As announced in October 2007, the FDA in the US has requested additional clinical data prior to submission of a new drug application (NDA) for TAK-475 and recommended the suspension of clinical studies with higher doses.
Takeda has made the decision to discontinue development of TAK-475 based on judgment that the profile of the compound is not superior to existing marketed drugs from both efficacy and safety viewpoints. This conclusion follows a thorough review of the clinical data available to date including Phase II clinical trial result in Japan and discussions with the relevant regulatory authorities.