Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PRAX-114 · 2 trials · 1 indication
The HAM-D17 is a depression rating scale consisting of 17 items; 9 items are scored on a 5-point scale (ranging from 0 to 4), and 8 items are scored on a 3-point scale (ranging from 0 to 2). The total score of the 17 items ranges from 0 to 52 with higher scores indicating greater depression. Therefore, a decrease in the total score or on individual item scores indicates improvement.
The HAM-D17 is a depression rating scale consisting of 17 items; 9 items are scored on a 5-point scale (ranging from 0 to 4), and 8 items are scored on a 3-point scale (ranging from 0 to 2). The total score of the 17 items ranges from 0 to 52 with higher scores indicating greater depression. Therefore, a decrease in the total score or on individual item scores indicates improvement.
| Arm | Type | Description |
|---|---|---|
| PRAX-114 (10 mg) | EXPERIMENTAL | 10 mg PRAX-114 once daily |
| PRAX-114 (20 mg) | EXPERIMENTAL | 20 mg PRAX-114 once daily |
| PRAX-114 (40 mg) | EXPERIMENTAL | 40 mg PRAX-114 once daily |
| PRAX-114 (60 mg) | EXPERIMENTAL | 60 mg PRAX-114 once daily |
| Placebo | PLACEBO_COMPARATOR | Placebo once daily |
| PRAX-114 | EXPERIMENTAL | 40 mg PRAX-114 once daily |
| Name | Type | Description |
|---|---|---|
| 10 mg PRAX-114 | DRUG | Once daily oral treatment |
| 20 mg PRAX-114 | DRUG | Once daily oral treatment |
| 40 mg PRAX-114 | DRUG | Once daily oral treatment |
| 60 mg PRAX-114 | DRUG | Once daily oral treatment |
| Placebo | DRUG | Once daily oral treatment |
| PRAX-114 | DRUG | 40 mg once daily |
Inclusion Criteria: 1. Recurrent MDD diagnosis with a current episode duration of at least 12 weeks and no more than 24 months. 2. HAM-D17 total score of ≥20 at Screening and Baseline 3. Body mass index (BMI) between 18 and 38 kg/m2 (inclusive). 4. Adjunctive treatment participants only: Inadequate...
Top 20 of 29 competitors
PRAX-114 is an investigational small molecule being developed for the treatment of Major Depressive Disorder (MDD). It is currently in Phase 2 clinical development, meaning it has not yet been approved by regulatory authorities and remains under investigation for safety and efficacy in clinical trials.
PRAX-114 is being developed by Praxis Precision Medicines, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol PRAX. The company is conducting clinical trials to evaluate the drug's potential as a treatment for Major Depressive Disorder.
PRAX-114 is in Phase 2 clinical development for Major Depressive Disorder. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. Two Phase 2 trials have been completed, and the drug is not currently in active clinical trials.
PRAX-114 has completed two Phase 2 clinical trials for Major Depressive Disorder. The first trial, NCT04832425, enrolled 216 participants and was conducted in the United States and Australia. The second trial, NCT04969510, enrolled 110 participants and evaluated both adjunctive and monotherapy use of PRAX-114 in the same countries.
PRAX-114 is a small molecule being studied for Major Depressive Disorder. Its specific molecular target has not been disclosed in the available clinical trial information, so its mechanism of action is not described here. The drug is being evaluated in placebo-controlled, double-blind trials to assess its efficacy and safety.
No, PRAX-114 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Major Depressive Disorder. Two Phase 2 trials have been completed, but the drug has not yet received regulatory approval and is not available for clinical use outside of research settings.