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Also known as Agomelatine (AGO178C), AGO178
agomelatine · 7 trials · 3 indications
Blood samples will be collected at various time points on day 1 and day 2
Blood samples will be collected at various time points on day 1 and day 2
| Arm | Type | Description |
|---|---|---|
| AGO178C 0.5 mg /day | EXPERIMENTAL | - |
| AGO178C 1 mg / day | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | PLACEBO_COMPARATOR | - |
| Agomelatine | EXPERIMENTAL | Dosing for each subject in this extension study began with the same dose (25 mg or 50 mg of agomelatine orally once daily) the subject was receiving at the end of Week 8, the week before this study began. |
| Mild Hepatic Impaired Participants | EXPERIMENTAL | Mild hepatic impaired participants will receive a single sublingual dose of AGO178, 1 milligram (mg) on Day 1. |
| Moderate Hepatic Impaired Participants | EXPERIMENTAL | Moderate hepatic impaired participants will receive a single sublingual dose of AGO178, 1 mg on Day 1. |
| Healthy Participants Matched by Aged, Gender and Body Mass Index (BMI) | EXPERIMENTAL | Healthy participants matched by aged, gender and BMI will receive a single sublingual dose of AGO178, 1 mg on Day 1. |
| Name | Type | Description |
|---|---|---|
| Agomelatine (AGO178C) | DRUG | - |
| Placebo | DRUG | - |
| agomelatine | DRUG | - |
| paroxetine | DRUG | - |
| AGO178 | DRUG | AGO178 is administered as a sublingual tablet. |
Inclusion Criteria: * Patients with diagnosis of MDD, single or recurrent episode, according to DSM-IV criteria. * Current episode ≥4 weeks. * CGI-Severity score ≥4 at Screening and Baseline. Exclusion Criteria: * History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eat...
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Agomelatine is being developed for the treatment of major depressive disorder (MDD). It is an investigational small molecule studied in adults aged 18 years and older. Clinical development has focused on both acute treatment of depressive episodes and prevention of relapse of major depressive disorder.
Agomelatine targets HTR2C, MTNR1A and MTNR1B. It acts as an antagonist at these receptors, combining serotonin 2C receptor antagonism with melatonin MT1 and MT2 receptor activity. This dual receptor profile distinguishes it from conventional antidepressant mechanisms.
Novartis AG, which trades under the ticker NVS, is the developer of agomelatine. The company has sponsored the clinical trial program evaluating the drug in major depressive disorder, including placebo-controlled and active-comparator Phase 3 studies conducted primarily in the United States and Puerto Rico.
Agomelatine is in Phase 3 development for major depressive disorder. It is an investigational therapy and has not been established as approved. Six Phase 3 trials have been completed, with no active trials currently ongoing, and total enrollment across the program is 3,327 participants.
Completed Phase 3 trials include NCT01110902 and NCT01110889, which tested agomelatine sublingual tablets in major depressive disorder, NCT00467402, which studied relapse prevention, and NCT00463242, a placebo- and paroxetine-controlled study of 25 or 50 mg doses. All were randomized, double-blind and placebo-controlled.
Yes, AGO178C is an alternative designation for agomelatine. Both names refer to the same small molecule developed by Novartis AG for major depressive disorder, so searches using either name point to the same investigational compound and its Phase 3 clinical program.