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A study to evaluate the effectiveness and safety of NBI-1117570 in adults with schizophrenia who require hospital treatment.

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study aims to evaluate the effectiveness and safety of the experimental drug NBI-1117570 in adults diagnosed with Schizophrenia, a mental health disorder that can affect how a person thinks, feels, and behaves. The research focuses on individuals who require inpatient hospitalization, which means staying in a hospital facility to receive constant care and supervision. Participants will be assigned to receive either NBI-1117570, which is administered in the form of an oral capsule, or a placebo.

The study is a randomized and double-blind trial, meaning that participants are assigned to groups by chance and neither the individuals nor the medical staff know which specific treatment is being given during the study period. This design helps ensure that the results are based on the actual effects of the medication. Researchers will observe how the medication affects the behavioral and psychological symptoms of the condition over time.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study participation

    The clinical trial involves the administration of either the test medication, nbi-1117570, or a placebo, which is an inactive substance that looks like the real medicine.

    The medication, provided in capsule form for oral use, is administered to assess its effects on schizophrenia, a mental health condition that affects how a person thinks, feels, and behaves.

  2. Step 2

    Symptom monitoring

    The effectiveness of the medication is monitored by measuring changes in the positive and negative syndrome scale (panss). this scale is a tool used to track the severity of schizophrenia symptoms.

Who can join the trial?

6 criteria

  • You must be between 18 and 55 years old.
  • Your main diagnosis must be schizophrenia, which is a long-term mental health condition, and this diagnosis must have been made at least 1 year before joining this study.
  • You must be experiencing an acute exacerbation, which means a sudden worsening or a sudden increase in the severity of your symptoms, or a relapse, which is a return of symptoms after a period of improvement.
  • These worsening symptoms must have started less than 2 months before your screening.
  • You must currently require inpatient hospitalization, meaning you need to stay in a hospital to receive care.
  • You must have had a positive response, meaning the treatment worked well for you, to at least one antipsychotic therapy (medicine used to manage symptoms of psychosis), excluding a specific medicine called clozapine, when treating a previous episode of worsening symptoms.

Who cannot join the trial?

14 criteria

  • People who are thought to be at immediate risk of suicide (attempting to end their own life) or harming themselves or other people.
  • Anyone with a history of epilepsy (a condition that causes repeated seizures), seizures (sudden electrical disturbances in the brain), or convulsions (uncontrollable shaking of the body).
  • People with orthostatic hypotension (a sudden drop in blood pressure when standing up).
  • People with a history of pulmonary hypertension (high blood pressure in the arteries of the lungs).
  • People with obstructive coronary artery disease (a condition where blood flow to the heart is partially blocked by buildup in the arteries).
  • People with hypertrophic cardiomyopathy (a condition where the heart muscle becomes abnormally thick).
  • People who have had a myocardial infarction (commonly known as a heart attack).
  • People who have undergone coronary artery revascularization (a procedure to improve blood flow to the heart, such as placing a stent or bypass surgery).
  • People with heart failure (a condition where the heart cannot pump blood effectively enough to meet the body's needs).
  • People with left ventricular hypertrophy (a thickening of the heart's main pumping chamber).
  • People with moderate or severe cardiac valvopathy (problems or diseases affecting the valves that control blood flow in the heart).
  • People with any other cardiovascular conditions (heart or blood vessel problems) that would make it unsafe to participate.
  • People who are currently taking prohibited medications (specific medicines that are not allowed during this study).
  • People who are pregnant or lactating (breastfeeding).
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Investigated drugs

NBI-1117570 is an experimental medication taken by mouth in capsule form that is being studied to see if it can help improve the behavior and mental symptoms in adults living with schizophrenia.

What is already known about the treatment

NBI-1117570 - This experimental medication is taken by mouth in the form of a capsule. It is currently being studied in clinical trials to see if it can help treat schizophrenia, a mental health condition. The drug works by targeting specific proteins in the brain to help balance chemical signals that influence mood and behavior. It is classified as an investigational antipsychotic medication.

Investigated diseases

Schizophrenia - This is a long-term mental health disorder that affects how a person thinks, feels, and behaves. It often involves a disconnection from reality, which can manifest as seeing or hearing things that are not there. People may also experience disorganized thinking or unusual belief systems. The symptoms can fluctuate in intensity over time. As the condition progresses, it can impact a person's ability to manage daily activities and social interactions.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521868-35-00Protocol codeNBI-1117570-SCZ2035Estimated enrolment197 patientsSponsorNeurocrine Biosciences Inc.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).