Nefiracetam. Daiichi Seiyaku.

: Nefiracetam (DM-9384) is a cerebral metabolic product under development by Daiichi for the potential treatment of the after-effects of cerebrovascular disorders. By September 1999, nefiracetam was In phase II trials in the US for the treatment of mental symptoms associated with sequelae of stroke and Alzheimer's type dementia. By August 2000, clinical trials in China had been completed in preparation for an NDA filing In November 2000, the companypredicted a launch in 2002. Modified phase III trials of the compound were being repeated in Japan in preparation for re-filing of an NDA. The protocol for the initial Japanese phase III retrial in patients with sequelae of cerebral infarction was approved at the end of July 1999, with completion of the trial expected by the end of 2000. However, in February 2002 Daiichi withdrew its Japanese NDA due to insufficient efficacy in the revised trial. In December 2001, analysts at Morgan Stanley predicted that nefiracetam would be submitted for approval in Japan in 2002, with its approval/launch taking place in late 2002 or 2003. Estimated sales in Japan of yen 3 billon in 2002, rising to yen 13 billion in 2005 and peak sales of yen 20 to 30 billion are predicted.