Data updated: Jun 28, 2026
LINACLOTIDE · Teva
Gastrointestinal
Approved 2012-08-30
LINACLOTIDE is FDA-approved to treat 2 conditions (same as LINZESS).
Source: FDA Label
2
Indications
--
Phase 3 Trials
13
Years on Market
Details
- Status
- Prescription
- First Approved
- 2012-08-30
- Routes
- ORAL
- Dosage Forms
- CAPSULE
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 indicationsLINACLOTIDE is approved for 2 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Irritable Bowel Syndrome
- Constipation
Same approved indications as LINZESS (same active ingredient).
Source: FDA Label
Teva's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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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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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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
Indications & Usage
LINACLOTIDE is FDA-approved to treat 2 conditions — same approved indications as LINZESS.
Looking for the branded version?
LINZESS
Full clinical data, patents, trials, and competitive landscape for linaclotide.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.