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VHX-896 and iloperidone

Phase 1

Schizophrenia | Small molecule | Psychiatry |Vanda Pharmaceuticals Inc.|Trials Updated: Sep 19, 2025

VHX-896 and iloperidone development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Jul 2021

VHX-896 and iloperidone target and mechanism

ModalitySmall molecule

Also known as VHX-896

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

VHX-896 and iloperidone clinical trials

VHX-896 and iloperidone · 1 trial · 2 indications

Phase 1 1
NCT06494397Pharmacokinetic Study of VHX-896 and Iloperidone Tablets Under Steady-State ConditionsSchizophrenia
COMPLETED26 Analytics
PHASE1COMPLETED
Pharmacokinetic Study of VHX-896 and Iloperidone Tablets Under Steady-State Conditions
SchizophreniaUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence between VHX-896 tablets relative to iloperidone tablets
12 hours

As measured by plasma concentrations

Secondary Endpoints

Assessment of safety and tolerability of VHX-896 and iloperidone
24 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Sequence A: VHX-896 then iloperidoneEXPERIMENTAL -
Sequence B: Iloperidone then VHX-896EXPERIMENTAL -

Interventions

NameTypeDescription
VHX-896 and iloperidoneDRUGoral tablet
Iloperidone and VHX-896DRUGoral tablet
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Male or female patients 18 to 65 years of age (inclusive) * Diagnosed with either schizophrenia or bipolar I disorder, manic or mixed type, according to the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition, Text Revision (DSM-5-TR) * Patients must be symptom...

Countries:United States
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Frequently asked questions about VHX-896 and iloperidone

What is VHX-896?

VHX-896 is an investigational small molecule being developed by Vanda Pharmaceuticals Inc. (ticker: VNDA) for schizophrenia. It is in Phase 1 clinical development. VHX-896 is also known as iloperidone. It has been studied in a single completed Phase 1 pharmacokinetic trial.

What is VHX-896 used for?

VHX-896 is being developed for the treatment of schizophrenia. The completed Phase 1 trial of VHX-896 also enrolled patients with Bipolar I Disorder. VHX-896 is investigational and has not been approved for any indication.

Who makes VHX-896?

VHX-896 is being developed by Vanda Pharmaceuticals Inc., which trades on the Nasdaq under the ticker symbol VNDA. Vanda is the sponsor of the clinical program for VHX-896.

What phase is VHX-896 in?

VHX-896 is in Phase 1 clinical development. One Phase 1 trial of VHX-896 has been completed, and no active trials are currently listed. VHX-896 is investigational and has not received FDA approval.

What clinical trials is VHX-896 in?

VHX-896 has been studied in one completed Phase 1 trial, NCT06494397, titled a Pharmacokinetic Study of VHX-896 and Iloperidone Tablets Under Steady-State Conditions. The trial enrolled 26 participants in the United States, was randomized and controlled, and included adults 18 years and older.

Is VHX-896 the same as iloperidone?

Yes, VHX-896 is also known as iloperidone. Vanda Pharmaceuticals Inc. is developing VHX-896, and the completed Phase 1 trial NCT06494397 studied VHX-896 and iloperidone tablets under steady-state conditions in 26 participants with schizophrenia or Bipolar I Disorder.