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New schizophrenia drug tested for Long-Term safety in major trial

NCT ID NCT07114874

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial is testing the long-term safety of the drug NBI-1117568 in 600 adults with schizophrenia. Participants will receive the drug and be monitored for side effects over time. The study is open-label, meaning everyone knows they are getting the drug, and it focuses on safety rather than how well the drug works.

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
What this could lead to
If successful, this could provide a new long-term treatment option for schizophrenia with a favorable safety profile.
What could go wrong
This is an open-label study focused on safety, not efficacy. The drug may still have side effects or fail to control symptoms long-term.

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 600 people

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

Started

Jul 2025

Expected to finish

Dec 2031

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 * Participants taking prohibited medications, including antipsychotics, must discontinue before study participation * Participant must reside in a stable housing situation Key Exclusion Criteria: * Participant has known hypersensitivity to any component of the formulation of NBI-1117568 * Participant has an unstable or poorly controlled medical condition or chronic disease * Participant is considered by the investigator to be at imminent risk of suicide or injury to self or others * Participant has a diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening * Participant has a positive alcohol test or drug screen for disallowed substances * Participant has a history of poor or suspected poor compliance in clinical research studies and/or in the investigator's opinion, the participant is not capable of adhering to the protocol requirements. Note: Other protocol-specified inclusion/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

    56 sites in 4 countries. 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 Clincial Site

    RECRUITING

    Staten Island, New York, 10314, United States

  • Neurocrine Clinical Site

    RECRUITING

    Bryant, Arkansas, 72022, United States

  • Neurocrine Clinical Site

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Neurocrine Clinical Site

    RECRUITING

    Cerritos, California, 90703, United States

  • Neurocrine Clinical Site

    RECRUITING

    Chino, California, 91710, United States

  • Neurocrine Clinical Site

    RECRUITING

    Culver City, California, 90230, United States

  • 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

    Pico Rivera, California, 90660, United States

  • Neurocrine Clinical Site

    RECRUITING

    Riverside, California, 92506, United States

  • Neurocrine Clinical Site

    RECRUITING

    San Diego, California, 92123, United States

  • Neurocrine Clinical Site

    RECRUITING

    Sherman, California, 91403, 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

    Atlantis, Florida, 30328, United States

  • Neurocrine Clinical Site

    RECRUITING

    Aventura, Florida, 33108, United States

  • Neurocrine Clinical Site

    RECRUITING

    Doral, Florida, 33178, 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

    Miami Lakes, Florida, 33016, United States

  • Neurocrine Clinical Site

    RECRUITING

    Tampa, Florida, 33629, United States

  • Neurocrine Clinical Site

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • Neurocrine Clinical Site

    RECRUITING

    Atlanta, Georgia, 30328, United States

  • Neurocrine Clinical Site

    RECRUITING

    Atlanta, Georgia, 30331, United States

  • Neurocrine Clinical Site

    RECRUITING

    Decatur, Georgia, 30030, United States

  • Neurocrine Clinical Site

    RECRUITING

    Chicago, Illinois, 60640, United States

  • Neurocrine Clinical Site

    RECRUITING

    Gaithersburg, Maryland, 20877, United States

  • Neurocrine Clinical Site

    RECRUITING

    Boston, Massachusetts, 02116, United States

  • Neurocrine Clinical Site

    RECRUITING

    Watertown, Massachusetts, 02472, United States

  • Neurocrine Clinical Site

    RECRUITING

    Flowood, Mississippi, 39232, United States

  • Neurocrine Clinical Site

    RECRUITING

    St Louis, Missouri, 63141, United States

  • Neurocrine Clinical Site

    RECRUITING

    Marlton, New Jersey, 08053, 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

    Philadelphia, Pennsylvania, 19104, United States

  • Neurocrine Clinical Site

    RECRUITING

    Austin, Texas, 78754, United States

  • Neurocrine Clinical Site

    RECRUITING

    DeSoto, Texas, 75115, United States

  • Neurocrine Clinical Site

    RECRUITING

    Houston, Texas, 77043, United States

  • Neurocrine Clinical Site

    RECRUITING

    Orem, Utah, 84058, United States

  • Neurocrine Clinical Site

    RECRUITING

    Bellevue, Washington, 98007, United States

  • Neurocrine Clinical Site

    WITHDRAWN

    Veliko Tarnovo, 5047, Bulgaria

  • Neurocrine Clinical Site

    RECRUITING

    Vratsa, 5047, Bulgaria

  • Neurocrine Clinical Site

    RECRUITING

    Brasov, 500123, Romania

  • Neurocrine Clinical Site

    RECRUITING

    Bucharest, 41914, Romania

  • Neurocrine Clinical Site

    RECRUITING

    Sânpetru, 507190, Romania

  • Neurocrine Clinical Site

    RECRUITING

    Belgrade, 11000, Serbia

  • Neurocrine Clinical Site

    RECRUITING

    Gornja Toponica, 18202, Serbia

  • Neurocrine Clinical Site

    RECRUITING

    Kragujevac, 34000, Serbia

  • Neurocrine Clinical Sites

    RECRUITING

    Peachtree Corners, Georgia, 30071, United States

  • Neurocrine Clinical Sites

    RECRUITING

    The Bronx, New York, 10461, United States

  • Neurocrine Clinical Sites

    RECRUITING

    North Canton, Ohio, 44720, United States

  • Neurocrine Clinical Sites

    RECRUITING

    Orem, Utah, 84058, United States

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