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Also known as [14C]-NV-5138, SPN-820
NV-5138 · 2 trials · 2 indications
MADRS is a 10-item scale (Reported sadness, Apparent sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimist thoughts, and Suicidal thoughts) where each item is scored from 0 to 6. The total score is the sum of the 10 items ranging from 0 to 60 where higher scores indicate more severe depression, and lower scores are better outcomes. A negative change from baseline indicates improvement in depressive symptoms.
The HAM-D6 scale consists of 6 items: five of them (depressed mood, work and activities, feeling of guilt, anxiety, psychic, retardation) are scored on a scale of 0 to 4, and one item (somatic symptoms general) is scored on a scale 0 to 2. The total score is the sum of the 6 items ranging from 0 to 22, higher scores indicate severe depression, and lower scores are better outcomes.
| Arm | Type | Description |
|---|---|---|
| NV-5138 400 mg oral capsules | EXPERIMENTAL | Participants received either 800 or 1600 mg NV-5138 (2 or 4, 400 mg capsules) once daily for 4 weeks. During the first week of the Treatment Period, all participants took 1600 mg once a day. Participants who experienced an intolerable adverse effect at 1600 mg at Week 2, could have their dose reduced to 800 mg. Participants who had an inadequate response to 800 mg might have their dose increased again to 1600 mg per Investigator judgment to maximize their treatment response; however, no dose adjustments were allowed after Week 3. The dose at Week 4 was the same as stable dose at Week 3. After completion of the 4-week treatment, all participants received placebo in a double-blinded fashion and continued the treatment for one week. |
| matched placebo | PLACEBO_COMPARATOR | Participants received either 2 or 4 capsules of placebo once daily for 5 weeks. |
| SPN-820 6 x 400 mg capsules | OTHER | - |
| Name | Type | Description |
|---|---|---|
| NV-5138 | DRUG | NV-5138 is a novel, orally bioavailable, selective, direct enhancer of mTORC1 cellular signaling |
| matched placebo | DRUG | matched placebo oral capsules |
Inclusion Criteria: * Male or female, aged 18 to 70 years at Screening. * Diagnosis of Major Depressive Disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) for either recurrent or single episode MDD without psychotic features that is confirmed ...
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NV-5138 is an investigational small molecule developed by Supernus Pharmaceuticals for major depressive disorder and treatment resistant depression. It has completed Phase 2 clinical testing. It is not approved for commercial use and remains in clinical development.
NV-5138 is being studied for major depressive disorder and treatment resistant depression. It is an investigational therapy that has completed Phase 2 trials and is not approved for any indication.
NV-5138 is developed by Supernus Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker SUPN. Supernus is the sponsor of the clinical program evaluating NV-5138 in depression.
NV-5138 has completed Phase 2 clinical development. It is investigational and has not been approved by the FDA. No active trials are currently listed for NV-5138.
NV-5138 has been evaluated in two completed Phase 2 trials. NCT05066672 studied NV-5138 in adults with treatment resistant depression and enrolled 250 participants. NCT06235905 was an open-label Phase 2 study of SPN-820 in adults with major depressive disorder and enrolled 40 participants in the United States.
Yes, [14C]-NV-5138 is an alternative name for NV-5138. The carbon-14 label refers to a radiolabeled form used in research. Both names refer to the same investigational compound developed by Supernus Pharmaceuticals for depression.