Agomelatine (Valdoxan) for major depressive episodes

Agomelatine (Valdoxan, Melitor, Thymanax) is a recently marketed new drug for the treatment of major depression with a novel mechanism of action. It can be included in the class of  “other antidepressants”, or classified as a melatonergic drug.

Mechanism of action

Agomelatine acts as an agonist on melatonin MT1 and MT2 receptors. Additionally, it blocks serotonin 2C (5-HT2C) receptors.


Efficacy and place in therapy

On November 2008, EMEA issued a positive opinion for granting a Marketing Authorization to Valdoxan, after a resubmission by the applicant.  Agomelatine was launched in the UK in June 2009 for the treatment of major depressive episodes in adults.

Few trials have compared agomelatine with  ‘established’ antidepressants like venlafaxine and sertraline. Most clinical trials compared agomelatine to placebo. As with most new drugs, time and experience from experts will tell which place it has on the therapeutic options for the treatment of depression.

The following document is a drug specific review for agomelatine by the London New Drugs Group.



Download review (PDF file)



References and further reading

Agomelatine for depression – horizon scanning review. Centre for Reviews and Dissemination. 2003.

J Pierre Olié, S Kasper.  Efficacy of agomelatine, a MT1/MT2 receptor agonist with 5-HT2C antagonistic properties, in major depressive disorder (abstract). The International Journal of Neuropsychopharmacology, 2007. Cambridge Univ Press.

S.H. Kennedy , R. Emsley. Placebo-controlled trial of agomelatine in the treatment of major depressive disorder. (PDF Free Full text). European Neuropsychopharmacology, 2006.

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