MedPath

Agomelatine

Generic Name
Agomelatine
Brand Names
Valdoxan
Drug Type
Small Molecule
Chemical Formula
C15H17NO2
CAS Number
138112-76-2
Unique Ingredient Identifier
137R1N49AD
Background

Agomelatine is structurally closely related to melatonin. Agomelatine is a potent agonist at melatonin receptors and an antagonist at serotonin-2C (5-HT2C) receptors, tested in an animal model of depression. Agomelatine was developed in Europe by Servier Laboratories Ltd. and submitted to the European Medicines Agency (EMA) in 2005. The Committee for Medical Products for Human Use (CHMP) recommended refusal of marketing authorization on 27 July 2006. The major concern was that efficacy had not been sufficiently shown. In 2006 Servier sold the rights to develop Agomelatine in the US to Novartis.

The development for the US market was discontinued in October 2011. It is currently sold in Australia under the Valdoxan trade name.

Indication

Agomelatine is indicated to treat major depressive episodes in adults.

Associated Conditions
Major Depressive Episode
Clinical Trials
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