Chemistry |
Bicyclic fatty acid called a prostone |
14 amino acid peptide, analogue of guanylin |
Target receptor |
Chloride channel (ClC2); ? CFTR involved |
Guanylate cyclase C receptor activation with CFTR-mediated secretion |
Pharmacodynamics in humans |
Accelerated small bowel and colonic transit in health |
Accelerated colonic transit in IBS-C in dose-related fashion |
Clinical trial efficacy |
Phase II and III portfolio in chronic constipation and C-IBS |
Phase IIB in chronic constipation and IBS-C |
Open label effectiveness |
Clinical practice experience |
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Arrhythmogenicity |
No arrhythmic activity |
Low bioavailability, no arrhythmic activity |
Cardiovascular safety |
Healthy subjects 'thorough' QTc study |
Healthy subjects 'thorough' QTc study |
Commonest AEs |
Diarrhoea, nausea |
Diarrhoea |
Potential other actions |
Mucosal protection |
Anti-neoplastic |
Approval status |
FDA |
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