Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07076407 | A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3) | PHASE3 | RECRUITING | 450 | — | — | Jul 8, 2025 | Jul 1, 2027 | Jun 2, 2026 | 44 | United States, Finland +4 |
| NCT06922110 | An Open-Label Study of Azetukalner in Major Depressive Disorder | PHASE3 | ENROLLING BY_INVITATION | 460 | — | — | Mar 18, 2025 | Mar 1, 2027 | Jun 1, 2026 | 63 | United States |
| NCT06775379 | A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder | PHASE3 | RECRUITING | 450 | — | — | Dec 20, 2024 | Oct 1, 2026 | Oct 22, 2025 | 46 | United States |
The HAMD-17 consists of 17 items that are used to rate the severity of depression symptoms. Each item is scored in a range of 0 to 2 points or 0 to 4 points, with higher scores indicating a greater degree of depression. The score for each item is summed to compute a total score, which ranges from 0 to 52 points.
| Arm | Type | Description |
|---|---|---|
| Azetukalner | EXPERIMENTAL | Azetukalner 20 mg |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Azetukalner 20 mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Azetukalner | DRUG | Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 6 weeks |
| Placebo | DRUG | Placebo taken orally once a day with food (with the evening meal when possible) for 6 weeks |
Key Inclusion Criteria: * Adults ≥18 and ≤74 years of age and experienced their first major depressive episode (MDE) prior to 50 years of age * Body Mass Index (BMI) ≤40 kg/m2 * Meets the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) criteria for curren...