Agomelatine

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.

Indication

Agomelatine is indicated to treat major depressive episodes in adults.

Associated Conditions

Major Depressive Episode

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression（SMART-I)	2025/06/10	NCT07011693	Phase 4	Not yet recruiting	Xinyu Zhou
Study of ALTO-300 in MDD	2023/06/28	NCT05922878	Phase 2	Recruiting	Alto Neuroscience
A Study on the Efficacy of Agomelatine Combined With Antipsychotics to Treat Negative Symptoms in Schizophrenia	2022/12/12	NCT05646264	Phase 4	Recruiting	Shanghai Mental Health Center
Prophylactic Effects of Agomelatine for Poststroke Depression	2022/06/21	NCT05426304	Phase 4	UNKNOWN	First Affiliated Hospital, Sun Yat-Sen University
A Double-blind, Placebo-controlled Study of Antidepressant Augmentation With Agomelatine	2020/10/19	NCT04589143	Phase 4	Completed	Central South University
Comparison of the Efficacy, Safety, and Relapse of ECT to ECT Plus Agomelatine for Depressed Patients	2019/11/29	NCT04181567	Phase 4	Completed	Kaohsiung Kai-Suan Psychiatric Hospital
the Efficacy and Safety of Agomelatine in the Patients With Parkinson's Disease	2019/06/06	NCT03977441	Phase 4	UNKNOWN	Second Affiliated Hospital of Soochow University
A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression	2019/02/25	NCT03852160	Phase 3	Withdrawn	Janssen-Cilag International NV
Melatonin Decreases Eye Pressure in Normotensive Patients	2017/06/20	NCT03193112	N/A	Completed	Kahramanmaras Sutcu Imam University
Pharmacovigilance in Gerontopsychiatric Patients	2015/03/02	NCT02374567	Phase 3	Terminated	Hannover Medical School

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Valdoxan	Les Laboratoires Servier,50, rue Carnot,F-92284 Suresnes Cedex,France	Authorised	2/19/2009

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
VALDOXAN Tablet 25mg	LES LABORATOIRES SERVIER INDUSTRIE [LSI], SERVIER (IRELAND) INDUSTRIES LTD. [SII]	SIN13770P	TABLET, FILM COATED	25 mg	2/26/2010

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Agomelatine Tablets	四川科伦药业股份有限公司	国药准字H20253067	化学药品	片剂	1/2/2025
Agomelatine Tablets	华益泰康药业股份有限公司	国药准字H20249790	化学药品	片剂	12/25/2024
Agomelatine Tablets	浙江华海药业股份有限公司	国药准字H20253567	化学药品	片剂	3/4/2025
Agomelatine Tablets	湖南洞庭药业股份有限公司	国药准字H20253553	化学药品	片剂	3/4/2025
Agomelatine Tablets	北京海步医药科技有限公司	国药准字H20253920	化学药品	片剂	4/15/2025
Agomelatine Tablets	安徽艾立德制药有限公司	国药准字H20253818	化学药品	片剂	4/8/2025
Agomelatine Tablets	北京福元医药股份有限公司	国药准字H20244560	化学药品	片剂	7/30/2024
Agomelatine Tablets	宝利化（南京）制药有限公司	国药准字H20249190	化学药品	片剂	10/29/2024
Agomelatine Tablets	四川国为制药有限公司	国药准字H20249122	化学药品	片剂	10/22/2024
Agomelatine Tablets	LES LABORATOIRES SERVIER	国药准字HJ20150581	化学药品	片剂	8/17/2020

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
AGOMELATINE-WGR agomelatine 25 mg film coated tablet blister pack.	439352	Servier Laboratories (Aust) Pty Ltd	Medicine	A	5/8/2024
DOMION agomelatine 25 mg film-coated tablet blister pack.	279057	Servier Laboratories (Aust) Pty Ltd	Medicine	A	11/15/2016
NORTIM agomelatine 25 mg film-coated tablet blister pack.	279058	Servier Laboratories (Aust) Pty Ltd	Medicine	A	11/15/2016
VALDOXAN agomelatine 25 mg film coated tablet blister pack.	159712	Servier Laboratories (Aust) Pty Ltd	Medicine	A	8/9/2010
ARDIX AGOMELATINE agomelatine 25 mg film-coated tablet blister pack.	279059	Servier Laboratories (Aust) Pty Ltd	Medicine	A	11/15/2016

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