atai Life Sciences Announces First Patient Dosed in Phase 2 Study of EMP-01 for the Treatment of Social Anxiety Disorder
atai Life Sciences (NASDAQ: ATAI) has initiated dosing in its Phase 2 study of EMP-01 (oral R-MDMA) for treating social anxiety disorder (SAD). The exploratory, randomized, double-blind, placebo-controlled trial will evaluate approximately 60 adult patients, who will receive two administrations of either EMP-01 or placebo, four weeks apart.
The study aims to assess safety, tolerability, and efficacy, with symptom monitoring for six weeks after the first dose. In previous Phase 1 studies, EMP-01 showed a unique, dose-dependent profile more similar to classical psychedelics than racemic MDMA. Topline data is expected in Q1 2026.
atai Life Sciences (NASDAQ: ATAI) ha iniziato la somministrazione nella sua fase 2 dello studio su EMP-01 (R-MDMA orale) per il trattamento del disturbo d'ansia sociale (SAD). Questo studio esplorativo, randomizzato, in doppio cieco e controllato con placebo, coinvolgerà circa 60 pazienti adulti, che riceveranno due somministrazioni di EMP-01 o placebo, a distanza di quattro settimane.
L'obiettivo dello studio è valutare sicurezza, tollerabilità ed efficacia, monitorando i sintomi per sei settimane dopo la prima dose. Negli studi di fase 1 precedenti, EMP-01 ha mostrato un profilo unico e dose-dipendente, più simile ai classici psichedelici che al MDMA racemico. I dati principali sono attesi nel primo trimestre del 2026.
atai Life Sciences (NASDAQ: ATAI) ha iniciado la dosificación en su estudio de Fase 2 de EMP-01 (R-MDMA oral) para el tratamiento del trastorno de ansiedad social (SAD). El ensayo exploratorio, aleatorizado, doble ciego y controlado con placebo evaluará a aproximadamente 60 pacientes adultos, quienes recibirán dos administraciones de EMP-01 o placebo, con un intervalo de cuatro semanas.
El estudio tiene como objetivo evaluar la seguridad, tolerabilidad y eficacia, con un seguimiento de los síntomas durante seis semanas después de la primera dosis. En estudios previos de Fase 1, EMP-01 mostró un perfil único y dependiente de la dosis, más parecido a los psicodélicos clásicos que al MDMA racémico. Se esperan los datos principales en el primer trimestre de 2026.
atai Life Sciences (NASDAQ: ATAI)는 사회불안장애(SAD) 치료를 위한 EMP-01(경구용 R-MDMA)의 2상 임상시험 투약을 시작했습니다. 이 탐색적 무작위 이중맹검 위약대조 시험은 약 60명의 성인 환자를 대상으로 하며, 이들은 4주 간격으로 EMP-01 또는 위약을 두 차례 투여받게 됩니다.
본 연구는 안전성, 내약성 및 효능을 평가하는 것을 목표로 하며, 첫 투여 후 6주간 증상을 모니터링합니다. 이전 1상 연구에서 EMP-01은 고전적 사이키델릭과 더 유사한 독특하고 용량 의존적인 프로필을 보였으며, 라세믹 MDMA와는 차별화되었습니다. 주요 결과는 2026년 1분기에 발표될 예정입니다.
atai Life Sciences (NASDAQ : ATAI) a commencé l'administration dans son étude de phase 2 sur EMP-01 (R-MDMA oral) pour le traitement du trouble d'anxiété sociale (SAD). Cet essai exploratoire, randomisé, en double aveugle et contrôlé par placebo, évaluera environ 60 patients adultes, qui recevront deux administrations d'EMP-01 ou de placebo, à quatre semaines d'intervalle.
L'étude vise à évaluer la sécurité, la tolérabilité et l'efficacité, avec un suivi des symptômes pendant six semaines après la première dose. Lors des études de phase 1 précédentes, EMP-01 a montré un profil unique, dépendant de la dose, plus proche des psychédéliques classiques que du MDMA racémique. Les données principales sont attendues au premier trimestre 2026.
atai Life Sciences (NASDAQ: ATAI) hat mit der Dosierung in seiner Phase-2-Studie zu EMP-01 (orale R-MDMA) zur Behandlung der sozialen Angststörung (SAD) begonnen. Die explorative, randomisierte, doppelblinde, placebokontrollierte Studie wird etwa 60 erwachsene Patienten einschließen, die zwei Verabreichungen von EMP-01 oder Placebo im Abstand von vier Wochen erhalten.
Ziel der Studie ist die Bewertung von Sicherheit, Verträglichkeit und Wirksamkeit, mit einer Symptomüberwachung für sechs Wochen nach der ersten Dosis. In früheren Phase-1-Studien zeigte EMP-01 ein einzigartiges, dosisabhängiges Profil, das klassischen Psychedelika ähnlicher ist als racemischem MDMA. Die wichtigsten Daten werden im ersten Quartal 2026 erwartet.
- Phase 1 study demonstrated unique dose-dependent effects for EMP-01
- Targeting social anxiety disorder, which affects millions and represents a large market opportunity
- Clear development timeline with topline data expected in Q1 2026
- Early-stage clinical trial with uncertain outcomes
- Will require additional studies and regulatory approvals before commercialization
Insights
ATAI advances R-MDMA to Phase 2 for social anxiety disorder, targeting a large unmet need with potential results in Q1 2026.
ATAI has initiated a Phase 2 study for EMP-01 (R-MDMA), reaching a significant development milestone with the first patient dosed in their clinical program targeting social anxiety disorder (SAD). This follows a Phase 1 study that yielded an interesting pharmacological profile - EMP-01 demonstrated dose-dependent effects more similar to classical psychedelics than to racemic MDMA, suggesting a potentially differentiated mechanism of action.
The newly launched trial employs a robust methodology: it's a randomized, double-blind, placebo-controlled study involving approximately 60 adults with SAD. The design includes two administrations of either EMP-01 or placebo spaced four weeks apart, with a six-week monitoring period. This design will provide preliminary efficacy signals while prioritizing safety assessment.
This advancement addresses a substantial market opportunity. SAD affects millions of patients with limited effective treatment options currently available. The existing therapeutic landscape for anxiety disorders remains inadequate, with many patients experiencing partial responses or intolerable side effects from conventional treatments like SSRIs or benzodiazepines.
From a timeline perspective, ATAI anticipates topline results in Q1 2026, positioning this as a medium-term catalyst for the company. If successful, this could represent a significant step toward establishing ATAI's psychedelic-based treatment approach for anxiety disorders, potentially expanding their therapeutic pipeline beyond depression applications that many competitors focus on.
The focus on safety as the primary endpoint reflects appropriate regulatory caution with novel psychoactive compounds, while simultaneously gathering crucial efficacy data that will determine future development decisions. This milestone moves ATAI closer to addressing a substantial unmet clinical need with an innovative therapeutic approach.
- In a Phase 1 study, EMP-01 (oral R-MDMA) demonstrated a unique, dose-dependent subjective effect profile that was generally found to be more similar to classical psychedelics than to racemic MDMA
- The exploratory, randomized, double-blind, placebo-controlled Phase 2 study will assess the safety, tolerability and efficacy of EMP-01 in adults with social anxiety disorder
- Topline data anticipated in the first quarter of 2026
NEW YORK and BERLIN, May 13, 2025 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company on a mission to develop highly effective mental health treatments to transform patient outcomes, 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).
"We are pleased to have dosed the first patient in the exploratory Phase 2 study evaluating EMP-01 in adults with social anxiety disorder," stated Kevin Craig, M.D., Chief Medical Officer of atai. "Social anxiety disorder affects millions and remains significantly underserved by current treatment options. We believe this Phase 2 study will provide critical insights into EMP-01’s potential to address this large and growing market with substantial unmet need.”
The Phase 2 study is an exploratory, randomized, double-blind, placebo-controlled trial (NCT06693609) to assess the safety, tolerability and efficacy of EMP-01 in approximately 60 adults with SAD. Patients will be randomized 1:1 to receive two double-blind administrations of either EMP-01 or placebo, spaced four weeks apart. Symptoms will be monitored for six weeks following the first dose. The primary objective of the study is to assess the safety and tolerability of EMP-01 in adults with SAD. The secondary objective is to estimate any improvements in social anxiety symptoms compared to placebo.
About EMP-01 (Oral R-MDMA)
EMP-01 is an oral formulation of R-3,4-methylenedioxy-methamphetamine (R-MDMA) that demonstrated a unique, dose-dependent subjective effect profile in a Phase 1 trial that was generally found to be more similar to classical psychedelics than to racemic MDMA. Anxiety disorders are the most common mental health disorders worldwide, affecting how one experiences worry, fear and anxiety in everyday situations. Social anxiety disorder (SAD) is an area of high unmet medical need with approximately 18 million people currently diagnosed in the United States and no novel molecules approved in over two decades. atai is currently enrolling patients into an exploratory, randomized, double-blind, placebo-controlled Phase 2 study to assess the safety, tolerability and efficacy of EMP-01 in adults with SAD. Topline data from the Phase 2 study is anticipated in the first quarter of 2026.
About atai Life Sciences
atai is a clinical-stage biopharmaceutical company on a mission to develop highly effective mental health treatments to transform patient outcomes. Our pipeline of psychedelic-based therapies includes VLS-01 (buccal film DMT) for treatment-resistant depression (TRD) and EMP-01 (oral R-MDMA) for social anxiety disorder, which are in Phase 2 clinical development. We are also advancing a drug discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists for TRD. These programs aim to address the complex nature of mental health providing commercially scalable interventional psychiatry therapies that can integrate seamlessly into healthcare systems. For the latest updates and to learn more about our mission, visit www.atai.com or follow us on LinkedIn.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “anticipate,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things: our business strategy and plans; the potential, success, cost and timing of development and progress of trials and related milestones of our product candidates such as EMP-01; expectations regarding our cash runway; and the plans and objectives of management for future operations, research and development and capital expenditures.
Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors described in the section titled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”), as such factors may be updated from time to time in atai's other filings with the SEC. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by applicable law.
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