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Label indication LINZESS is indicated for the treatment of: • irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older • chronic idiopathic constipation (CIC) in adults • functional constipation (FC) in pediatric patients 2 years of age and older LINZESS is a guanylate cyclase-C agonist indicated for treatment of: Irritable bowel syndrome with constipation (IBS-C) in adults and… FDA label
Linaclotide · 1 trial · 1 indication
A 12-week Abdominal Pain/Abdominal Discomfort Responder is a patient who meets the Abdominal Pain/Abdominal Discomfort Weekly Responder criteria (i.e., an improvement of ≥30% from baseline in either the mean abdominal pain score or mean abdominal discomfort score for that week, with neither score worsening from baseline for that week) for at least 6 out of the 12 weeks of the Treatment Period. Abdominal pain at its worst (in the last 24 hours) was assessed daily by patients on an 11-point numerical rating scale (NRS) where 0 represents no abdominal pain and 10 represents very severe abdominal pain. Abdominal discomfort (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal discomfort and 10 represents very severe abdominal discomfort.
A 12-week IBS Degree of Relief Responder is a patient who meets the IBS Degree of Relief Weekly Responder criteria (i.e., response to the degree of relief of IBS symptoms question for that week was "Considerably relieved" or "Completely relieved") for at least 6 out of the 12 weeks of the Treatment Period. Degree of relief of IBS symptoms (in the last 7 days) was assessed weekly by patients on a 7-point balanced ordinal scale where 1 = Completely relieved, 4 = Unchanged, and 7 = As bad as I can imagine.
| Arm | Type | Description |
|---|---|---|
| controlled arm | PLACEBO_COMPARATOR | - |
| treatment arm | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | matching Placebo Capsules, Oral, once daily |
| Linaclotide | DRUG | Linaclotide 290 ug Capsules, Oral, once daily |
Inclusion Criteria: 1. Patient has signed an Informed Consent Form(ICF). 2. Patient Must not be pregnant or breastfeeding and agree to use birth control 3. Patient meets the colonoscopy requirements defined by the American Gastroenterological Association guidelines and no clinically-significant lab...
Linaclotide is used for irritable bowel syndrome with constipation (IBS-C). It is being developed as an oral treatment for adults with this condition, and the clinical program has studied it in patients 18 years and older. The Phase 3 trial enrolled 1,722 participants with IBS-C across the United States, Australia, Canada, China, and New Zealand.
Linaclotide targets GUCY2C, also known as guanylate cyclase C. It acts as an agonist at this receptor, meaning it activates the target. Linaclotide is a small molecule designed for oral administration, and its activity at GUCY2C is the basis for its development in gastrointestinal conditions such as IBS-C.
Linaclotide is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is the sponsor behind the clinical development program for the drug in irritable bowel syndrome with constipation.
Linaclotide is in Phase 3 development for irritable bowel syndrome with constipation. It is an investigational small molecule and is not described as approved. The Phase 3 program includes one completed trial, and no active trials are currently listed for this asset.
Linaclotide has been studied in the Phase 3 trial NCT01880424, titled a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group efficacy and safety trial of oral linaclotide for 12 weeks in patients with IBS-C. The trial is completed, enrolled 1,722 participants, and was conducted in the United States, Australia, Canada, China, and New Zealand.
The linaclotide Phase 3 trial NCT01880424 was a randomized, double-blind, placebo-controlled, parallel-group study. It evaluated oral linaclotide over 12 weeks in 1,722 patients with IBS-C, enrolled adults aged 18 years and older of all sexes. The study was international and multicenter, with sites in the United States, Australia, Canada, China, and New Zealand.