Product Description
Linaclotide is used to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC). It works by increasing intestinal fluid secretion, which helps ease the passage of stools and relieve the symptoms of constipation. (Sourced from: https://www.mayoclinic.org/drugs-supplements/linaclotide-oral-route/description/drg-20075770)
Mechanisms of Action: GUC Agonist
Novel Mechanism: No
Modality: Peptide/Protein
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Canada | Croatia | Czech | Denmark | Egypt | Estonia | European Medicines Agency | Finland | Greece | Hong Kong | Hungary | Iceland | Ireland | Italy | Japan | Latvia | Lithuania | Luxembourg | Mexico | Netherlands | New Zealand | Norway | Peru | Poland | Portugal | Saudi Arabia | Slovakia | Spain | Sweden | Switzerland | United Kingdom | United States
Approved Indications: Irritable Bowel Syndrome | Constipation
Known Adverse Events: Abdominal Pain | Pain Unspecified | Diarrhea | Flatulence
Company: Ironwood
Company Location: BOSTON MA 02110
Company CEO: Thomas McCourt
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Belgium, Bulgaria, Canada, Croatia, Estonia, Germany, Hungary, Israel, Italy, Netherlands, Poland, Puerto Rico, Serbia, Spain, Ukraine, United Kingdom, United States
Active Clinical Trial Count: 6
Highest Development Phases
Phase 3: Constipation|Irritable Bowel Syndrome
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| M21-572 | P3 |
Unknown Status |
Constipation |
2025-11-21 |
|
| M21-862 | P2 |
Recruiting |
Constipation |
2025-09-01 |
|
| M21-572 | P3 |
Active, not recruiting |
Constipation |
2025-08-01 |
|
| LIN-MD-64 | P3 |
Completed |
Irritable Bowel Syndrome|Constipation |
2024-05-20 |