Ramelteon: TAK 375.

Drugs in R&D 2005

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Ramelteon [TAK 375] is a melatonin (MT1/MT2) receptor agonist that is being developed by Takeda as a treatment for sleep disorders. It is undergoing regulatory review in the US, phase III trials in Europe, and phase II trials in Japan for the treatment of insomnia. Phase II trials are also being conducted in the US for the treatment of circadian rhythm sleep disordersIn September 2004, Takeda submitted an NDA to the US FDA for ramelteon for the treatment of insomnia. In May 2003, data presented at the 156th Annual Meeting of the American Psychiatric Association report that ramelteon is highly selective for the MT1 receptor, and has greater affinity, selectivity and potency than melatonin.