Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
risperidone IR and LAI formulation · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | risperidone IR and LAI formulation 1 mg risperidone IR single injection followed after 7 to 14 days with 75mg risperidone 4-week-LAI single injection |
| Name | Type | Description |
|---|---|---|
| risperidone IR and LAI formulation | DRUG | 1 mg risperidone IR single injection, followed after 7 to 14 days with 75mg risperidone 4-week-LAI single injection |
Inclusion Criteria: * Patients with a diagnosis of schizophrenia * Clinically stable with no change in current antipsychotic medications * Meet Positive and Negative Symptom Score (PANSS) and Clinical Global Impression (CGI) score criteria * Have a body mass index (BMI) between 18 and 35 kilogram (...
Risperidone IR and LAI formulation refers to two dose forms of risperidone: an immediate-release (IR) version and a long-acting injectable (LAI) version given intramuscularly. Johnson & Johnson develops this product, and it is being studied in psychotic disorders including schizophrenia. The LAI form is designed to deliver risperidone over an extended period after injection.
Risperidone IR and LAI formulation is used for psychotic disorders, including schizophrenia. The immediate-release form provides standard oral dosing, while the long-acting injectable form is given intramuscularly to maintain drug exposure over time. The clinical program has focused on patients with schizophrenia and related psychotic conditions.
Risperidone IR and LAI formulation targets the serotonin receptors HTR2A and HTR2C and the dopamine receptor DRD2. It acts as an antagonist at these targets. Antagonism at DRD2 and HTR2A is the mechanism associated with its antipsychotic activity in psychotic disorders.
Johnson & Johnson, which trades under the ticker JNJ, is the developer of risperidone IR and LAI formulation. The company is associated with both the immediate-release and long-acting injectable versions of risperidone in this program.
Risperidone IR and LAI formulation is in Phase 1 development. It is an investigational product and is not approved as a new therapy based on this program. The Phase 1 work has focused on characterizing the long-acting injectable formulation in patients.
Risperidone IR and LAI formulation has been studied in one completed Phase 1 trial, NCT00821600. That trial, titled Characterization of Intramuscular Injections of Risperidone 4 Week Long-acting Injectable (LAI) Formulation in the Buttock of Patients With Schizophrenia, enrolled 24 patients in the United States. It was an uncontrolled study without randomization or blinding.