INVEGA (paliperidone)
INVEGA is an atypical antipsychotic agent indicated for Treatment of schizophrenia Adults: Efficacy was established in three 6-week trials and one maintenance trial. Adolescents (ages 12–17): Efficacy was established in one 6-week trial. Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants. Efficacy was established in two 6-week trials in adult patients. Studies ] .
Development Insights
Details
- Status
- Prescription
- First Approved
- 2006-12-19
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
INVEGA Approval History
What INVEGA Treats
5 FDA approvalsOriginally approved for its first indication in 2006 . Covers 5 distinct patient populations.
- Other (5)
INVEGA 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. INVEGA is 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 psych...
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. INVEGA is 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. INVEGA is not approved for use in patients with dementia-related psychosis. ( 5.1 )
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.
INVEGA FDA Label Details
Indications & Usage
FDA Label (PDF)INVEGA is an atypical antipsychotic agent indicated for Treatment of schizophrenia Adults: Efficacy was established in three 6-week trials and one maintenance trial. Adolescents (ages 12–17): Efficacy was established in one 6-week trial. Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants. Efficacy was established in two 6-week trials in adult patients. 1.1 Schizophrenia INVEGA (paliperidone) Extended-Release Tablets are indicated for the treatment of schizophrenia [see Clinical Studies ] . The efficacy of INVEGA in schizophrenia wa...
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. INVEGA is not approved for the treatment of patients with dementia-related psychosis. [see Warnings an...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment