Clinical
Studies
We are conducting a number of clinical studies in several therapeutic areas.
Clinical studies are an essential part of the development process to determine if an investigational treatment should be approved for use in the general population.
Movement Disorders
KINECT-HD2
A Phase 3, open-label study to evaluate the long-term safety and tolerability of valbenazine* for the potential treatment of chorea in patients with Huntington disease (HD).
Indication
Chorea in HD
Type
Phase 3
Status
Enrolling
NBI-98854-DCP3018
A Phase 3, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of valbenazine* in patients with dyskinetic cerebral palsy (DCP).
Indication
DCP
Type
Phase 3
Status
Enrolling
Epilepsy
STEAMBOAT™
A Phase 2, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, tolerability, and pharmacokinetics of investigational NBI-827104 in pediatric patients with epileptic encephalopathy with continuous spike-and-wave during sleep (EE-CSWS).
Indication
EE-CSWS
Type
Phase 2
Status
Enrolling
NBI-921352-FOS2021
A Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess the safety, efficacy, tolerability, and pharmacokinetics of investigational NBI-921352 as adjunctive therapy in adults living with focal onset seizures.
Indication
Focal onset seizures
Type
Phase 2
Status
Enrolling
KAYAK™
A Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of investigational NBI-921352 as an adjunctive therapy in children and young adults (2 to 21 years old) living with SCN8A developmental and epileptic encephalopathy (SCN8A-DEE).
Indication
SCN8A-DEE
Type
Phase 2
Status
Enrolling
Congenital Adrenal Hyperplasia
CAHtalyst™ Adult
A global, registrational, Phase 3, randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, and tolerability of investigational crinecerfont in adults (18 years and older) with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency (21-OHD).
Indication
Classic CAH in adults
Type
Phase 3
Status
Enrolling
CAHtalyst™ Pediatric
A global, registrational, Phase 3, randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, and tolerability of investigational crinecerfont in children and adolescents (2 to 17 years old) with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency (21-OHD).
Indication
Classic CAH in children & adolescents
Type
Phase 3
Status
Enrolling
Neuropsychiatric Disorders
Journey™ Study
A Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of valbenazine* as an add-on treatment for schizoprenia.
Indication
Schizophrenia
Type
Phase 3
Status
Enrolling
TERPSIS™
A Phase 2, randomized, double-blind, placebo-controlled, proof-of-concept study to evaluate the efficacy and safety of investigational NBI-1065846 in patients with anhedonia in major depressive disorder (MDD).
Indication
Anhedonia
Type
Phase 2
Status
Enrolling
SAVITRI™
A Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of investigational NBI-1065845 in patients with inadequate responses to treatment in major depressive disorder (MDD).
Indication
MDD
Type
Phase 2
Status
Enrolling
ERUDITE™
A Phase 2, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of investigational luvadaxistat for the potential treatment of cognitive symptoms of schizophrenia (CIAS).
Indication
CIAS
Type
Phase 2
Status
Enrolling
NBI-1117568
A Phase 2, multicenter, multi-stage inpatient study to assess the efficacy, safety, tolerability, and pharmacokinetics of investigational NBI-1117568 in adults with schizophrenia.
Indication
Schizophrenia
Type
Phase 2
Status
Enrolling
NBI-1070770
A Phase 1 study of investigational NBI-1070770 for the treatment of major depressive disorder.
Indication
MDD
Type
Phase 1
Status
Enrolling
| Neurocrine Biosciences has global rights unless otherwise noted. | |
| * | Mitsubishi Tanabe Pharma Corporation has commercialization rights in Japan and other select Asian markets. |
Pipeline
