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BTRX-246040 · 2 trials · 3 indications
UPDRS = Unified Parkinson's Disease Rating Scale. The Unified Parkinson's Disease Rating Scale (UPDRS) Part III is a 14-item rating scale, which consists of the motor examination. Each item is scored from 0 (Normal) to 4 (Most severe). The score ranges from 0-56.
The Investigator-administered MADRS includes 10 items assessing the following symptoms: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (absence of symptom) to 6 (severe symptom); the overall score ranges from 0 to 60. MADRS total scores from 0 to 6 indicate normal/symptom absent, from 7 to 19 indicate mild depression, from 20 to 34 indicate moderate depression, and from 35 to 60 indicate severe depression.
| Arm | Type | Description |
|---|---|---|
| BTRX-246040 Cohort 1 | EXPERIMENTAL | BTRX-246040 40 mg administered orally |
| BTRX-246040 Cohort 2 | EXPERIMENTAL | BTRX-246040 80 mg administered orally |
| BTRX-246040 Cohort 3 | EXPERIMENTAL | BTRX-246040 120 mg administered orally |
| Placebo Cohorts 1-3 | PLACEBO_COMPARATOR | Placebo is administered orally at the same number of capsules as active drug in each Cohort. Placebo capsules consist of inactive ingredients and look identical to BTRX-246040. |
| BTRX-246040 | EXPERIMENTAL | 40 mg administered orally as 1 capsule QD for 1 week, followed by 80 mg as 2 capsules QD for 7 weeks. |
| Placebo | PLACEBO_COMPARATOR | administered orally as 1 capsule QD for 1 week, followed by 2 capsules QD for 7 weeks. |
| Name | Type | Description |
|---|---|---|
| BTRX-246040 | DRUG | oral capsule |
| Placebo | DRUG | oral capsule matching BTRX-246040 capsule |
| BTRX-246040 oral capsule(s) | DRUG | BTRX-246040 administered once daily to patients with MDD for 8 weeks |
| Placebo oral capsule(s) | DRUG | administered once daily to patients with MDD for 8 weeks |
Inclusion Criteria: * Diagnosed with Parkinson's disease (PD), consistent with the United Kingdom PD Society Brain Bank Criteria for the Diagnosis of PD * Men or women ≥ 30 years old and ≤ 76 years old * Female participants must be either surgically sterilized or 2 years post menopausal at screenin...
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BTRX-246040 is an investigational small molecule being studied for the treatment of Major Depressive Disorder and Parkinson's Disease with motor fluctuations. It is developed by Neumora Therapeutics, Inc. (NASDAQ: NMRA) and is currently in Phase 2 clinical development.
BTRX-246040 is a small molecule that targets the nociceptin/orphanin FQ peptide receptor. This receptor is involved in modulating various neurological and psychiatric functions, and its modulation is being explored for potential therapeutic effects in depression and Parkinson's disease.
BTRX-246040 is developed by Neumora Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol NMRA. The company is advancing this investigational drug through clinical trials for psychiatric and neurological indications.
BTRX-246040 is in Phase 2 clinical development. Two Phase 2 trials have been completed, one in Major Depressive Disorder and one in Parkinson's Disease with motor fluctuations. The drug is investigational and has not been approved by regulatory authorities.
BTRX-246040 has completed two Phase 2 clinical trials. NCT03193398 evaluated the drug in 104 patients with Major Depressive Disorder in the United States. NCT03608371 studied 24 participants with Parkinson's Disease and motor fluctuations. Both trials were randomized, double-blind, and placebo-controlled.
BTRX-246040 is the sole name provided for this investigational compound. No alternative names have been reported in the clinical trial records. It is being studied under this identifier in trials for Major Depressive Disorder and Parkinson's Disease.