Loxiglumide Rotta research

Rotta was developing loxiglumide, a competitive cholecystokinin (CCK) antagonist, for potential use in the treatment of cancer, gastrointestinal disease, eating disorders and pancreatitis. However, by April 2002 its development for indications other than acute and chronic pancreatitis had been discontinued in favor of the D-enantiomer, dexloxiglumide [449509], which is in clinical trials for gastrointestinal disorders [370620]. Loxiglumide is awaiting approval in Japan where it is being developed for acute and chronic pancreatitis by Mitsubishi Pharma and Kaken Pharmaceuticals, respectively [365460], [449509]. By September 1999, Kaken had submitted a Japanese NDA for the intravenous formulation for acute pancreatitis; approval was still pending in May 2001. At this time, the oral formulation was still 'pre-NDA' [411053]. By February 2000, loxiglumide had also been filed for approval in Japan for the treatment of acute pancreatitis by Mitsubishi-Tokyo [365460], [371091] and was still awaiting approval in October 2001 [422712], [430428]. In December 2001, analysts at Merrill Lynch predicted launch of loxiglumide in early 2002 for acute pancreatitis and late 2004 for chronic pancreatitis, with sales of Yen 1 billion in 2003 rising to Yen 6 billion in 2006 [450719].