NEW YORK, July 6, 2026
AtaiBeckley Inc. announced that the final patient has been dosed in Elumina, its international Phase 2b clinical trial evaluating VLS-01, an investigational oral transmucosal DMT formulation, in adults with treatment-resistant depression (TRD). The randomized, double-blind, placebo-controlled study enrolled 156 patients, with topline efficacy and safety results expected in Q4 2026. Beyond TRD, the company intends to advance VLS-01 into a Phase 3 program for major depressive disorder (MDD), subject to supportive Phase 2 findings, while also identifying generalized anxiety disorder (GAD) as a potential future indication. Together with the company’s Phase 3 asset BPL-003, VLS-01 is expected to expand AtaiBeckley’s portfolio across multiple mood and anxiety disorders.
Phase 2b Elumina Trial Evaluates Repeated Dosing Strategy
The Elumina study is designed as a multicenter, randomized, double-blind, placebo-controlled Phase 2b trial evaluating the efficacy, safety, and tolerability of repeated VLS-01 administration in adults with treatment-resistant depression. Participants were randomized in a 1:1 ratio to receive either VLS-01 buccal oral transmucosal film or placebo through two treatment sessions administered two weeks apart, followed by a 12-week observation period. The primary endpoint measures the change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) scores at Day 29, while secondary endpoints include longer-term depression assessments, suicide risk evaluation using the Columbia-Suicide Severity Rating Scale (C-SSRS), and overall safety and tolerability. Following completion of the placebo-controlled portion, participants receive an additional randomized VLS-01 dose to further characterize dose-response and long-term safety.
Company Positions VLS-01 for Broader Depression and Anxiety Treatment
Based on positive Phase 2 outcomes, AtaiBeckley plans to initiate Phase 3 clinical development of VLS-01 in patients with major depressive disorder, expanding beyond the treatment-resistant population. Company leadership believes the shared biological mechanisms between TRD and MDD provide a strong scientific rationale for this strategy. The investigational therapy utilizes a proprietary oral buccal film formulation of N,N-Dimethyltryptamine (DMT) that acts as an agonist of multiple serotonin receptors (5-HT1/2/6/7), aiming to provide rapid, durable antidepressant effects while fitting within an approximately two-hour interventional psychiatry treatment session. The company also sees significant long-term potential in generalized anxiety disorder, where repeat treatment may benefit from the therapy’s convenient administration profile.
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Mental Health Pipeline Expands with Complementary Clinical Programs
AtaiBeckley continues building a diversified late-stage mental health pipeline designed to address patients across the spectrum of depressive and anxiety disorders. While BPL-003, a mebufotenin benzoate nasal spray, is advancing through Phase 3 development for treatment-resistant depression after receiving FDA Breakthrough Therapy Designation, VLS-01 is positioned to potentially serve the broader major depressive disorder population pending successful clinical results. The company is also advancing EMP-01 for social anxiety disorder and developing non-hallucinogenic serotonin receptor agonists targeting opioid use disorder and depression. Completion of patient dosing in Elumina marks an important operational milestone as AtaiBeckley prepares for the anticipated Phase 2b data readout later this year, which will determine the next stage of VLS-01’s clinical development.
Source: AtaiBeckley press release
