Research

LSD Pill Beats Depression in Phase 3 Trial

Is LSD a paradigm shift in treating depression or dangerous hype that papers over serious risks?

JUN 23·Updated JUN 24

LSD Pill Beats Depression in Phase 3 Trial

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Above: The Definium logo displayed on a phone screen. Image credit: Thomas Fuller/SOPA Images/Getty Images

The Facts

Definium Therapeutics announced positive topline results from its Phase 3 Emerge trial on Monday, showing a single dose of its LSD-based pill DT120 reduced depression symptoms by 13.3 points on a 35-point scale after six weeks, beating placebo by 8.1 points.
Investors
Definium
The drug's effect was rapid, with treated patients showing a placebo-adjusted 14.2-point reduction in depression scores at week one. By week 12, the placebo-adjusted improvement was 7.3 points, indicating durable efficacy from the single dose.
STAT
Clinical Trials Arena
DT120's 8.1-point placebo-adjusted reduction on the Montgomery-Åsberg Depression Rating Scale exceeded results seen in trials for Johnson & Johnson's Spravato, Compass Pathways' COMP360, Takeda's Trintellix and Axsome Therapeutics' Auvelity, according to Definium.
Reuters
FierceBiotech.com
The Emerge trial enrolled 149 participants aged 18 to 74 with a confirmed MDD diagnosis across 20 sites. DT120 was generally well tolerated, with 99% of adverse events mild to moderate, no new safety signals and no increase in suicidal ideation or behavior.
Clinical Trials Arena
Definium
Definium shares rose nearly 50% to $36.67 on Monday following the data release. Leerink Partners analyst Marc Goodwin projected peak sales of $1.5 billion to $2 billion for DT120 in MDD treatment alone, raising his price target for the stock to $52.
Clinical Trials Arena
Investors
Definium is running a second Phase 3 MDD trial called Ascend and expects topline readouts from two Phase 3 generalized anxiety disorder studies later this year. In April, President Donald Trump signed an executive order to speed up access to psychedelic-based treatments.
Reuters
FierceBiotech.com

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The Spin

Narrative A

With a single dose of LSD outperforming the placebo by 8.1 points on a depression scale in a rigorous Phase 3 trial, Definium just opened a life-changing door for psychiatric patients. Existing antidepressants leave two-thirds of patients without remission, and DT120 delivered rapid relief within the first week that held through 12 weeks. The safety profile was clean, with no uptick in suicidal ideation, making this the most compelling depression treatment data in years.

Investors

Definium

Narrative B

Psychedelic trials routinely exclude people with psychosis-related disorders because these drugs can worsen psychosis or trigger mania, so the excitement around these studies hides a massive blind spot. Psilocybin, the most-studied psychedelic, performs no better than standard antidepressants already on the market, and the broader field is riddled with hype masquerading as science. Rushing LSD to approval without fixing the broken mental health infrastructure will repeat decades-old mistakes.