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 31 competitors
PRAX-114 is an investigational small molecule being studied for the treatment of major depressive disorder. It has been evaluated in Phase 2 clinical trials as both adjunctive therapy and monotherapy in adults with major depressive disorder. It is not approved for any indication.
PRAX-114 is being developed by Praxis Precision Medicines, Inc., which trades on the Nasdaq under the ticker PRAX. The company sponsored the Phase 2 clinical program evaluating the drug in major depressive disorder.
PRAX-114 is in Phase 2 development. Two Phase 2 trials in major depressive disorder have been completed, and no trials are currently active. The drug remains investigational and has not been approved by the FDA for any indication.
PRAX-114 has been studied in two completed Phase 2 trials: NCT04969510, which evaluated adjunctive and monotherapy PRAX-114 in 110 participants, and NCT04832425, which enrolled 216 participants. Both trials were randomized, double-blind, placebo-controlled studies in adults with major depressive disorder conducted in the United States and Australia.
Across the two completed Phase 2 trials, 326 participants were enrolled in total. NCT04969510 enrolled 110 participants, and NCT04832425 enrolled 216 participants. Both studies included adults aged 18 years and older with major depressive disorder.