Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SSR125543 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| SSR125543 20 mg | EXPERIMENTAL | 1 capsule of SSR125543 20 mg + 1 capsule of placebo |
| SSR125543 50 mg | EXPERIMENTAL | 1 capsule of SSR125543 50 mg + 1 capsule of placebo |
| SSR125543 100 mg | EXPERIMENTAL | 2 capsules of SSR125543 50 mg |
| escitalopram 10 mg | ACTIVE_COMPARATOR | 1 capsule of escitalopram 10 mg + 1 capsule of placebo |
| placebo | PLACEBO_COMPARATOR | 2 capsules of placebo |
| Name | Type | Description |
|---|---|---|
| SSR125543 | DRUG | Pharmaceutical form: capsule Route of administration: oral |
| escitalopram | DRUG | Pharmaceutical form: encapsulated tablets Route of administration: oral |
| placebo | DRUG | Pharmaceutical form: capsule Route of administration: oral |
Inclusion criteria: * Patients with a diagnosis of major depressive disorder, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria (296.3) and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI). ...
SSR125543 is an investigational small molecule being developed for the treatment of Major Depression. It is a Phase 2 candidate that has been studied in outpatients with major depressive disorder. The drug is not approved and remains in clinical development.
SSR125543 is being developed by Sanofi, a global biopharmaceutical company traded on the stock exchange under the ticker SNY. The drug is currently in Phase 2 clinical development for Major Depression.
SSR125543 is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, placebo-controlled study. The drug is investigational and has not been approved by regulatory authorities.
SSR125543 has been studied in one clinical trial, registered as NCT01034995. This was a Phase 2, randomized, double-blind, placebo-controlled study evaluating the efficacy and tolerability of SSR125543 in outpatients with major depressive disorder. The trial enrolled 580 participants and has been completed.
SSR125543 is not FDA approved. It is an investigational drug that has completed a Phase 2 clinical trial for Major Depression. The drug is still in clinical development and has not received regulatory approval.