NBI-1117568 for Schizophrenia

Recruiting at 22 trial locations

Overseen By Neurocrine Medical Information Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Neurocrine Biosciences

Must not be taking: Antipsychotics

Disqualifiers: Substance use disorder, Unstable condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 36 months

800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medication, NBI-1117568, to determine its safety for long-term use in individuals with schizophrenia. Schizophrenia is a mental health condition affecting thoughts, feelings, and behavior. Participants will take the medication daily for up to 36 months. Ideal candidates for this trial have a primary diagnosis of schizophrenia, live in stable housing, and can discontinue other antipsychotic medications. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the development of a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

Yes, if you are taking certain medications like antipsychotics, you must stop them before joining the study.

Is there any evidence suggesting that NBI-1117568 is likely to be safe for humans?

Research has shown that NBI-1117568 holds promise for treating schizophrenia. In an earlier study, patients taking NBI-1117568 experienced positive results, suggesting the treatment might be safe. Importantly, the data indicated that most participants tolerated it well.

While specific side effects were not listed, the study's progression to a later phase suggests that earlier safety tests were satisfactory. This phase focuses on long-term safety, indicating researchers' confidence in studying its effects over an extended period.

In summary, NBI-1117568 appears to be a promising treatment with a good safety record based on earlier studies. However, ongoing research will provide more information on its long-term use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for schizophrenia?

Unlike the standard treatments for schizophrenia, which often include antipsychotics like risperidone or olanzapine, NBI-1117568 offers a fresh approach. Researchers are excited about NBI-1117568 because it targets specific brain pathways differently, potentially reducing symptoms with fewer side effects. Additionally, its once-daily oral administration is convenient and could improve patient adherence. This new mechanism and delivery method could significantly enhance the quality of life for those affected by schizophrenia.

What evidence suggests that NBI-1117568 might be an effective treatment for schizophrenia?

Research has shown that NBI-1117568, which participants in this trial will receive, holds promise for treating schizophrenia. One study found that a 20 mg daily dose led to noticeable improvements in symptoms by the third week. Participants in earlier studies achieved better scores on a test measuring schizophrenia symptoms within six weeks. These results suggest that NBI-1117568 might be more effective and safer than some current antipsychotic medications. Initial findings offer hope for its potential benefits for people with schizophrenia. ^{1 3 5 6 7}

Who Is on the Research Team?

Clinical Development Lead

Principal Investigator

Neurocrine Biosciences

Are You a Good Fit for This Trial?

Adults with a primary diagnosis of schizophrenia can join this trial if they stop taking any prohibited medications before starting. They must live in stable housing and be able to follow the study rules. People with unstable health conditions, recent substance abuse (except nicotine or caffeine), positive drug screens, or risk of harm to self/others cannot participate.

Inclusion Criteria

I am not taking any medications that are not allowed in the study.

I have been diagnosed with schizophrenia.

Participant must reside in a stable housing situation

Exclusion Criteria

I have a history of not following clinical study rules well.

I have a chronic condition that is not well-managed.

Participant is considered by the investigator to be at imminent risk of suicide or injury to self or others

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NBI-1117568 once daily orally

36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NBI-1117568

Trial Overview The trial is testing the long-term safety of a medication called NBI-1117568 for adults with schizophrenia. It aims to understand how well people tolerate the drug over an extended period.

How Is the Trial Designed?

Group I: NBI-1117568 Experimental Treatment 1 Intervention

Participants will receive NBI-1117568 once daily (QD) orally for up to 36 months.

Who Is Running the Clinical Trial?

Neurocrine Biosciences

Lead Sponsor

Trials

78

Recruited

6,600+

Kyle W. Gano

Neurocrine Biosciences

Chief Executive Officer since 2024

PhD in Pharmacology

Dr. Sanjay Keswani

Neurocrine Biosciences

Chief Medical Officer

MD

Citations

1. neurocrine.gcs-web.com neurocrine.gcs-web.com/news-releases/news-release-details/neurocrine-biosciences-presents-new-positive-data-phase-2-study

Release Details - Neurocrine Biosciences The study showed statistically significant improvements in PANSS total score with 20 mg of NBI-1117568 once daily by Week 3 and at all ...

2. prnewswire.com prnewswire.com/news-releases/neurocrine-biosciences-presents-new-positive-data-from-phase-2-study-of-nbi-1117568-in-adults-with-schizophrenia-at-american-society-of-clinical-psychopharmacology-2025-302467554.html

Neurocrine Biosciences Presents New Positive Data from ... The primary endpoint was the change in total Positive and Negative Syndrome Scale (PANSS) score from baseline to Week 6. The study showed ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06963034?term=NCT06963034&rank=1

Evaluation of NBI-1117568 in Inpatient Adults With ... The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving behavioral and psychological symptoms of ...

4. psychiatrictimes.com psychiatrictimes.com/view/positive-phase-2-results-on-nbi-1117568-for-schizophrenia-presented-at-2025-ascp-annual-meeting

Positive Phase 2 Results on NBI-1117568 for ... NBI-1117568 showed significant symptom improvement in schizophrenia, particularly with the 20 mg dose, in a phase 2 study. The study ...

5. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/neurocrine-starts-phase-3-trial-of-nbi-1117568-for-schizophrenia/

Neurocrine Starts Phase 3 Trial of NBI-1117568 for ... The positive Phase 2 results suggest NBI-1117568 could offer improved efficacy and safety compared to existing antipsychotics, potentially ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07114874

Study Details | NCT07114874 | NBI-1117568-SCZ3032: ... Also called a data safety and monitoring board, or DSMB. ... This study will evaluate the long-term safety of NBI-1117568 in adults with schizophrenia.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05545111

Study Details | NCT05545111 | Efficacy, Safety, Tolerability ... ... Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization. Conditions. Schizophrenia.