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New hope for schizophrenia: valbenazine shows promise in phase 3 trial

NCT ID NCT05110157

Symptom relief Sponsor: Neurocrine Biosciences Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding valbenazine to standard antipsychotic medication helps reduce schizophrenia symptoms in adults who did not respond well to treatment alone. Over 400 participants took either valbenazine or a placebo for 10 weeks. Researchers measured changes in symptom severity, overall illness, and daily functioning.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

442 people

The number who actually took part.

Started

Nov 2021

Finished

Feb 2025

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 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: • Participants must meet all of the following inclusion criteria: 1. Completed written informed consent. 2. At the time of signing the informed consent, participant must be ≥18 years of age 3. Medically confirmed diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). 4. The initial diagnosis of schizophrenia must be ≥1 year before the screening visit. 5. Plasma levels for at least 1 of the participant's antipsychotic medications must be detectable by an available assay. 6. The participant is treated with a stable regimen antipsychotic medication. 7. Must meet all of the following criteria at the screening visit and Day 1: * PANSS total score ≥70 * PANSS score of ≥4 on at least 1 of the following: * P1 (delusions) * P3 (hallucinations) * P6 (suspiciousness) * G9 (unusual thought content) * CGI-S score ≥4 * Stable background antipsychotic medication dose between the screening visit and Day 1 * Stable PANSS total score between the screening visit and Day 1 8. The participant is outpatient with stable symptomatology 9. The participant must have an adult informant (for example, a family member, relative, partner, social worker, caseworker, residential facility staff, or nurse). 10. Female participants of childbearing potential must agree to use contraception consistently from the screening visit until 30 days after the last dose of study drug or final study visit, whichever is longer. 11. Male participants must agree to use contraception consistently from screening until 30 days after last dose of study treatment. Exclusion Criteria: * Participants will be excluded from the study if they meet any of the following criteria: 1. Pregnant or breastfeeding or plans to become pregnant during the study. This criterion must be reconfirmed prior to the first dose of study treatment on Day 1. 2. Known hypersensitivity to any component of the formulation of valbenazine. 3. Has history of treatment resistant schizophrenia. 4. Evidence of depression as measured by a Calgary Depression Scale for Schizophrenia (CDSS) score ≥11 at the screening visit or Day 1. 5. Participants with any suicidal behavior or suicidal ideation within 6 months before the screening visit or Day 1. 6. Diagnosis of moderate or severe substance use disorder within the 6 months before the screening visit. 7. Have a clinically significant unstable medical condition within 60 days before the screening visit in the judgement of the investigator or any laboratory value outside the normal range that is considered by the investigator to be clinically significant at the screening visit. 8. Prior (within 6 months of the screening visit) or concomitant use of any VMAT2 inhibitor.

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Conditions

The condition(s) this trial relates to.

schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Schizophrenia

Contacts and locations

Locations

  • Neurocrine Clinical Site

    Anaheim, California, 92805, United States

  • Neurocrine Clinical Site

    Bellflower, California, 90706, United States

  • Neurocrine Clinical Site

    Culver City, California, 90230, United States

  • Neurocrine Clinical Site

    Garden Grove, California, 92845, United States

  • Neurocrine Clinical Site

    Lemon Grove, California, 91945, United States

  • Neurocrine Clinical Site

    Long Beach, California, 90807, United States

  • Neurocrine Clinical Site

    Oceanside, California, 92056, United States

  • Neurocrine Clinical Site

    Pico Rivera, California, 90660, United States

  • Neurocrine Clinical Site

    Riverside, California, 92506, United States

  • Neurocrine Clinical Site

    San Diego, California, 92102, United States

  • Neurocrine Clinical Site

    San Diego, California, 92103, United States

  • Neurocrine Clinical Site

    San Jose, California, 95124, United States

  • Neurocrine Clinical Site

    Santa Ana, California, 92705, United States

  • Neurocrine Clinical Site

    Stanford, California, 94305, United States

  • Neurocrine Clinical Site

    Torrance, California, 90502, United States

  • Neurocrine Clinical Site

    Aventura, Florida, 33180, United States

  • Neurocrine Clinical Site

    Coral Gables, Florida, 33134, United States

  • Neurocrine Clinical Site

    Daytona Beach, Florida, 32114, United States

  • Neurocrine Clinical Site

    Hialeah, Florida, 33012, United States

  • Neurocrine Clinical Site

    Hialeah, Florida, 33013, United States

  • Neurocrine Clinical Site

    Hialeah, Florida, 33016, United States

  • Neurocrine Clinical Site

    Miami, Florida, 33133, United States

  • Neurocrine Clinical Site

    Miami, Florida, 33137, United States

  • Neurocrine Clinical Site

    Miami, Florida, 33144, United States

  • Neurocrine Clinical Site

    Miami Lakes, Florida, 33016, United States

  • Neurocrine Clinical Site

    Okeechobee, Florida, 34972, United States

  • Neurocrine Clinical Site

    Tampa, Florida, 33629, United States

  • Neurocrine Clinical Site

    West Palm Beach, Florida, 33407, United States

  • Neurocrine Clinical Site

    Atlanta, Georgia, 30328, United States

  • Neurocrine Clinical Site

    Evanston, Illinois, 60208, United States

  • Neurocrine Clinical Site

    Springfield, Illinois, 62702, United States

  • Neurocrine Clinical Site

    Grand Rapids, Michigan, 49503, United States

  • Neurocrine Clinical Site

    St Louis, Missouri, 63125, United States

  • Neurocrine Clinical Site

    St Louis, Missouri, 63128, United States

  • Neurocrine Clinical Site

    Lincoln, Nebraska, 68526, United States

  • Neurocrine Clinical Site

    Las Vegas, Nevada, 89102, United States

  • Neurocrine Clinical Site

    Cedarhurst, New York, 11516, United States

  • Neurocrine Clinical Site

    New York, New York, 10032, United States

  • Neurocrine Clinical Site

    New York, New York, 10035, United States

  • Neurocrine Clinical Site

    Charlotte, North Carolina, 28211, United States

  • Neurocrine Clinical Site

    Dayton, Ohio, 45417, United States

  • Neurocrine Clinical Site

    Oklahoma City, Oklahoma, 73112, United States

  • Neurocrine Clinical Site

    Austin, Texas, 78754, United States

  • Neurocrine Clinical Site

    Dallas, Texas, 75390, United States

  • Neurocrine Clinical Site

    DeSoto, Texas, 75115, United States

  • Neurocrine Clinical Site

    Houston, Texas, 77081, United States

  • Neurocrine Clinical Site

    Houston, Texas, 77090, United States

  • Neurocrine Clinical Site

    Buenos Aires, 1133, Argentina

  • Neurocrine Clinical Site

    Córdoba, 5004, Argentina

  • Neurocrine Clinical Site

    Kardzhali, 6600, Bulgaria

  • Neurocrine Clinical Site

    Lovech, 5500, Bulgaria

  • Neurocrine Clinical Site

    Plovdiv, 4002, Bulgaria

  • Neurocrine Clinical Site

    Plovdiv, 4004, Bulgaria

  • Neurocrine Clinical Site

    Rousse, 7003, Bulgaria

  • Neurocrine Clinical Site

    Sofia, 1113, Bulgaria

  • Neurocrine Clinical Site

    Sofia, 1408, Bulgaria

  • Neurocrine Clinical Site

    Sofia, 1510, Bulgaria

  • Neurocrine Clinical Site

    Sofia, 1680, Bulgaria

  • Neurocrine Clinical Site

    Veliko Tarnovo, 5000, Bulgaria

  • Neurocrine Clinical Site

    Vratsa, 3000, Bulgaria

  • Neurocrine Clinical Site

    Belgrade, 11108, Serbia

  • Neurocrine Clinical Site

    Gornja Toponica, 18202, Serbia

  • Neurocrine Clinical Site

    Niš, 18000, Serbia

  • Neurocrine Clinical Site

    Niš, 34000, Serbia

  • Neurocrine Clinical Site

    Novi Kneževac, 23330, Serbia

  • Neurocrine Clinical Site

    Vojvodina, 26300, Serbia

  • Neurocrine Clinical Site

    Vršac, 26300, Serbia

  • Neurocrine Clinical Site

    Phoenix, Arizona, 85012, United States

  • Neurocrine Clinical Site

    Rogers, Arkansas, 72758, United States

  • Neurocrine Clinical Site 1

    Pleven, 5800, Bulgaria

  • Neurocrine Clinical Site 1

    Plovdiv, 4000, Bulgaria

  • Neurocrine Clinical Site 1

    Sofia, 1000, Bulgaria

  • Neurocrine Clinical Site 1

    Belgrade, 11000, Serbia

  • Neurocrine Clinical Site 1

    Kovin, 26220, Serbia

  • Neurocrine Clinical Site 1

    Kragujevac, 34000, Serbia

  • Neurocrine Clinical Site 2

    Pleven, 5800, Bulgaria

  • Neurocrine Clinical Site 2

    Plovdiv, 4000, Bulgaria

  • Neurocrine Clinical Site 2

    Sofia, 1000, Bulgaria

  • Neurocrine Clinical Site 2

    Belgrade, 11000, Serbia

  • Neurocrine Clinical Site 2

    Kovin, 26220, Serbia

  • Neurocrine Clinical Site 2

    Kragujevac, 34000, Serbia

  • Neurocrine Clinical Site 3

    Belgrade, 11000, Serbia

  • Neurocrine Clinical Site 3

    Kragujevac, 34000, Serbia

  • Neurocrine Clinical Site 4

    Belgrade, 11000, Serbia

  • Neurocrine Clinical Site 5

    Belgrade, 11000, Serbia

  • Neurocrine Clinical Site 6

    Belgrade, 11000, Serbia

  • Neurocrine Clinical Sites

    Glen Oaks, New York, 11004, United States

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