SchizophreniaPhase 3NCT07114874
NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With Schizophrenia
A Phase 3 study testing NBI-1117568 in people with Schizophrenia, run by Neurocrine Biosciences at 61 sites in 5 countries.
Trial summary
This study will evaluate the long-term safety of NBI-1117568 in adults with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- NBI-1117568
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 61 sitesin 5 countries
- Study dates
- 11 Jul 2025to Dec 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
61 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
61 sites in 5 countries
United States50 sites, 47 recruiting
- Recruiting
Neurocrine Clinical Site
Atlanta, Georgia, 30328
- Recruiting
Neurocrine Clinical Site
Atlanta, Georgia, 30331
- Recruiting
Neurocrine Clinical Site
Atlantis, Florida, 30328
- Recruiting
Neurocrine Clinical Site
Austin, Texas, 78754
- Recruiting
Neurocrine Clinical Site
Aventura, Florida, 33108
- Recruiting
Neurocrine Clinical Site
Bellevue, Washington, 98007
- Recruiting
Neurocrine Clinical Site
Boston, Massachusetts, 02116
- Recruiting
Neurocrine Clinical Site
Bryant, Arkansas, 72022
- Recruiting
Neurocrine Clinical Site
Cedarhurst, New York, 11516
- Recruiting
Neurocrine Clinical Site
Cerritos, California, 90703
- Recruiting
Neurocrine Clinical Site
Chicago, Illinois, 60640
- Recruiting
Neurocrine Clinical Site
Chino, California, 91710
- Recruiting
Neurocrine Clinical Site
Culver City, California, 90230
- Recruiting
Neurocrine Clinical Site
Decatur, Georgia, 30030
- Recruiting
Neurocrine Clinical Site
DeSoto, Texas, 75115
- Withdrawn
Neurocrine Clinical Site
Doral, Florida, 33178
- Recruiting
Neurocrine Clinical Site
Flowood, Mississippi, 39232
- Recruiting
Neurocrine Clinical Site
Gaithersburg, Maryland, 20877
- Recruiting
Neurocrine Clinical Site
Garden Grove, California, 92845
- Recruiting
Neurocrine Clinical Site
Hollywood, Florida, 33024
- Recruiting
Neurocrine Clinical Site
Houston, Texas, 77043
- Recruiting
Neurocrine Clinical Site
La Habra, California, 90631
- Recruiting
Neurocrine Clinical Site
Lemon Grove, California, 91945
- Recruiting
Neurocrine Clinical Site
Little Rock, Arkansas, 72211
- Recruiting
Neurocrine Clinical Site
Maitland, Florida, 32751
- Recruiting
Neurocrine Clinical Site
Marlton, New Jersey, 08053
- Recruiting
Neurocrine Clinical Site
Miami, Florida, 33122
- Withdrawn
Neurocrine Clinical Site
Miami, Florida, 33155
- Recruiting
Neurocrine Clinical Site
Miami Lakes, Florida, 33016
- Recruiting
Neurocrine Clinical Site
New York, New York, 10029
- Recruiting
Neurocrine Clinical Site
New York, New York, 10036
- Recruiting
Neurocrine Clinical Sites
North Canton, Ohio, 44720
- Recruiting
Neurocrine Clinical Site
Oak Brook, Illinois, 60523
- Recruiting
Neurocrine Clinical Site
Oceanside, California, 92056
- Recruiting
Neurocrine Clinical Sites
Orem, Utah, 84058
- Recruiting
Neurocrine Clinical Site
Orem, Utah, 84058
- Recruiting
Neurocrine Clinical Sites
Peachtree Corners, Georgia, 30071
- Recruiting
Neurocrine Clinical Site
Philadelphia, Pennsylvania, 19104
- Recruiting
Neurocrine Clinical Site
Pico Rivera, California, 90660
- Recruiting
Neurocrine Clinical Site
Riverside, California, 92506
- Recruiting
Neurocrine Clinical Site
San Diego, California, 92123
- Recruiting
Neurocrine Clinical Site
Sherman, California, 91403
- Recruiting
Neurocrine Clinical Site
St Louis, Missouri, 63141
- Recruiting
Neurocrine Clincial Site
Staten Island, New York, 10314
- Recruiting
Neurocrine Clinical Site
Tampa, Florida, 33629
- Recruiting
Neurocrine Clinical Sites
The Bronx, New York, 10461
- Recruiting
Neurocrine Clinical Site
Torrance, California, 90504
- Recruiting
Neurocrine Clinical Site
Watertown, Massachusetts, 02472
- Completed
Neurocrine Clinical Site
West Hills, California, 91307
- Recruiting
Neurocrine Clinical Site
West Palm Beach, Florida, 33407
Serbia4 sites, 3 recruiting
- Recruiting
Neurocrine Clinical Site
Belgrade, 11000
- Withdrawn
Neurocrine Clinical Site
Belgrade, 11000
- Recruiting
Neurocrine Clinical Site
Gornja Toponica, 18202
- Recruiting
Neurocrine Clinical Site
Kragujevac, 34000
Bulgaria3 sites, 2 recruiting
- Recruiting
Neurocrine Clinical Site
Pleven, 5802
- Withdrawn
Neurocrine Clinical Site
Veliko Tarnovo, 5047
- Recruiting
Neurocrine Clinical Site
Vratsa, 5047
Romania3 sites, 2 recruiting
- Recruiting
Neurocrine Clinical Site
Brasov, 500123
- Completed
Neurocrine Clinical Site
Bucharest, 41914
- Recruiting
Neurocrine Clinical Site
Sânpetru, 507190
Puerto Rico1 site, 1 recruiting
- Recruiting
Neurocrine Clinical Site
San Juan, 00981
About this study
Official title: A Global, Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety and Tolerability of NBI-1117568 in Adults With Schizophrenia
This study will evaluate the long-term safety of NBI-1117568 in adults with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- NBI-1117568
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBI-1117568Drug
NBI-1117568 will be administered per schedule specified in the arm description.
| Study group | Role | What they receive |
|---|---|---|
| NBI-1117568 | Experimental | Participants will receive NBI-1117568 once daily (QD) orally for up to 36 months. Receives: Drug: NBI-1117568 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-emergent Adverse Events
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start11 Jul 2025
- Primary completionDec 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Neurocrine BiosciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurocrine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Lead, Study director, Neurocrine Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114874
- Sponsor's protocol ID
- NBI-1117568-SCZ3032
- Other IDs
- 2025-521216-19-00, 2025
- Status last verified
- Sep 2026
- First submitted
- 29 Jul 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Global, Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety and Tolerability of NBI-1117568 in Adults With Schizophrenia
- ClinicalTrials.gov ID
- NCT07114874
- Acronym / sponsor ID
- NBI-1117568-SCZ3032
- Conditions
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Neurocrine BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the long-term safety of NBI-1117568 in adults with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NBI-1117568 | Experimental | Drug: NBI-1117568Participants will receive NBI-1117568 once daily (QD) orally for up to 36 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NBI-1117568NBI-1117568 will be administered per schedule specified in the arm description. | Drug | NBI-1117568 |
Primary outcome
Number of Participants with Treatment-emergent Adverse Events
Time frame: Up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Development Lead study director
Neurocrine Biosciences
61 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NBI-1117568 in people with Schizophrenia, run by Neurocrine Biosciences at 61 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, Serbia, Bulgaria, Romania, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neurocrine Medical Information Call Center (877-641-3461, medinfo@neurocrine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-emergent Adverse Events (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.