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Long-term treatment with NBI-1117568 for 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

Phase 3 Interventional Neurocrine Biosciences · NCT07114874

This trial tests whether long-term treatment with NBI-1117568 is safe for adults living with schizophrenia.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment800 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorNeurocrine Biosciences Industry-sponsored
Locations53 sites (Bryant, Arkansas and 52 other locations)
Trial IDNCT07114874 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial administers NBI-1117568 to adults with a primary diagnosis of schizophrenia and follows them over an extended period to monitor safety. Participants must discontinue prohibited medications, including other antipsychotics, and live in a stable housing situation. Key exclusions include known hypersensitivity to the drug, unstable medical conditions, recent moderate-to-severe substance use disorder, positive disallowed drug/alcohol screens, imminent suicide risk, or inability to comply with study procedures. Safety monitoring will include regular clinical assessments and adverse event reporting at Neurocrine clinical sites in Arkansas and California.

Who should consider this trial

Good fit: Adults with a primary diagnosis of schizophrenia who can stop prohibited medications, maintain stable housing, and comply with study visits are the intended participants.

Not a fit: Patients with unstable medical conditions, recent moderate or severe substance use disorder, known hypersensitivity to the drug, imminent suicide risk, or inability to adhere to procedures are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could establish that NBI-1117568 is a safe long-term treatment option for adults with schizophrenia.

How similar studies have performed: Advancement to Phase 3 implies earlier-phase data showed enough safety or efficacy signal to continue, but long-term safety for this compound has not yet been confirmed publicly.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Bryant, Arkansas and 52 other locations

+3 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Schizophrenia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.