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Also known as VLS-01-203 BU
VLS-01 · 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 is being developed for the treatment of treatment resistant depression, a form of major depressive disorder that has not responded adequately to prior antidepressant therapies. It is an investigational small molecule in Phase 2 clinical development and has not been approved for any indication.
VLS-01 targets the 5-HT2A receptor, also written 5-HT2AR, a serotonin receptor. The drug is a small molecule designed to act at this receptor target as part of its investigational profile in treatment resistant depression.
VLS-01 is being developed by AtaiBeckley Inc., which trades under the ticker ATAI. The company is the sponsor of the clinical program evaluating the drug in treatment resistant depression.
VLS-01 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 2 study is currently recruiting participants.
VLS-01 is being studied in the ELUMINA trial, registered as NCT06524830. This Phase 2 study is randomized, double blind, and placebo controlled, with an enrollment of 142 patients with treatment resistant depression across the United States, Australia, Canada, and the United Kingdom.
Yes, VLS-01-203 BU is another name for VLS-01. The buccal film formulation of the drug is referred to as VLS-01 Buccal Film in its clinical study, so searches for VLS-01-203 BU refer to the same investigational asset.