Plecanatide

Overview

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)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Efficacy and Safety of Plecanatide Comparing With Placebo in the Treatment of Functional Constipation	2021/12/09	NCT05151328	Phase 3	Completed	Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
GCC Agonist Signal in the Small Intestine	2021/11/04	NCT05107219	Phase 1	Active, not recruiting	University of Wisconsin, Madison
Efficacy and Safety of Plecanatide in Children 6 to <18 Years of Age With Irritable Bowel Syndrome With Constipation (IBS-C)	2018/07/24	NCT03596905	Phase 2	Completed	Bausch Health Americas, Inc.
A Postmarketing Study of Plecanatide in Breast Milk of Lactating Women Treated With TRULANCE®	2018/06/11	NCT03551873	N/A	Completed	Bausch Health Americas, Inc.
An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation	2017/04/19	NCT03120520	Phase 2	Completed	Bausch Health Americas, Inc.
Long Term Safety Study of Plecanatide	2016/03/11	NCT02706483	Phase 3	Completed	Bausch Health Americas, Inc.
Second Plecanatide Study In Irritable Bowel Syndrome With Constipation (IBS-C)	2015/07/09	NCT02493452	Phase 3	Completed	Bausch Health Americas, Inc.
The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)	2015/03/13	NCT02387359	Phase 3	Completed	Bausch Health Americas, Inc.
12-Week Study of Plecanatide for CIC (The National CIC3 Study)	2014/04/24	NCT02122471	Phase 3	Completed	Bausch Health Americas, Inc.
12-Week Study of Plecanatide for CIC (The CIC3 Study)	2013/11/13	NCT01982240	Phase 3	Completed	Bausch Health Americas, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Trulance Immediate release	Salix Pharmaceuticals Inc.	65649-003	ORAL	3 mg in 1 1	4/4/2024

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
TRULANCE	bausch health, canada inc.	02493012	Tablet - Oral	3 MG	1/12/2022

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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