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: *
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: None
Known Adverse Events: None
Company: Ironwood
Company Location: BOSTON MA 02110
Company CEO: Thomas McCourt
Additional 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: 7
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Ironwood announced they will present P1 Intestinal Diseases|Irritable Bowel Syndrome|Biliary Cirrhosis results in 3Q24 for Linaclotide
- Clinical Outcomes Reported - Ironwood presented P3 Irritable Bowel Syndrome results on 2024-05-21 for Linaclotide
- Clinical Outcomes Reported - Ironwood presented P3 Constipation results on 2024-01-09 for Linaclotide
Highest Development Phases
Phase 3: Constipation|Irritable Bowel Syndrome
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04026113 |
LIN-MD-64 | P3 |
Completed |
Constipation|Irritable Bowel Syndrome |
2024-05-20 |
80% |
2024-11-27 |
Primary Endpoints|Treatments |
NCT05652205 |
M21-572 | P3 |
Completed |
Constipation |
2025-09-02 |
31% |
2025-09-17 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2019-001955-38 |
Long-term Safety of Linaclotide in Pediatric Participants with FC or IBS-C. | P3 |
Active, not recruiting |
Irritable Bowel Syndrome|Constipation |
2023-04-30 |
48% |
2022-03-13 |
Treatments |
NCT05760313 |
M21-862 | P2 |
Completed |
Constipation |
2025-06-09 |
12% |
2025-06-25 |
Primary Endpoints |
2022-501946-31-00 |
M21-572 | P3 |
Active, not recruiting |
Constipation |
2025-11-21 |
31% |
2025-05-02 |
Treatments |
2019-001500-38 |
Linaclotide Safety and Efficacy Functional Constipation (FC), | P3 |
Completed |
Constipation |
2024-05-29 |
80% |
2025-05-06 |
Primary Completion Date |
2022-501947-34-00 |
M21-862 | P2 |
Recruiting |
Constipation |
2024-12-19 |
2025-05-02 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
11/10/2025 |
News Article |
Ironwood Pharmaceuticals Reports Strong Third Quarter 2025 Results; Raises Full Year 2025 Financial Guidance |
|
10/07/2025 |
News Article |
Pharmaceutical Market Size Worth USD 3.03 Trillion by 2034 |
|
08/07/2025 |
News Article |
Ironwood Pharmaceuticals Reports Second Quarter 2025 Results; Maintains Full Year 2025 Financial Guidance |
|
05/07/2025 |
News Article |
Ironwood Pharmaceuticals Reports First Quarter 2025 Results |