Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MM120, lysergide tartrate, LSD D-Tartrate
DT120 · 6 trials · 5 indications
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.
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.
To investigate the dose-response relationship for different doses of MM120 versus placebo in change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Week 4. The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety: Anxious mood, Tension, Fears, Insomnia, Intellectual, Depressed mood, Somatic (muscular), Somatic (sensory), Cardiovascular symptoms, Respiratory symptoms, Gastrointestinal symptoms, Genitourinary symptoms, Autonomic symptoms, and Behavior at interview (general). The central rater assessed the extent to which the subject displayed each given criterion and gave a rating on a scale of 0-4, where 4 represents the most severe symptoms. Minimum score = 0, maximum score = 56. Scores are summed and the greater the total score, the more severe illness.
The Adult ADHD investigator symptom rating scale (AISRS) total score consists of 18 items from the original Attention-deficit/hyperactivity Disorder Rating Scale (ADHD-RS). The ADHD-RS includes 9 items that address symptoms of inattention, and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.
| Arm | Type | Description |
|---|---|---|
| Arm 1 - Placebo | PLACEBO_COMPARATOR | A substance that is designed to have no therapeutic value |
| Arm 2 - 50µg DT120 | SHAM_COMPARATOR | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A) |
| Arm 3 - 100µg DT120 | EXPERIMENTAL | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A) |
| Arm 2 - 100µg DT120 | EXPERIMENTAL | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A) |
| Arm 1- Placebo | PLACEBO_COMPARATOR | A substance that is designed to have no therapeutic value. |
| Arm 2- 25 μg MM120 | EXPERIMENTAL | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A). |
| Arm 3- 50 μg MM120 | EXPERIMENTAL | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A). |
| Arm 4- 100 μg MM120 | EXPERIMENTAL | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A). |
| Arm 5- 200 μg MM120 | EXPERIMENTAL | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A). |
| Arm 2- MM120 | EXPERIMENTAL | A total of 26 patients will receive 20 μg of MM120 administered orally twice weekly for 6 weeks. |
| Name | Type | Description |
|---|---|---|
| Placebo | OTHER | A substance that is designed to have no therapeutic value |
| DT120 | DRUG | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A) |
| MM120 | DRUG | A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A). |
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...
DT120 is an investigational small molecule being developed by Definium Therapeutics, Inc. for psychiatric conditions. It is in Phase 3 clinical development for generalized anxiety disorder and major depressive disorder. DT120 has received Breakthrough Therapy designation from the FDA. It is not yet approved for commercial use and remains under clinical study.
DT120 is being studied as a treatment for generalized anxiety disorder and major depressive disorder in adults. Both are psychiatric conditions characterized by persistent anxiety or depressive symptoms. The clinical program includes Phase 3 trials in each indication, with enrollment restricted to adults 18 years and older.
DT120 targets the 5-HT2A receptor, a serotonin receptor subtype. Its mechanism of action involves activity at this receptor, which is relevant to psychiatric conditions such as generalized anxiety disorder and major depressive disorder. DT120 is a small molecule developed by Definium Therapeutics.
DT120 is being developed by Definium Therapeutics, Inc., which trades under the ticker DFTX. The company is running a Phase 3 clinical program for DT120 in generalized anxiety disorder and major depressive disorder. Definium Therapeutics holds the development rights for this asset.
DT120 is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The program includes multiple Phase 3 trials in generalized anxiety disorder and major depressive disorder, and DT120 has received Breakthrough Therapy designation from the FDA.
DT120 is being evaluated in Phase 3 trials including NCT07592689 (Ascend) and NCT06941844 (Emerge) in major depressive disorder, and NCT06741228 (Voyage) in generalized anxiety disorder. A related Phase 3 trial, NCT06809595 (Panorama), studies MM120 in generalized anxiety disorder across the United States and Europe.