N,N-dimethyltryptamine (VLS-01) / AtaiBeckley, Eli Lilly - LARVOL DELTA

Next-Generation Pharmacotherapies for Unipolar Mood Disorders: A Leading Article on Phase II/III Drug Development Across Diverse Mechanisms. (PubMed, CNS Drugs) - "Following the US Food and Drug Administration (FDA) approval of esketamine and brexanolone in 2019, industry investment in therapeutics with novel mechanisms for mood and anxiety disorders has expanded, catalyzing a new wave of innovative interventions...The drug names discussed are ALTO-100, ALTO-203, ALTO-207, ALTO-300, BHV-7000, BI-1569912, BPL-003, COMP360, DT120, ELE-101, GATE-251, GH001, GM-1020, GM-2505, HLP003, MK-1942, NBI-1065845, NBI-1070770, NV-5138, PIPE-307, SEP-363856, SPT-300, VLS-01, and XEN1101. The US Clinical Trials registry (clinicaltrials.gov), MEDLINE, conference proceedings, and company communications such as press releases were consulted to obtain up-to-date trial information and reported outcomes. Overall, the therapeutic landscape shows an expanding range of clinical compounds under active development; nonetheless, persistent challenges remain, including approaches to therapeutics where functional unblinding may occur, the ways in which to..."

Journal • P2/3 data • Review • CNS Disorders • Mood Disorders • Psychiatry

A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA) (clinicaltrials.gov) - P2 | N=142 | Recruiting | Sponsor: atai Therapeutics, Inc. | Trial completion date: Mar 2026 ➔ Aug 2026 | Trial primary completion date: Mar 2026 ➔ Aug 2026

Trial completion date • Trial primary completion date • CNS Disorders • Depression • Mood Disorders • Psychiatry

A study to assess two formulations of VLS-01 (VLS-01-IV and VLS-01-BU) in Healthy Adult Volunteers (ANZCTR) - P1 | N=16 | Completed | Sponsor: atai Therapeutics Pty. Ltd. | Not yet recruiting ➔ Completed

Trial completion • CNS Disorders • Depression • Mood Disorders • Psychiatry

atai Life Sciences Announces First Patient Dosed in Elumina, the Phase 2 Clinical Trial of VLS-01 for Treatment-Resistant Depression (GlobeNewswire) - "atai Life Sciences...announced that the first patient has been dosed in the Phase 2 Elumina trial of VLS-01, atai’s proprietary oral transmucosal film formulation of N,N-Dimethyltryptamine (DMT) applied to the buccal surface, in people suffering from treatment-resistant depression (TRD)....Topline results from the first treatment period are anticipated in the first quarter of 2026."

P2 data • Trial status • Depression

A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (clinicaltrials.gov) - P2 | N=142 | Recruiting | Sponsor: atai Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Depression • Mood Disorders • Psychiatry

A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (clinicaltrials.gov) - P2 | N=142 | Not yet recruiting | Sponsor: atai Therapeutics, Inc.

New P2 trial • CNS Disorders • Depression • Mood Disorders • Psychiatry

A study to assess two formulations of VLS-01 (VLS-01-IV and VLS-01-BU) in Healthy Adult Volunteers (ANZCTR) - P1 | N=16 | Not yet recruiting | Sponsor: atai Therapeutics Pty. Ltd.

New P1 trial • CNS Disorders • Depression • Mood Disorders • Psychiatry

atai Life Sciences Reports Second Quarter 2023 Financial Results and Operational Highlights, and Announces Clinical Data from the Phase 1 Study of DMX-1002 (Ibogaine) (GlobeNewswire) - P1/2 | N=116 | NCT05029401 | Sponsor: DemeRx IB, Inc.| "atai Life Sciences...reported second quarter 2023 financial results and provided corporate updates...Today, the company announced results from the Phase 1 study of DMX-1002, a cholinergic, glutamatergic and monoaminergic receptor modulator being developed for the treatment of OUD...Results of the Phase 1 trial demonstrated that oral doses of DMX-1002 at 9 mg/kg achieved plasma concentrations in line with those described in previous studies in which subjects reported psychedelic experiences and obtained therapeutic benefit in OUD...The on-going Phase 2b study...of RL-007 vs placebo...The company expects to report topline results from this study in the 2nd half of 2024...on-going Phase 1 study...of VLS-01...The company expects to report additional clinical data in Q3 2023."

P1 data • P1/2 data • P2b data • Cognitive Disorders • Schizophrenia