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VHX-896

Phase 1

Healthy | Small molecule | Other |Vanda Pharmaceuticals Inc.|Last Updated: Jan 31, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment49

FDA Designations

No designations recorded

Clinical trial landscape

VHX-896 · 2 trials · 1 indication

Phase 1 2
NCT06803290Food Effect Study of VHX-896 in Healthy VolunteersHealthy
COMPLETED24 Analytics
NCT04969211Bioequivalence Study Between VHX-896 Tablets and Iloperidone Tablets in Healthy VolunteersHealthy
COMPLETED25 Analytics
PHASE1COMPLETED
Food Effect Study of VHX-896 in Healthy Volunteers
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study Between VHX-896 Tablets and Iloperidone Tablets in Healthy Volunteers
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Comparative bioavailability of VHX-tablets under fed versus fasted conditions.
96 Hours

As measured by plasma concentrations

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

as measured by plasma concentrations

Assessment of Safety and Tolerability of a single dose of VHX-896
17 days

As measured by the incidence of adverse events and clinically significant changes in laboratory values, ECG parameters, and vital signs

Secondary Endpoints

Assessment of safety and tolerability of single dose of VHX-896 tablets
17 Days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Sequence A: fed then fastedEXPERIMENTAL -
Sequence B: fasted then fedEXPERIMENTAL -
Sequence A: VHX-896 then iloperidoneEXPERIMENTAL -
Sequence B: Iloperidone then VHX-896EXPERIMENTAL -

Interventions

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

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female participants between 18 to 55 years (inclusive). * Have a Body Mass Index (BMI) of \> 18.0 and \< 30.0 kg/m2; (BMI = weight (kg)/ \[height (m)\]2). * Good health as determined by no clinically significant deviations from normal in medical history, cl...

Countries:United States
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Frequently asked questions about VHX-896

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.