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VLS-01-203 BU · 1 trial · 1 indication
| 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...
VLS-01-203 BU is an investigational small molecule being developed for the treatment of Treatment Resistant Depression. It is currently in Phase 2 clinical development and is being studied in patients with this condition.
VLS-01-203 BU is being developed by AtaiBeckley Inc., a biopharmaceutical company listed on the stock exchange under the ticker ATAI. The company is conducting clinical trials to evaluate the drug's efficacy and safety.
VLS-01-203 BU is in Phase 2 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 2 trial is designed to assess its efficacy, safety, and tolerability.
VLS-01-203 BU is being evaluated in a Phase 2 clinical trial with the identifier NCT06524830, known as the ELUMINA study. This randomized, double-blind, placebo-controlled trial is recruiting 142 participants with Treatment Resistant Depression across the United States, Australia, Canada, and the United Kingdom.
VLS-01-203 BU is a specific formulation of the drug VLS-01, delivered as a buccal film. The ongoing Phase 2 trial evaluates this buccal film formulation in patients with Treatment Resistant Depression.