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 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
- First Posted Date
- 2023-03-08
- Last Posted Date
- 2024-12-20
- Lead Sponsor
- AbbVie
- Target Recruit Count
- 30
- Registration Number
- NCT05760313
- Locations
- 🇧🇬
UMHAT Sveti Georgi /ID# 250808, Plovdiv, Bulgaria
🇧🇬UMHAT Kanev /ID# 248931, Ruse, Bulgaria
🇺🇸Velocity Clinical Research Phoenix /ID# 263871, Phoenix, Arizona, United States
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
- Conditions
- Interventions
- First Posted Date
- 2022-12-15
- Last Posted Date
- 2024-12-18
- Lead Sponsor
- AbbVie
- Target Recruit Count
- 116
- 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
Effect and Safety of Polyethylene Glycol Combined With Linaclotide on Colon Cleansing for Patients With Chronic Constipation
- Conditions
- Interventions
- First Posted Date
- 2021-11-30
- Last Posted Date
- 2021-11-30
- 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
- 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
- First Posted Date
- 2021-11-04
- Last Posted Date
- 2024-05-17
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 43
- Registration Number
- NCT05107219
- Locations
- 🇺🇸
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
🇺🇸University of Wisconsin Carbone Cancer Center - University Hospital, Madison, Wisconsin, United States
🇺🇸Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Evaluation of Clinical Equivalence Between Two Linaclotide Products in the Treatment of Chronic Idiopathic Constipation
- Conditions
- Interventions
- 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
- 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
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)
- Conditions
- Interventions
- 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
Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer
- Conditions
- Stage 0 Colorectal Cancer AJCC v8Stage I Colorectal Cancer AJCC v8Stage IIB Colorectal Cancer AJCC v8Stage IIIA Colorectal Cancer AJCC v8Colorectal AdenomaStage II Colorectal Cancer AJCC v8Stage IIC Colorectal Cancer AJCC v8Stage IIIB Colorectal Cancer AJCC v8Stage IIA Colorectal Cancer AJCC v8Stage III Colorectal Cancer AJCC v8
- Interventions
- First Posted Date
- 2019-01-08
- Last Posted Date
- 2024-05-03
- 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
A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
- Conditions
- Interventions
- First Posted Date
- 2018-06-29
- Last Posted Date
- 2020-12-01
- Lead Sponsor
- Ironwood Pharmaceuticals, Inc.
- Target Recruit Count
- 614
- Registration Number
- NCT03573908
- Locations
- 🇺🇸
Long Island Gastrointestinal Research Group, LLP, Great Neck, New York, United States
🇺🇸Meritus Center For Clinical Research, Hagerstown, Maryland, United States
🇺🇸Boston Clinical Trials, Inc., Boston, Massachusetts, United States
Drug Development Updates
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