, Hyogo, Japan
A Study of the Effect of Linaclotide on Abdominal Girth in Participants With Irritable Bowel Syndrome With Constipation (IBS-C)
- Conditions
- Interventions
- First Posted Date
- 2016-07-20
- Last Posted Date
- 2021-12-06
- Lead Sponsor
- Ironwood Pharmaceuticals, Inc.
- Target Recruit Count
- 20
- Registration Number
- NCT02837783
- Locations
- 🇬🇧
Peter Whorwell, Wythenshawe, Manchester, United Kingdom
A Study of Oral Dosing of ASP0456 in Patients With Chronic Constipation
- First Posted Date
- 2016-06-22
- Last Posted Date
- 2024-10-18
- Lead Sponsor
- Astellas Pharma Inc
- Target Recruit Count
- 186
- Registration Number
- NCT02809105
- Locations
- 🇯🇵
Site JP00036, Osaka, Japan
🇯🇵Site JP00011, Tokyo, Japan
🇯🇵Site JP00013, Tokyo, Japan
An Open-Label, Long-term Study to Assess the Immunogenicity of LINZESS® (Linaclotide) Administered Orally to Adult Participants With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation
- Conditions
- Interventions
- First Posted Date
- 2015-10-29
- Last Posted Date
- 2019-08-22
- Lead Sponsor
- Forest Laboratories
- Target Recruit Count
- 828
- Registration Number
- NCT02590432
- Locations
- 🇺🇸
Clinical Research of Brandon LLC, Brandon, Florida, United States
🇺🇸G & L Research, LLC, Foley, Alabama, United States
🇺🇸Applied Research Center of Arkansas, Little Rock, Arkansas, United States
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
- Conditions
- Interventions
- First Posted Date
- 2015-09-24
- Last Posted Date
- 2020-04-24
- Lead Sponsor
- Ironwood Pharmaceuticals, Inc.
- Target Recruit Count
- 759
- Registration Number
- NCT02559206
- Locations
- 🇺🇸
Ironwood Investigational Site, La Crosse, Wisconsin, United States
Single-dose Linaclotide for Capsule Endoscopy Preparation
- Conditions
- Interventions
- First Posted Date
- 2015-06-08
- Last Posted Date
- 2016-07-14
- Lead Sponsor
- University of Virginia
- Target Recruit Count
- 30
- Registration Number
- NCT02465385
- Locations
- 🇺🇸
University of Virginia Health System, Charlottesville, Virginia, United States
Caecal pH as a Biomarker for Irritable Bowel Syndrome
- Conditions
- Interventions
- First Posted Date
- 2015-02-10
- Last Posted Date
- 2016-11-03
- Lead Sponsor
- Wingate Institute of Neurogastroenterology
- Target Recruit Count
- 48
- Registration Number
- NCT02360384
- Locations
- 🇬🇧
Wingate Institute of Neurogastroenterology, London, United Kingdom
Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome
- Conditions
- Interventions
- First Posted Date
- 2014-12-15
- Last Posted Date
- 2024-10-18
- Lead Sponsor
- Astellas Pharma Inc
- Target Recruit Count
- 500
- Registration Number
- NCT02316899
- Locations
- 🇯🇵
Site JP00001, Hokkaido, Japan
🇯🇵Site JP00048, Aichi, Japan
🇯🇵Site JP00038, Chiba, Japan
Trial of Linaclotide in Patients With Chronic Idiopathic Constipation
- Conditions
- Interventions
- First Posted Date
- 2014-11-14
- Last Posted Date
- 2017-06-15
- Lead Sponsor
- Ironwood Pharmaceuticals, Inc.
- Target Recruit Count
- 1223
- Registration Number
- NCT02291679
- Locations
- 🇺🇸
Ironwood Investigational Site, La Crosse, Wisconsin, United States
Efficacy of Linaclotide to Senna for CIC
- Conditions
- Interventions
- First Posted Date
- 2014-09-12
- Last Posted Date
- 2019-07-02
- Lead Sponsor
- TriHealth Inc.
- Target Recruit Count
- 9
- Registration Number
- NCT02239510
- Locations
- 🇺🇸
TriHealth, Cincinnati, Ohio, United States
Drug Development Updates
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