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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06524830 | A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA) | PHASE2 | RECRUITING | 142 | — | — | Dec 30, 2024 | Aug 30, 2026 | May 11, 2026 | 48 | United States, Australia +2 |
| Arm | Type | Description |
|---|---|---|
| VLS-01-BU | EXPERIMENTAL | - |
| VLS-01-BU Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| VLS-01-203 BU | DRUG | VLS-01 buccal transmucosal administration |
| VLS-01-BU Placebo | DRUG | Placebo buccal transmucosal administration |
Inclusion Criteria: * Participant must be 18 to 65 years of age inclusive at the time of signing the Informed Consent. * Has a diagnosis of recurrent moderate or severe MDD without psychotic features or single- episode MDD with duration greater than or equal to 3 months without psychotic features a...