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
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