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NCT07114874From ClinicalTrials.govRecruiting

NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With Schizophrenia

A Global, Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety and Tolerability of NBI-1117568 in Adults With Schizophrenia

  • Schizophrenia

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Neurocrine Biosciences
Enrolment target
600
Started
11 July 2025
Main results due
December 2031
Study sites
61
Registry updated
25 September 2026

Can you take part?

  • Ages 18 years to 65 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

This study will evaluate the long-term safety of NBI-1117568 in adults with schizophrenia.

Study sites(61)

  • Neurocrine Clinical Site

    Bryant, Arkansas, United States

    Recruiting

  • Neurocrine Clinical Site

    Little Rock, Arkansas, United States

    Recruiting

  • Neurocrine Clinical Site

    Cerritos, California, United States

    Recruiting

  • Neurocrine Clinical Site

    Chino, California, United States

    Recruiting

  • Neurocrine Clinical Site

    Culver City, California, United States

    Recruiting

  • Neurocrine Clinical Site

    Garden Grove, California, United States

    Recruiting

  • Neurocrine Clinical Site

    La Habra, California, United States

    Recruiting

  • Neurocrine Clinical Site

    Lemon Grove, California, United States

    Recruiting

  • Neurocrine Clinical Site

    Oceanside, California, United States

    Recruiting

  • Neurocrine Clinical Site

    Pico Rivera, California, United States

    Recruiting

  • Neurocrine Clinical Site

    Riverside, California, United States

    Recruiting

  • Neurocrine Clinical Site

    San Diego, California, United States

    Recruiting

  • Neurocrine Clinical Site

    Sherman, California, United States

    Recruiting

  • Neurocrine Clinical Site

    Torrance, California, United States

    Recruiting

  • Neurocrine Clinical Site

    West Hills, California, United States

    Completed

  • Neurocrine Clinical Site

    Atlantis, Florida, United States

    Recruiting

  • Neurocrine Clinical Site

    Aventura, Florida, United States

    Recruiting

  • Neurocrine Clinical Site

    Doral, Florida, United States

    Withdrawn

  • Neurocrine Clinical Site

    Hollywood, Florida, United States

    Recruiting

  • Neurocrine Clinical Site

    Maitland, Florida, United States

    Recruiting

  • Neurocrine Clinical Site

    Miami, Florida, United States

    Recruiting

  • Neurocrine Clinical Site

    Miami, Florida, United States

    Withdrawn

  • Neurocrine Clinical Site

    Miami Lakes, Florida, United States

    Recruiting

  • Neurocrine Clinical Site

    Tampa, Florida, United States

    Recruiting

  • Neurocrine Clinical Site

    West Palm Beach, Florida, United States

    Recruiting

  • Neurocrine Clinical Site

    Atlanta, Georgia, United States

    Recruiting

  • Neurocrine Clinical Site

    Atlanta, Georgia, United States

    Recruiting

  • Neurocrine Clinical Site

    Decatur, Georgia, United States

    Recruiting

  • Neurocrine Clinical Sites

    Peachtree Corners, Georgia, United States

    Recruiting

  • Neurocrine Clinical Site

    Chicago, Illinois, United States

    Recruiting

  • Neurocrine Clinical Site

    Oak Brook, Illinois, United States

    Recruiting

  • Neurocrine Clinical Site

    Gaithersburg, Maryland, United States

    Recruiting

  • Neurocrine Clinical Site

    Boston, Massachusetts, United States

    Recruiting

  • Neurocrine Clinical Site

    Watertown, Massachusetts, United States

    Recruiting

  • Neurocrine Clinical Site

    Flowood, Mississippi, United States

    Recruiting

  • Neurocrine Clinical Site

    St Louis, Missouri, United States

    Recruiting

  • Neurocrine Clinical Site

    Marlton, New Jersey, United States

    Recruiting

  • Neurocrine Clinical Site

    Cedarhurst, New York, United States

    Recruiting

  • Neurocrine Clinical Site

    New York, New York, United States

    Recruiting

  • Neurocrine Clinical Site

    New York, New York, United States

    Recruiting

  • Neurocrine Clincial Site

    Staten Island, New York, United States

    Recruiting

  • Neurocrine Clinical Sites

    The Bronx, New York, United States

    Recruiting

  • Neurocrine Clinical Sites

    North Canton, Ohio, United States

    Recruiting

  • Neurocrine Clinical Site

    Philadelphia, Pennsylvania, United States

    Recruiting

  • Neurocrine Clinical Site

    Austin, Texas, United States

    Recruiting

  • Neurocrine Clinical Site

    DeSoto, Texas, United States

    Recruiting

  • Neurocrine Clinical Site

    Houston, Texas, United States

    Recruiting

  • Neurocrine Clinical Sites

    Orem, Utah, United States

    Recruiting

  • Neurocrine Clinical Site

    Orem, Utah, United States

    Recruiting

  • Neurocrine Clinical Site

    Bellevue, Washington, United States

    Recruiting

  • Neurocrine Clinical Site

    Pleven, Bulgaria

    Recruiting

  • Neurocrine Clinical Site

    Veliko Tarnovo, Bulgaria

    Withdrawn

  • Neurocrine Clinical Site

    Vratsa, Bulgaria

    Recruiting

  • Neurocrine Clinical Site

    San Juan, Puerto Rico

    Recruiting

  • Neurocrine Clinical Site

    Brasov, Romania

    Recruiting

  • Neurocrine Clinical Site

    Bucharest, Romania

    Completed

  • Neurocrine Clinical Site

    Sânpetru, Romania

    Recruiting

  • Neurocrine Clinical Site

    Belgrade, Serbia

    Recruiting

  • Neurocrine Clinical Site

    Belgrade, Serbia

    Withdrawn

  • Neurocrine Clinical Site

    Gornja Toponica, Serbia

    Recruiting

Showing 60 of 61 sites — filter to narrow it down. 55 of the 61 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07114874. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With Schizophrenia | Trialion