Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BTRX-335140, CYM-53093, Navacaprant
NMRA-335140 · 5 trials · 2 indications
The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item will be scored on a 7- point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. Thus, scores in the MADRS range from 0 to 60, with increasing scores indicating increasing severity.
The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item will be scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. Thus, scores in the MADRS range from 0 to 60, with increasing scores indicating increasing severity.
The HAMD-17 was a 17-item clinician-rated instrument used to assess the range of symptoms that were most frequently observed in participants with major depression. All items were scored on an ordinal scale between 0 and 4 (9 items) or 0 and 2 (8 items) of increasing severity. Each of 17 items was rated by clinician with rating of 0: absent, 1: doubtful to mild, 2: mild to moderate, 3: moderate to severe, and 4: very severe. A total score (0 to 52) was calculated by adding scores of all 17 items, where 0 indicated no depression and 52 indicated severe depression. Higher score represents more severe condition. Baseline is defined as the latest non-missing measurement prior to or within 1 hour of the first administration of study drug. Change from Baseline is defined as post dose visit value minus Baseline value.
| Arm | Type | Description |
|---|---|---|
| NMRA-335140 80 milligrams (mg) once daily (QD) | EXPERIMENTAL | Participants will receive a NMRA-335140 tablet at a dose of 80 mg QD |
| Placebo | PLACEBO_COMPARATOR | Placebo participants will receive matching placebo tablet once daily |
| NMRA-335140 (BTRX-335140) | EXPERIMENTAL | NMRA-335140 will be administered. |
| Name | Type | Description |
|---|---|---|
| NMRA-335140 | DRUG | Participants will receive NMRA-335140 at a dose of 80 mg QD, orally |
| Placebo | DRUG | Placebo will be administered orally |
| NMRA-335140 80 mg | DRUG | Participants will receive NMRA-335140 at a dose of 80 mg QD, orally. |
Key Inclusion Criteria: * Have a primary Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) diagnosis of MDD without psychotic features confirmed by Structured Clinical Interview for DSM 5 Disorders, Clinical Trials Version (SCID 5 CT) at screening (this may...
Top 20 of 31 competitors
NMRA-335140 is an investigational small molecule being developed by Neumora Therapeutics, Inc. for major depressive disorder and for major depressive episodes associated with bipolar II disorder. It is a Phase 3 clinical candidate that has been studied in randomized, double-blind, placebo-controlled trials. It is not approved for any indication.
NMRA-335140 is being studied for the treatment of major depressive disorder and for major depressive episodes associated with bipolar II disorder. Both are psychiatric conditions within the psychiatry therapeutic area. The program is in Phase 3 development, and the drug has not been approved for any use.
NMRA-335140 targets the kappa opioid receptor, or KOR. It is a small molecule directed at this receptor, which places it in the kappa opioid receptor antagonist class of psychiatric drug candidates. Neumora Therapeutics is developing it for major depressive disorder and for major depressive episodes associated with bipolar II disorder.
NMRA-335140 is developed by Neumora Therapeutics, Inc., which trades under the ticker NMRA. The company is the sponsor of the clinical program studying the drug in major depressive disorder and in major depressive episodes associated with bipolar II disorder.
NMRA-335140 is in Phase 3 clinical development. Four trials have been completed, including three Phase 3 studies in major depressive disorder and one Phase 2 study in major depressive episodes associated with bipolar II disorder. The drug is investigational and has not been approved by the FDA.
Completed trials of NMRA-335140 include NCT06058039, NCT06058013, and NCT06029426, all Phase 3 studies in major depressive disorder, plus NCT06429722, a Phase 2 study in major depressive episodes associated with bipolar II disorder. Total enrollment across these randomized, double-blind, placebo-controlled trials was 1,439 participants.