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March 29, 2013

New Drug Approvals

Lu AE58054


C20H19F5N2O, 398.37


1H-​Indole-​3-​ethanamine, 6-​fluoro-​N-​[[3-​(2,​2,​3,​3-​tetrafluoropropoxy)​phenyl]​methyl]​-


CAS No: 467458-02-2  hydrochloride, M.Wt: 434.83
Lu AE58054 Hydrochloride Formula: C20H20ClF5N2O


H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced a license and development agreement for Lu AE58054, a selective 5HT6receptor antagonist currently in development for the treatment of Alzheimer’s disease. Under the terms of the agreement, Lundbeck will grant Otsuka co-development and co-commercialization rights to Lu AE58054 in the U.S., Canada, East Asia including Japan, major European countries and Nordic countries.

Lu AE58054 is a potent and selective 5-HT6 receptor antagonist under development byLundbeck as an augmentation therapy for the treatment of cognitive deficits associated with Alzheimer’s disease and schizophrenia.[1][2]

Phase III trials recently began for Lu-AE58054, a novel 5-HT6 antagonist for Alzheimer’s disease (AD) from H Lundbeck and Otsuka. Lu-AE58054 already demonstrated significant improvement of cognitive function in an earlier phase II trial when administered with Aricept.


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