TheraRadar
Data updated: May 26, 2026

LINACLOTIDE

Gastrointestinal Approved 2021-02-09
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
5
Years on Market

Details

Status
None (Tentative Approval)
First Approved
2021-02-09
Routes
ORAL
Dosage Forms
CAPSULE

Companies

Teva Viatris Aurobindo Pharma
Active Ingredient: LINACLOTIDE

LINACLOTIDE Approval History

2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
10 FDA actions from 2021 to 2024
Jul 2024 SUPPL
Label · Labeling
Feb 2023 ORIGINAL
Update
May 2022 SUPPL
Label · Labeling

What LINACLOTIDE Treats

2 FDA approvals

Originally approved for its first indication in 2021 . Covers 2 distinct patient populations.

  • Other (2)
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Clinical Trial Registry

20 trials
Trial Sponsor ID Phase Status Title
NCT05107219 NCI-2021-11620 NCI-2021-11620, UWI21-06-01 Ph 1 completed GCC Agonist Signal in the Small Intestine
NCT03796884 18F.524 CDMRP-CA170223, JT 13271 Ph 2 active not recruiting Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer
NCT05760313 results posted M21-862 2022-501947-34-00 Ph 2 completed 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
NCT05652205 results posted M21-572 2022-501946-31-00 Ph 3 completed 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
NCT04026113 results posted LIN-MD-64 2019-001500-38 Ph 3 completed 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)
NCT02809105 0456-CL-1031 Ph 3 completed A Study of Oral Dosing of ASP0456 in Patients With Chronic Constipation
NCT01714843 0456-CL-0021 Ph 2 completed A Study to Evaluate the Effect of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome
NCT02316899 0456-CL-0031 Ph 3 completed Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome
NCT04110145 results posted LIN-MD-67 2019-002126-75 Ph 2 completed Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation
NCT02837783 results posted MCP-103-403 Ph 4 terminated A Study of the Effect of Linaclotide on Abdominal Girth in Participants With Irritable Bowel Syndrome With Constipation (IBS-C)
NCT02220348 LIN-PK-01 LIN-PK-01 Ph 1 completed A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically
NCT03573908 results posted MCP-103-312 Ph 3 completed A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
NCT02559206 results posted MCP-103-204 Ph 2 completed Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
NCT02590432 results posted LIN-MD-10 Ph 4 completed 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
NCT00765999 results posted LIN-MD-02 Ph 3 completed An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
NCT00730171 results posted MCP-103-305 Ph 3 completed An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
NCT02291679 results posted MCP-103-309 Ph 3 completed Trial of Linaclotide in Patients With Chronic Idiopathic Constipation
NCT01880424 D5630C00001 results posted ICP-103-307 Ph 3 completed 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)
NCT02465385 17803 Ph 4 completed Single-dose Linaclotide for Capsule Endoscopy Preparation
NCT00730015 results posted MCP-103-303 Ph 3 completed Trial of Linaclotide in Patients With Chronic Constipation
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

LINACLOTIDE FDA Label Details

Looking for the branded version?

LINZESS

Full clinical data, patents, trials, and competitive landscape for linaclotide.

See LINZESS

Data Sources

FDA Approval: ANDA211255 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.