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)

Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)

Phase 3
Completed
Conditions
Chronic Idiopathic Constipation
Interventions
First Posted Date
2013-08-09
Last Posted Date
2019-07-02
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
2370
Registration Number
NCT01919697
Locations
🇨🇦

Synergy Research Site, St-Romuald, Quebec, Canada

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

Phase 2
Completed
Conditions
Irritable Bowel Syndrome Characterized by Constipation
Interventions
Drug: Placebo
First Posted Date
2012-11-06
Last Posted Date
2019-05-28
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
428
Registration Number
NCT01722318
Locations
🇺🇸

San Marcus Research Clinic, Inc., Miami, Florida, United States

🇺🇸

Genoma Research Group, Inc., Miami, Florida, United States

🇺🇸

South Medical Research Group, Inc., Miami, Florida, United States

and more 94 locations

The Plecanatide Chronic Idiopathic Constipation (CIC) Study

Phase 2
Completed
Conditions
Chronic Idiopathic Constipation
Interventions
Other: Placebo
First Posted Date
2011-09-07
Last Posted Date
2019-05-28
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
951
Registration Number
NCT01429987
Locations
🇺🇸

Southwest Gastroenterology Assoc, Oak Lawn, Illinois, United States

🇺🇸

Medex Healthcare Research, Inc., Chicago, Illinois, United States

🇺🇸

Advance Medical Research Service Corp, Miami, Florida, United States

and more 109 locations
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