EMP-01 / atai Life Sci - LARVOL DELTA

atai Life Sciences Announces First Patient Dosed in Phase 2 Study of EMP-01 for the Treatment of Social Anxiety Disorder (GlobeNewswire) - "atai Life Sciences...today announced that the first patient has been dosed in the exploratory Phase 2 study of EMP-01 (R-3,4-methylenedioxy-methamphetamine (R-MDMA)) for the treatment of social anxiety disorder (SAD)....Topline data anticipated in the first quarter of 2026."

P2 data • Trial status • Social Anxiety Disorder

Exploratory Safety and Efficacy of EMP-01 in Social Anxiety Disorder (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: atai Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Mood Disorders • Psychiatry • Social Anxiety Disorder

atai Life Sciences Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Corporate Highlights (GlobeNewswire) - "Recent Clinical Highlights and Upcoming Milestones:...EMP-01: R-enantiomer of 3,4-methylenedioxy-methamphetamine (R-MDMA) for social anxiety disorder (SAD): (i) Initiated an exploratory Phase 2, randomized, double-blind, placebo-controlled clinical study to assess the safety, tolerability and efficacy of EMP-01 in adults with SAD; (ii) Topline data from the Phase 2 study of EMP-01 are anticipated in the first quarter of 2026."

P2a data • Trial status • Social Anxiety Disorder

Exploratory Safety and Efficacy of EMP-01 in Social Anxiety Disorder (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: atai Therapeutics, Inc.

New P2 trial • CNS Disorders • Mood Disorders • Psychiatry • Social Anxiety Disorder

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses of EMP-01 in Healthy Adult Volunteers (ANZCTR) - P1 | N=32 | Completed | Sponsor: EmpathBio Australia Pty. Ltd. | Recruiting ➔ Completed

Trial completion • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

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