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NV-5138 · 4 trials · 3 indications
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.
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 percentage of the radioactive dose recovered in urine, faeces and in total
| Arm | Type | Description |
|---|---|---|
| SPN-820 6 x 400 mg capsules | OTHER | - |
| 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. |
| [14C]-NV-5138 | EXPERIMENTAL | \[14C\]-NV-5138 oral solution |
| Name | Type | Description |
|---|---|---|
| NV-5138 | DRUG | NV-5138 is a novel, orally bioavailable, mechanistic target of rapamycin complex 1 (mTORC1) signaling enhancer |
| matched placebo | DRUG | matched placebo oral capsules |
| [14C]-NV-5138 | DRUG | Single dose, given as oral solution, 1600 mg |
Inclusion Criteria: * Male or female subject, aged 18 to 65 years (inclusive) at screening. * Diagnosis of 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 by the M...
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NV-5138 is an investigational small molecule being studied for major depressive disorder and treatment resistant depression. It has also been evaluated in healthy volunteers in early phase studies. The drug is not approved and remains in clinical development.
NV-5138 is being developed by Supernus Pharmaceuticals, Inc., a company traded on the NASDAQ under the ticker symbol SUPN. The company has sponsored clinical trials of the drug in the United States and the United Kingdom.
NV-5138 is in Phase 1 and Phase 2 clinical development. It has completed Phase 1 mass balance studies in healthy volunteers and a Phase 2 study in adults with treatment resistant depression. The drug is investigational and not FDA approved.
NV-5138 has been studied in several completed trials. NCT05066672 was a Phase 2 study in 250 adults with treatment resistant depression in the United States. NCT05152680 and NCT05384977 were Phase 1 mass balance studies in healthy male subjects in the United Kingdom. NCT06235905 was an open-label Phase 2 study in 40 adults with major depressive disorder.
NV-5138 is also known as SPN-820. Clinical trial NCT06235905, an open-label study in adults with major depressive disorder, refers to the drug as SPN-820. Both names refer to the same investigational compound developed by Supernus Pharmaceuticals.
NV-5138 is a small molecule being studied for its effects on major depressive disorder and treatment resistant depression. The specific molecular target of the drug has not been disclosed in the available clinical trial information.