LINZESS (linaclotide)
Linzess treats adults and children who suffer from chronic or functional constipation. It helps patients with irritable bowel syndrome with constipation (IBS-C) starting at age 7, as well as adults with chronic idiopathic constipation. It is also used for pediatric patients aged 6 and older who have functional constipation.
How LINZESS Works
This drug works by binding to guanylate cyclase-C receptors on the surface of the intestine to increase levels of cyclic guanosine monophosphate (cGMP). This process triggers the secretion of fluid into the gut to speed up bowel transit and helps reduce abdominal pain by decreasing the activity of pain-sensing nerves.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2012-08-30
- Patent Cliff
- 2034
- Revenue
- $283M (Q1-2026)
- Routes
- ORAL
- Dosage Forms
- CAPSULE
LINZESS Approval History
What LINZESS Treats
2 indicationsLINZESS is approved for 2 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Irritable Bowel Syndrome
- Constipation
LINZESS Boxed Warning
RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE LINZESS is contraindicated in patients less than 2 years of age; in nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 )]. WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE See full prescribing ...
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE LINZESS is contraindicated in patients less than 2 years of age; in nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 )]. WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE See full prescribing information for complete boxed warning. LINZESS is contraindicated in patients less than 2 years of age; in neonatal mice, linaclotide caused deaths due to dehydration. ( 4 , 5.1 , 8.4 )
LINZESS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to LINZESS
3 of 11FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
LINZESS FDA Label Details
Indications & Usage
FDA Label (PDF)LINZESS is indicated for the treatment of Irritable Bowel Syndrome; Constipation.
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE LINZESS is contraindicated in patients less than 2 years of age; in nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydratio...
LINZESS Patents & Exclusivity
Patents (14 active)
Exclusivity
Pro Intelligence Preview
Deep insights for LINZESS
Revenue Insights
- • Q1-2026: $283M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2034
- • 126 active patents
Trial Analysis
- • 20 total trials
- • Stage: Declining
Competitive Landscape
- • 11 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment