A study testing a low-dosage LSD treatment for adult attention-deficit/hyperactivity disorder (ADHD) didn’t pan out as planned. A new article in JAMA (Journal of American Medical Association) Psychiatry reviewed a study that looked at microdosing of LSD since the practice has gained so much attention. Unfortunately, the study found no evidence that it worked.

The researchers were prompted to engage in the study due to the anecdotal claims that microdosing LSD alleviated ADHD symptoms. The say that a microdose is generally considered one-tenth to one-twentieth of a recreational dose, an amount that does not induce significant acute perceptual changes or interfere with daily activities. The researchers said that microdoses or low doses of LSD typically range from 5 to 20 μg, with a common practice of taking the psychedelic once every 3 days over several weeks.

The study

It was a 6-week, multicenter, double-blind, placebo-controlled, parallel-group phase 2A randomized clinical trial conducted between December 17, 2021, and December 4, 2023.  Adults aged 18 to 65 years with a prior ADHD diagnosis who presented with moderate to severe symptoms were eligible for inclusion.

Mind Medicine acted as the legal sponsor, monitored the study, and provided the data for the analysis.

A total of 53 participants were picked to either take LSD or the placebo. The patients received either LSD (20 μg) or placebo twice weekly for 6 weeks (total of 12 doses) in a drinkable solution. The report stated that after the first dose, participants stayed on-site for 6 hours for clinical surveillance and to assess acute effects and pharmacokinetics. On subsequent dosing days, the participants were allowed to leave the study center immediately after drug administration.

According to the study, both the LSD and placebo groups exhibited a significant reduction of ADHD symptoms. “However, there was no difference in symptom reduction between the 2 groups,” said the report.

The study did determine that the LSD was physically safe and psychologically well-tolerated overall.

MindMed recently reported earnings and told investors that its lead drug candidate, an orally dissolving tablet form of LSD, had shown promising results in earlier studies. The company noted that the formulation offered better absorption and fewer stomach-related side effects than traditional methods.

Mind Medicine Inc. (NASDAQ: MNMD) said in its earnings release that it has started dosing patients in two final-stage clinical trials for its LSD-based treatment aimed at generalized anxiety disorder.

The company, which develops treatments for mental health disorders, disclosed in its year-end financial results that it raised approximately $250 million last year, significantly beefing its position.

“2024 was a year of significant progress for MindMed,” CEO Rob Barrow said in a statement. “The positive data from our MM120 Phase 2b study in GAD helped secure breakthrough therapy designation from the FDA and led to the expansion of our pipeline into major depressive disorder.”

The company reported $273.7 million in cash as of Dec. 31, 2024, versus $99.7 million at the end of 2023. The funding’s expected to sustain operations into 2027, extending at least a year beyond when the company expects initial results from its anxiety disorder treatment trials.

MindMed’s lead drug candidate is an orally dissolving tablet form of LSD that’s shown promising results in earlier studies. The company noted that the formulation offers better absorption and fewer stomach-related side effects than traditional methods.

The company began its Voyage study in late 2024, which will enroll about 200 participants in the U.S. Results are expected in the first half of 2026. A second trial called Panorama began in early 2025 and will include approximately 250 participants in the U.S. and Europe.

Research spending increased to $21.8 million for the fourth quarter of 2024, up from $11.5 million in the same period of 2023, which the company attributed mainly to costs for its late-stage clinical trials.

MindMed reported a net loss of $34.7 million for the fourth quarter and $108.7 million for the full year.

The company is also expanding its research to include major depression. MindMed plans to begin a trial called Emerge in the first half of 2025, with results expected in late 2026.

Additionally, MindMed completed early testing of a different compound derived from MDMA that it’s developing for autism spectrum disorder, with further studies planned.

The company’s market position was boosted by its addition to the Nasdaq Biotechnology Index in November 2024 and the Russell 2000 and Russell 3000 Indexes earlier in the year.

Psychedelic drug company Mind Medicine Inc. (MindMed) (NASDAQ: MNMD) published its 2025 Investor Presentation this week with more detail on its plans than the company’s 2024 presentation. The company was sitting on a generous cash cushion last year but has now added an additional $250 million equity investment to the plans.

Last month, MindMed told investors that it would be added to the Nasdaq Biotechnology Index (NBI), effective at market opening on Monday, December 23, 2024.

MM120 focus

MindMed is initiating two Phase 3 studies for its lysergide D-tartrate (LSD) drug in the first half of 2025. One is for generalized anxiety disorder (GAD) and it is called Panorama, while the other is set to treat major depressive disorder (MDD) and is called Emerge. The other trail for GAD, called Voyage has begun and the Phase 3 readout is expected in the first half of 2026.

Last month, MindMed announced that the first patient had been dosed in its Phase 3 Voyage study of MM120 ODT and is the first of two Phase 3 studies in GAD evaluating the efficacy and safety of MM120 ODT versus placebo and is expected to enroll approximately 200 participants in the United States.

The Panorama study, the second Phase 3 trial, will be conducted in the U.S. and Europe and is on track to initiate in the first half of 2025. In the new presentation, MindMed stated that the first readout was expected in the second half of 2025.

Milestones

In 2024, MindMed told investors its goal was regulatory alignment with the FDA after a successful end-of-Phase 2 meeting. In 2025, the company was able to inform investors that it had achieved the Breakthrough Therapy Designation granted by the FDA for MM120 in March 2024. In December 2025, MindMed told investors it had been granted an Innovation Passport for the potential treatment of GAD under ILAP by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA). The Innovation Passport is the entry point to the ILAP, which aims to accelerate time to market and facilitate patient access to medicines in the U.K.

Commercialization

MindMed gave more detail to investors regarding its prelaunch strategy for MM120. This will include partnerships with clinics, addressing education on the unmet needs in GAD and MDD and aligning with existing reimbursement frameworks. The company also said it plans on targeting the 2800 Spravato (esketamine) prescribers and their delivery infrastructure with over 4,500 certified centers. This has proven reimbursement, documentation and logistics pathways.

Additional money

Last year, MindMed said it had $295.3 million in cash and cash equivalents as of September 30, 2024. That runway was expected to fund operations into 2027 based on the existing plan. The new presentation added the $250 million equity investment, emphasizing financial support for clinical trials and commercialization. The first financing occurred earlier in 2024 raising $175 million and the second was completed in August 2024, generating gross proceeds of $75 million.

MindMed added that it expects its cash runway to extend at least 12 months beyond the first Phase 3 topline data readout for MM120 ODT in GAD.

MindMed January 2025 Corporate Presentation