A Phase 3 interventional study of NBI-1117568 in Schizophrenia, sponsored by Neurocrine Biosciences. Recruiting at 61 sites in 5 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Neurocrine Biosciences · Phase 3, Interventional, and Treatment
This study will evaluate the long-term safety of NBI-1117568 in adults with schizophrenia.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 600 is above the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Neurocrine Biosciences is the lead sponsor of 86 studies on the registry; 16 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-specified inclusion/exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive NBI-1117568 once daily (QD) orally for up to 36 months.
Drug: NBI-1117568
NBI-1117568 will be administered per schedule specified in the arm description.
Number of Participants with Treatment-emergent Adverse Events
Time frame: Up to 36 months
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Started Jul 2025 (actual). Primary completion is estimated for Dec 2031, 77 months after the start.
Of 99 industry-sponsored phase 3 interventional studies under Schizophrenia, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 41. This study's planned 77 months is above that.
Counting every sponsor, half of 113 studies reached it within 32 months; a quarter within 20 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Direclidine