Linzess

(Linaclotide)

ApprovedPeptide

Linaclotide is used to treat irritable bowel syndrome with constipation and chronic idiopathic constipation by helping to increase bowel movements and relieve constipation.[2] Linzess is currently approved and in use across 4 indications[4].[1]

Linzess is one of 44 small molecule programs targeting Colorectal Adenoma. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Colorectal AdenomaActive, not recruiting

Irritable Bowel SyndromeCompleted

SMAActive, not recruiting

Constipation DisorderActive, not recruiting

Colorectal AdenomaApproved

Active, not recruiting

Irritable Bowel SyndromeApproved

Completed

SMAPhase 1

Active, not recruiting

Constipation DisorderApproved

Active, not recruiting

Competition

Competitive Landscape

43 competitors in Irritable Bowel Syndrome

#DrugCompanyPhaseTrials

Resotran

Takeda

Approved

2 2

Cymbalta

Jazz Pharmaceuticals

Approved

2 3

Lexapro

AbbVie

Approved

1 4

Nurtec

Pfizer

Approved

1 5

Azulfidine

Golytely

Linzess

12 8

Lyrica

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

2 9

Alinia

RRomark Laboratories L.C.

Approved

2 10

Ibsrela

AArdelyx

Approved

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

Timeline

Expected Milestones

Q1 2027

Phase 2Active, not recruiting

Colorectal Adenoma

NCT03796884

Clinical

Trials by Indication[1]

Irritable Bowel Syndrome12 trials

An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

Completed·IIronwood Pharmaceuticals, Inc.·Phase 3·NCT00730171·1,743 enrolled

An Open-Label, Long-term Study to Assess the Immunogenicity of LINZESS® (Linaclotide) Administered Orally to Adult Participants With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation

Completed·FForest Laboratories·Phase 4·NCT02590432·828 enrolled

Post-marketing Surveillance of Linaclotide Tablet in Patients With Irritable Bowel Syndrome With Constipation or Chronic Constipation (Excluding Constipation Due to Organic Diseases)

Completed· Astellas logo

Astellas··NCT03471728·2,475 enrolled

Show 9 more trials

Caecal pH as a Biomarker for Irritable Bowel Syndrome

Unknown status·—·N/A·NCT02360384·48 enrolled

Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome

Completed· Astellas logo

Astellas·Phase 3·NCT02316899·500 enrolled

An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

Completed·FForest Laboratories·Phase 3·NCT00765999·1,559 enrolled

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)

Completed· AbbVie logo

AbbVie·Phase 3·NCT04026113·438 enrolled

A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT01880424·1,722 enrolled

A Study to Evaluate the Effect of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome

Completed· Astellas logo

Astellas·Phase 2·NCT01714843·559 enrolled

A Study of the Effect of Linaclotide on Abdominal Girth in Participants With Irritable Bowel Syndrome With Constipation (IBS-C)

Terminated·IIronwood Pharmaceuticals, Inc.·Phase 4·NCT02837783·20 enrolled

Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Completed·IIronwood Pharmaceuticals, Inc.·Phase 2·NCT02559206·759 enrolled

A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Completed·IIronwood Pharmaceuticals, Inc.·Phase 3·NCT03573908·614 enrolled

Constipation5 trials

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

Completed· AbbVie logo

AbbVie·Phase 2·NCT04110145·35 enrolled

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

Completed· AbbVie logo

AbbVie·Phase 2·NCT05760313·19 enrolled

Trial of Linaclotide in Patients With Chronic Idiopathic Constipation

Completed·IIronwood Pharmaceuticals, Inc.·Phase 3·NCT02291679·1,223 enrolled

Show 2 more trials

A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation

Completed· AbbVie logo

AbbVie·Phase 3·NCT05652205·123 enrolled

Evaluation of Clinical Equivalence Between Two Linaclotide Products in the Treatment of Chronic Idiopathic Constipation

Unknown status· Jiangsu Hansoh Pharmaceutical Co., Ltd. logo

Jiangsu Hansoh Pharmaceutical Co., Ltd.·Phase 3·NCT04804267·750 enrolled

Chronic constipation3 trials

A Study of Oral Dosing of ASP0456 in Patients With Chronic Constipation

Completed· Astellas logo

Astellas·Phase 3·NCT02809105·186 enrolled

Effect and Safety of Polyethylene Glycol Combined With Linaclotide on Colon Cleansing for Patients With Chronic Constipation

Unknown status·SSecond Affiliated Hospital of Xi'an Jiaotong University·N/A·NCT05137145·300 enrolled

Trial of Linaclotide in Patients With Chronic Constipation

Completed·IIronwood Pharmaceuticals, Inc.·Phase 3·NCT00730015·643 enrolled

AIN1 trial

Investigation of Linaclotide's Effect on the Bi-directional Brain and Gut Axis in IBS-C Patients

Completed·—·N/A·NCT02078323·39 enrolled

Breastfeeding1 trial

A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically

Completed·FForest Laboratories·Phase 1·NCT02220348·7 enrolled

4 more indications

SMA1 trial

GCC Agonist Signal in the Small Intestine

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

Functional Gastrointestinal Disorders1 trial

Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders

Unknown status·RRenJi Hospital·Phase 4·NCT05134584·78 enrolled

Endoscopy1 trial

Single-dose Linaclotide for Capsule Endoscopy Preparation

Completed·UUniversity of Virginia·Phase 4·NCT02465385·30 enrolled

Colorectal Adenoma1 trial

Phase II Randomized, Placebo-Controlled Trial of Linaclotide to Demonstrate Bioactivity in Patients With Sporadic Colorectal Adenomas and With Colorectal Cancer

Active, not recruiting·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 2·NCT03796884·150 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 25, 2017

LINZESS

NDA NDA202811

Sources

References

[1]
ClinicalTrials.gov — 26 trial records for Linaclotide. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Linzess drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Linaclotide compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Linaclotide. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA202811). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Linzess. U.S. Food & Drug Administration.
[7]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Heat-Stable Enterotoxin Receptor Agonist[3]
Modality: Peptide[3]
Highest Phase: Approved[1]
Company: AbbVie

Patent Landscape[6]

Patent Cliff

Feb 28, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7304036Aug 30, 2026

7304036*PEDFeb 28, 2027

8933030Feb 17, 2031

10702576Aug 11, 2031

10675325Aug 11, 2031

9 more patents

8933030*PEDAug 17, 2031

8802628Oct 30, 2031

8748573Oct 30, 2031

10702576*PEDFeb 11, 2032

10675325*PEDFeb 11, 2032

8802628*PEDApr 30, 2032

8748573*PEDApr 30, 2032

9708371Aug 16, 2033

9708371*PEDFeb 16, 2034

Linzess

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2027

Trials by Indication[1]

Irritable Bowel Syndrome12 trials

Constipation5 trials

Chronic constipation3 trials

AIN1 trial

Breastfeeding1 trial

SMA1 trial

Functional Gastrointestinal Disorders1 trial

Endoscopy1 trial

Colorectal Adenoma1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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