FANAPT (iloperidone)
FANAPT is indicated for the treatment of Schizophrenia; Bipolar I Disorder.
How FANAPT Works
While the precise mechanism of action is unknown, the efficacy of iloperidone is thought to be mediated through the antagonism of dopamine type 2 (D2) and serotonin type 2 (5-HT2) receptors. The medication also forms an active metabolite called P88, which possesses a receptor binding profile similar to the parent drug. By blocking these specific receptors in the brain, the drug helps manage the symptoms associated with schizophrenia and bipolar I disorder.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2009-05-06
- Patent Cliff
- 2031
- Routes
- ORAL
- Dosage Forms
- TABLET
FANAPT Approval History
What FANAPT Treats
2 indicationsFANAPT is approved for 2 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Schizophrenia
- Bipolar I Disorder
FANAPT 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. FANAPT 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. FANAPT 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. FANAPT is not approved for use in patients with dementia-related psychosis. ( 5.1 )
FANAPT 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 FANAPT
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
16 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07090161 | VP-VYV-683-2401 | Ph 2 | recruiting | Evaluation of Efficacy and Safety of Iloperidone for the Treatment of Participants With Uncontrolled Hypertension |
| NCT06961968 | VP-VYV-683-3102 | Ph 3 | recruiting | Randomized Withdrawal Study in Patients With Schizophrenia |
| NCT05648591 | VP-VYV-683-4101 | Ph 4 | recruiting | Safety and Tolerability of Open-Labeled Iloperidone in Adolescents |
| NCT04819776 results posted | VP-VYV-683-3201 | Ph 3 | completed | Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder |
| NCT05344365 | VP-VYV-683-2301 | Ph 2 | withdrawn | A Study to Evaluate Iloperidone for the Treatment of Parkinson's Disease Psychosis |
| NCT01291511 REPRIEVE results posted | CILO522D2301 | Ph 3 | completed | Relapse Prevention Study in Patients With Schizophrenia |
| NCT04712734 | VP-VYV-683-1005 | Ph 1 | completed | A Study to Evaluate Iloperidone Long-acting Injection (LAI) for the Treatment of Schizophrenia |
| NCT04127058 | VP-VYV-683-1004 | Ph 1 | completed | Evaluating a New Iloperidone Titration Scheme in Bipolar I Disorder or Schizophrenia |
| NCT01917318 results posted | 13-0207 IIRP-1371 | Ph 2 | terminated | Iloperidone for Symptoms of Arousal in Post Traumatic Stress Disorder (PTSD) |
| NCT02413918 results posted | HSC20120137 | Ph 4 | completed | Iloperidone in Mixed States of Bipolar Disorder |
| NCT01464229 results posted | 2011P002043 | Ph 4 | completed | Iloperidone Augmentation of SSRIs for Patients With Major Depressive Disorder With Residual Anger and Irritability |
| NCT01920802 results posted | 6525 | Ph 4 | completed | Assessment and Comparison of Metabolic Changes in Non-psychotic Adults Taking Iloperidone or Olanzapine or Placebo |
| NCT01929889 results posted | CIL0522DUS03T | Ph 4 | terminated | Assessing the Effects of Fanapt® on Social Cognition in Schizophrenia |
| NCT01623713 | YPLT20111123 | Ph 2 | completed | Efficacy and Safety Study of Iloperidone Virus Risperidone to Treat Schizophrenia |
| NCT01207414 i-FANS results posted | CILO522DUS01 | Ph 4 | completed | Switching to Iloperidone From Other Antipsychotics in Schizophrenia |
| NCT01529294 | CILO522D2401 | Ph 1 | completed | Single-dose Iloperidone Pharmacokinetics in Patients With Mild or Moderate Liver Disease, Compared to Healthy Volunteers |
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.
FANAPT FDA Label Details
Indications & Usage
FDA Label (PDF)FANAPT is indicated for the treatment of Schizophrenia; Bipolar I 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. FANAPT is not approved for the treatment of patients with dementia-related psychosis [see Warnings and...
FANAPT Patents & Exclusivity
Patents (8 active)
Exclusivity
Pro Intelligence Preview
Deep insights for FANAPT
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 392 active patents
Trial Analysis
- • 16 total trials
- • Stage: Declining
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.
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