Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Paliperidone palmitate eq · 1 trial · 1 indication
The PANSS measures the severity of psychotic symptoms of schizophrenia. Scores range from 30 to 210, where 30=best and 210=worst. The change in PANSS total score for all eligible subjects was measured from the beginning of the study to Week 13 (i.e., the end of the double-blind treatment period) or, if the subject left the study early, from the beginning of the study to the last assessment after baseline.
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | Paliperidone palmitate 25 mg eq. Paliperidone palmitate 150 mg eq. i.m. Day 1 and 25 mg eq. i.m. Days 8 36 64 |
| 002 | EXPERIMENTAL | Paliperidone palmitate 100 mg eq. Paliperidone palmitate 150 mg eq. i.m. Day 1 and 100 mg eq. i.m. Days 8 36 64 |
| 003 | EXPERIMENTAL | Paliperidone palmitate 150 mg eq. Paliperidone palmitate 150 mg eq. i.m. Days 1 8 36 64 |
| 004 | PLACEBO_COMPARATOR | Placebo Placebo i.m. Days 1 8 36 64 |
| Name | Type | Description |
|---|---|---|
| Paliperidone palmitate 25 mg eq. | DRUG | Paliperidone palmitate 150 mg eq. i.m. Day 1 and 25 mg eq. i.m. Days 8, 36, 64 |
| Paliperidone palmitate 150 mg eq. | DRUG | Paliperidone palmitate 150 mg eq. i.m. Days 1, 8, 36, 64 |
| Placebo | DRUG | Placebo i.m. Days 1, 8, 36, 64 |
| Paliperidone palmitate 100 mg eq. | DRUG | Paliperidone palmitate 150 mg eq. i.m. Day 1 and 100 mg eq. i.m. Days 8, 36, 64 |
Inclusion Criteria: * Met diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) for at least 1 year before screening. Prior medical records, written documentation or verbal information obtained from previous psychiatric pro...
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Paliperidone palmitate eq is used for the treatment of schizophrenia. It is a small molecule therapy developed by Johnson & Johnson under the ticker JNJ. The drug is currently in Phase 3 clinical development, and a completed Phase 3 trial evaluated fixed doses in adults with schizophrenia.
Paliperidone palmitate eq targets the serotonin 5-HT2A receptor (HTR2A) and the dopamine D2 receptor (DRD2). It acts as an antagonist at both targets. This receptor activity is the basis for its use in schizophrenia, a condition in which dopaminergic and serotonergic signaling are implicated.
Paliperidone palmitate eq is being developed by Johnson & Johnson, which trades under the ticker JNJ. The company is responsible for the clinical program, including the completed Phase 3 trial NCT00590577 that studied the drug in schizophrenia.
Paliperidone palmitate eq is in Phase 3 clinical development. It is an investigational therapy and has not been approved by the FDA for any indication. The Phase 3 trial NCT00590577 has been completed, and no active trials are currently listed for this asset.
Paliperidone palmitate eq has been studied in one completed Phase 3 trial, NCT00590577, titled "Effectiveness and Safety of 3 Fixed Doses (25 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Patients With Schizophrenia." The trial enrolled 652 participants across the United States, Malaysia, Romania, Russia, Serbia, South Korea, Taiwan, and Ukraine.