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DT120

Phase 3

Generalized Anxiety Disorder | Small molecule | Psychiatry |Definium Therapeutics, Inc.|Last Updated: Sep 4, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment459

FDA Designations

No designations recorded

Clinical trial landscape

DT120 · 4 trials · 2 indications

Phase 3 4
NCT07592689A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend)Major Depressive Disorder
RECRUITING165 Analytics
NCT06941844A Phase 3 Trial of DT120 for Major Depressive Disorder (Emerge)Major Depressive Disorder
ACTIVE NOT_RECRUITING149 Analytics
NCT06809595A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Panorama)Generalized Anxiety Disorder
ACTIVE NOT_RECRUITING245 Analytics
NCT06741228A Phase 3 Trial of DT120 for Generalized Anxiety Disorder (Voyage)Generalized Anxiety Disorder
ACTIVE NOT_RECRUITING214 Analytics
PHASE3RECRUITING
A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend)
Major Depressive DisorderUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Phase 3 Trial of DT120 for Major Depressive Disorder (Emerge)
Major Depressive DisorderUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Panorama)
Generalized Anxiety DisorderUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Phase 3 Trial of DT120 for Generalized Anxiety Disorder (Voyage)
Generalized Anxiety DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6
Baseline to Week 6

The MADRS is used to assess depression severity and to detect changes due to antidepressant treatment. The MADRS includes 10 clinician-completed items. Each of the 10 questions is scored with a range of 0-6 points. An item score of 0 indicates item not present or normal, while an item score of 6 indicates severe or continuous presence of the symptoms. The total possible score is 60, and higher scores represent a more severe condition.

Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Week 12
Baseline to Week 12

The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

Secondary Endpoints

Change from Baseline in the MADRS total score at Week 12, Week 4, Week 2, and Week 1
Week 12, Week 4, Week 2, and Week 1
MADRS response (reduction from Baseline score of ≥50%) at each timepoint assessed during the 12-week double-blind period
Baseline to Week 12
MADRS remission (total score ≤12) at each timepoint assessed during the 12-week double-blind treatment period
Baseline to Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1 - PlaceboPLACEBO_COMPARATORA substance that is designed to have no therapeutic value
Arm 2 - 50µg DT120SHAM_COMPARATORA psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
Arm 3 - 100µg DT120EXPERIMENTALA psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
Arm 2 - 100µg DT120EXPERIMENTALA psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)

Interventions

NameTypeDescription
PlaceboOTHERA substance that is designed to have no therapeutic value
DT120DRUGA psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
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Eligibility Criteria

Age Range18 Years to 74 Years
SexALL
Healthy VolunteersNo
Study Sites30

Inclusion Criteria: 1. Diagnosis of MDD per DSM-5 2. Male or female aged 18 to 74 3. Currently experiencing a major depressive episode (MDE) of ≥8 weeks and ≤24 months duration 4. MADRS Total Score ≥26 5. CGI-S Score ≥4 Exclusion Criteria: 1. Certain psychiatric disorders (other than major depres...

Countries:United StatesCzechiaFranceGermanyPolandUnited Kingdom
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Recent Changes (Last 90 Days)

LOWSep 4, 2026NCT06809595primaryCompletionDate: changed
LOWSep 4, 2026NCT06809595primaryCompletionDate: changed
LOWSep 2, 2026NCT06741228primaryCompletionDate: changed
LOWSep 2, 2026NCT06741228primaryCompletionDate: changed
LOWSep 2, 2026NCT06741228primaryCompletionDate: changed
LOWAug 28, 2026NCT06941844lastUpdatePostDate: changed
LOWAug 28, 2026NCT06941844lastUpdatePostDate: changed
LOWAug 11, 2026NCT07592689lastUpdatePostDate: changed
LOWAug 11, 2026NCT06809595lastUpdatePostDate: changed
LOWAug 11, 2026NCT06941844lastUpdatePostDate: changed
LOWAug 11, 2026NCT07592689lastUpdatePostDate: changed
LOWAug 11, 2026NCT06809595lastUpdatePostDate: changed
LOWAug 11, 2026NCT06941844lastUpdatePostDate: changed
LOWAug 11, 2026NCT07592689lastUpdatePostDate: changed
LOWAug 11, 2026NCT06809595lastUpdatePostDate: changed
LOWAug 11, 2026NCT06941844lastUpdatePostDate: changed
LOWAug 7, 2026NCT07592689lastUpdatePostDate: changed
LOWAug 7, 2026NCT07592689lastUpdatePostDate: changed
LOWAug 5, 2026NCT07592689lastUpdatePostDate: changed
LOWAug 4, 2026NCT07592689lastUpdatePostDate: changed

Frequently asked questions about DT120

What is DT120 used for?

DT120 is an investigational small molecule being developed for Generalized Anxiety Disorder and Major Depressive Disorder. It is currently in Phase 3 clinical trials for both psychiatric conditions.

Who makes DT120?

DT120 is being developed by Definium Therapeutics, Inc., a biopharmaceutical company. Definium Therapeutics is advancing DT120 through Phase 3 clinical trials for Generalized Anxiety Disorder and Major Depressive Disorder.

What phase is DT120 in?

DT120 is in Phase 3 clinical development. It is being studied in multiple Phase 3 trials for Generalized Anxiety Disorder and Major Depressive Disorder, and it remains investigational, not yet approved by regulatory authorities.

What clinical trials is DT120 in?

DT120 is being evaluated in four Phase 3 trials: NCT06741228 (Voyage) and NCT06809595 (Panorama) for Generalized Anxiety Disorder, and NCT06941844 (Emerge) and NCT07592689 (Ascend) for Major Depressive Disorder. All are randomized, double-blind, placebo-controlled studies.

Is DT120 the same as MM120?

DT120 is not the same as MM120. While both are being studied in Phase 3 trials for Generalized Anxiety Disorder, they are distinct investigational drugs. DT120 is developed by Definium Therapeutics, and the trials are separate.