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
- -
A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically
- Conditions
- Interventions
- 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
- Conditions
- Interventions
- 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)
- Conditions
- Interventions
- 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
- Conditions
- Interventions
- 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
- Conditions
- Interventions
- 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
Trial of Linaclotide in Patients With Chronic Constipation
- First Posted Date
- 2008-08-08
- Last Posted Date
- 2013-01-30
- Lead Sponsor
- Ironwood Pharmaceuticals, Inc.
- Target Recruit Count
- 643
- Registration Number
- NCT00730015
- Locations
- 🇺🇸
Ironwood Investigational Site, Milwaukee, Wisconsin, United States
An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
- Conditions
- Interventions
- First Posted Date
- 2008-08-08
- Last Posted Date
- 2018-02-19
- Lead Sponsor
- Ironwood Pharmaceuticals, Inc.
- Target Recruit Count
- 1743
- Registration Number
- NCT00730171
- Locations
- 🇺🇸
Ironwood Investigational Site, Milwaukee, Wisconsin, United States
Drug Development Updates
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