PALIPERIDONE
PALIPERIDONE is indicated for the treatment of Schizophrenia; Schizoaffective Disorder.
How PALIPERIDONE Works
Paliperidone is the major active metabolite of risperidone. While its exact mechanism of action in schizophrenia is unclear, its therapeutic effects are believed to be mediated through the antagonism of specific receptors in the central nervous system. Specifically, the drug acts as an antagonist to central dopamine Type 2 (D2) and serotonin Type 2 (5HT2A) receptors.
Details
- Status
- Prescription
- First Approved
- 2015-08-03
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
Companies
PALIPERIDONE Approval History
What PALIPERIDONE Treats
2 indicationsPALIPERIDONE is approved for 2 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Schizophrenia
- Schizoaffective Disorder
PALIPERIDONE Boxed Warning
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Paliperidone extended-release tablets are not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patie...
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Paliperidone extended-release tablets are not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Paliperidone is not approved for use in patients with dementia-related psychosis. (5.1)
PALIPERIDONE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to PALIPERIDONE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
22 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04478838 | 154-2018 | Ph 4 | recruiting | "Extended" (Alternate Day) Antipsychotic Dosing |
| NCT03485417 | SToP-S | Ph 2, Ph 3 | completed | Substance Misuse To Psychosis for Stimulants |
| NCT02634463 | CR108047 CODX0001-NAP-1004 | Ph 1 | completed | Whole Blood and Plasma Sample Collection for the Development of Antipsychotic Immunoassays From Participants Taking Aripiprazole, Olanzapine, Paliperidone, or Risperidone |
| NCT03557931 results posted | 4345-CL-0015 | Ph 2 | completed | A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication |
| NCT02146547 EULAST | ABR49490 | Ph 4 | completed | European Long-acting Antipsychotics in Schizophrenia Trial |
| NCT03425552 | PAL.100/316 | Ph 1, Ph 2 | completed | A Clinical Study to Evaluate the Bioavailability Between Two Products Containing Paliperidone 100 mg in the Form of a Prolonged Release Suspension for Injection in Patients With Schizophrenia Who Are Already Stabilized in This Treatment |
| NCT01399450 | PAL-KOR-9015 PAL-KOR-9015 | Ph 4 | completed | Paliperidone ER(Invega®) on Depressive Symptoms of Schizophrenia Patients |
| NCT03730857 | T1-02 | Ph 1 | completed | Early Predictors of Poor Treatment Response in Patients With Schizophrenia Treated With Atypical Antipsychotics |
| NCT02307396 | 1723/1-1 2013-000338-37, DO 1723/1-1 | Ph 4 | completed | Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic Patients |
| NCT02374567 GAP | GAP-2014 | Ph 3 | terminated | Pharmacovigilance in Gerontopsychiatric Patients |
| NCT02462473 results posted | CR106922 CODX0001NAP2002 | Ph 2 | terminated | A Study to Assess the Clinical Utility of Antipsychotic Medication Levels in Plasma as Determined by Liquid Chromatography-Tandem Mass Spectrometry |
| NCT00766064 | 0804003717 | Ph 4 | withdrawn | Effects of Paliperidone in Posttraumatic Stress Disorder (PTSD) |
| NCT01134731 AFSP results posted | F100329001 | Ph 4 | completed | Paliperidone and Lithium in the Treatment of Suicidality - Treatment Indication and Epigenetic Regulation |
| NCT01157351 results posted | CR015625 R092670SCH3006 | Ph 4 | completed | 15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated |
| NCT01822730 | 100000-068943 | Ph 4 | completed | A Comparison of Paliperidone and Risperidone for Treatment of Patirnts With Methamphetamine-Associated Psychosis |
| NCT01662310 results posted | CR100427 R076477-SCH-3041 | Ph 3 | completed | An Efficacy Study of Paliperidone for the Prevention of Relapse in Participants With Schizophrenia |
| NCT00761605 PASS results posted | CR015253 PAL-KOR-4003 | Ph 4 | completed | Phase 4 Study to Evaluate Efficacy of Paliperidone Extended-Release(ER) in Schizophrenic Participants |
| NCT00761579 PERFECT results posted | CR015250 PAL-KOR-4002 | Ph 4 | completed | Paliperidone Extended Release(ER) Effectiveness Study to Evaluate the Objective Symptom Change and Symptomatic Remission |
| NCT00784238 Power results posted | CR015391 R076477SCH4028 | Ph 4 | completed | Efficacy Study of Paliperidone to Evaluate Subjective Change in Well-being and Drug Attitude in Schizophrenic Participants |
| NCT00761189 PANDORA results posted | CR015079 PAL-KOR-4001 | Ph 4 | completed | PaliperidoNe Extended-Release [ER] Dosing and Clinical Response in Acute Schizophrenia |
| NCT01193166 | CR017110 R092670SCH4003 | Ph 4 | withdrawn | Twelve Month Study Comparing Paliperidone Palmitate and Select Oral Antipsychotics in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital |
| NCT01607762 | CR100831 INDIGO-APS-1001, 2011-006133-41 | Ph 1 | completed | A Study to Compare Capillary and Venous Whole Blood and Plasma Concentrations of Five Antipsychotics |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PALIPERIDONE FDA Label Details
Indications & Usage
PALIPERIDONE is indicated for the treatment of Schizophrenia; Schizoaffective Disorder.
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Paliperidone extended-release tablets are not approved for the treatment of patients with dementia-rel...
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Full clinical data, patents, trials, and competitive landscape for paliperidone.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.