INVEGA HAFYERA (paliperidone palmitate)
INVEGA HAFYERA is indicated for the treatment of Schizophrenia.
How INVEGA HAFYERA Works
Paliperidone palmitate is hydrolyzed in the body to paliperidone, which is the major active metabolite of risperidone. While the exact mechanism of action is unclear, the drug's efficacy in treating schizophrenia is thought to be mediated through the central nervous system. Specifically, it acts as an antagonist at both dopamine D2 and serotonin 5HT2A receptors.
Details
- Status
- Prescription
- First Approved
- 2015-05-18
- Patent Cliff
- 2041
- Routes
- INTRAMUSCULAR
- Dosage Forms
- SUSPENSION, EXTENDED RELEASE
INVEGA HAFYERA Approval History
What INVEGA HAFYERA Treats
1 indicationsINVEGA HAFYERA is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Schizophrenia
INVEGA HAFYERA 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 HAFYERA is not approved for use in 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 psychos...
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 HAFYERA is not approved for use in 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 HAFYERA is not approved for use in patients with dementia-related psychosis. ( 5.1 )
INVEGA HAFYERA 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 INVEGA HAFYERA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
21 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01051531 | CR016522 R092670SCH3009 | Ph 3 | completed | A Safety, Tolerability, and Treatment Response Study of Paliperidone Palmitate Administered to Patients With Schizophrenia |
| NCT01527305 PREVAIL | CR100739 R092670SCH4009, PALM-KOR-4004 | Ph 4 | completed | A Study to Evaluate the Effectiveness and Safety of Paliperidone Palmitate in Subjects With Acute Schizophrenia |
| NCT01451736 | P50 MH066286 Phase II P50MH066286, R092670SCH4005 | Ph 4 | completed | Oral Risperidone Versus Injectable Paliperidone Palmitate for Treating First-Episode Schizophrenia |
| NCT04572685 | LY03010/CT-USA-102 | Ph 1 | completed | Evaluate the PK of LY03010 Process 1 and Process 2 Drug Product vs INVEGA SUSTENNA After Intramuscular Injection in Schizophrenia Patients |
| NCT02146547 EULAST | ABR49490 | Ph 4 | completed | European Long-acting Antipsychotics in Schizophrenia Trial |
| NCT03345979 results posted | ALK9072-A306 | Ph 3 | completed | A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia |
| NCT01136772 ACLAIMS results posted | #6017 R01MH081107 | Ph 4 | completed | A Comparison of Long-acting Injectable Medications for Schizophrenia |
| NCT01947803 | CR100855 R092670SCH4018 | Ph 4 | completed | A Safety and Effectiveness Study of Paliperidone Palmitate in Chinese Patients With Schizophrenia |
| NCT01685931 | CR100880 R092670SCH4019 | Ph 4 | completed | A Study of Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated by Oral Antipsychotics |
| NCT01860781 sustenna | R092670-SCH-4008 | Ph 4 | completed | The Effect of Paliperidone Palmitate in Schizophrenia |
| NCT01157351 results posted | CR015625 R092670SCH3006 | Ph 4 | completed | 15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated |
| NCT01193153 results posted | CR016618 R092670SCA3004 | Ph 3 | completed | A Study to Evaluate the Efficacy of Paliperidone Palmitate in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder |
| NCT01211704 | 20081123 | Ph 4 | withdrawn | Paliperidone Palmitate Efficacy and Safety in Bipolar Disorder Complicated by Alcoholism |
| NCT01448720 | CR017977 R092670SCH3012 | Ph 3 | completed | Treatment of Patients With Recently Exacerbated Schizophrenia With Paliperidone Palmitate |
| NCT01682161 | CR100740 R092670SCH4010, PALM-KOR-4001 | Ph 4 | completed | A Comparative Study to Evaluate the Evolution of Medication Satisfaction and Adherence in Patients Unsatisfied With Current Oral Atypical Antipsychotics by Switching Medication to Paliperidone Palmitate |
| NCT01258920 | CR017077 PALM-JPN-5 | Ph 3 | completed | A Study of Paliperidone Palmitate in Japanese Patients With Schizophrenia |
| NCT01281527 PALMFlexS | CR017215 R092670SCH3010 | Ph 3 | completed | Paliperidone Palmitate Flexible Dosing in Schizophrenia |
| NCT01942382 | CR100413 PALM-JPN-3 | Ph 1 | completed | A Clinical Pharmacology Study of JNS010 (Paliperidone Palmitate) in Patients With 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 |
| NCT01299389 results posted | CR017026 PALM-JPN-4 | Ph 3 | completed | An Efficacy and Safety Study of Paliperidone Palmitate in Participants With Schizophrenia |
| NCT00946985 results posted | CR015646 R092670SCH3004 | Ph 4 | terminated | 28-30 Month Study Comparing Paliperidone Palmitate With Oral Risperidone for Treating Adults Diagnosed With Schizophrenia Within the Past 5 Years |
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 HAFYERA FDA Label Details
Indications & Usage
FDA Label (PDF)INVEGA HAFYERA is indicated for the treatment of Schizophrenia.
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 HAFYERA is not approved for use in patients with dementia-related psychosis [see Warnings and P...
INVEGA HAFYERA Patents & Exclusivity
Patents (5 active)
Pro Intelligence Preview
Deep insights for INVEGA HAFYERA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2041
- • 36 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.