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Drug

Agomelatine

Approved · EMA
ClassMelatonin receptor agonistEmerging researchLate-stage development

Also known as Agomelatina.

RxNorm306718ChEMBLCHEMBL10878ATCN06AX22UNII137R1N49AD
1
Research papers
1
Active clinical trials
3
Protein targets
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

STAT3 Signaling Mediates Agomelatine Restoration of Prefrontal Cortex Synaptic Plasticity in Chronic Social Defeat Stress Mice.

Research2025-12-22Molecular neurobiology

Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression（SMART-I): An Open-Label, Multicenter, Randomized Controlled Trial

Clinical trial2025-06-10Results expected Q2 2027 · ClinicalTrials.gov

A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Agomelatine in the Prevention of Poststroke Depression

Clinical trial2024-05-31Primary completion · ClinicalTrials.gov

A Real World Study on the Efficacy and Safety of Agomelatin Combined With Second Generation Antipsychotics in the Treatment of Negative Symptoms in Patients With Schizophrenia

Clinical trial2023-08-01Primary completion · ClinicalTrials.gov

Agomelatine Augmentation in Early-Nonresponsive Patients With Major Depressive Disorder Receiving SSRIs or SNRIs: a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

Clinical trial2023-01-30Completed · ClinicalTrials.gov

A Randomized, Double-Blind, Active-Controlled, International, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Flexibly-dosed 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

Clinical trial2021-07-25Withdrawn · ClinicalTrials.gov

A 52-week, Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel-group Study of the Long-term Efficacy, Tolerability and Safety of Agomelatine 25 and 50 mg in the Prevention of Relapse of Major Depressive Disorder (MDD) Following Open-label Treatment of 16-24 Weeks

Clinical trial2020-12-23Completed · ClinicalTrials.gov

An 8-week, Multicenter, Randomized, Double-blind, Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine 25 or 50 mg Given Once Daily in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-week Open-label Treatment With Agomelatine 25 or 50 mg

Clinical trial2020-12-23Completed · ClinicalTrials.gov

An 8-week, Randomized, Double-blind, Fixed Dosage, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy, Safety and Tolerability of Agomelatine 25 mg and 50 mg in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-week, Open-label Extension (CAGO178A2301E)

Clinical trial2020-12-23Completed · ClinicalTrials.gov

Drug Safety Update: Agomelatine (Valdoxan): risk of liver toxicity

Regulatory2014-12-11MHRA

Drug Safety Update: Agomelatine (Valdoxan/ Thymanax): risk of dose-related hepatotoxicity and liver failure

Regulatory2014-12-11MHRA

Approval: Valdoxan (EMA)

Regulatory2009-02-19EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Agomelatine
Aliases & brands
Agomelatina
RxNorm CUI
306718
ChEMBL ID
CHEMBL10878
ATC codes
N06AX22
UNII
137R1N49AD
Primary mechanism
Melatonin receptor agonist
Regulatory jurisdictions
emamhra

Pharmacology & targets

3 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Melatonin receptor type 1A
MTNR1A · P48039
AGONISTMelatonin receptor agonist
Melatonin receptor type 1B
MTNR1B · P49286
AGONISTMelatonin receptor agonist
5-hydroxytryptamine receptor 2C
HTR2C · P28335
ANTAGONISTSerotonin 2c (5-HT2c) receptor antagonist

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2009-02-19
Latest approval
2009-02-19
Authorities
EMA · MHRA
Total events
3
emaEuropean Medicines Agency· 1 event
2009-02-19Approval
Approval: Valdoxan (EMA)

Indication: Treatment of major depressive episodes in adults.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 2 events
2014-12-11Safety communicationSafety
Drug Safety Update: Agomelatine (Valdoxan): risk of liver toxicity
Evidence ↗
2014-12-11Safety communicationSafety
Drug Safety Update: Agomelatine (Valdoxan/ Thymanax): risk of dose-related hepatotoxicity and liver failure
Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

17 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
17
registered trials across all phases
LATEST COMPLETION 2023
1
Active studies
1
Recruiting
17
Late-stage (III+)
10
Completed
6
Discontinued
PHASE DISTRIBUTIONn = 17
Phase 39Phase 47Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression（SMART-I): An Open-Label, Multicenter, Randomized Controlled Trial

Not yet recruitingPH IVXinyu Zhoun=4002027

A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Agomelatine in the Prevention of Poststroke Depression

Unknown statusPH IVFirst Affiliated Hospital, Sun Yat-Sen Universityn=4202024

A Real World Study on the Efficacy and Safety of Agomelatin Combined With Second Generation Antipsychotics in the Treatment of Negative Symptoms in Patients With Schizophrenia

Unknown statusPH IVShanghai Mental Health Centern=2202023

Agomelatine Augmentation in Early-Nonresponsive Patients With Major Depressive Disorder Receiving SSRIs or SNRIs: a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

CompletedPH IVCentral South Universityn=1372023

A Randomized, Double-blind, Comparison of the Efficacy, Safety, and Relapse of Electroconvulsive Therapy (ECT) to ECT Plus Agomelatine in the Treatment of Patients With Major Depressive Disorder

CompletedPH IVKaohsiung Kai-Suan Psychiatric Hospitaln=972019

Recent completions

Trials that read out recently, adding to the completed evidence base.

Agomelatine Augmentation in Early-Nonresponsive Patients With Major Depressive Disorder Receiving SSRIs or SNRIs: a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

CompletedPH IVCentral South Universityn=1372023

A Randomized, Double-blind, Comparison of the Efficacy, Safety, and Relapse of Electroconvulsive Therapy (ECT) to ECT Plus Agomelatine in the Treatment of Patients With Major Depressive Disorder

CompletedPH IVKaohsiung Kai-Suan Psychiatric Hospitaln=972019

Agomelatine Treatment of Major Depressive Episodes in the Course of Schizophrenic Psychoses (AGOPSYCH)

CompletedPH IVCentral Institute of Mental Health, Mannheimn=272015

A Randomised, Double-blind, Parallel-group, Active-controlled, Flexible Dose Study Evaluating the Effects of [Vortioxetine] Lu AA21004 Versus Agomelatine in Adult Patients Suffering From Major Depressive Disorder With Inadequate Response to Antidepressant Treatment

CompletedPH IIIH. Lundbeck A/Sn=4952012

An 8-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy and Safety of Agomelatine 0.5 mg and 1 mg Sublingual Tablets Administered Once Daily in Patients With Major Depressive Disorder (MDD)

CompletedPH IIINovartis Pharmaceuticalsn=5822011

A 8-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy and Safety of Agomelatine 0.5 mg and 1 mg Sublingual Tablets Administered Once Daily in Patients With Major Depressive Disorder (MDD)

CompletedPH IIINovartis Pharmaceuticalsn=5892011

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Major research themes7
Acetamides1Neuronal Plasticity1Prefrontal Cortex1Signal Transduction1Social Defeat1STAT3 Transcription Factor1Stress, Psychological1
Journals, researchers & institutions
Top journals
  • Molecular neurobiology1
Leading researchers
  • Chang HS1
  • Chen YF1
  • Lee CW1
  • Li CT1
  • Liao LD1
  • Lin CH1
  • Lin HC1
  • Mao WC1
Leading institutions
free-text, unnormalised
  • Brain Research Center1
  • Cheng-Hsin General Hospital1
  • College of Medical Science and Technology1
  • Department and Institute of Physiology1
  • Institute of Biomedical Engineering and Nanomedicine1
  • Institute of Brain Science1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.