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Also known as RL-007 (Inidascamine)
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 developed by AtaiBeckley Inc. (ticker ATAI) for cognitive impairment, including cognitive impairment associated with schizophrenia (CIAS). It is in Phase 2 clinical development and is not approved for any indication. It has also been studied in adults with schizophrenia.
RL-007 is being developed to treat cognitive impairment associated with schizophrenia (CIAS), a condition in which people with schizophrenia experience deficits in attention, memory, and executive function. It is investigational and has not been approved for this or any other use. Its clinical program also covers cognitive impairment more broadly.
RL-007 is developed by AtaiBeckley Inc., which trades under the ticker ATAI. The company is the sponsor of the clinical program evaluating RL-007 in cognitive impairment and cognitive impairment associated with schizophrenia.
RL-007 is in Phase 2 clinical development. Two Phase 2 trials have been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA or any other regulatory agency for cognitive impairment or cognitive impairment associated with schizophrenia.
RL-007 has been evaluated in two completed Phase 2 trials. NCT05686239 studied RL-007 in cognitive impairment associated with schizophrenia across the United States, Bulgaria, Czechia, and Poland, enrolling 242 participants. NCT04822883 was a safety and biomarker study in 37 subjects with schizophrenia conducted in the United States.
Yes. RL-007 is also known as inidascamine, so the two names refer to the same investigational compound. Searches for either name lead to the same Phase 2 program in cognitive impairment and cognitive impairment associated with schizophrenia being run by AtaiBeckley Inc. (ticker ATAI).