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AQW051 · 6 trials · 5 indications
The primary objective is to evaluate the pro-cognitive effects of AQW051 in a chronic stable schizophrenic patient population at week 4 as measured by the absolute change from baseline in CPAL number of errors (CogState battery) at week 4.
Dyskinesia with a maximal score of 24.
Anti-parkinsonian effect in PD patients.
Safety and tolerability of AQW051 as measured by the number of participants with adverse events, any clinically significant abnormalities in safety labs or electrocardiograms (ECGs), and relevant orthostatic changes in blood pressure
| Arm | Type | Description |
|---|---|---|
| AQW051 10 mg/day | EXPERIMENTAL | Two 5mg AQW051 capsules will be taken orally daily by patients from Day 1 until Day 84. |
| Placebo to AQW051 | PLACEBO_COMPARATOR | Matching placebo administered orally. |
| AQW051 High Dose | EXPERIMENTAL | AQW051 high dose daily given orally for 28 days. |
| AQW051 Low Dose | EXPERIMENTAL | AQW051 low dose daily given orally for 28 days. |
| Placebo | PLACEBO_COMPARATOR | Placebo daily given orally for 28 days. |
| AQW051 Dose 1 | EXPERIMENTAL | - |
| AQW051 Dose 2 | EXPERIMENTAL | - |
| AQW051 Dose 3 | EXPERIMENTAL | - |
| AQW051 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AQW051 | DRUG | - |
| Placebo | DRUG | - |
| Placebo (single and multiple doses) | DRUG | - |
| AQW051 2 mg (single and multiple doses) | DRUG | - |
| AQW051 15mg (single and multiple doses) | DRUG | - |
| AQW051 100mg (single dose), and 50mg (multiple doses) | DRUG | - |
Inclusion Criteria: * Diagnosis of schizophrenia * Symptomatically stable and currently treated with a stable regimen for at least 3 (three) months prior to dosing with one of the following second generation of antipsychotics: risperidone, paliperidone, quetiapine, ziprasidone, aripiprazole. * Spec...
AQW051 is an investigational small molecule being studied for schizophrenia, schizophrenia disorders, and L-dopa induced dyskinesias in Parkinson's disease. It has been evaluated in clinical trials for its effects on cognitive function in stable schizophrenia patients and for safety and efficacy in dyskinesias. AQW051 is not approved and remains in clinical development.
AQW051 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. Novartis has sponsored clinical trials of AQW051 in the United States and several European countries.
AQW051 has completed Phase 2 clinical trials. These trials investigated its effects on cognitive function in schizophrenia and on L-dopa induced dyskinesias in Parkinson's disease. AQW051 is an investigational drug and has not been approved by regulatory authorities.
AQW051 has been studied in several completed trials. NCT00825539 was a Phase 1 pharmacodynamic and pharmacokinetic study in schizophrenia. NCT01163227 and NCT01730768 were Phase 2 trials evaluating cognitive function in stable schizophrenia patients. NCT01474421 was a Phase 2 trial in L-dopa induced dyskinesias in Parkinson's disease.
AQW051 is the code name used by Novartis for this investigational compound. No alternative brand names or chemical names have been publicly associated with AQW051 in the clinical trial records. It is identified solely by the code AQW051 in all registered studies.