Functional Constipation

7
Pipeline Programs
2
Companies
5
Clinical Trials
1 recruiting
2
Approved Products

Pipeline by Development Stage

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

Drug Modality Breakdown

Peptide
5100%

On Market (2)

Approved therapies currently available

U
LINACLOTIDEApproved
linaclotide
Unknown Company
oral2023
AbbVie
LINZESSApproved
linaclotide
AbbVie
Guanylate Cyclase-C Agonist [EPC]oral2012

Competitive Landscape

2 companies ranked by most advanced pipeline stage

AbbVie
AbbVieNORTH CHICAGO, IL
2 programs
1
1
1
LinaclotidePhase 3Peptide1 trial
LinaclotidePhase 2Peptide3 trials
Active Trials
NCT05796388Recruiting65Est. Jun 2026
NCT05760313Completed19Est. Jun 2025
NCT04166058Completed381Est. Jun 2025
+1 more trials
Ironwood Pharmaceuticals
3 programs
2
1
LinaclotidePhase 3Peptide
LinaclotidePhase 2Peptide1 trial
LinaclotidePhase 2Peptide
Active Trials
NCT04110145CompletedEst. Apr 2021

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
AbbVieLinaclotide
AbbVieLinaclotide
AbbVieLinaclotide
Ironwood PharmaceuticalsLinaclotide
AbbVieLinaclotide

Clinical Trials (5)

Total enrollment: 903 patients across 5 trials

NCT04166058AbbVieLinaclotide

Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C

Start: Nov 2019Est. completion: Jun 2025381 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
NCT04110145Ironwood PharmaceuticalsLinaclotide

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

Start: Oct 2019Est. completion: Apr 2021
Phase 2Completed
NCT05796388AbbVieLinaclotide

A Study of Virtual Reality and Linaclotide for IBS-C

Start: May 2024Est. completion: Jun 202665 patients
N/ARecruiting

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
1 actively recruiting trials targeting 903 patients
2 companies competing in this space