Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NRX-1074 · 2 trials · 1 indication
Change in Hamilton Depression Rating Scale HDRS-17
Observed side effects and changes in laboratory values
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo |
| NRX-1074 1 mg | EXPERIMENTAL | NRX-1074 1 mg, intravenous |
| NRX-1074 5 mg | EXPERIMENTAL | NRX-1074 5 mg, intravenous |
| NRX-1074 10 mg | EXPERIMENTAL | NRX-1074 10 mg, intravenous |
| Drug: Placebo | PLACEBO_COMPARATOR | Single oral administration on Day 1 |
| Drug: NRX-1074 375 mg | EXPERIMENTAL | Single oral administration on Day 1 |
| Drug: NRX-1074 500 mg | EXPERIMENTAL | Single oral administration on Day 1 |
| Drug: NRX-1074 750 mg | EXPERIMENTAL | Single oral administration on Day 1 |
| Name | Type | Description |
|---|---|---|
| NRX-1074 1 mg | DRUG | Single intravenous administration of 1 mg into arm on Day 0 |
| Placebo | DRUG | Single intravenous injection into the arm on Day 0 |
| NRX-1074 5 mg | DRUG | Single intravenous injection of 5 mg into the arm on Day 0 |
| NRX-1074 10 mg | DRUG | Single intravenous injection of 10 mg into the arm on Day 0 |
| NRX-1074 375 mg | DRUG | Single oral administration of 375 mg consumption on Day 1 |
| NRX-1074 500 mg | DRUG | Single oral administration of 500 mg consumption on Day 1 |
| NRX-1074 750 mg | DRUG | Single oral administration of 750 mg consumption on Day 1 |
Inclusion Criteria: * Male and female subjects * Aged 18 to 65 years * Meets Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) criteria for major depressive disorder (MDD) * Current episode has lasted ≥ 8 weeks before Screening * HDRS-17 score ≥ 21 before beginning the wa...
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NRX-1074 is an investigational small molecule being developed by AbbVie Inc. (ticker ABBV) for the treatment of major depressive disorder. It is a Phase 2 clinical-stage candidate in the psychiatry therapeutic area and has been studied in two completed clinical trials enrolling a total of 166 participants.
NRX-1074 is being studied as a treatment for major depressive disorder. Its clinical program includes a Phase 2 trial in patients with major depressive disorder and a Phase 1 trial in normal healthy volunteers. The Phase 2 study was randomized, double-blind, and placebo-controlled, enrolling 151 patients in the United States.
NRX-1074 is being developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the sponsor behind the clinical program evaluating the small molecule in major depressive disorder.
NRX-1074 is in Phase 2 development for major depressive disorder. It is an investigational drug and is not approved. Both of its recorded trials, a Phase 1 study in healthy volunteers and a Phase 2 study in patients, have been completed, and no trials are currently active.
NRX-1074 has been evaluated in two completed trials: NCT02067793, a Phase 2 study of intravenous NRX-1074 in 151 patients with major depressive disorder in the United States, and NCT02366364, a Phase 1 study of safety, tolerability, and pharmacokinetics in 15 normal healthy volunteers, also in the United States.