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New schizophrenia drug aims to calm severe symptoms in hospitalized patients

NCT ID NCT07105098

Disease control Sponsor: Neurocrine Biosciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tests whether a new drug called NBI-1117568 can improve schizophrenia symptoms like hallucinations and disorganized thinking. About 284 adults with schizophrenia who need hospital care will receive either the drug or a placebo for 5 weeks. The study measures symptom changes using a standard rating scale.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NBI-1117568
What this could lead to
If successful, this could provide a new treatment option for managing schizophrenia symptoms, potentially reducing hospital stays.
What could go wrong
This is an early Phase 3 trial with only 284 participants. The drug may not work better than placebo, and side effects are unknown. Results may not apply to all schizophrenia patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 284 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Participant has a primary diagnosis of schizophrenia * Participant is experiencing an acute exacerbation or relapse of symptoms and currently warrants hospitalization. * Participants taking prohibited medications, including antipsychotics, must discontinue before study participation * Participant is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements 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.

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Conditions

The condition(s) this trial relates to.

schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Schizophrenia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    14 sites in 5 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Neurocrine Clinical Site

    RECRUITING

    Culver City, California, 90230, United States

  • Neurocrine Clinical Site

    RECRUITING

    Garden Grove, California, 92845, United States

  • Neurocrine Clinical Site

    RECRUITING

    Riverside, California, 92506, United States

  • Neurocrine Clinical Site

    RECRUITING

    Atlanta, Georgia, 30328, United States

  • Neurocrine Clinical Site

    RECRUITING

    North Canton, Ohio, 44720, United States

  • Neurocrine Clinical Site

    RECRUITING

    Sliven, 8800, Bulgaria

  • Neurocrine Clinical Site

    WITHDRAWN

    Veliko Tarnovo, 5047, Bulgaria

  • Neurocrine Clinical Site

    RECRUITING

    Vratsa, 3001, Bulgaria

  • Neurocrine Clinical Site

    RECRUITING

    Győr, 9024, Hungary

  • Neurocrine Clinical Site

    RECRUITING

    Brasov, 500123, Romania

  • Neurocrine Clinical Site

    RECRUITING

    Brasov, 507190, Romania

  • Neurocrine Clinical Site

    RECRUITING

    Bucharest, 41914, Romania

  • Neurocrine Clinical Site

    RECRUITING

    Belgrade, 11000, Serbia

  • Neurocrine Clinical Site

    RECRUITING

    Gornja Toponica, 18202, Serbia

  • Neurocrine Clinical Site

    RECRUITING

    Kragujevac, 34000, Serbia

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