Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Linaclotide 290 micrograms · 3 trials · 3 indications
A 9/12 Week CSBM 3+1 Responder is a patient who is a CSBM 3+1 Weekly Responder for at least 9 out of the 12 weeks of the Treatment Period. A CSBM 3+1 Weekly Responder is a patient who had a CSBM Weekly Frequency Rate that was 3 or greater and increased by 1 or more from baseline.
A patient is considered to be an APC responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs, experienced an increase of at least 1 CSBM from baseline, and experienced a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week. The AP score assesses the worst of a patient's AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP. A CSBM is defined as a spontaneous bowel movement, associated with a sense of complete evacuation.
A patient is considered to be a CSBM 3+1 responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs and experienced an increase of at least 1 CSBM from baseline during a particular week. A CSBM was defined as a Spontaneous Bowel Movement (SBM) that was associated with a sense of complete evacuation. An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.
A patient is considered to be an abdominal pain responder if, for at least 9 out of the 12 weeks of the treatment period, they experienced a decrease of at least 30 percent in the mean abdominal pain score from baseline during a particular week. The Abdominal Pain score assesses the worst of a patient's abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain.
A patient is considered an APC responder if, for at least 6 of the 12 weeks of the treatment, the patient experienced an increase of at least 1 Complete Spontaneous Bowel Movement (CSBM) from baseline and experienced a decrease of at least 30 percent in their Abdominal Pain (AP)score during a particular week. The AP score assesses the worst of a patient's AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP. A CSBM was defined as a Spontaneous Bowel Movement (SBM) that was associated with a sense of complete evacuation.
A 12-week CSBM overall responders was defined as a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline. A CSBM was defined as a spontaneous bowel movement (SBM) that was associated with a sense of complete evacuation. An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.
| Arm | Type | Description |
|---|---|---|
| Linaclotide 290 micrograms | EXPERIMENTAL | Linaclotide 290 micrograms |
| Linaclotide 145 Micrograms | EXPERIMENTAL | Linaclotide 145 micrograms |
| Placebo | PLACEBO_COMPARATOR | Matching placebo |
| Linaclotide | EXPERIMENTAL | Linaclotide 290 micrograms |
| 1 | EXPERIMENTAL | Linaclotide 290 micrograms |
| 2 | EXPERIMENTAL | Linaclotide 145 micrograms |
| 3 | PLACEBO_COMPARATOR | Matching placebo |
| Name | Type | Description |
|---|---|---|
| Linaclotide 290 micrograms | DRUG | oral capsule, taken once daily each morning at least 30 minutes before breakfast |
| Linaclotide 145 micrograms | DRUG | oral capsule, taken once daily each morning at least 30 minutes before breakfast |
| Matching placebo | DRUG | oral capsule, taken once daily each morning at least 30 minutes before breakfast |
| Placebo | DRUG | Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study |
Inclusion Criteria: * Patient has completed a colonoscopy according to the American Gastroenterological Association criteria with no clinically significant findings * Patient has successfully completed protocol procedures (with no clinically significant findings) * Patient meets protocol criteria f...
Linaclotide 290 micrograms is used for treating irritable bowel syndrome characterized by constipation and chronic constipation. It is a small molecule being developed by Ironwood Pharmaceuticals, Inc. for gastrointestinal conditions. The drug is currently in Phase 3 clinical development and is considered investigational.
Linaclotide 290 micrograms targets the guanylate cyclase-C receptor in the gastrointestinal tract. By activating this receptor, it helps increase fluid secretion and accelerate intestinal transit, which can relieve constipation. This mechanism is relevant for its use in chronic constipation and irritable bowel syndrome with constipation.
Linaclotide 290 micrograms is developed by Ironwood Pharmaceuticals, Inc., a biopharmaceutical company. The company's stock ticker is IRWD. Ironwood is conducting clinical trials to evaluate the drug's safety and efficacy for gastrointestinal conditions.
Linaclotide 290 micrograms is in Phase 3 clinical development. It has completed two Phase 3 trials, with no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities based on the available data.
Linaclotide 290 micrograms has completed two Phase 3 trials. One trial, NCT00765882, enrolled 633 patients with chronic constipation. Another trial, NCT00948818, enrolled 803 patients with irritable bowel syndrome characterized by constipation. Both were randomized, double-blind, and placebo-controlled, conducted in the United States and Canada.
Linaclotide 290 micrograms is a specific dosage strength of the drug linaclotide. The clinical trials for this asset used the 290 microgram dose. Linaclotide is the active pharmaceutical ingredient, and 290 micrograms refers to the amount per dose administered in the studies.