Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Linaclotide 290 micrograms · 3 trials · 3 indications
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 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 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 | EXPERIMENTAL | Linaclotide 290 micrograms |
| Placebo | PLACEBO_COMPARATOR | Matching placebo |
| Linaclotide 290 micrograms | EXPERIMENTAL | Linaclotide 290 micrograms |
| Linaclotide 145 Micrograms | EXPERIMENTAL | Linaclotide 145 micrograms |
| 1 | EXPERIMENTAL | Linaclotide 290 micrograms |
| 2 | EXPERIMENTAL | Linaclotide 145 micrograms |
| 3 | PLACEBO_COMPARATOR | Matching placebo |
| Name | Type | Description |
|---|---|---|
| Linaclotide 290 micrograms | DRUG | Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study |
| Matching placebo | DRUG | Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study |
| Linaclotide 145 micrograms | 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 meets protocol criteria for IBS: reports abdominal discomfort or pain that has two or more of the following three features: 1. Relieved with defecation 2. Onset associated with a change in frequency of stool 3. Onset associated with a change in form (appearance)...
Linaclotide 290 micrograms is a small molecule drug developed by Ironwood Pharmaceuticals, Inc. (ticker IRWD) for gastrointestinal conditions. It is being studied in chronic constipation and irritable bowel syndrome characterized by constipation. The 290 microgram figure refers to a specific dose strength of the drug.
Linaclotide 290 micrograms is used for chronic constipation and irritable bowel syndrome characterized by constipation. It is a small molecule therapeutic in the gastrointestinal area. Clinical development has focused on adults 18 years and older with these conditions.
Linaclotide 290 micrograms targets GUCY2C, also known as guanylate cyclase C. It acts as an agonist at this receptor. GUCY2C agonism is the mechanism of action for this small molecule in the gastrointestinal therapeutic area.
Linaclotide 290 micrograms is developed by Ironwood Pharmaceuticals, Inc., which trades under the ticker IRWD. Ironwood is the company associated with the clinical development program for this drug in chronic constipation and irritable bowel syndrome characterized by constipation.
Linaclotide 290 micrograms is in Phase 3 development. The program includes completed Phase 3 trials in chronic constipation and irritable bowel syndrome characterized by constipation. It is an investigational agent in clinical development and is not described as approved.
Linaclotide 290 micrograms has been studied in Phase 3 trials including NCT01642914 in chronic constipation with prominent abdominal bloating, NCT00948818 in irritable bowel syndrome with constipation, and NCT00765882 in chronic constipation. All three are completed, randomized, double-blind, and placebo-controlled, with enrollment of 487, 803, and 633 participants respectively.