drug
as of 2026-07-01Iloperidone
VHX-896 and iloperidoneIloperidone and VHX-896iloperidone (oral tablet)Iloperidone crystalline formulationIloperidone microparticle formulationOral iloperidoneiloperidone
UNII VPO7KJ050NRxCUI 848722, 848726, 848728, 848730, 848732, 848734FDA_ApplNo NDA022192SPL_set_id 33f60b40-3fca-11de-8f56-0002a5d5c51bFDA_sponsor VANDA PHARMS INCOrangeBook_Appl A206890, A207098, A207231, N022192
at a glance
small molecule · Atypical Antipsychotic [EPC]
US-approved (2009) as FANAPT
Developed by Vanda Pharmaceuticals
Orange Book protection to 2031
14 trials in the graph
Synthesized from structured facts only — each point cited above.
Mechanism & identity
Modality
small molecule
FDA class
Atypical Antipsychotic [EPC]
Mechanism of action
12.1 Mechanism of Action The mechanism of action of iloperidone in schizophrenia and bipolar I disorder is unknown. However, the efficacy of iloperidone could be mediated through a combination of dopamine type 2 (D 2 ) and serotonin type 2 (5-HT 2 ) antagonism. Iloperidone forms an active metabolite, P88, that has an in vitro receptor binding profile similar to the parent drug.
Indications
Labeled
SchizophreniaBipolar depressionBipolar mania
Patents & exclusivity
Orange Book
patent 9074254 · U-16742031-12-28
patent 9074256 · U-16742031-02-10
patent 9072742 · U-16742031-01-16
patent 9074255 · U-16742030-12-17
patent 8999638 · U-16742030-10-28
patent 12606869 · U-45042030-09-22
patent 8652776 · U-16852030-08-31
patent 9157121 · U-16742030-04-05
patent 8586610 · U-16252027-11-02
exclusivity I-9392027-04-02
Adverse-event signal
FAERS spontaneous · within-drug share
Eps Akathisia6.6%
top term: DYSKINESIA
Sedation5.7%
top term: FATIGUE
Gi4.1%
top term: NAUSEA
Qt Cardiac3.2%
top term: TACHYCARDIA
Orthostatic2.9%
top term: ORTHOSTATIC HYPOTENSION
Weight Metabolic2.8%
top term: WEIGHT INCREASED
Anticholinergic2.5%
top term: DRY MOUTH
Mortality0.9%
top term: DEATH
Prolactin0.4%
top term: BLOOD PROLACTIN INCREASED
Spontaneous reports — a signal of reporting share, not incidence.
Trials
14
Randomized Withdrawal Study in Patients With Schizophrenia
NCT06961968Phase 3Recruiting
Safety and Tolerability of Open-Labeled Iloperidone in Adolescents
NCT05648591Phase 4Recruiting
Pharmacokinetic Study of VHX-896 and Iloperidone Tablets Under Steady-State Conditions
NCT06494397Phase 1Completed
A Study to Evaluate Iloperidone Long-acting Injection (LAI) for the Treatment of Schizophrenia
NCT04712734Phase 1Completed
Evaluating a New Iloperidone Titration Scheme in Bipolar I Disorder or Schizophrenia
NCT04127058Phase 1Completed
Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)
NCT02600741—Completed
Risperidone-controlled,Multicentre Clinical Trial of Iloperidone in Patients With Schizophrenia
NCT02453893Phase 3Unknown
Tolerability and Pharmacokinetics of Iloperidone in Adolescent Patients
NCT01495169Phase 1Completed
Relapse Prevention Study in Patients With Schizophrenia
NCT01291511Phase 3Completed
Assessing the Effects of Fanapt® on Social Cognition in Schizophrenia
NCT01929889Phase 4Terminated
Efficacy and Safety Study of Iloperidone Virus Risperidone to Treat Schizophrenia
NCT01623713Phase 2Completed
Safety, Tolerability, and Pharmacokinetics of Iloperidone Depot in Schizophrenic Patients
NCT01348100Phase 1, Phase 2Completed
Switching to Iloperidone From Other Antipsychotics in Schizophrenia
NCT01207414Phase 4Completed
KOLs & investigators
3
Facts & assertions
28 sourced
Anda Generic Count
21
Boxed Warning
present
Dosing Frequency
twice daily
Faers Share Anticholinergic
0.025
Faers Share Eps Akathisia
0.066
Faers Share Gi
0.041
Faers Share Mortality
0.01
Faers Share Orthostatic
0.03
Faers Share Prolactin
0.004
Faers Share Qt Cardiac
0.032
Faers Share Sedation
0.057
Faers Share Weight Metabolic
0.028
Fda Pharm Class Epc
Atypical Antipsychotic [EPC]
Has Generic Competition
yes
Latest Exclusivity Expiry
2027-04-02
Latest Patent Expiry
2031-12-28
Latest Protection Date
2031-12-28
Mechanism Of Action
12.1 Mechanism of Action The mechanism of action of iloperidone in schizophrenia and bipolar I disorder is unknown. However, the efficacy of iloperidone could be mediated through a combination of dopamine type 2 (D 2 ) and serotonin type 2 (5-HT 2 ) antagonism. Iloperidone forms an active metabolite
Originator Company
Vanda Pharms Inc
Safety Eps Akathisia
present in label
Safety Nms
present in label
Safety Orthostatic
present in label
Safety Prolactin
present in label
Safety Qt Prolongation
present in label
Safety Sedation Somnolence
present in label
Safety Weight Metabolic
present in label
Us Approved
yes
Us Original Approval Date
2009-05-06
relationships
The graph out of here
developer
company
trial
indication
indication
indication
indication
indication
KOL
John G Csernansky, MD
personKOL score 5
Li hua fang, Ph.D
personKOL score —
Marla Hochfeld, MD, MD
personKOL score —