lysergic acid diethylamide (MM-120) / Mindmed, University Hospital Basel, Maastricht University Medical Centre - LARVOL DELTA

A Virtual Clinical Trial of Psychedelics to Treat Patients With Disorders of Consciousness. (PubMed, Adv Sci (Weinh)) - "Here, individualized whole-brain computational models are developed for patients with DoC, optimized with empirical functional magnetic resonance imaging data and diffusion-weighted imaging data, upon which the administration of lysergic acid diethylamide (LSD) and psilocybin is simulated...In patients with UWS, the treatment response correlated with structural connectivity, while in patients in the MCS, it aligned with baseline functional connectivity. These results offer a computational foundation for using psychedelics in DoC treatment and highlight the potential future role of computational modeling in drug discovery and personalized medicine."

Journal • Anesthesia

Acute effects of mescaline on emotional and cognitive empathy (ECNP 2025) - "Introduction: Mescaline is a classic psychedelic inducing similar acute effects like lysergic acid diethylamide (LSD) and psilocybin [1]... The findings indicate that mescaline acutely increases emotional empathy, especially for positive stimuli and at higher doses. These findings further support the evidence that classic psychedelics enhance prosocial effects and emotional empathy, which might be relevant to psychedelic's therapeutic use. Similar to LSD and psilocybin mescaline increased oxytocin plasma concentrations but only after higher doses."

CNS Disorders

LSD increases working memory-related brain function in patients with major depressive disorder (ECNP 2025) - "Background: Classic psychedelics including lysergic acid diethylamide (LSD) show promise as treatment for major depressive disorder (MDD), yet the underlying neural mechanisms remain poorly understood... Compared to low-dose, high-dose LSD significantly decreased depressive symptoms and increased WM-related activity in frontoparietal and subcortical regions in patients with MDD, diverging from the typical normalisation pattern seen with standard treatments. The lack of any significant associations between neural activity and depression symptoms raises the possibility that LSD's effects on cognitive brain function may be mechanistically distinct from its antidepressant effects. These findings indicate that psychedelics modulate cognitive brain function in clinical cohorts and warrant further investigation."

Clinical • CNS Disorders • Cognitive Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Behavioral effects of psychedelic and non-psychedelic serotonin 2A receptor agonist drugs in pigs (ECNP 2025) - "Here, we have determined the relationship between plasma concentration and cerebral 5-HT2AR occupancy of N,N-dimethyltryptamine (DMT), psilocybin, lysergic acid diethylamide (LSD) and lisuride in pigs, and measured psychedelic-induced behavior (headshakes) at doses generating 60-70% occupancy...The behavioral study was done in 8 awake female pigs each receiving IV DMT, 0.4 mg/kg (injected 30 min after monoamine oxidase inhibitor, moclobemide, 0.85 mg/kg), psilocybin, 30 µg/kg, LSD, 0.6 µg/kg, and lisuride, 5.8 µg/kg, in a randomized order, with 3-4 days separating each drug... We have for the first time established relationships between cerebral 5-HT2AR occupancy, drug plasma concentrations and drug dose for 5-HT2AR agonists in vivo in pigs, and subsequently compared psychedelic-induced behavior in awake pigs on the basis of the cerebral 5-HT2AR occupancy."

CNS Disorders

A randomised placebo-controlled study of the effects of lysergic acid diethylamide microdosing (15 μg) on pain perception in healthy volunteers. (PubMed, Br J Pain) - "The dose used in this study may be below the threshold dose that is needed to produce a solid and consistent analgesic effect. Future research with larger, appropriately selected samples and higher doses is recommended to further elucidate LSD's analgesic effects and its application in clinical settings."

Journal • Pain

Single Treatment With MM120 (Lysergide) in Generalized Anxiety Disorder: A Randomized Clinical Trial. (PubMed, JAMA) - P2 | "These results support the dose-dependent efficacy of MM120 and inform the dose selection for phase 3 pivotal trials. ClinicalTrials.gov Identifier: NCT05407064."

Clinical • Journal • CNS Disorders • Depression • General Anxiety Disorder • Mental Retardation • Mood Disorders • Pain • Psychiatry

Implementing psychedelic-assisted therapy: History and characteristics of the Swiss limited medical use program. (PubMed, Neurosci Appl) - "In 2024, there were approximately 100 physicians who held authorizations to treat 723 patients with MDMA (245 patients), lysergic acid diethylamide (130 patients), or psilocybin (348 patients)...Various aspects of the program, including its history, provider characteristics and setting, legal requirements, treatment cost, the role of professional societies, education and continuous formation, personal experience, patient characteristics, outcome, and adverse effects, are described and discussed relative to other recently established programs in Canada and Australia. Such information could be of interest to psychedelic-assisted therapy stakeholders, including professionals, patients, and regulatory bodies that are considering setting up similar restricted access programs."

Journal • Review

Motivation and retrospective appraisal of psychedelic study participation: a qualitative study in healthy volunteers. (PubMed, Psychopharmacology (Berl)) - "This paper identified four pivotal factors to be considered for psychedelic study experiences: (1) a secure interpersonal relationship, (2) an aesthetically pleasing environment, (3) access to nature, and (4) the use of music. This analysis reveals subjective views of volunteers in psychedelic Phase-I trials and may improve research standards."

Clinical • Journal • Retrospective data • CNS Disorders

Potential therapeutic effects of psychedelics in small doses: Is there a role for microdosing in psychiatry? (PubMed, Int Rev Neurobiol) - "The chapter also discusses the influence of extra-pharmacological factors, such as the baseline subjective state, expectations, and individual differences in drug metabolism, on treatment outcomes. Overall, controlled microdosing studies suggest the potential therapeutic applications of small psychedelic doses, warranting further exploration through large-scale trials in clinical populations."

Journal • CNS Disorders • Depression • Pain • Psychiatry

Clinical pharmacology. (PubMed, Int Rev Neurobiol) - "This chapter summarizes pharmacological characteristics of the serotonergic psychedelics psilocybin, lysergic acid diethylamide (LSD), mescaline, N,N-dimethyltryptamine (DMT), 5-methoxy-DMT (5-MeO-DMT), and MDMA. Thus, MDMA, but not the psychedelics, exhibits marked acute pharmacological tolerance. A good understanding of the pharmacology of classic psychedelics and MDMA forms the basis for their clinical use and the design of clinical therapeutic trials."

Journal

Efficacy and safety of low- versus high-dose-LSD-assisted therapy in patients with major depression: A randomized trial. (PubMed, Med) - P2 | "The findings of this exploratory study support further investigation of LSD-assisted therapy in depression in a larger phase 3 trial."

Journal • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Absolute Oral Bioavailability and Bioequivalence of LSD Base and Tartrate in a Double-Blind, Placebo-Controlled, Crossover Study. (PubMed, Clin Pharmacol Ther) - "Lysergic acid diethylamide (LSD) is currently being investigated as a potential treatment for psychiatric and neurological disorders...Intravenous LSD administration produced higher "any drug effect," "good drug effect," and "ego dissolution" compared with oral LSD tartrate, more "anxiety" compared with all oral formulations, and more "nausea" and "bad drug effect" compared with oral LSD base and tartrate. In conclusion, dosing with LSD base and tartrate can be considered bioequivalent with high and similar oral bioavailability."

Clinical • Journal • CNS Disorders • Mood Disorders • Psychiatry

Clinical Trial Participant and Clinician Experience in a Phase 2 (US-only) Trial of MM120 for Generalized Anxiety Disorder (ISPOR 2025) - "This research outlines a successful strategy for soliciting input regarding clinical trial participant experiences. Projective techniques and visual stimuli worked well to gain a holistic picture of the participant’s experience, including difficult-to-quantify emotional experiences. These insights may provide practical solutions to improving psychedelic clinical trials."

Clinical • P2 data • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

Program Updates and Anticipated Milestones (Businesswire) - "Enrollment is on track in the Phase 3 Voyage study of MM120 ODT for the treatment of GAD. Voyage is expected to enroll approximately 200 participants in the U.S. who will be randomized 1:1 to receive MM120 ODT 100 µg or placebo. Topline data from the 12-week double-blind period (Part A) is anticipated in the first half of 2026; Enrollment is on track in the second Phase 3 Panorama study of MM120 ODT for the treatment of GAD. Panorama is expected to enroll approximately 250 participants (randomized 2:1:2 to receive MM120 ODT 100 µg, MM120 ODT 50 µg or placebo) in the U.S. and Europe. Topline data from the 12-week double-blind period (Part A) is anticipated in the second half of 2026....Topline data from the 12-week double-blinded period (Part A) is anticipated in the second half of 2026. The Company expects to conduct a second Phase 3 registrational study in MDD, with the study design and timing to be informed by the progress of Emerge..."

Enrollment status • New P3 trial • P3 data: top line • General Anxiety Disorder • Major Depressive Disorder

Contextual and experiential aspects of the psychedelic experience predicting improvement in subjective wellbeing: results from a Norwegian internet convenience sample. (PubMed, Front Pharmacol) - "This relationship seems dependent upon various experiential aspects of acute subjective drug effects. These findings should be viewed as hypothesis-generating rather than confirmatory due to the study's limitations."

Journal

A Phase 3 Trial of MM120 for Major Depressive Disorder (Emerge) (clinicaltrials.gov) - P3 | N=140 | Recruiting | Sponsor: Mind Medicine, Inc.

New P3 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

MindMed Announces First Patient Dosed in Phase 3 Emerge Study of MM120 in Major Depressive Disorder (MDD) (Businesswire) - "Mind Medicine...announced that the first patient has been dosed in its Phase 3 Emerge study evaluating MM120 ODT, a proprietary, pharmaceutically optimized form of LSD for the treatment of MDD....Topline data from the 12-week double-blind period anticipated in the second half of 2026."

P3 data: top line • Trial status • Major Depressive Disorder

Safety and Efficacy of Repeated Low-Dose LSD for ADHD Treatment in Adults: A Randomized Clinical Trial. (PubMed, JAMA Psychiatry) - P2 | "Microdosing psychedelics, including lysergic acid diethylamide (LSD), has gained attention for its potential benefits in several psychiatric disorders, including attention-deficit/hyperactivity disorder (ADHD)...In this randomized clinical trial, repeated low-dose LSD administration was safe in an outpatient setting, but it was not more efficacious than placebo in reducing ADHD symptoms. ClinicalTrials.gov Identifier: NCT05200936."

Clinical • Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Mental Retardation • Psychiatry

MindMed Reports Fourth Quarter and Full-Year 2024 Financial Results and Recent Business Updates (Businesswire) - "First Patients Dosed in Phase 3 Voyage and Panorama studies of MM120 Orally Disintegrating Tablet (ODT) in Generalized Anxiety Disorder (GAD); 12-week topline data anticipated in 1H 2026 for Voyage and 2H 2026 for Panorama...On track to initiate Emerge, the first Phase 3 study of MM120 ODT for the treatment of MDD in the first half of 2025. Emerge is expected to enroll 140 participants (randomized 1:1 to receive MM120 ODT 100 µg or placebo). Topline data from the 12-week double-blinded period (Part A) is anticipated in the second half of 2026."

New P3 trial • P3 data: top line • General Anxiety Disorder • Major Depressive Disorder

Acute Effects and Pharmacokinetics of LSD after Paroxetine or Placebo Pre-Administration in a Randomized, Double-Blind, Cross-Over Phase I Trial. (PubMed, Clin Pharmacol Ther) - "Psychedelics, such as psilocybin and lysergic acid diethylamide (LSD), are being investigated for the treatment of depressive and anxiety disorders, for which concomitant treatment with selective serotonin reuptake inhibitors (SSRIs) is prevalent. The pharmacokinetic and pharmacodynamic interactions indicate that no dose adjustment of LSD seems necessary in the presence of an SSRI that inhibits CYP2D6. For SSRIs that do not relevantly inhibit CYP2D6, a dose increase of LSD might be appropriate, but due to lacking data and potential other pharmacokinetic interactions with these compounds, no definitive dose recommendation can be made."

Clinical • Journal • P1 data • PK/PD data • CNS Disorders • Mood Disorders • Psychiatry • CYP2D6

Treatment of neuropathic pain with repeated low-dose MDMA: a case report. (PubMed, Front Psychiatry) - "A 64-year-old male patient who suffered from traumatic life experiences and neuropathic pain after oncological chemotherapy was treated with medium to high doses of lysergic acid diethylamide (LSD) and high doses and microdoses of methylenedioxymethamphetamine (MDMA)...This case documents benefits of low doses of MDMA for the treatment of a pain disorder. Further research is needed on effects of MDMA on pain."

Journal • Neuralgia • Pain

Lysergic Acid Diethylamide (LSD) as Treatment for Cluster Headache (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: University Hospital, Basel, Switzerland | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Chronic Cluster Headache • Pain

Panorama: A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (clinicaltrials.gov) - P3 | N=250 | Recruiting | Sponsor: Mind Medicine, Inc.

New P3 trial • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (VOYAGE) (clinicaltrials.gov) - P3 | N=200 | Recruiting | Sponsor: Mind Medicine, Inc. | Trial completion date: Jun 2027 ➔ Nov 2026 | Trial primary completion date: Dec 2026 ➔ May 2026

Trial completion date • Trial primary completion date • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry

A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (VOYAGE) (clinicaltrials.gov) - P3 | N=200 | Recruiting | Sponsor: Mind Medicine, Inc.

New P3 trial • CNS Disorders • General Anxiety Disorder • Mood Disorders • Psychiatry