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
A Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine (25 or 50 mg) in the Treatment of Major Depressive Disorder (MDD)
- Conditions
- Major Depressive Disorder
- Interventions
- First Posted Date
- 2007-04-20
- Last Posted Date
- 2020-12-23
- Lead Sponsor
- Novartis
- Target Recruit Count
- 501
- Registration Number
- NCT00463242
- Locations
- 🇵🇷
Novartis Investigative Site, Hato Rey, Puerto Rico
The Effect of Agomelatine or Fluoxentine on Heart Rate Variability in Patients With Major Depressive Disorder
- Conditions
- Depressive Disorder, Major
- First Posted Date
- 2007-03-23
- Last Posted Date
- 2008-01-08
- Lead Sponsor
- National Taiwan University Hospital
- Target Recruit Count
- 24
- Registration Number
- NCT00451490
- Locations
- 🇨🇳
National Taiwan University Hospital, Taipei, Taiwan
Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder
- Conditions
- Major Depressive Disorder (MDD)
- Interventions
- Drug: placebo
- First Posted Date
- 2006-12-13
- Last Posted Date
- 2020-12-23
- Lead Sponsor
- Novartis
- Target Recruit Count
- 503
- Registration Number
- NCT00411242
- Locations
- 🇺🇸
Novartis Investigative Site, Milwaukee, Wisconsin, United States
Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder
- First Posted Date
- 2006-12-13
- Last Posted Date
- 2020-12-23
- Lead Sponsor
- Novartis
- Target Recruit Count
- 508
- Registration Number
- NCT00411099
- Locations
- 🇵🇷
Novartis Investigative Site, Rio Piedras, Puerto Rico
Drug Development Updates
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