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alosetron · 2 trials · 2 indications
| Name | Type | Description |
|---|---|---|
| alosetron | DRUG | - |
Inclusion Criteria: * Diagnosed with severe diarrhea-predominant Irritable Bowel Syndrome (IBS). * Failed conventional therapy. * Willing to make daily calls on a touch-tone telephone. Exclusion criteria: * History of or current chronic or severe constipation. * Bloody diarrhea, abdominal pain wi...
Alosetron is used to treat irritable colon, specifically diarrhea-predominant irritable bowel syndrome (IBS) in women who have failed conventional therapy. It is a small molecule developed by GSK plc for gastrointestinal use. The clinical program studied women aged 18 years and older with severe diarrhea-predominant IBS.
Alosetron targets HTR3A, the serotonin 5-HT3 receptor, and acts as an antagonist. By blocking this receptor, alosetron modulates serotonin signaling in the gastrointestinal tract, which is the proposed mechanism underlying its effects in diarrhea-predominant irritable bowel syndrome. Its mechanism is characterized as HTR3A antagonism.
Alosetron is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor behind the clinical development program for alosetron in irritable colon and diarrhea-predominant irritable bowel syndrome. The drug is a small molecule in the gastrointestinal therapeutic area.
Alosetron has been studied in Phase 3 clinical development for irritable colon and diarrhea-predominant irritable bowel syndrome. The program includes two completed Phase 3 trials with a combined enrollment of 1,402 participants. Both trials were randomized and double-blind, and both are now completed.
Alosetron has been evaluated in two completed Phase 3 trials: NCT00067561, which enrolled 702 women, and NCT00067457, which enrolled 700 women. Both studied women aged 18 years and older with severe diarrhea-predominant irritable bowel syndrome who had failed conventional therapy, and both were conducted in the United States and Australia.