Clinical Trials

Agomelatine has been evaluated in numerous clinical trials across various phases, targeting major depressive disorder, sleep and circadian rhythm disturbances, obsessive-compulsive disorder, post-viral depression, and treatment-resistant adolescent depression. These studies, which also include pharmacokinetic assessments of CYP1A2 and CYP2C9 genetic polymorphisms, range from completed trials to active and upcoming protocols. Sponsorship is provided by both academic medical centers and major pharmaceutical corporations, such as Novartis and Institut de Recherches Internationales Servier.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07011693 NOT_YET_RECRUITING
Major Depressive Disorder (MDD)
Xinyu Zhou
 2025-06-20 PHASE4
NCT05426304 UNKNOWN
Depression; Acute Ischemic Stroke
First Affiliated Hospital, Sun Yat-Sen University
 2022-10-01 PHASE4
NCT06120543 Not yet recruiting
Polymorphism Genetic|Depression|CYP1A2 Polymorphism|CYP2C9 Polymorphism|Polymerase Chain Reaction|Plasma Concentration
Affiliated Hospital of Nantong University
 2023-10-31 --
NCT05646264 UNKNOWN
Schizophrenia; Negative Symptoms in Schizophrenia
Shanghai Mental Health Center
 2023-01-01 PHASE4
NCT04589143 COMPLETED
Major Depressive Disorder
Central South University
 2020-10-01 PHASE4
NCT05323994 Recruiting
Depression|COVID-19
Servier Russia
 2022-04-19 --
NCT03852160 WITHDRAWN
Depressive Disorder, Treatment-Resistant
Janssen-Cilag International NV
 2019-12-01 PHASE3
NCT03977441 UNKNOWN
Parkinson Disease; Depression; Sleep Disorders; Circadian Rhythm Disorders
Second Affiliated Hospital of Soochow University
 2019-07 PHASE4
NCT04181567 COMPLETED
Major Depressive Disorder
Kaohsiung Kai-Suan Psychiatric Hospital
 2014-03-03 PHASE4
NCT03977441 Unknown status
Parkinson Disease|Depression|Sleep Disorders|Circadian Rhythm Disorders
Second Affiliated Hospital of Soochow University
 2019-07 Phase 4
NCT02374567 TERMINATED
Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders
Hannover Medical School
 2015-01 PHASE3
NCT01822418 COMPLETED
Schizophrenia; Schizoaffective Disorder; Delusional Disorder
Central Institute of Mental Health, Mannheim
 2013-01 PHASE4
NCT01483053 UNKNOWN
Major Depressive Disorder (MDD)
Baker Heart and Diabetes Institute
 2014-01 PHASE4
NCT01488071 COMPLETED
Major Depressive Disorder
H. Lundbeck A/S
 2012-01 PHASE3
NCT01108393 COMPLETED
Obsessive Compulsive Disorder
Institut de Recherches Internationales Servier
 2010-05 PHASE2
NCT01156415 TERMINATED
Major Depressive Disorder
Novartis Pharmaceuticals
 2010-06 PHASE3
NCT01110889 COMPLETED
Major Depressive Disorder
Novartis Pharmaceuticals
 2010-05 PHASE3
NCT01110902 COMPLETED
Major Depressive Disorder
Novartis Pharmaceuticals
 2010-05 PHASE3
NCT00467402 COMPLETED
Major Depressive Disorder
Novartis
 2007-04 PHASE3
NCT00463242 COMPLETED
Major Depressive Disorder
Novartis
 2007-03 PHASE3
NCT00411099 COMPLETED
Major Depressive Disorder
Novartis
 2006-12 PHASE3
NCT00411242 COMPLETED
Major Depressive Disorder (MDD)
Novartis
 2006-12 PHASE3
NCT00463242 Completed
Major Depressive Disorder
Novartis
 2007-03 Phase 3
NCT00451490 WITHDRAWN
Depressive Disorder, Major
National Taiwan University Hospital
 2006-10

(data from https://clinicaltrials.gov, updated on 2025-06-10)

Check the Agomelatine (S20098) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Agomelatine functions as a potent melatonin receptor agonist and a 5-HT2C serotonin receptor antagonist, thereby disinhibiting downstream frontocortical dopamine and norepinephrine release. This dual neurochemical activity enhances frontocortical monoaminergic signaling while resynchronizing circadian rhythms, providing therapeutic efficacy in clinical conditions such as major depressive disorder and sleep disorders.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.