Nisha Pandey

LSD-Based Treatment Clears Second Phase 3 Trial: Could It Be The First New GAD Drug In 2 Decades?

An LSD-based treatment has cleared its second Phase 3 trial for generalized anxiety disorder (GAD), sparking hope to bring the first new drug for the condition in nearly two decades closer to FDA approval.

Definium Therapeutics recently said that its drug DT120, a tablet containing lysergide, the pharmaceutical form of LSD, significantly reduced anxiety symptoms compared to placebo in the Panorama Phase 3 trial that included 245 participants.

The company said participants receiving a single 100-microgram dose had a 9.8-point reduction in their score on the Hamilton Anxiety Rating Scale (HAM-A) after 12 weeks, compared to a 4.7-point reduction among those receiving placebo. The difference with placebo was 5.1 points. 

The improvement surfaced quickly as differences from placebo seen as early as Day 2 and sustained through the 12-week assessment. 

<h2>A Promising Second Phase 3 Trial </h2>

Also read: <a href="https://www.healthandme.com/health-wellness/world-patient-safety-day-why-insulin-innovation-in-diabetes-care-demands-an-ecosystem-approach-article-156172445" data-type="tilCustomLink">World Patient Safety Day: Why Insulin Innovation in Diabetes Care Demands an Ecosystem Approach</a>

Panorama is the second positive Phase 3 trial for DT120 in <a href="https://www.healthandme.com/health-wellness/suicide-prevention-day-when-does-a-distressing-thought-become-a-suicide-warning-sign-experts-explain-article-156129079" data-type="tilCustomLink">GAD</a>. An earlier Phase 3 study, called Voyage, also found a significant improvement in anxiety symptoms, with a placebo-adjusted difference in HAM-A of 5.4 points at 12 weeks.

Phase 3 trials are generally the pivotal studies in any research as they are used to provide evidence of a treatment's efficacy and safety before regulatory review and approval. 

Rob Barrow, Chief Executive Officer of Definium Therapeutics, said, “The Panorama results again met our high expectations and confirmed the unprecedented efficacy of DT120 in GAD.” 

Barrow added, “With strong positive results across four complementary studies, we have built a compelling body of evidence that increases our confidence in the potential best-in-class profile of DT120.” 

The drug also hopes to bridge the long-overdue treatment gap in GAD. Definium says the last new drug approved for GAD was in 2007, meaning DT120 could potentially become the first newly approved <a href="https://www.healthandme.com/health-wellness/eclectic-therapy-why-mental-health-treatment-cannot-follow-a-one-size-fits-all-approach-article-156124866" data-type="tilCustomLink">GAD treatment</a> in almost 20 years if it ultimately clears regulatory review.

Definium has a pre-New Drug Application meeting with the US Food and Drug Administration planned for the fourth quarter of 2026 and anticipates filing its application in the first half of 2027. 

Barrow also said, “Building on this momentum, we are advancing toward an NDA submission and look forward to aligning with the FDA at our upcoming pre-NDA meeting. We are deeply grateful to the participants, investigators, site personnel, and our team whose commitment and hard work made this progress possible.” 

Also read: <a href="https://www.healthandme.com/parenting/after-lindsay-clancy-trial-massachusetts-pushes-stronger-postpartum-mental-health-screening-article-156165684" data-type="tilCustomLink">After Lindsay Clancy Trial, Massachusetts Pushes Stronger Postpartum Mental Health Screening</a>

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<a href="https://www.healthandme.com/health-news/mental-health-emergency-visits-among-children-aged-6-9-rise-62-in-england-article-156031742" data-type="tilCustomLink">DT120</a> is designed as a single-dose treatment rather than a daily tablet. In the Panorama trial, participants were monitored for at least eight hours after dosing because LSD can temporarily lead to certain cognitive and emotional changes.

Among those receiving 100 micrograms, the average time to meet the study's end-of-session criteria was 6.2 hours, while 94% met those criteria within eight hours. 

The treatment works through the serotonin 5-HT2A receptor, although exactly how <a href="https://www.healthandme.com/health-news/us-fda-to-hold-psychedelic-drug-hearing-amid-trump-push-what-it-means-for-depression-ptsd-article-156157480" data-type="tilCustomLink">LSD</a> produces longer-lasting improvements in psychiatric symptoms remains unclear.

The company reported that DT120 was generally well tolerated. It also said that side-effects were mild to moderate, temporary and occurring mainly on the day of dosing. 

Among people receiving the 100-microgram dose, common adverse events on dosing day included illusions in 68%, nausea in 37% and headache in 24%. There were no drug-related serious adverse events or signals of increased suicidality in the trial, according to Definium. 

It is important to know that these results are reported by the company, and the complete data will need regulatory and scientific scrutiny for the drug’s approval.

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An LSD-based treatment has cleared its second Phase 3 trial for generalized anxiety disorder (GAD), sparking hope to bring the first new drug for the condition in nearly two decades closer to FDA approval. Definium Therapeutics recently said that its drug DT120, a tablet containing lysergide, the pharmaceutical form of LSD, significantly reduced anxiety symptoms compared to placebo in the Panorama Phase 3 trial that included 245 participants. The company said participants receiving a single 100-microgram dose had a 9.8-point reduction in their score on the Hamilton Anxiety Rating Scale (HAM-A) after 12 weeks, compared to a 4.7-point reduction among those receiving placebo. The difference with placebo was 5.1 points. The improvement surfaced quickly as differences from placebo seen as early as Day 2 and sustained through the 12-week assessment. A Promising Second Phase 3 Trial Also read: World Patient Safety Day: Why Insulin Innovation in Diabetes Care Demands an Ecosystem ApproachPanorama is the second positive Phase 3 trial for DT120 in GAD. An earlier Phase 3 study, called Voyage, also found a significant improvement in anxiety symptoms, with a placebo-adjusted difference in HAM-A of 5.4 points at 12 weeks. Phase 3 trials are generally the pivotal studies in any research as they are used to provide evidence of a treatment's efficacy and safety before regulatory review and approval. Rob Barrow, Chief Executive Officer of Definium Therapeutics, said, “The Panorama results again met our high expectations and confirmed the unprecedented efficacy of DT120 in GAD.” Barrow added, “With strong positive results across four complementary studies, we have built a compelling body of evidence that increases our confidence in the potential best-in-class profile of DT120.” The drug also hopes to bridge the long-overdue treatment gap in GAD. Definium says the last new drug approved for GAD was in 2007, meaning DT120 could potentially become the first newly approved GAD treatment in almost 20 years if it ultimately clears regulatory review. Definium has a pre-New Drug Application meeting with the US Food and Drug Administration planned for the fourth quarter of 2026 and anticipates filing its application in the first half of 2027. Barrow also said, “Building on this momentum, we are advancing toward an NDA submission and look forward to aligning with the FDA at our upcoming pre-NDA meeting. We are deeply grateful to the participants, investigators, site personnel, and our team whose commitment and hard work made this progress possible.” Also read: After Lindsay Clancy Trial, Massachusetts Pushes Stronger Postpartum Mental Health ScreeningLSD-Based Treatment For GAD             DT120 is designed as a single-dose treatment rather than a daily tablet. In the Panorama trial, participants were monitored for at least eight hours after dosing because LSD can temporarily lead to certain cognitive and emotional changes. Among those receiving 100 micrograms, the average time to meet the study's end-of-session criteria was 6.2 hours, while 94% met those criteria within eight hours. The treatment works through the serotonin 5-HT2A receptor, although exactly how LSD produces longer-lasting improvements in psychiatric symptoms remains unclear. The company reported that DT120 was generally well tolerated. It also said that side-effects were mild to moderate, temporary and occurring mainly on the day of dosing. Among people receiving the 100-microgram dose, common adverse events on dosing day included illusions in 68%, nausea in 37% and headache in 24%. There were no drug-related serious adverse events or signals of increased suicidality in the trial, according to Definium. It is important to know that these results are reported by the company, and the complete data will need regulatory and scientific scrutiny for the drug’s approval.

lsd-based treatment clears second phase 3 trial: could it be the first new gad drug in 2 decades?

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