New formulation of mental health drug tested for similarity to standard treatment
NCT ID NCT06494397
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested whether a new tablet called VHX-896 works the same as the standard drug iloperidone in 26 adults with schizophrenia or bipolar I disorder. Participants took both versions at different times to compare drug levels in the blood and check for side effects. The goal was to see if VHX-896 could be used as an alternative to iloperidone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- VHX-896 (a new formulation of iloperidone)
- What this could lead to
- If successful, this could show that VHX-896 works the same as iloperidone but may offer a different dosing option for patients.
- What could go wrong
- This is a small, early-phase study focused on drug levels, not on treating symptoms. It does not prove VHX-896 is better or safer than existing treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
26 people
The number who actually took part.
- Started
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Jul 2024
- Finished
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Oct 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 symptomatically stable and on a stable treatment with an oral atypical antipsychotic at an adequate dose (3 months prior to enrollment) and not suffer from acute increase of their psychosis or be hospitalized within the past 2 months Exclusion Criteria: * History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes * Cytochrome P450 2D6 (CYP2D6) poor metabolizers and use of prescription medication or OTC medication that strongly inhibits CYP2D6 or CYP3A4 or induces CYP3A4 within 5 half-lives of baseline
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Vanda Investigational Site
Los Alamitos, California, 90720, United States
-
Vanda Investigational Site
Gaithersburg, Maryland, 20877, United States
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Vanda Investigational Site
Marlton, New Jersey, 08053, United States
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Other studies related to the condition(s) this trial covers.
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