Agomelatine

Generic Name: Agomelatine

Brand Names: Valdoxan

Drug Type: Small Molecule

Chemical Formula: C_₁₅H_₁₇NO_₂

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

Agomelatine in Depressed Patients With Fibromyalgia

Completed

Conditions: Major Depression
Fibromyalgia

Interventions: Drug: agomelatine

First Posted Date: 2012-11-22

Last Posted Date: 2014-05-07

Lead Sponsor: Universidad de Granada

Target Recruit Count: 27

Registration Number: NCT01731899

Locations: 🇪🇸
Instituto de Neurociencias, Granada, Spain

Pharmacokinetics of AGO178 in Participants With Liver Impairment

Phase 1

Completed

Conditions: Hepatic Impairment

Interventions: Drug: AGO178

First Posted Date: 2012-02-10

Last Posted Date: 2021-05-11

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 32

Registration Number: NCT01531309

Locations: 🇺🇸
Orlando Clinical Research Center, Orlando, Florida, United States

A Study of Vortioxetine (Lu AA21004) in Comparison to Agomelatine in Adults Suffering From Major Depression With Inadequate Response to Previous Medication

Phase 3

Completed

Conditions: Major Depressive Disorder

Interventions: Drug: Vortioxetine (Lu AA21004)
Drug: Agomelatine

First Posted Date: 2011-12-08

Last Posted Date: 2014-03-26

Lead Sponsor: H. Lundbeck A/S

Target Recruit Count: 495

Registration Number: NCT01488071

Cardiovascular Effects of Agomelatine and Escitalopram in Patients With Major Depressive Disorder (MDD)

Phase 4

Conditions: Major Depressive Disorder (MDD)

Interventions: Drug: Agomelatine
Drug: Escitalopram

First Posted Date: 2011-12-01

Last Posted Date: 2013-12-18

Lead Sponsor: Baker Heart and Diabetes Institute

Target Recruit Count: 40

Registration Number: NCT01483053

Locations: 🇦🇺
Monash Medical Centre - Monash Health, Clayton, Victoria, Australia
🇦🇺
Alfred and Baker Medical Unit - Alfred Hospital, Melbourne, Victoria, Australia
🇦🇺
Baker IDI Heart & Diabetes Institute, Melbourne, Victoria, Australia

Pharmacokinetics, Safety and Tolerability of AGO178C in Subjects With Renal Deficiencies Compared With Healthy Subjects

Phase 1

Completed

Conditions: Renal Impairment

Interventions: Drug: AGO178C

First Posted Date: 2011-10-25

Last Posted Date: 2020-12-08

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 32

Registration Number: NCT01459250

Locations: 🇺🇸
Novartis Investigative Site, Knoxville, Tennessee, United States

Open-label Long Term (52 Weeks) Safety and Tolerability of Agomelatine Sublingual Tablets in Major Depressive Disorder (MDD)

Phase 3

Terminated

Conditions: Major Depressive Disorder

Interventions: Drug: AGO178

First Posted Date: 2010-07-02

Last Posted Date: 2020-12-24

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 837

Registration Number: NCT01156415

Locations: 🇺🇸
Emory University, Atlanta, Georgia, United States
🇺🇸
Atlanta Center for Medical Research, Atlanta, Georgia, United States
🇺🇸
Pharmacology Research Institute, Newport Beach, California, United States

and more 94 locations

Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder (MDD)

Phase 3

Completed

Conditions: Major Depressive Disorder

Interventions: Drug: Agomelatine (AGO178C)
Drug: Placebo

First Posted Date: 2010-04-27

Last Posted Date: 2020-12-24

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 589

Registration Number: NCT01110902

Locations: 🇺🇸
CRI Worldwide, LLC - Lourdes Division, Willingboro, New Jersey, United States
🇺🇸
Medical University of South Carolina, North Charleston, South Carolina, United States
🇺🇸
SP Research, Oklahoma City, Oklahoma, United States

and more 42 locations

Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder

Phase 3

Completed

Conditions: Major Depressive Disorder

Interventions: Drug: Placebo
Drug: Agomelatine (AGO178C)

First Posted Date: 2010-04-27

Last Posted Date: 2020-12-23

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 582

Registration Number: NCT01110889

Locations: 🇺🇸
The Ohio State University - Harding Hospital, Columbus, Ohio, United States
🇺🇸
KRK Medical Research, Dallas, Texas, United States
🇺🇸
FutureSearch Trials of Dallas, Dallas, Texas, United States

and more 45 locations