Drugs / Agomelatine
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Valdoxan | — | 2009-02-19 | europa.eu ↗ |
| Refused (EMA) | EU (EMA) | Valdoxan | — | 2007-01-16 | europa.eu ↗ |
| Refused (EMA) | EU (EMA) | Thymanax | — | 2006-11-18 | europa.eu ↗ |
Trials 17
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01108393 | May 2010 → Aug 2012 | obsessive-compulsive disorder | Servier | Completed | No outcome recorded |
| Phase 38 trials | ||||||
| Phase 3 | NCT02374567 | Jan 2015 → Jun 2017 | anxiety disorder, dementia, depressive disorder, schizophrenia +1 | Hannover Medical School | Terminated | No outcome recorded |
| Phase 3 | NCT01156415 | Jun 2010 → Oct 2011 | major depressive disorder | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT01110902 | May 2010 → Jun 2011 | major depressive disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01110889 | May 2010 → Jul 2011 | major depressive disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00467402 | Apr 2007 → Sep 2009 | major depressive disorder | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00463242 | Mar 2007 → Jun 2008 | major depressive disorder | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00411242 | Dec 2006 → Jan 2008 | major depressive disorder | Novartis | Completed | Mixed |
| Phase 3 | NCT00411099 | Dec 2006 → Jan 2008 | major depressive disorder | Novartis | Completed | No outcome recorded |
| Phase 47 trials · 1 missed | ||||||
| Phase 4 | NCT07011693 | Jun 2025 → Jun 2027 expected | major depressive disorder | Xinyu Zhou | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05646264 | Jan → Aug 2023 | schizophrenia | Shanghai Mental Health Center | Unknown | No outcome recorded |
| Phase 4 | NCT05426304 | Oct 2022 → May 2024 | depressive disorder, ischemic stroke | First Affiliated Hospital, Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 4 | NCT04589143 | Oct 2020 → Dec 2022 | major depressive disorder | Central South University | Completed | Missed primary |
| Phase 4 | NCT03977441 | Jul 2019 → Dec 2020 | Parkinson disease, circadian rhythm sleep disorder, depressive disorder | Second Affiliated Hospital of Soochow University | Unknown | No outcome recorded |
| Phase 4 | NCT04181567 | Mar 2014 → Oct 2019 | major depressive disorder | Kaohsiung Kai-Suan Psychiatric Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01822418 | Jan 2013 → Dec 2015 | delusional disorder, schizoaffective disorder, schizophrenia | Central Institute of Mental Health, Mannheim | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00451490 | Oct 2006 → Dec 2007 | major depressive disorder | National Taiwan University Hospital | Withdrawn | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 3 | NCT03852160 Background | Dec 2019 → Jul 2021 | major depressive disorder | Janssen-Cilag International NV | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT02400346 Background | Mar 2015 → Jun 2016 | major depressive disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 3 | NCT01488071 Comparator | Jan → Dec 2012 | major depressive disorder | H. Lundbeck A/S | Completed | Met primary |
| Phase 4 | NCT01483053 Comparator | Jan 2014 → Feb 2015 | major depressive disorder | Baker Heart and Diabetes Institute | Unknown | No outcome recorded |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | agomelatine | “Citalopram, ecitalopram, fluoxetine, sertraline, paroxetine IR, paroxetine CR, venlafaxine IR, venlafaxine XR (extended release), desvenlafaxine, duloxetine, mirtazapine,...” NCT02400346 ↗20“formulation of agomelatine (AGO178)” NCT01156415 ↗ |
| Known as | AGO | “The new melatonergic antidepressant agomelatine (AGO) appears promising for the treatment of MDEs in schizophrenia for several reasons.” NCT01822418 ↗ |
| Known as | AGO178 | “This study will demonstrate the efficacy of agomelatine (AGO178) 25 mg and 50 mg in the prevention of relapse in patients with Major Depressive Disorder (MDD).” NCT00467402 ↗3“This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50 mg in patients with Major Depressive Disorder (MDD).” NCT00411099 ↗ “This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50 mg in patients with Major Depressive Disorder (MDD).” NCT00411242 ↗ “formulation of agomelatine (AGO178)” NCT01156415 ↗ |
| Known as | AGO178C | “Agomelatine (AGO178C)” NCT01110902 ↗1“Agomelatine (AGO178C)” NCT01110889 ↗ |
| Known as | Agomelatina | ChEMBL registry synonym — accepted as the source's own label CHEMBL10878 ↗ |
| Known as | S-20098 | “Here, we determined the effects of agomelatine (S-20098), a new antidepressant, on various phases of neurogenesis in the dentate gyrus of adult rat.” PMID 16499883 ↗ Feb 2006 |
| Known as | Thymanax | ChEMBL registry synonym — accepted as the source's own label CHEMBL10878 ↗ |
| Known as | Valdoxan | ChEMBL registry synonym — accepted as the source's own label CHEMBL10878 ↗ |
| Action | Inhibit | “Serotonin 2c (5-HT2c) receptor antagonist” CHEMBL10878 ↗ |
| Modality | Small molecule | “Agomelatine, a naphthalene analog of melatonin” PMID 18583104 ↗ Jun 2008 |
| Route | Oral | “Either 25 mg or 50 mg agomelatine orally once daily” NCT00463242 ↗ |
| Target | HTR2C | “Serotonin 2c (5-HT2c) receptor antagonist” CHEMBL10878 ↗ |