Definium's DT120 is an investigational LSD tablet: three positive sponsor-reported Phase 3 readouts, Breakthrough status, no FDA approval yet, and LSD remains Schedule I.
Definium Therapeutics DT120 is an investigational oral drug candidate that is not approved by the Food and Drug Administration (FDA). LSD (lysergide) is a Schedule I controlled substance under federal law, and DT120 can currently be accessed only through clinical trials. At Mind Medicine Law, we track federal scheduling policies, drug pipeline disclosures, and regulatory milestones across emerging psychedelic compounds. Definium Therapeutics (Nasdaq: DFTX) is developing DT120 as an orally disintegrating tablet (ODT) formulation of lysergide, the active molecule commonly known as lysergic acid diethylamide (LSD). The asset was previously developed by MindMed under the code MM120 and the program is now run by Definium Therapeutics.
DT120 is an investigational drug, not a marketed one. The sponsor announced that a pre-NDA meeting with the FDA is scheduled for the fourth quarter of 2026, with an official NDA filing anticipated during the first half of 2027. Investigational status means the drug can be studied in authorized clinical trials. It does not allow commercial sales or general clinical prescribing.
This experimental therapy does not serve patients looking for immediate treatment, or off-label psychiatric prescriptions. Individuals who need clinical care today cannot obtain DT120 outside an active research protocol. Our regulatory verdict on DT120 would change only if Definium Therapeutics completes its application process, secures formal FDA approval, and the Drug Enforcement Administration (DEA) completes a separate process to change how the approved product is scheduled.
Definium Therapeutics reported positive topline outcomes across three separate Phase 3 clinical trials evaluating a single 100-microgram dose of DT120. These studies examined the compound in major depressive disorder (MDD) and generalized anxiety disorder (GAD). For Panorama, Definium says participants were monitored for a minimum of 8 hours on dosing day.
The Emerge trial evaluated DT120 in major depressive disorder. Announced in June 2026, this Phase 3 trial enrolled 149 participants, with 75 patients randomized to a single 100-microgram dose of DT120 ODT and 74 patients randomized to placebo. The study protocol featured a 12-week double-blind evaluation period known as Part A, followed by a 40-week open-label extension known as Part B. The trial record is cataloged on ClinicalTrials.gov under NCT06941844, with Definium's announcement filed as an SEC exhibit.
On the primary endpoint of Montgomery-Åsberg Depression Rating Scale (MADRS) score changes at week 6, the active group achieved a least squares mean reduction of -13.3 points compared to -5.2 points for placebo. This resulted in a placebo-adjusted difference of -8.1 points (P<0.0001). Symptom separation appeared early and persisted through the primary window: the placebo-adjusted MADRS difference was -14.2 points at week 1 and -7.3 points at week 12 (both P<0.0001). The sponsor reported clinical response in 35 percent of DT120 participants versus 7 percent of placebo participants. Clinical remission was achieved by 24 percent of the DT120 cohort compared to 3 percent on placebo. Definium Therapeutics reported that 99 percent of treatment-emergent adverse events were mild or moderate, with no increase in suicidal ideation or behavior and comparable discontinuation rates between study arms.
The Voyage trial evaluated DT120 in generalized anxiety disorder. Announced in August 2026, this Phase 3 study tested a single 100-microgram dose against placebo and met its primary and key secondary endpoints. Registered under ClinicalTrials.gov identifier NCT06741228 and announced in an SEC exhibit, the trial demonstrated an 11.6-point mean improvement from baseline on the Hamilton Anxiety Rating Scale (HAM-A). The placebo-adjusted HAM-A reduction at week 12 reached 5.4 points (Cohen's d 0.81, P<0.0001). Symptom relief separated from placebo by week 1. Definium Therapeutics reported no serious adverse events, no deaths, and no treatment-related suicide signals among active participants.
The Panorama trial provided the second positive Phase 3 dataset in GAD and the third positive Phase 3 readout for the DT120 program. Announced on September 14, 2026 in a Definium press release, Panorama was a randomized, double-blind, placebo-controlled study enrolling 245 adults aged 18 to 74 years across approximately 32 clinical sites. The trial randomized participants across three arms: DT120 ODT 100 micrograms (96 participants), DT120 ODT 50 micrograms (52 participants), and placebo (97 participants).
On the primary endpoint of HAM-A reduction at week 12, the 100-microgram arm showed a change of -9.8 points compared to -4.7 points in the placebo cohort. This yielded a placebo-adjusted reduction of -5.1 points (p<0.0001) with an effect size of d=0.64. The 100-microgram dose produced a 32 percent response rate compared to 14 percent for placebo, alongside a 15 percent remission rate (defined as a HAM-A score of 7 or lower) versus 4 percent for placebo. The most frequent dosing-day adverse events in the 100-microgram arm were perceptual illusions (68 percent), nausea (37 percent), and headache (24 percent). The overall treatment-emergent adverse event rate was 94.8 percent. Discontinuation rates stood at approximately 10 percent across all groups, with no reported suicidality signal.
Definium reported that Panorama participants were monitored for a minimum of 8 hours on dosing day. The average time to meet end-of-session criteria was 6.2 hours, and 94 percent had met them by hour 8.
These findings represent corporate topline disclosures from Definium Therapeutics. We have not identified peer-reviewed publications of these Phase 3 results; check the primary sources linked above for the latest status. Readers and clinicians should treat these figures as preliminary sponsor communications until formal publication occurs.
The table below summarizes the three announcements. Primary endpoints were MADRS at week 6 for Emerge and HAM-A at week 12 for Voyage and Panorama.
| Study Name | Target Indication | Enrollment (n) | Primary Evaluation Endpoint | Placebo-Adjusted Outcome | Reported Safety and Session Parameters |
|---|---|---|---|---|---|
| Emerge | Major Depressive Disorder (MDD) | 149 participants (75 DT120, 74 placebo) | MADRS score change at week 6 | -8.1 points (P<0.0001); -7.3 points at week 12 | 99% of adverse events mild or moderate; no increase in suicidal ideation or behavior; 40-week open-label Part B |
| Voyage | Generalized Anxiety Disorder (GAD) | Not listed in the sources here (single 100 µg dose vs placebo) | HAM-A score change at week 12 | -5.4 points (P<0.0001, d=0.81) | No serious adverse events, deaths or drug-related suicide signal in the treatment group (sponsor-reported); separation from placebo by week 1 |
| Panorama | Generalized Anxiety Disorder (GAD) | 245 participants (96 at 100 µg, 52 at 50 µg, 97 placebo) | HAM-A score change at week 12 | -5.1 points (P<0.0001, d=0.64) | Illusions (68%), nausea (37%), headache (24%); 6.2 hours average to end-of-session criteria |
In Panorama, the sponsor reported that the average time to meet end-of-session criteria was 6.2 hours. All efficacy figures above are sponsor-reported topline data.
Food and Drug Administration Breakthrough Therapy designation provides DT120 with enhanced agency guidance but does not allow commercial distribution. The agency granted Breakthrough Therapy status for DT120 in generalized anxiety disorder in March 2024, when the asset was cataloged as MM120 under MindMed. On September 21, 2026, Healio reported that the FDA granted Breakthrough Therapy designation for DT120 in major depressive disorder as well.
Breakthrough Therapy designation is an FDA program that speeds the development and review of a drug. It is not approval and does not permit commercial sales. Our detailed analysis of this administrative mechanism is available in our guide to FDA breakthrough therapy for psychedelics.
Definium Therapeutics is conducting further clinical investigations to support its planned regulatory filings. The company is advancing the Ascend Phase 3 study in major depressive disorder and plans to launch a Phase 3 trial in post-traumatic stress disorder (PTSD) starting in 2027. Following the pre-NDA conference in late 2026, Definium Therapeutics anticipates filing its initial NDA in the first half of 2027.
Lysergide remains classified as a Schedule I controlled substance under federal law regardless of ongoing corporate drug development. Under the federal Controlled Substances Act (21 U.S.C. § 812), Schedule I substances are defined as having a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. The legal framework governing this classification is detailed in our guide to the Controlled Substances Act and psychedelics.
State laws do not offer an alternative access path: no US state has a regulated therapeutic program for LSD, and no state has decriminalized it (see our legal status by state tracker for current state-level detail). For background on the pharmacological distinctions between these compounds, see our comparisons of LSD vs psilocybin and LSD vs MDMA, as well as our primary guide to LSD law and research.
A future FDA approval of DT120 would not automatically legalize generic LSD. If the FDA approves Definium's NDA, marketing authorization applies solely to DT120 as a specific, manufactured prescription product. Any change to how an approved product is scheduled would be a separate DEA process, and we have no published timeline for it. Lysergide outside an approved product would remain Schedule I.
Patients can access DT120 exclusively by qualifying for and enrolling in an authorized clinical trial. DT120 is an investigational drug and LSD is Schedule I, so there is no prescription route and no regulated clinic or state program offering it. Nothing on this page is guidance for obtaining it outside a trial.
Each trial sets its own eligibility criteria, which are listed on its registry page. Definium is also running Ascend, a further Phase 3 study in major depressive disorder. Check ClinicalTrials.gov for current enrollment status.
To locate clinical trial opportunities, patients and clinicians should monitor listings on ClinicalTrials.gov or search active research sites through our clinical trial locator.
DT120 is an investigational orally disintegrating tablet formulation of lysergide (LSD) developed by Definium Therapeutics for major depressive disorder and generalized anxiety disorder. MindMed previously developed the compound under the development code MM120.
DT120 is not approved by the FDA. The drug candidate remains investigational, with Definium Therapeutics preparing for a pre-NDA meeting in late 2026 and targeting a formal NDA submission during the first half of 2027.
LSD itself would stay Schedule I. FDA approval would apply only to the specific DT120 product, and any change to its scheduling would be a separate DEA process. Lysergide outside an approved product would remain Schedule I.
Three Phase 3 clinical trials (Emerge in major depressive disorder, alongside Voyage and Panorama in generalized anxiety disorder) reported that the 100-microgram dose produced statistically significant reductions in depression and anxiety scores compared to placebo. Definium reported that 99 percent of adverse events in Emerge were mild or moderate and reported no suicidality signal. In Panorama, 94.8 percent of participants had treatment-emergent adverse events overall.
You cannot obtain DT120 outside an authorized clinical trial. There is no prescription or regulated-program route. Clinical trials are the only route we know of; check each trial's registry page for eligibility.
Breakthrough Therapy designation is an FDA administrative program designed to speed the development and review of drugs showing early clinical evidence of substantial improvement over existing treatments. It is not FDA approval and does not permit commercial sales.
We track FDA milestones, scheduling policy, and clinical-access changes across psychedelic medicine.
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