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Fanapt (ILOPERIDONE)
Fanapt works by blocking the action of serotonin at the 5-hydroxytryptamine receptor 2A, which helps to reduce symptoms of schizophrenia.
Fanapt (Iloperidone) is a small molecule atypical antipsychotic medication developed by Vanda Pharms Inc, targeting the 5-hydroxytryptamine receptor 2A. It is FDA-approved for the treatment of schizophrenia. Fanapt is commercially available, with multiple generic manufacturers. Key safety considerations include the risk of orthostatic hypotension, somnolence, and QT interval prolongation. As an atypical antipsychotic, Fanapt offers a different side effect profile compared to typical antipsychotics.
At a glance
| Generic name | ILOPERIDONE |
|---|---|
| Sponsor | Vanda Pharms Inc |
| Drug class | Atypical Antipsychotic [EPC] |
| Target | 5-hydroxytryptamine receptor 2A |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2009 |
Mechanism of action
The mechanism of action of iloperidone in schizophrenia; is unknown. However the efficacy of iloperidone could be mediated through combination of dopamine type (D2) and serotonin type (5-HT2) antagonism. Iloperidone forms an active metabolite, P88, that has an in vitro receptor binding profile similar to the parent drug.
Approved indications
- Schizophrenia
Boxed warnings
- 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 )
Common side effects
- Dizziness
- Tachycardia
- Somnolence
- Dry Mouth
- Nausea
- Fatigue
- Orthostatic Hypotension
- Weight Increased
- Nasopharyngitis
- Diarrhea
- Abdominal Discomfort
- Upper Respiratory Tract Infection
Drug interactions
- High Risk QT Prolonging Agents
- atazanavir
- boceprevir
- clarithromycin
- cobicistat
- conivaptan
- indinavir
- itraconazole
- ketoconazole
- methadone
- mibefradil
- nefazodone
Key clinical trials
- Evaluation of Efficacy and Safety of Iloperidone for the Treatment of Participants With Uncontrolled Hypertension (PHASE2)
- Randomized Withdrawal Study in Patients With Schizophrenia (PHASE3)
- Pharmacokinetic Study of VHX-896 and Iloperidone Tablets Under Steady-State Conditions (PHASE1)
- A Study to Assess Stroke Risk Among Users of Typical Versus Atypical Antipsychotics Stratified by Broad Age Group
- Safety and Tolerability of Open-Labeled Iloperidone in Adolescents (PHASE4)
- Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia (PHASE3)
- Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder (PHASE3)
- A Study to Evaluate Iloperidone for the Treatment of Parkinson's Disease Psychosis (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |