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VHX-896 and iloperidone

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

VHX-896 is an investigational small molecule being developed by Vanda Pharmaceuticals for use in schizophrenia and bipolar I disorder. It is currently in Phase 1 clinical development and has been studied in healthy volunteers as well as in patients with these conditions.

What does VHX-896 target?

VHX-896 is a small molecule being studied as a potential treatment for schizophrenia and bipolar I disorder. The specific molecular target has not been disclosed in available clinical trial information.

Who makes VHX-896?

VHX-896 is being developed by Vanda Pharmaceuticals Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol VNDA. The company is conducting Phase 1 clinical trials to evaluate the drug.

What phase is VHX-896 in?

VHX-896 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Three Phase 1 trials have been completed, with a total enrollment of 49 participants.

What clinical trials is VHX-896 in?

VHX-896 has completed three Phase 1 trials: NCT04969211, a bioequivalence study in healthy volunteers; NCT06494397, a pharmacokinetic study in schizophrenia and bipolar I disorder; and NCT06803290, a food effect study in healthy volunteers. All trials were conducted in the United States.

Is VHX-896 the same as iloperidone?

VHX-896 is being studied in comparison to iloperidone tablets in bioequivalence and pharmacokinetic trials. The studies evaluate how VHX-896 compares to iloperidone, but VHX-896 is a distinct investigational drug being developed by Vanda Pharmaceuticals.