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Neboglamine (XY2401) was in-licensed from Rottapharm (Italy) in January 2005 for development in the US, Canada, Japan, Australia and New Zealand. It is a norepinephrine uptake inhibitor that has shown antidepressant-like activity in animal models. Xytis completed three Phase I clinical studies: single ascending dose, food interaction, and multiple ascending dose studies in a total of 76 healthy volunteers. In these trials, Neboglamine had an excellent safety profile, and was well tolerated. Preliminary clinical findings support the antidepressant effect predicted by non clinical studies. In addition, Xytis and the NIDA have a Cooperative Research and Development Agreement (CRADA) under which the NIH will fund up to $40M in Phase I and II clinical trial costs in order to evaluate the utility of Neboglamine in the prevention of relapse to cocaine abuse. |