Failed Clinical Drug Development Programs as Teaching Examples

Failed Clinical Drug Development Programs as Teaching Examples 

One way to learn how to avoid the pitfalls of drug discovery and development is to examine examples of failed programs. We will examine three cases  

Tasosartan, which the sponsor withdrew from FDA review during the NDA/BLA review since it was likely not to be approved. 

Cisapride, for which the FDA requested revised labeling, leading the sponsor to withdraw the drug from U.S. marketing. 

On March 3, 1998, the tasosartan application was withdrawn from FDA consideration by the sponsor, who stated that the action was the result of an unresolved question [with FDA] regarding the safety profile of the product (57). The product had been found to be associated with liver enzyme elevations during clinical trials. The sponsor is reanalyzing the safety data for this angiotensin II inhibitor in hopes of resubmitting the NDA. 

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