Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Agomelatine · 6 trials · 2 indications
| 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. |
| Name | Type | Description |
|---|---|---|
| Agomelatine (AGO178C) | DRUG | - |
| Placebo | DRUG | - |
| agomelatine | DRUG | - |
| paroxetine | DRUG | - |
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...
Top 20 of 29 competitors
Agomelatine is an investigational small molecule being developed for the treatment of Major Depressive Disorder (MDD). It is currently in Phase 3 clinical development and has not been approved by the FDA. The drug is being studied in adult patients aged 18 years and older.
Agomelatine is being developed by Novartis AG, a multinational pharmaceutical company listed on the NYSE under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with Major Depressive Disorder.
Agomelatine is in Phase 3 clinical development for the treatment of Major Depressive Disorder. It is an investigational drug and has not received FDA approval. All five completed trials were Phase 3 studies, with a total enrollment of 2,824 participants.
Agomelatine has completed five Phase 3 clinical trials, including NCT00411099, NCT00463242, NCT01110889, and NCT01110902. These randomized, double-blind, placebo-controlled studies evaluated the drug in patients with Major Depressive Disorder across the United States and Puerto Rico.
Agomelatine is a distinct investigational compound being developed by Novartis. No alternative names have been reported for this drug in the available clinical trial data. It is being studied specifically for its potential use in treating Major Depressive Disorder.