MedPath

Plecanatide

Generic Name
Plecanatide
Brand Names
Trulance
Drug Type
Small Molecule
Chemical Formula
C65H104N18O26S4
CAS Number
467426-54-6
Unique Ingredient Identifier
7IK8Z952OK
Background

Plecanatide is a drug approved in January 2017 by the FDA for the treatment of chronic idiopathic constipation (CIC). It should not be used in children less than six years of age, and should be avoided in patients six years to 18 years of age

Indication

Plecanatide is indicated for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) in adult patients.

Associated Conditions
Irritable Bowel Syndrome With Constipation (IBS-C), Chronic idiopathic constipation (CIC)

Efficacy and Safety of Plecanatide Comparing With Placebo in the Treatment of Functional Constipation

Phase 3
Completed
Conditions
Functional Constipation
Interventions
First Posted Date
2021-12-09
Last Posted Date
2024-07-11
Lead Sponsor
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
Target Recruit Count
648
Registration Number
NCT05151328
Locations
🇨🇳

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 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
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

Efficacy and Safety of Plecanatide in Children 6 to <18 Years of Age With Irritable Bowel Syndrome With Constipation (IBS-C)

Phase 2
Recruiting
Conditions
Irritable Bowel Syndrome With Constipation
Interventions
Drug: Matching placebo
First Posted Date
2018-07-24
Last Posted Date
2023-02-08
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
210
Registration Number
NCT03596905
Locations
🇺🇸

Synergy Research Site, Newport News, Virginia, United States

A Postmarketing Study of Plecanatide in Breast Milk of Lactating Women Treated With TRULANCE®

Completed
Conditions
Chronic Idiopathic Constipation
First Posted Date
2018-06-11
Last Posted Date
2019-11-22
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
7
Registration Number
NCT03551873
Locations
🇺🇸

Synergy Research Center 001, Raleigh, North Carolina, United States

🇺🇸

Synergy Research Center 002, North Hollywood, California, United States

🇺🇸

Syergy Research Center 003, Tamarac, Florida, United States

An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation

Phase 2
Completed
Conditions
Chronic Idiopathic Constipation
Interventions
Drug: Matching placebo
First Posted Date
2017-04-19
Last Posted Date
2019-10-04
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
124
Registration Number
NCT03120520
Locations
🇺🇸

Synergy Research Site, Newport News, Virginia, United States

Long Term Safety Study of Plecanatide

Phase 3
Completed
Conditions
Irritable Bowel Syndrome
Interventions
First Posted Date
2016-03-11
Last Posted Date
2020-08-18
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
2272
Registration Number
NCT02706483
Locations
🇺🇸

Synergy Research Site, Milwaukee, Wisconsin, United States

🇺🇸

Synergy Research Site., Charlotte, North Carolina, United States

Second Plecanatide Study In Irritable Bowel Syndrome With Constipation (IBS-C)

Phase 3
Completed
Conditions
Irritable Bowel Syndrome Characterized by Constipation
Interventions
Drug: Placebo
First Posted Date
2015-07-09
Last Posted Date
2019-06-14
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
1135
Registration Number
NCT02493452
Locations
🇺🇸

Synergy Research Site, La Crosse, Wisconsin, United States

🇺🇸

Synergy Research Site., Orlando, Florida, United States

The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)

Phase 3
Completed
Conditions
Irritable Bowel Syndrome Characterized by Constipation
Interventions
Drug: Placebo
First Posted Date
2015-03-13
Last Posted Date
2019-06-14
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
1054
Registration Number
NCT02387359
Locations
🇺🇸

Synergy Research Site, Wauwatosa, Wisconsin, United States

🇺🇸

Synergy Research Site., Nashville, Tennessee, United States

12-Week Study of Plecanatide for CIC (The National CIC3 Study)

Phase 3
Completed
Conditions
Chronic Idiopathic Constipation
Interventions
Drug: Placebo
First Posted Date
2014-04-24
Last Posted Date
2019-05-28
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
1410
Registration Number
NCT02122471
Locations
🇺🇸

Synergy Research Site, Richland, Washington, United States

12-Week Study of Plecanatide for CIC (The CIC3 Study)

Phase 3
Completed
Conditions
Chronic Idiopathic Constipation
Interventions
First Posted Date
2013-11-13
Last Posted Date
2019-12-26
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
1394
Registration Number
NCT01982240
Locations
🇨🇦

Synergy Research Site, St-Romuald, Quebec, Canada

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