Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SR58611A · 8 trials · 5 indications
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | SR58611A 350mg twice daily with escitalopram 10mg once daily |
| Group 2 | ACTIVE_COMPARATOR | placebo with escitalopram 10mg once daily |
| Group 3 | PLACEBO_COMPARATOR | placebo |
| Name | Type | Description |
|---|---|---|
| SR58611A | DRUG | oral administration |
| escitalopram | DRUG | oral administration |
| placebo | DRUG | oral administration |
Inclusion Criteria: * Inpatients or outpatients with Major Depressive Disorder characterized by a recurrent Major Depressive Episode with Montgomery and Asberg Depression Rating Scale (MADRS) total score =\> 30 Exclusion Criteria: * Patient is at immediate risk for suicidal behavior * Patient wit...
Top 5 of 9 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Definium Therapeutics, Inc. | DFTX | 2 | PHASE3 | DT120 |
| Vistagen Therapeutics, Inc. | VTGN | 3 | PHASE3 | Fasedienol |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | VQW-765 |
| AbbVie, Inc. | ABBV | 1 | PHASE2 | ABBV-932 |
| Psyence Biomedical Ltd. | PBM | 1 | PHASE2 | Psilocybin therapy |
SR58611A is an investigational small molecule developed by Sanofi for psychiatric conditions. It was studied in Phase 3 clinical trials for major depressive disorder, depressive disorder, and generalized anxiety disorder. All of its recorded trials have been completed, and no trials are currently active.
SR58611A was studied for the treatment of major depressive disorder, depressive disorder, and anxiety disorders, including generalized anxiety disorder. Its clinical program included an eight-week generalized anxiety disorder study and depression studies, one of which enrolled elderly patients aged 65 and older.
SR58611A is developed by Sanofi, which trades under the ticker SNY. Sanofi sponsored the Phase 3 clinical program evaluating the compound across major depressive disorder, depressive disorder, and generalized anxiety disorder.
SR58611A reached Phase 3 clinical development. All four recorded trials are completed and none are active, so the compound is not currently advancing in an ongoing registrational program. It is an investigational agent and is not described as approved.
SR58611A was evaluated in completed Phase 3 trials: NCT00432614 with escitalopram in major depressive disorder, NCT00345098 for depression relapse prevention, NCT00332891 in generalized anxiety disorder, and NCT00319709 in elderly patients with depression. Total enrollment across these studies was 1,454 participants.
The SR58611A trials were randomized and double blind, with a minimum participant age of 18 years, except NCT00319709, which enrolled patients aged 65 and older. The studies were conducted across Europe, Asia, Latin America, Africa, and Russia, and all have been completed.