VLS-01 · program
VLS-01 for Treatment-resistant depression
VLS-01 (DMT buccal film) for treatment-resistant depression — AtaiBeckley's lead program for this asset, paired with a digital therapeutic. Pivotal-stage Phase 2 'Elumina' trial ongoing (first patient dosed March 2025); positive Phase 1b PK reported Aug 2024.
Development timeline
Clinical trials in Treatment-resistant depression
NCT06524830VLS-01-203 (Elumina)Phase 2Recruitingn=142
Phase 2 Trial of VLS-01 Buccal Film in Treatment Resistant Depression (ELUMINA)
Formulations
| Formulation | Route | Regimen | Pharmacokinetics |
|---|---|---|---|
| VLS-01 buccal film (DMT oral transmucosal film)oral transmucosal film (OTF) applied to the buccal surface Buccal film doses of 20 mg, 60 mg, 120 mg and 160 mg evaluated in the Phase 1b trial; Phase 2 (Elumina) administers repeat doses (Day 1 and Week 2, optional third dose at Week 14). | Buccal | Single dose | Tmax 0.63 h |
Mechanism of action
DMT is a non-selective serotonergic agonist; psychedelic/antidepressant effects are attributed primarily to 5-HT2A agonism, with additional 5-HT2C and 5-HT1A activity.
| Target | Action | Affinity |
|---|---|---|
| 5-HT2AprimaryHTR2A | Agonist | —ⓘ |
| 5-HT1AHTR1A | Agonist | — |
| 5-HT2CHTR2C | Agonist | — |
← Full VLS-01 compound page (identity, identifiers, all indications)
Sources
- Agonist properties of N,N-dimethyltryptamine at serotonin 5-HT2A and 5-HT2C receptors — PubMed
- atai Life Sciences Announces Positive Preliminary Results from Phase 1b Trial of VLS-01 (Buccal Film DMT) — atai Life Sciences (press release)
- ELUMINA (NCT06524830) — ClinicalTrials.gov
- First Patient Dosed in Elumina Phase 2 — AtaiBeckley IR
- Positive Phase 1b results for VLS-01 — BioSpace