Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as amibegron (SR58611A)
amibegron · 4 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| 3 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| amibegron (SR58611A) | DRUG | - |
| placebo | DRUG | oral administration 12 hours intervals |
| paroxetine | DRUG | oral 20 mg/day |
Inclusion Criteria: * Patient with Major Depressive Disorder diagnosed according to Diagnostic and Statistical Manual of Mental Disorders DSM-IV-TR * Patient meets criteria for a recurrent Major Depressive Episode (MDE) * Patient meets severity assessments of depression specified by the study Excl...
Top 20 of 31 competitors
Amibegron was developed for the treatment of major depressive disorder. It is a small molecule studied in Phase 3 clinical trials as an oral treatment for adults with this condition. All four of its clinical trials have been completed, and no active trials are currently listed.
Amibegron targets the beta-3 adrenergic receptor, also known as ADRB3. It acts as an agonist at this receptor, meaning it activates the receptor. This mechanism distinguishes it from many conventional antidepressants, which typically act on serotonin or norepinephrine pathways.
Amibegron was developed by Sanofi, which trades under the ticker SNY. The compound, also known as SR58611A, was studied in a clinical program for major depressive disorder.
Amibegron reached Phase 3 clinical development for major depressive disorder. All four of its Phase 3 trials have been completed, and there are no active trials. It is an investigational drug and has not been approved by the FDA for any indication.
Amibegron has been studied in four completed Phase 3 trials: NCT00855530, a long-term safety and tolerability study; NCT00825058, which compared it with placebo and paroxetine; NCT00825019, a single-dose comparison with placebo and paroxetine; and NCT00385307, known as SIRIUS. Together these trials enrolled 1,830 participants.
Yes, amibegron is also known as SR58611A. SR58611A was the code name used by Sanofi during development, and amibegron is the international nonproprietary name for the same compound. Both names refer to the same investigational drug for major depressive disorder.