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New schizophrenia pill aims to keep symptoms at bay

NCT ID NCT07227818

Disease control Sponsor: Neurocrine Biosciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether the experimental drug NBI-1117568 can delay relapse of schizophrenia symptoms compared to a placebo. About 560 adults with stable schizophrenia will first receive the drug openly, then be randomly assigned to continue it or switch to placebo. The main goal is to see how long it takes for symptoms to return.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NBI-1117568 (oral capsules)
What this could lead to
If successful, this could provide a new treatment option to help people with schizophrenia maintain stability and prevent symptom relapse.
What could go wrong
This is an early Phase 3 study, so results are not yet proven. The drug may not work better than placebo, and side effects are still being evaluated.

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

About 560 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jul 2029

An estimate. End dates often move.

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

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.

Key Inclusion Criteria: * Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria. * Participant had the initial diagnosis of schizophrenia ≥1 year before screening. * Participant has had a positive response to ≥1 antipsychotic therapy (other than clozapine) at a therapeutic dose. Key Exclusion Criteria: * Participant has an unstable or poorly controlled medical condition or chronic disease (including history of neurological \[including dementing illness, myasthenia gravis\], hepatic, renal, cardiovascular, gastrointestinal, pulmonary, autoimmune, or endocrine disease that may affect study participation or results) or malignancy within 30 days before Day 1. * Participant has any laboratory abnormalities suggestive of clinically significant, poorly managed, or unmanaged undiagnosed disease. * Participant has a history of clozapine treatment for treatment-resistant psychosis. * Participant has a history of a stay in a psychiatric inpatient facility for ≥30 consecutive days (other than for purely social reasons or due to participation in a different clinical trial) during the 90 days before screening. * Participant has initiated or increased intensity of nonpharmacological psychosocial therapeutic treatment within 3 weeks before screening or is expected to change throughout the length of the study. Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    20 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Neurocrine Clinical Site

    RECRUITING

    Garden Grove, California, 92845, United States

  • Neurocrine Clinical Site

    RECRUITING

    La Habra, California, 90631, United States

  • Neurocrine Clinical Site

    RECRUITING

    Lemon Grove, California, 91945, United States

  • Neurocrine Clinical Site

    RECRUITING

    Oceanside, California, 92056, United States

  • Neurocrine Clinical Site

    RECRUITING

    Torrance, California, 90504, United States

  • Neurocrine Clinical Site

    RECRUITING

    West Hills, California, 91307, United States

  • Neurocrine Clinical Site

    RECRUITING

    Hollywood, Florida, 33024, United States

  • Neurocrine Clinical Site

    RECRUITING

    Maitland, Florida, 32751, United States

  • Neurocrine Clinical Site

    RECRUITING

    Miami, Florida, 33122, United States

  • Neurocrine Clinical Site

    RECRUITING

    Miami, Florida, 33155, United States

  • Neurocrine Clinical Site

    RECRUITING

    Tampa, Florida, 33629, United States

  • Neurocrine Clinical Site

    RECRUITING

    West Palm Beach, Florida, 33024, United States

  • Neurocrine Clinical Site

    RECRUITING

    Atlanta, Georgia, 30318, United States

  • Neurocrine Clinical Site

    RECRUITING

    Boston, Massachusetts, 02116, United States

  • Neurocrine Clinical Site

    RECRUITING

    Flowood, Mississippi, 39232, United States

  • Neurocrine Clinical Site

    RECRUITING

    Cedarhurst, New York, 11516, United States

  • Neurocrine Clinical Site

    RECRUITING

    New York, New York, 10029, United States

  • Neurocrine Clinical Site

    RECRUITING

    New York, New York, 10036, United States

  • Neurocrine Clinical Site

    RECRUITING

    The Bronx, New York, 10461, United States

  • Neurocrine Clinical Site

    RECRUITING

    Bellevue, Washington, 98007, United States

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