MindMed Announces First Patient Dosed in Phase 3 Emerge Study of MM120 in Major Depressive Disorder (MDD)
MindMed (NASDAQ: MNMD) has initiated its Phase 3 Emerge study by dosing the first patient with MM120 ODT, a proprietary form of LSD, for Major Depressive Disorder (MDD) treatment. The study will evaluate MM120 ODT 100 µg versus placebo, enrolling approximately 140 U.S. participants.
The 52-week Emerge study consists of two parts: a 12-week double-blind, placebo-controlled phase and a 40-week extension period. The primary endpoint will measure changes in Montgomery-Åsberg Depression Rating Scale (MADRS) score at Week 6. Topline data from the double-blind period is expected in H2 2026.
This marks MindMed's third Phase 3 study of MM120 ODT, alongside ongoing Voyage and Panorama studies in Generalized Anxiety Disorder (GAD). The development builds on positive Phase 2b results, which showed significant MADRS score improvements after a single MM120 100 µg dose compared to placebo.
MindMed (NASDAQ: MNMD) ha avviato lo studio di Fase 3 Emerge somministrando la prima dose di MM120 ODT, una forma proprietaria di LSD, per il trattamento del Disturbo Depressivo Maggiore (MDD). Lo studio valuterà MM120 ODT 100 µg rispetto al placebo, arruolando circa 140 partecipanti negli Stati Uniti.
Lo studio Emerge, della durata di 52 settimane, è composto da due fasi: una fase in doppio cieco, controllata con placebo, di 12 settimane e un periodo di estensione di 40 settimane. L’endpoint principale misurerà le variazioni nel punteggio della Montgomery-Åsberg Depression Rating Scale (MADRS) alla settimana 6. I dati principali della fase in doppio cieco sono attesi nella seconda metà del 2026.
Questo rappresenta il terzo studio di Fase 3 di MindMed su MM120 ODT, insieme agli studi in corso Voyage e Panorama sul Disturbo d’Ansia Generalizzato (GAD). Lo sviluppo si basa sui positivi risultati della Fase 2b, che hanno mostrato miglioramenti significativi nel punteggio MADRS dopo una singola dose di 100 µg di MM120 rispetto al placebo.
MindMed (NASDAQ: MNMD) ha iniciado su estudio de Fase 3 Emerge al administrar la primera dosis de MM120 ODT, una forma patentada de LSD, para el tratamiento del Trastorno Depresivo Mayor (MDD). El estudio evaluará MM120 ODT 100 µg frente a placebo, reclutando aproximadamente 140 participantes en EE. UU.
El estudio Emerge de 52 semanas consta de dos partes: una fase doble ciego controlada con placebo de 12 semanas y un periodo de extensión de 40 semanas. El objetivo principal medirá los cambios en la puntuación de la Escala de Evaluación de la Depresión de Montgomery-Åsberg (MADRS) en la semana 6. Se esperan los datos principales del periodo doble ciego en la segunda mitad de 2026.
Este es el tercer estudio de Fase 3 de MindMed con MM120 ODT, junto con los estudios en curso Voyage y Panorama sobre el Trastorno de Ansiedad Generalizada (GAD). El desarrollo se basa en resultados positivos de la Fase 2b, que mostraron mejoras significativas en la puntuación MADRS tras una dosis única de 100 µg de MM120 comparado con placebo.
MindMed (NASDAQ: MNMD)가 주요 우울 장애(MDD) 치료를 위한 독점 LSD 형태인 MM120 ODT의 첫 환자 투여로 3상 Emerge 연구를 시작했습니다. 이 연구는 MM120 ODT 100 µg과 위약을 비교하며 약 140명의 미국 참가자를 모집합니다.
52주간 진행되는 Emerge 연구는 12주간의 이중맹검 위약 대조 시험과 40주간의 연장 기간으로 구성됩니다. 주요 평가지표는 6주차의 Montgomery-Åsberg 우울 평가 척도(MADRS) 점수 변화를 측정합니다. 이중맹검 기간의 주요 데이터는 2026년 하반기에 발표될 예정입니다.
이번 연구는 MindMed의 세 번째 3상 연구로, 진행 중인 일반화 불안 장애(GAD) 대상 Voyage 및 Panorama 연구와 함께 진행됩니다. 이 개발은 단일 100 µg MM120 투여 후 위약 대비 MADRS 점수에서 유의미한 개선을 보인 긍정적인 2b상 결과를 기반으로 합니다.
MindMed (NASDAQ : MNMD) a lancé son étude de phase 3 Emerge en administrant la première dose de MM120 ODT, une forme propriétaire de LSD, pour le traitement du trouble dépressif majeur (MDD). L’étude évaluera MM120 ODT 100 µg versus placebo, en recrutant environ 140 participants aux États-Unis.
L’étude Emerge de 52 semaines se compose de deux parties : une phase en double aveugle contrôlée par placebo de 12 semaines et une période d’extension de 40 semaines. Le critère principal mesurera les changements du score de l’échelle de dépression de Montgomery-Åsberg (MADRS) à la semaine 6. Les données principales de la phase en double aveugle sont attendues au second semestre 2026.
Il s’agit de la troisième étude de phase 3 de MindMed sur MM120 ODT, en parallèle des études en cours Voyage et Panorama sur le trouble anxieux généralisé (GAD). Ce développement s’appuie sur des résultats positifs de la phase 2b, qui ont montré des améliorations significatives du score MADRS après une dose unique de 100 µg de MM120 comparée au placebo.
MindMed (NASDAQ: MNMD) hat seine Phase-3-Studie Emerge gestartet, indem der erste Patient mit MM120 ODT, einer proprietären Form von LSD, zur Behandlung der Major Depression (MDD) dosiert wurde. Die Studie wird MM120 ODT 100 µg gegen Placebo vergleichen und etwa 140 Teilnehmer in den USA einschließen.
Die 52-wöchige Emerge-Studie besteht aus zwei Teilen: einer 12-wöchigen doppelblinden, placebokontrollierten Phase und einer 40-wöchigen Verlängerungsphase. Der primäre Endpunkt misst die Veränderungen im Montgomery-Åsberg Depression Rating Scale (MADRS) Score in Woche 6. Die wichtigsten Daten aus der doppelblinden Phase werden für das zweite Halbjahr 2026 erwartet.
Dies ist die dritte Phase-3-Studie von MindMed mit MM120 ODT, neben den laufenden Voyage- und Panorama-Studien zur Generalisierten Angststörung (GAD). Die Entwicklung basiert auf positiven Ergebnissen der Phase 2b, die signifikante Verbesserungen im MADRS-Score nach einer einzigen 100 µg MM120-Dosis gegenüber Placebo zeigten.
- First-ever Phase 3 study of LSD (MM120) for Major Depressive Disorder initiated
- Positive Phase 2b results showed significant clinical improvements
- Large market potential with 21 million people affected by MDD in the U.S.
- Running concurrent Phase 3 trials for both MDD and GAD increases operational efficiency
- Long timeline to topline results (H2 2026)
- Relatively small trial size of 140 participants may limit statistical power
- Second MDD trial timing and design still uncertain pending regulatory discussions
Insights
The dosing of the first patient in MindMed's Phase 3 Emerge trial represents a significant clinical milestone for MM120, their proprietary orally disintegrating LSD formulation. This marks the first-ever Phase 3 trial of LSD for Major Depressive Disorder (MDD), positioning the company at the forefront of psychedelic medicine development.
The trial design is methodologically sound—a randomized, double-blind, placebo-controlled study with the Montgomery-Åsberg Depression Rating Scale (MADRS) as the primary endpoint at week 6. This measurement tool is the gold standard for assessing depression severity changes. The 140-participant target suggests appropriate statistical power while maintaining manageable operational scale.
Particularly noteworthy is that Emerge builds upon positive Phase 2b results that demonstrated statistically and clinically significant improvements in depression scores. The company is leveraging potential efficiencies by running concurrent Phase 3 programs for both MDD and generalized anxiety disorder (GAD), recognizing the symptom overlap between these conditions.
The 52-week study structure (12-week controlled period followed by 40-week extension) will provide comprehensive safety data and insights into durability of effect—crucial factors for regulatory approval. While the 2026 timeline for topline data is extended, this reflects the thorough approach necessary for novel neuropsychiatric therapeutics.
With 21 million Americans affected by MDD and many experiencing inadequate relief from current treatments, MM120 represents a potential paradigm shift in psychiatric care if successful in demonstrating sustained efficacy and manageable safety from a single-dose treatment.
MindMed's advancement of MM120 into Phase 3 for MDD significantly strengthens their clinical pipeline and commercial potential. This represents the third concurrent Phase 3 program for their lead asset, creating multiple paths to potential commercialization and diversifying clinical risk.
The strategic decision to pursue both MDD and GAD indications reflects intelligent pipeline development—targeting related conditions with shared symptomatology maximizes R&D efficiency while addressing two substantial market opportunities. The MDD market alone represents 21 million potential patients in the US, many inadequately served by current treatment options.
The orally disintegrating tablet (ODT) formulation provides potential competitive advantages if approved—offering a pharmaceutical-grade, standardized alternative to other developmental psychedelic approaches with potentially simpler administration protocols. The single-dose treatment paradigm, if successful, could disrupt traditional daily-dosing antidepressant models.
While the 2026 timeline for topline data creates a substantial runway before potential commercialization, it establishes a clear catalyst timeline for investors. The concurrent operation of multiple Phase 3 programs demonstrates operational capability but will require careful capital management through this extended development period.
Phase 3 progression naturally reduces development risk but important challenges remain—regulatory pathways for psychedelic compounds are still evolving, and commercial acceptance will require educational efforts for providers and payers. Nevertheless, this milestone positions MindMed among the leaders in next-generation neuropsychiatric treatments with a differentiated approach targeting significant unmet needs.
- Emerge is the first Phase 3 study of lysergide D-tartrate (LSD) in MDD; primary endpoint will measure change from baseline in
- Emerge builds on positive Phase 2b study results in generalized anxiety disorder (GAD), which showed MM120’s potential antidepressant effects -
- Topline data from the 12-week double-blind period anticipated in the second half of 2026 -
Image of MM120 Orally Disintegrating Tablets
“In our Phase 2b study, MADRS score improvements after a single MM120 100 µg dose were clinically and statistically significant compared to placebo, providing meaningful benefits to participants. Having dosed the first participant in the Phase 3 Emerge study, we are excited for the therapeutic potential that MM120 ODT shows for the 21 million people in the
The Phase 3 development program for MM120 ODT in MDD is anticipated to include two pivotal clinical trials. The first, the 52-week Emerge study, will be conducted in two parts: Part A, a 12-week, randomized, double-blind, placebo-controlled, parallel-group study assessing the efficacy and safety of a single dose of MM120 ODT versus placebo; and Part B, a 40-week extension period during which participants will be eligible for open-label treatment with MM120 ODT based on symptom severity. In Part A, participants will be randomized 1:1 to receive MM120 ODT 100 µg or placebo. The primary endpoint of Emerge is the change from baseline in MADRS score at week 6 between MM120 ODT 100 µg and placebo. The design and timing of a second MDD trial will be informed by the progress from Emerge and additional regulatory discussions.
"The initiation of Emerge will allow the assessment of the potential of MM120 ODT in the treatment of MDD, a disorder associated with significant increased and premature morbidity and mortality, and reduced quality of life. Many patients with MDD are not fully helped by current therapies, making this study an important step in the search for more effective treatments,” said Paul Summergrad, M.D., Professor of Psychiatry and Medicine at Tufts University School of Medicine and Chairman Emeritus of the department of psychiatry at Tufts Medical Center and a member of the MindMed Scientific Advisory Board.
About Major Depressive Disorder (MDD)
Major Depressive Disorder (MDD) is the second-most common mental health disorder in the
About MM120 Orally Disintegrating Tablet (ODT)
MM120 ODT (lysergide D-tartrate or LSD) is a synthetic ergotamine belonging to the group of classic, or serotonergic, psychedelics, which acts as a partial agonist at human serotonin-2A (5-HT2A) receptors. MM120 ODT is MindMed’s proprietary and pharmaceutically optimized form of LSD. MM120 ODT is an advanced formulation incorporating Catalent’s Zydis® ODT fast-dissolve technology which has a unique clinical profile with more rapid absorption, improved bioavailability and reduced gastrointestinal side effects.
The MM120 ODT Phase 3 clinical development program includes the Voyage and Panaroma studies in generalized anxiety disorder (GAD) and the Emerge study in major depressive disorder (MDD). Additional clinical indications are under consideration. MindMed’s Phase 2b study of MM120 for GAD, MMED008, met its primary and key secondary endpoints and demonstrated rapid, clinically meaningful, and statistically significant improvements on the Hamilton Anxiety Rating Scale (HAM-A) at Week 4 and Week 12, with a
Based on the significant unmet medical need in the treatment of GAD along with the initial clinical data from the Phase 2b study and other research conducted by MindMed, the
About MindMed
MindMed is a late-stage clinical biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health. MindMed trades on NASDAQ under the symbol MNMD.
Forward-Looking Statements
Certain statements in this news release related to the Company constitute "forward-looking information" within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as "will", "may", "should", "could", "intend", "estimate", "plan", "anticipate", "expect", "believe", "potential" or "continue", or the negative thereof or similar variations. Forward-looking information in this news release includes, but is not limited to, statements regarding the Company’s anticipated topline readout (Part A results) for the Phase 3 Emerge study of MM120 ODT in MDD in the second half of 2026; the Company’s plans to conduct a second Phase 3 study in MDD; the Company’s expectations to enroll approximately 140 participants in the Emerge study; the Company’s beliefs regarding potential benefits of its product candidates; the Company’s expectations regarding potential additional indications for MM120. There are numerous risks and uncertainties that could cause actual results and the Company's plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; compliance with laws and regulations; legislative and regulatory developments, including decisions by the Drug Enforcement Administration and states to reschedule any of our product candidates, if approved, containing Schedule I controlled substances, before they may be legally marketed in the
References:
- National Institute of Mental Health (NIMH). "Major Depression: Prevalence of Major Depressive Episode Among Adults." Updated 2024.
- Substance Abuse and Mental Health Services Administration (SAMHSA). "2023 National Survey on Drug Use and Health (NSDUH)."
- World Health Organization (WHO). "Depression Fact Sheet." Updated 2023.
- American Psychiatric Association. "Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)." 2013.
- Cuijpers, P., et al. "Long-Term Mortality Risk in Depression: A 20-Year Follow-Up Study." JAMA Psychiatry, 2023.
-
Greenberg, P. E., et al. "The Economic Burden of Adults with Major Depressive Disorder in
the United States (2020)." Journal of Clinical Psychiatry, 2024. -
Hasin, D. S., et al. "Epidemiology of Adult DSM-5 Major Depressive Disorder and Its Specifiers in
the United States ." JAMA Psychiatry, 2018. - Rush, A. J., et al. "Acute and Longer-Term Outcomes in Depressed Outpatients Requiring One or Several Treatment Steps: A STAR*D Report." American Journal of Psychiatry, 2006.
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Source: Mind Medicine (MindMed) Inc.
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