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VHX-896 and iloperidone

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06494397Pharmacokinetic Study of VHX-896 and Iloperidone Tablets Under Steady-State ConditionsPHASE1 COMPLETED 26Jul 11, 2024Oct 24, 2024Sep 19, 20253 United States
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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 — 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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