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Functional Constipation

8
Pipeline Programs
7
Companies
8
Clinical Trials
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
1
2
0
2
2
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Peptide
7100%
+ 4 programs with unclassified modality

On Market (1)

Approved therapies currently available

AbbVie
LINZESSApproved
linaclotide
AbbVie
Guanylate Cyclase-C Agonist [EPC]oral2012
1.8B Part D

Competitive Landscape

7 companies ranked by most advanced pipeline stage

AbbVie
AbbVieNORTH CHICAGO, IL
3 programs
2
1
1
LinaclotidePhase 3Peptide1 trial
LinaclotidePhase 2Peptide1 trial
LinaclotidePhase 2Peptide1 trial
Active Trials
NCT04110145Completed35Est. Apr 2021
NCT05760313Completed19Est. Jun 2025
NCT04026113Completed438Est. May 2024
Norgine
NorgineAustria - Vienna
1 program
1
PolyethyleneglycolPhase 41 trial
Active Trials
NCT01622972Completed72Est. Feb 2014
Shandong Luoxin Pharmaceutical
1 program
1
PlecanatidePhase 3Peptide1 trial
Active Trials
NCT05151328Completed648Est. Oct 2023
NGM Biopharmaceuticals
1 program
1
NGM282Phase 1/21 trial
Active Trials
NCT02649062Completed31Est. Jan 2017
UNION therapeutics
UNION therapeuticsDenmark - Hellerup
1 program
1
Mosapride Citrate tabletPhase 11 trial
Active Trials
NCT01274793Unknown240Est. Dec 2015
Ironwood Pharmaceuticals
3 programs
LinaclotidePHASE_2Peptide
LinaclotidePHASE_2Peptide
LinaclotidePHASE_3Peptide
Angeles Therapeutics
Angeles TherapeuticsCA - Los Angeles
1 program
Sodium phosphate enemaN/A1 trial
Active Trials
NCT01823848Terminated40Est. Dec 2017

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
NorginePolyethyleneglycol
Shandong Luoxin PharmaceuticalPlecanatide
AbbVieLinaclotide
AbbVieLinaclotide
AbbVieLinaclotide
NGM BiopharmaceuticalsNGM282
UNION therapeuticsMosapride Citrate tablet
Angeles TherapeuticsSodium phosphate enema

Clinical Trials (8)

Total enrollment: 1,523 patients across 8 trials

NCT01622972NorginePolyethyleneglycol

Mode of Action of Moviprep

Start: Sep 2011Est. completion: Feb 201472 patients
Phase 4Completed
NCT05151328Shandong Luoxin PharmaceuticalPlecanatide

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

Start: Mar 2022Est. completion: Oct 2023648 patients
Phase 3Completed
NCT04026113AbbVieLinaclotide

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)

Start: Oct 2019Est. completion: May 2024438 patients
Phase 3Completed
NCT05760313AbbVieLinaclotide

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

Start: Apr 2023Est. completion: Jun 202519 patients
Phase 2Completed
NCT04110145AbbVieLinaclotide

Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation

Start: Oct 2019Est. completion: Apr 202135 patients
Phase 2Completed
NCT02649062NGM BiopharmaceuticalsNGM282

Study of NGM282 in Subjects With Functional Constipation and Healthy Individuals

Start: Dec 2015Est. completion: Jan 201731 patients
Phase 1/2Completed
NCT01274793UNION therapeuticsMosapride Citrate tablet

Trial for Quantity-Effect Relationship of Acupuncture With Two-ways Regulation to Treat Functional Enteropathy

Start: Nov 2010Est. completion: Dec 2015240 patients
Phase 1Unknown
NCT01823848Angeles TherapeuticsSodium phosphate enema

A Trial of Three Types of Enemas Used to Treat Functional Constipation in Children

Start: Apr 2013Est. completion: Dec 201740 patients
N/ATerminated

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 late-stage (Phase 3) programs, potential near-term approvals
Peptide is the dominant modality (100% of programs)
7 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.