Pipeline
Our research is focused on developing rapid-acting, effective and durable mental health treatments for large-scale patient impact.
Programs
Indication
Psychedelic Programs
Beckley Psytech Strategic Investment
Non-psychedelic Program
Compound: Neuromodulator
Route of administration: Oral formulation
Target treatment: Potential pro-cognitive neuromodulator, investigated in >500 participants and demonstrating consistent cognitive effects and good tolerability.
Abbreviations: DMT = N,N-Dimethyltryptamine; R-MDMA = R enantiomer of 3,4-Methylenedioxymethamphetamine; 5-MeO-DMT = 5-methoxy-N,N-dimethyltryptamine
1. Majority ownership stake in Recognify Life Sciences
About VLS-01 (buccal film DMT)
VLS-01 is a proprietary oral transmucosal film formulation of N,N-Dimethyltryptamine (DMT) applied to the buccal surface, being developed for the treatment of people suffering from treatment-resistant depression (TRD).
Pharmacologically, VLS-01 is a partial to full agonist of the 5-HT1/2/6/7 sub-receptors and is being developed to potentially offer rapid, robust, and durable efficacy with a favorable safety profile. VLS-01 is designed to fit within the established two-hour interventional psychiatry treatment paradigm, positioning it for integration into existing care models.
atai is enrolling patients into Elumina, a Phase 2, multicenter, double-blind, randomized, placebo-controlled, trial to assess the efficacy, safety, and tolerability of VLS-01 in people suffering from TRD. Topline data from the Phase 2 study is anticipated in the first quarter of 2026.
More information:
Read the Phase 1b data press release here.
EMP-01: R-MDMA for Social Anxiety Disorder (SAD)
EMP-01 is an oral formulation of R-MDMA, a moiety that is pharmacologically distinct from both racemic MDMA and S-MDMA. EMP-01 offers a novel approach to treating SAD by combining MDMA’s unique prosocial and empathogenic effects with improved tolerability and reduced adverse effects.
While MDMA is known for its therapeutic potential, its use has been hindered by adverse effects such as increased body temperature, blood pressure, and heart rate as well as its propensity to cause anxiety and bruxism (jaw clenching). Based on our research to date, what sets EMP-01 apart from MDMA is its more selective pharmacology, which has shown to improve tolerability on several key measures compared to racemic MDMA.
Following positive Phase 1 results, we plan to initiate an exploratory Phase 2a placebo-controlled study of EMP-01 in adults with SAD. This trial aims to build on our findings, investigating EMP-01’s potential to address the unmet needs of SAD patients with a safe and effective treatment.
More information:
Read the Phase 1 data press release here.
Learn more about the Phase 2 trial on clinicaltrials.gov here.