Ramelteon
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Ramelteon TAK 375 Abstract
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 disorders In September 2004, Takeda submitted an NDA to the US FDA for ramelteon for the treatment of insomnia.[1] 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.[2]
Table I. Features and properties Chemical name
(S)-N-[2-(1,6,7,8-tetrahydro-2H-indeno-[5,4-b]furan-8-yl)ethyl] propionamide
Molecular formula
C16 H21 N O2
CAS number
196597-26-9
WHO ATC code
N05C-M (Other hypnotics and sedatives)
EphMRA ATC code
N5B (Hypnotics/Sedatives)
Originator
Takeda: Japan
Highest development phase
Phase II (Japan, USA)
Properties Mechanism of action
Melatonin-1 agonists
Pharmacodynamics
Sleep-promoting activity in freely moving cats and monkeys
Route
Unknown route
1. Profile 1.1 Pharmacokinetics
In a randomised, double-blind study in 60 volunteers, ramelteon (4–64mg) was rapidly absorbed at all dose levels, with a tmax of
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