Approval Probability
TA Base Rate
Adjusted LOA
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Also known as ThrProProThr
GLYX-13 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Placebo injection | PLACEBO_COMPARATOR | Normal saline |
| GLYX-13, 5 mg/kg | EXPERIMENTAL | Low dose of GLYX-13 |
| GLYX-13, 10 mg/kg | EXPERIMENTAL | High dose of GLYX-13 |
| Normal Saline | PLACEBO_COMPARATOR | IV placebo |
| GLYX-13, 1 mg/kg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| GLYX-13 5 mg/kg | DRUG | Intravenous administration of 5 mg/kg into arm. |
| GLYX-13 10 mg/kg | DRUG | Intravenous administration of 10 mg/kg into arm. |
| Placebo | DRUG | Intravenous administration of normal saline into arm. |
| GLYX-13 | DRUG | single IV dose |
Inclusion Criteria: * Male and female subjects * Aged 18 to 65 years * Meets DSM-IV-TR) criteria for major depressive disorder (MDD) * Current episode has lasted ≥ 8 weeks before Screening with an inadequate response to all approved antidepressant agent(s) administered at an adequate dose and durat...
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GLYX-13 is an investigational small molecule being studied for the treatment of major depressive disorder. It has been evaluated in Phase 2 clinical trials in adults with depression, including patients with inadequate or partial response to antidepressants and patients with treatment-resistant depression.
GLYX-13 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the company associated with the clinical development program for this investigational antidepressant candidate.
GLYX-13 is in Phase 2 clinical development. It is an investigational drug and is not approved for commercial use. Two Phase 2 trials in major depressive disorder have been completed, and no trials are currently active.
GLYX-13 has been studied in two completed Phase 2 trials. NCT01684163 evaluated efficacy and safety in subjects with inadequate or partial response to antidepressants, enrolling 369 participants. NCT01234558 tested a single intravenous dose in patients with treatment-resistant depression, enrolling 115 participants. Both were conducted in the United States.
Both GLYX-13 Phase 2 trials were randomized, double-blind, and placebo-controlled studies in adults with major depressive disorder. Together they enrolled 484 participants across the two completed trials, which evaluated the drug in patients with inadequate response to antidepressants and in treatment-resistant depression.