Trulance

(Plecanatide)

Phase 2Peptide

SSalix

Trulance is one of 2 small molecule programs targeting Functional Constipation (FC). It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Functional Constipation (FC)Active, not recruiting

SMAActive, not recruiting

Functional Constipation (FC)Phase 2

Active, not recruiting

SMAPhase 1

Active, not recruiting

Competition

Competitive Landscape

1 competitor in SMA

#DrugCompanyPhaseTrials

Linzess

AbbVie

Phase 1

1 2

Trulance

SSalix

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 2Active, not recruiting

Functional Constipation (FC)

NCT07723924

Clinical

Trials by Indication[1]

Irritable Bowel Syndrome4 trials

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

Completed·BBausch Health Americas, Inc.·Phase 3·NCT02493452·1,135 enrolled

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

Completed·BBausch Health Americas, Inc.·Phase 2·NCT01722318·428 enrolled

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

Completed·BBausch Health Americas, Inc.·Phase 3·NCT02387359·1,054 enrolled

Show 1 more trial

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

Completed·BBausch Health Americas, Inc.·Phase 2·NCT03596905·218 enrolled

Constipation4 trials

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

Completed·BBausch Health Americas, Inc.·Phase 3·NCT01919697·2,370 enrolled

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

Completed·SShandong Luoxin Pharmaceutical Group Stock Co., Ltd.·Phase 3·NCT05151328·648 enrolled

The Plecanatide Chronic Idiopathic Constipation (CIC) Study

Completed·BBausch Health Americas, Inc.·Phase 2/3·NCT01429987·951 enrolled

Show 1 more trial

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

Completed·BBausch Health Americas, Inc.·Phase 2·NCT03120520·124 enrolled

Breast1 trial

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

Completed·BBausch Health Americas, Inc.··NCT03551873·7 enrolled

SMA1 trial

GCC Agonist Signal in the Small Intestine

Active, not recruiting·UUniversity of Wisconsin, Madison·Phase 1·NCT05107219·43 enrolled

Functional Constipation (FC)1 trial

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of Plecanatide in Children and Adolescents Age 6 to <18 Years of Age With Functional Constipation (FC)

Active, not recruiting·BBausch Health Americas, Inc.·Phase 2·NCT07723924·180 enrolled

1 more indication

Unspecified3 trials

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

Completed·BBausch Health Americas, Inc.·Phase 3·NCT01982240·1,394 enrolled

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

Completed·BBausch Health Americas, Inc.·Phase 3·NCT02122471·1,410 enrolled

Long Term Safety Study of Plecanatide

Completed·BBausch Health Americas, Inc.·Phase 3·NCT02706483·2,272 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 19, 2017

TRULANCE

NDA NDA208745

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for Plecanatide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Plecanatide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Plecanatide. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA208745). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Trulance. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Salix company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Peptide[2]
Highest Phase: Phase 2[1]
Company: SSalix

Patent Landscape[5]

Patent Cliff

Jan 30, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7041786Jan 30, 2028

9925231Sep 15, 2031

9610321Sep 15, 2031

9919024Sep 15, 2031

11319346Mar 1, 2032

5 more patents

9616097Aug 20, 2032

10011637Jun 5, 2034

11142549Jun 5, 2034

11834521Jun 5, 2034

12146003Jun 5, 2034

Trulance

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Trials by Indication[1]

Irritable Bowel Syndrome4 trials

Constipation4 trials

Breast1 trial

SMA1 trial

Functional Constipation (FC)1 trial

Unspecified3 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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