Recent Updates
Recently added Catalysts

VLS-01

Phase 2

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

Target and mechanism

ModalitySmall molecule

Also known as VLS-01-203 BU

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment142

FDA Designations

No designations recorded

Clinical trial landscape

VLS-01 · 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
Unlock trial analytics

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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria