Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RL-007 · 2 trials · 3 indications
change from baseline in composite of nine cognitive tests
Comparison of AE rates between active and placebo dosing
blood pressure measured in mmHg; baseline = Day -1
heart rate measured in beats per minute; baseline = Day -1
respiratory rate measured in breaths per minute; baseline = Day -1
temperature measured in degrees Celsius; baseline = Day -1
overall physician interpretation of ECG reading; baseline = Day -1
The C-SSRS assesses suicidal ideation and behavior; baseline = Day -1
| Arm | Type | Description |
|---|---|---|
| RL-007 20 mg (Inidascamine) | EXPERIMENTAL | oral dosing three times per day (TID) |
| RL-007 40 mg (Inidascamine) | EXPERIMENTAL | oral dosing three times per day (TID) |
| Placebo | PLACEBO_COMPARATOR | oral dosing three times per day (TID) |
| Dose-escalation - RL-007 | EXPERIMENTAL | Each cohort will include a single dose-strength. Within each cohort, the sequence of active capsules and matching placebo capsules will be varied and unknown to the participant. |
| Dose-escalation - matching Placebo | PLACEBO_COMPARATOR | Within each cohort, the sequence of active capsules and matching placebo capsules will be varied and unknown to the participant. |
| Name | Type | Description |
|---|---|---|
| RL-007 (Inidascamine) | DRUG | investigational study drug |
| Placebo | DRUG | placebo capsules matching the appearance and size of the active drug |
| RL-007 | DRUG | Cohorts are 10 mg, 20 mg, 40 mg, and 80 mg with TID dosing |
| RL-007 Matching Placebo | DRUG | Cohorts are 10 mg, 20 mg, 40 mg, and 80 mg with TID dosing |
Key Inclusion Criteria: * Diagnosis of schizophrenia, per Diagnostic and Statistical Manual (DSM) 5, with a duration of at least 6 months * Positive and Negative Symptoms Severity Score (PANSS) of less than or equal to 80 (inclusive) * Currently treated on a single atypical antipsychotic (other tha...
RL-007 is an investigational small molecule being developed for cognitive impairment, specifically cognitive impairment associated with schizophrenia (CIAS). It is in Phase 2 clinical development and has been studied in patients with schizophrenia-related cognitive deficits.
RL-007 is being developed by AtaiBeckley Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol ATAI.
RL-007 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials have been completed, including a larger study evaluating its effect on cognitive impairment associated with schizophrenia.
RL-007 has been studied in two completed Phase 2 trials. NCT04822883 was a safety and biomarker study in 37 subjects with schizophrenia in the United States. NCT05686239 evaluated RL-007 in 242 patients with cognitive impairment associated with schizophrenia across the US, Bulgaria, Czechia, and Poland.
RL-007 is a small molecule designed to address cognitive impairment. Its specific molecular target has not been disclosed in available clinical trial information, so its precise mechanism of action is not publicly detailed.