MedPath

Agomelatine

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

Overview

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.

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

FDA Approved Products

No FDA products found for this drug

Singapore Approved Products

VALDOXAN Tablet 25mg
Manufacturer:LES LABORATOIRES SERVIER INDUSTRIE [LSI], SERVIER (IRELAND) INDUSTRIES LTD. [SII]
Form:TABLET, FILM COATED
Strength:25 mg
Online:Yes
Approved: 2010/02/26
Approval:SIN13770P

Drug Development Updates

Stay informed with timely notifications on clinical trials and research advancements.

© Copyright 2025. All Rights Reserved by MedPath