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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
Also known as Linzess
Linaclotide 145 micrograms · 1 trial · 1 indication
Change from baseline in 8-Week SBM frequency rate (SBMs/week) during the Treatment Period.
| Arm | Type | Description |
|---|---|---|
| Linaclotide 145 micrograms | EXPERIMENTAL | Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast. |
| Linaclotide 290 micrograms | EXPERIMENTAL | Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast. |
| Placebo | EXPERIMENTAL | Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast. |
| Name | Type | Description |
|---|---|---|
| Linaclotide 145 micrograms | DRUG | - |
| Linaclotide 290 micrograms | DRUG | - |
| Placebo | DRUG | Matching placebo |
Inclusion Criteria: * Patient has chronic non-cancer pain that has been present for a minimum of 3 months * Patient has been receiving a stable oral dose of a full-opioid agonist for at least 4 days per week during the 8 consecutive weeks * Patient meets protocol criteria for Opioid-Induced Constip...
Linaclotide 145 micrograms is being studied for opioid-induced constipation in adults receiving chronic opioid treatment for non-cancer pain. It is a small molecule developed by Ironwood Pharmaceuticals, Inc. (ticker IRWD) and is in Phase 2 clinical development for this indication.
Linaclotide 145 micrograms targets GUCY2C, also known as guanylate cyclase C. It acts as an agonist at this receptor. This mechanism is being investigated in the context of opioid-induced constipation, a gastrointestinal condition.
Linaclotide 145 micrograms is being developed by Ironwood Pharmaceuticals, Inc., which trades under the ticker IRWD. The company is responsible for the clinical program evaluating this dose in opioid-induced constipation.
Linaclotide 145 micrograms is in Phase 2 clinical development. It is investigational and has not been approved by the FDA for opioid-induced constipation. The Phase 2 trial has been completed.
Linaclotide 145 micrograms has been evaluated in a Phase 2 randomized, double-blind, placebo-controlled trial, NCT02270983. The trial enrolled 254 patients with opioid-induced constipation receiving chronic opioid treatment for non-cancer pain and was conducted in the United States. It is now completed.