KC 11458 - A novel motilin agonist for the treatment of functional dyspepsia with delayed gastric emptying or diabetic gastroparesis?

In two clinical studies KC 11458 has been investigated in two different patient populations: (1) in patients suffering from functional dyspepsia with delayed gastric emptying and (2) in patients with diabetic gastroparesis. In contrast to animal studies and investigations in healthy volunteers KC 11458 (8 mg tid) did not significantly accelerate delayed gastric emptying in either of those indications. The effects of KC 11458 on dyspeptic symptoms were rather small and did not separate statistically from placebo effects. In the light of the clear effects in pharmacological models and in healthy volunteers further investigations in different patient populations and/or with different doses/dose regimens are recommended.