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VLS-01-203 BU

Phase 2

Treatment Resistant Depression | Small molecule | Psychiatry |AtaiBeckley Inc.|Last Updated: May 11, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment142
FDA Designations
No designations recorded
Clinical trial landscape

VLS-01-203 BU · 1 trial · 1 indication

Phase 2 1
NCT06524830A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA)Treatment Resistant Depression
RECRUITING142 Analytics
PHASE2RECRUITING
A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA)
Treatment Resistant Depression
NCT06524830142
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Study Endpoints
Primary Endpoints
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score
Baseline to Day 29
Secondary Endpoints
Change from Baseline in MADRS total score
Baseline to Day 43
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
VLS-01-BUEXPERIMENTAL -
VLS-01-BU PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
VLS-01-203 BUDRUGVLS-01 buccal transmucosal administration
VLS-01-BU PlaceboDRUGPlacebo buccal transmucosal administration
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Eligibility Criteria
Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites48

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...

Countries:United StatesAustraliaCanadaUnited Kingdom
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06524830primaryCompletionDate: changed
LOWMay 24, 2026NCT06524830studyFirstPostDate: changed