Psychedelic · VLS-01

VLS-01

Phase 2Atai Beckley N.V. (AtaiBeckley) (ATAI)

An oral transmucosal (buccal) film of synthetic N,N-dimethyltryptamine (DMT), a rapid- and short-acting serotonergic psychedelic engineered for a ~90-120 min in-clinic experience. Originated under atai's Viridia Life Sciences; lead indication is treatment-resistant depression. (Note: VLS-01 is a buccal film, not a transdermal patch.)

Also known as: VLS-01, N,N-dimethyltryptamine, DMT

Data current as of

Key facts

Modality
Psychedelic
Chemical class
tryptamine, indole
DEA schedule
Schedule I
Chemistry
Achiral
Mechanism
5-HT2A agonist
Highest phase
Phase 2
Lead indication
Treatment-resistant depression
Developer
Atai Beckley N.V. (AtaiBeckley) (ATAI)
Trials
1 tracked · 1 recruiting · 48 sites

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.

TargetActionAffinity
5-HT2AprimaryHTR2AAgonist—ⓘ
5-HT1AHTR1AAgonist—
5-HT2CHTR2CAgonist—

Formulations#

FormulationRouteRegimenPharmacokinetics
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).
BuccalSingle doseTmax 0.63 h

Development timeline#

Jan 25Jul 25Jan 26Jul 26TodayPhase 113 Aug 2024 — phase change — Positive Phase 1b results for VLS-01 buccal film DMT (effects resolved within 90-120 min).Phase 25 Nov 2025 — Acquisition — atai Life Sciences and Beckley Psytech complete strategic combination to form AtaiBeckley30 Dec 2024 — phase change — Phase 2 Elumina trial (NCT06524830) for TRD started; first patient dosed March 2025.
Phase change Readout Event UpcomingHover a marker for details.
Phase 2Dec 2024 – Nov 2025
  1. Acquisitionatai Life Sciences and Beckley Psytech complete strategic combination to form AtaiBeckley↗
  2. Phase 2 Elumina trial (NCT06524830) for TRD started; first patient dosed March 2025.↗
Phase 1Aug 2024
  1. Positive Phase 1b results for VLS-01 buccal film DMT (effects resolved within 90-120 min).↗

VLS-01 for Treatment-resistant depression#

Phase 2RecruitingTreatment-resistant depression indication →

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.

Clinical trials#

NCT06524830VLS-01-203 (Elumina)Phase 2Recruitingn=142

Phase 2 Trial of VLS-01 Buccal Film in Treatment Resistant Depression (ELUMINA)

Started Dec 2024· Primary completion Aug 2026· 48 sites across 4 countries

United StatesAustraliaUnited KingdomCanada

Sources#

  1. Agonist properties of N,N-dimethyltryptamine at serotonin 5-HT2A and 5-HT2C receptors — PubMed
  2. atai Life Sciences and Beckley Psytech Announce the Successful Completion of Their Strategic Combination to Create AtaiBeckley — AtaiBeckley Inc.
  3. atai Life Sciences Announces Positive Preliminary Results from Phase 1b Trial of VLS-01 (Buccal Film DMT) — atai Life Sciences (press release)
  4. ELUMINA (NCT06524830) — ClinicalTrials.gov
  5. First Patient Dosed in Elumina Phase 2 — AtaiBeckley IR
  6. Positive Phase 1b results for VLS-01 — BioSpace