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 R&D
Dexloxiglumide CR 2017
Brief non-confidential profile
Mechanism of action: CCK-1 receptor antagonist
Potential indications:
- Functional Bowel Disorders:
- Irritable Bowel Syndrome (IBS)
- Gastro-Esophageal Reflux disease (GERD)
- Functional dyspepsia (FD)
- Functional constipation (FC)
Highest development phase:Pre-clinical development
Dexloxiglumide (CR 2017) is a potent, selective and reversible antagonist of cholecystokinin-1 (CCK-1) receptors, that mediate this neuro-hormonal peptide involvement in the control of motility and sensitivity at different levels of the digestive system. It is the compound in the most advanced stage of development with this innovative mechanissm of action, whose relevance in the gastro-intestinal tract has
been validated by a thorough mapping of the CCK-1 receptor gene in human tissues.
After favourable phase II clinical trial data, the compound entered phase III clinical trials for IBS in the USA (in co-development with Forest Inc.) and in Europe. Two randomized placebo-controlled studies in constipation-predominant IBS patients have been completed and a third pivotal trial will be completed in Europe by the end of 2006.
A Phase II clinical trial in FD has been initiated in the USA in the first quarter of 2006 and should be completed in Europe by the second quarter of 2007. Phase II study protocols in GERD are being designed for implementation in the second half of 2006.
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