Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication ARISTADA is indicated for the treatment of schizophrenia in adults [see Clinical Studies ( 14 )]. ARISTADA is an atypical antipsychotic indicated for the treatment of schizophrenia in adults ( 1 ). FDA label
Also known as ARISTADA, ARISTADA INITIO, ARISTADA TM
Aripiprazole Lauroxil · 3 trials · 2 indications
Change within treatment groups of Positive and Negative Syndrome Scale (PANSS) total score between baseline and week 4 based on the observed data without imputation for missing data. The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition.
Area under the plasma-concentration time curve from time zero to the last quantifiable plasma concentration
Maximum plasma concentration
Time to maximum plasma concentration
| Arm | Type | Description |
|---|---|---|
| Treatment Group 1 | EXPERIMENTAL | Regular injections |
| Treatment Group 2 | ACTIVE_COMPARATOR | Regular injections |
| Location | OTHER | Deltoid or Gluteal Muscle |
| Aripiprazole Lauroxil - A | EXPERIMENTAL | Intramuscular (IM) injection Dose and Dosing Sequence A |
| Aripiprazole Lauroxil - B | EXPERIMENTAL | Intramuscular (IM) injection Dose and Dosing Sequence B |
| Aripiprazole Lauroxil - C | EXPERIMENTAL | Intramuscular (IM) injection Dose and Dosing Sequence C |
| Aripiprazole Lauroxil - D | EXPERIMENTAL | Intramuscular (IM) injection Dose and Dosing Sequence D |
| Name | Type | Description |
|---|---|---|
| Aripiprazole Lauroxil | COMBINATION_PRODUCT | Intramuscular injection; study drug provided using a pre-filled syringe |
| Paliperidone Palmitate | DRUG | Intramuscular injection |
Inclusion Criteria: * Has a diagnosis of schizophrenia * Requires acute treatment for symptoms of schizophrenia * Willing and able to be confined to an inpatient study unit for up to 3-4 weeks * Has experienced at least one previous hospitalization for schizophrenia * Has been able to achieve outpa...
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Aripiprazole Lauroxil is being developed for the treatment of schizophrenia. It is an investigational long-acting injectable antipsychotic studied in adults with schizophrenia and schizoaffective disorder. The clinical program includes Phase 3 and Phase 1 trials conducted in the United States.
Aripiprazole Lauroxil targets the dopamine D2 receptor (DRD2) and serotonin receptors HTR2A and HTR1A. It acts as an antagonist at these targets. This receptor profile is characteristic of aripiprazole-based antipsychotics used in schizophrenia.
Aripiprazole Lauroxil is being developed by Alkermes plc, which trades under the ticker ALKS. The company is responsible for the clinical development program, including the Phase 3 and Phase 1 trials conducted in the United States.
Aripiprazole Lauroxil is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA. The development program includes completed Phase 3 and Phase 1 trials in schizophrenia and schizoaffective disorder.
Aripiprazole Lauroxil has been studied in three completed clinical trials: NCT03345979, a Phase 3 study comparing it with paliperidone palmitate in schizophrenia; NCT02636842, a Phase 1 study in schizophrenia or schizoaffective disorder; and NCT02320032, an open-label Phase 1 study in stable schizophrenia.