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Since preclinical studies had indicated the potential efficacy and tolerability of racecadotril for the treatment of diarrhoea in man, a series of studies was carried out to assess the clinical effects of racecadotril. These studies were also designed to evaluate whether racecadotril possessed the clinical properties that had been previously identified for an ideal agent to treat infectious diarrhoea. The pure antisecretory action of racecadotril was confirmed in these clinical studies, as was the drug's rapid onset of action. The high therapeutic index of racecadotril was combined with a lack of effect on the central nervous system. Finally, racecadotril was found to be effective in treating acute diarrhoea in double-blind studies against both placebo and the mu opiate receptor agonist, loperamide. The efficacy of racecadotril in acute diarrhoea was not associated with adverse gastrointestinal effects, and its adverse events profile was similar to that of placebo. It was concluded that racecadotril offers a new approach to the treatment of diarrhoea via its mechanism of action as a true antisecretory agent.