NBI-1117568 for Schizophrenia

Recruiting at 17 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

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: 5 weeks

284 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, NBI-1117568, to determine its effectiveness on the behavioral and psychological symptoms of schizophrenia. Participants will receive either the actual treatment or a placebo (a pill with no active medication) to compare results over five weeks. The trial suits adults with schizophrenia experiencing a flare-up of symptoms who require hospitalization. Participants should not take certain medications and must remain in an inpatient setting during the trial. As a Phase 3 trial, this treatment is in the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking therapy.

Will I have to stop taking my current medications?

Yes, if you are taking antipsychotic medications or other prohibited drugs, you will need to stop them before joining the study.

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

A previous study found NBI-1117568 to be safe for treating adults with schizophrenia. Most patients tolerated the medication well, with only a few experiencing mild side effects that did not require stopping the treatment.

Another study is examining the long-term safety of NBI-1117568 in adults with schizophrenia. This ongoing research aims to confirm the medication's continued safety over time. Earlier studies suggest that this treatment is generally safe for people.

Since this trial is in a later phase, earlier tests have shown it is safe enough to continue studying its benefits. This provides a reasonable level of confidence in its safety for those considering joining the trial. ^{1 2 3 4 5}

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

Unlike the standard schizophrenia treatments that typically focus on adjusting neurotransmitter levels, NBI-1117568 is unique because it potentially targets a novel pathway related to the condition. This new approach might offer benefits for patients who do not respond well to traditional therapies like antipsychotics. Researchers are excited about NBI-1117568 because its innovative mechanism has the potential to improve symptoms more effectively and with fewer side effects compared to existing treatments.

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

Research has shown that NBI-1117568, which participants in this trial may receive, may help treat schizophrenia. In an earlier study, patients who took 20 mg of NBI-1117568 daily experienced significant symptom improvements by the third week. The treatment led to a noticeable drop in scores on a scale measuring schizophrenia symptoms, such as hallucinations and emotional withdrawal. These results suggest that NBI-1117568 could be more effective and safer than current antipsychotic treatments. The positive findings from earlier studies provide a strong reason to test its effectiveness further in this trial. ^{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?

This trial is for adults with a primary diagnosis of schizophrenia who are currently experiencing an acute exacerbation or relapse that requires hospitalization. Participants must be willing to stay inpatient and follow study procedures, and they can't be on prohibited medications like antipsychotics at the start.

Inclusion Criteria

I have been diagnosed with schizophrenia.

I am currently having a severe flare-up of my condition that requires hospitalization.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either NBI-1117568 or placebo once daily orally for 5 weeks

5 weeks

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 NBI-1117568's effectiveness compared to a placebo in improving symptoms of schizophrenia. Patients will either receive the experimental drug or a placebo while staying as inpatients during the study period.

How Is the Trial Designed?

Group I: NBI-1117568 Experimental Treatment 1 Intervention

Participants will receive NBI-1117568 once daily (QD) orally from Day 1 to Day 35 for a total of 5 weeks.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive matching placebo QD orally from Day 1 to Day 35 for a total of 5 weeks.

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.