Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 an investigational small molecule being studied for the treatment of opioid-induced constipation, a gastrointestinal condition. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities for this use.
Linaclotide 145 micrograms is a small molecule that targets the guanylate cyclase-C receptor in the gastrointestinal tract, which helps regulate fluid secretion and bowel function. By activating this receptor, it aims to relieve constipation associated with opioid use.
Linaclotide 145 micrograms is being developed by Ironwood Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IRWD. The company is conducting clinical trials to evaluate the drug's safety and efficacy for opioid-induced constipation.
Linaclotide 145 micrograms is in Phase 2 clinical development for opioid-induced constipation. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials to determine its safety and effectiveness.
Linaclotide 145 micrograms has one completed Phase 2 clinical trial, identified as NCT02270983. This randomized, double-blind, placebo-controlled, parallel group trial enrolled 254 patients with opioid-induced constipation who were receiving chronic opioid treatment for non-cancer pain. The study was conducted in the United States.
Linaclotide 145 micrograms is a specific dose of the drug linaclotide. While linaclotide is the active pharmaceutical ingredient, the 145 microgram formulation is being studied specifically for opioid-induced constipation. This dose is distinct from other formulations that may be approved for different indications.