Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
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Amibegron is an investigational small molecule being developed for the treatment of Major Depressive Disorder (MDD). It is a Phase 3 candidate studied in adult patients with this psychiatric condition. The drug has completed multiple clinical trials evaluating its efficacy and safety in treating depressive symptoms.
Amibegron is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi has sponsored the clinical development program for this investigational drug, which is currently in Phase 3 trials for Major Depressive Disorder.
Amibegron is in Phase 3 clinical development for the treatment of Major Depressive Disorder. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. All four Phase 3 trials listed for amibegron have been completed, with no active trials currently ongoing.
Amibegron has completed four Phase 3 clinical trials. These include NCT00385307 (SIRIUS study), NCT00825019, NCT00825058, and NCT00855530. The trials evaluated the efficacy, safety, and tolerability of amibegron in patients with Major Depressive Disorder, with some comparing it to placebo and paroxetine.
Yes, amibegron is also known as SR58611. Clinical trial records for amibegron use the name SR58611, such as in the SIRIUS study (NCT00385307) and other Phase 3 trials. This alternative name is used interchangeably in the clinical development program for this drug.