57 completed, 14 recruiting, 10 terminated, 4 not yet recruiting. 38 Phase 2, 23 Phase 1, 22 Phase 3, 5 Phase 4, 1 Not applicable.
By phase and status
| Phase | Trials | Status |
|---|
| Phase 2 | 38 | Completed 24, Terminated 7, Recruiting 4, Not yet recruiting 3 |
| Phase 1 | 23 | Completed 20, Withdrawn 2, Terminated 1 |
| Phase 3 | 22 | Recruiting 9, Completed 7, Active not recruiting 2, Terminated 2, Enrolling by invitation 1, Withdrawn 1 |
| Phase 4 | 5 | Completed 3, Recruiting 1, Withdrawn 1 |
| Not applicable | 1 | Completed 1 |
Follow this sponsor
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
Development of Healthcare Transition for Patients With Congenital Adrenal Hyperplasia exposure to healthcare transition protocol - Congenital Adrenal Hyperplasia | | Not yet recruiting | University of Alabama at Birmingham | 40 | 2027-01-01 | 2026-10-14 |
Efficacy, Safety, Tolerability, and Pharmacokinetics of NBIP-01435 in Adult Participants With Classic Congenital Adrenal Hyperplasia (CAH) NBIP-01435 - Congenital Adrenal Hyperplasia | Phase 2 | Not yet recruiting | Neurocrine Biosciences | 36 | 2026-12-01 | 2026-09-30 |
Evaluation of NBI-1117567 in Participants With Mild to Moderate Alzheimer's Disease (AD) Taking a Background Acetylcholinesterase Inhibitor NBI-1117567, Placebo - Alzheimer's Disease | Phase 2 | Not yet recruiting | Neurocrine Biosciences | 135 | 2026-10-01 | 2026-09-22 |
Valbenazine in Obsessive Compulsive Disorder Valbenazine, Placebo - Obsessive-Compulsive Disorder | Phase 2 | Not yet recruiting | University of Chicago | 30 | 2026-06-01 | 2026-06-10 |
Evaluation of NBI-1117570 in Inpatient Adults With Schizophrenia NBI-1117570, Placebo - Schizophrenia | Phase 2 | Recruiting | Neurocrine Biosciences | 120 | 2026-02-16 | 2026-07-22 |
Efficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive Dyskinesia NBI-1065890, Placebo - Tardive Dyskinesia | Phase 2 | Recruiting | Neurocrine Biosciences | 100 | 2026-02-06 | 2026-06-23 |
An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania NBI-1117568, Placebo - Bipolar I Disorder, Mania | Phase 2 | Recruiting | Neurocrine Biosciences | 150 | 2025-12-24 | 2026-09-29 |
Efficacy of NBI-1117568 in Preventing Relapse in Adults With Schizophrenia NBI-1117568, Placebo - Schizophrenia | Phase 3 | Recruiting | Neurocrine Biosciences | 560 | 2025-12-16 | 2026-09-25 |
A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor Valbenazine - Schizophrenia, Schizoaffective Disorder | Phase 4 | Recruiting | Neurocrine Biosciences | 100 | 2025-08-29 | 2026-09-18 |
A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD) NBI-1065845, Placebo - Major Depressive Disorder | Phase 3 | Recruiting | Neurocrine Biosciences | 550 | 2025-08-18 | 2026-07-24 |
NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia NBI-1117568, Placebo - Schizophrenia | Phase 3 | Recruiting | Neurocrine Biosciences | 284 | 2025-08-11 | 2026-09-25 |
NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With Schizophrenia NBI-1117568 - Schizophrenia | Phase 3 | Recruiting | Neurocrine Biosciences | 600 | 2025-07-11 | 2026-09-25 |
NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD) NBI-1065845, Placebo - Major Depressive Disorder | Phase 3 | Recruiting | Neurocrine Biosciences | 200 | 2025-05-30 | 2026-08-10 |
NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia NBI-1117568, Placebo - Schizophrenia | Phase 3 | Recruiting | Neurocrine Biosciences | 284 | 2025-05-08 | 2026-03-06 |
Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD) NBI-1065845 - Major Depressive Disorder | Phase 3 | Recruiting | Neurocrine Biosciences | 850 | 2025-04-16 | 2026-07-24 |
NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD) NBI-1065845, Placebo - Major Depressive Disorder | Phase 3 | Recruiting | Neurocrine Biosciences | 200 | 2025-03-31 | 2026-08-11 |
Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD) NBI-1065845, Placebo - Major Depressive Disorder | Phase 3 | Recruiting | Neurocrine Biosciences | 200 | 2025-01-22 | 2025-10-29 |
Valbenazine Treatment of Tardive Dyskinesia in Adults With Intellectual/Developmental Disabilities Valbenazine Oral Capsule - Tardive Dyskinesia, Intellectual Disability | Phase 4 | Withdrawn | Stephen Ruedrich | | 2025-01-01 | 2024-10-24 |
Reduction of Demoralization in Patients With Tardive Dyskinesia After Treatment With Valbenazine Valbenazine - Tardive Dyskinesia | Phase 1 | Withdrawn | Yale University | | 2024-10-18 | 2025-07-11 |
Long-term Study to Evaluate Safety and Tolerability of Valbenazine in Participants With Chorea Associated With Huntington Disease in Canada Valbenazine - Chorea, Huntington | Phase 3 | Enrolling by invitation | Neurocrine Biosciences | 7 | 2024-04-24 | 2026-06-18 |
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Conditions studied
Schizophrenia (15) · Tardive Dyskinesia (15) · Depressive Disorder, Major (10) · Depression (8) · Tourette Syndrome (8) · Adrenal Hyperplasia, Congenital (7) · Parkinson Disease (6) · Epilepsy (5) · Movement Disorders (4) · Huntington Disease (3) · Bipolar Disorder (2) · Chorea (2) · Congenital adrenal hyperplasia due to 21 hydroxylase deficiency (2) · Neurodegenerative Diseases (2) · Psychotic Disorders (2)
Interventions
valbenazine (31) · crinecerfont (4) · TAK-041 (3) · interleukin-4-Pseudomonas exotoxin (2) · opicapone (2) · Amphetamine (1) · Ketamine (1) · Ketoconazole (1) · NBI 5788 (1) · NBI 77860 (1) · NBI6024 (1) · Sertraline (1) · Surgical Procedures, Operative (1) · carbidopa, levodopa drug combination (1) · elagolix (1)
Countries
United States (74) · Puerto Rico (14) · Canada (13) · United Kingdom (13) · Spain (12) · Bulgaria (11) · Czechia (8) · Italy (8) · Belgium (7) · Poland (7) · Serbia (7) · France (5) · Hungary (5) · Romania (5) · Germany (4)
Top investigators
Chris O'Brien, MD (8) · Henry Pan, MD, PhD (2) · Steve Hersch, MD (2) · Areti Philotheou, MD (1) · Christopher O'Brien, MD (1) · Christy Foster, MD (1) · Gary K. Zammit, PhD (1) · John De Figueiredo, MD (1) · Jon E Grant, MD, JD, MPH (1) · Kristof Chwalisz, MD, PhD, MD (1) · Michael H. Bloch, MD (1)
Results publications
PMID 31617235, PMID 28404690, PMID 40265997, PMID 19690081, PMID 28320223, PMID 29141124, PMID 29476499, PMID 30695293, PMID 30802998, PMID 31127735, PMID 31650182, PMID 32250312, PMID 32419679, PMID 34649873, PMID 35277995, PMID 36153330, PMID 37210099, PMID 37216921, PMID 38828945, PMID 38828955, PMID 38943928, PMID 40817174, PMID 42032293
NIH funding
2025 (5), 2015 (3), 2017 (3), 2023 (2), 2016 (1), 2018 (1), 2019 (1)