Clinical Studies

We are conducting a number of clinical studies in several therapeutic areas.

 
clinical-studies-desktop (1)



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).

Therapeutic Focus

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).

Therapeutic Focus

DCP

Type

Phase 3

Status

Enrolling

NBI-1076986

A Phase 1 study of investigational NBI-1076986 for the potential treatment of movement disorders.

Therapeutic Focus

Movement Disorders

Type

Phase 1

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).

Therapeutic Focus

EE-CSWS

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).

Therapeutic Focus

SCN8A-DEE

Type

Phase 2

Status

Enrolling

Congenital Adrenal Hyperplasia

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 congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency (21-OHD).

Therapeutic Focus

CAH in children & adolescents

Type

Phase 3

Status

Active; not recruiting

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 congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency (21-OHD).

Therapeutic Focus

CAH in adults

Type

Phase 3

Status

Active; not recruiting

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 schizophrenia.

Therapeutic Focus

Schizophrenia

Type

Phase 3

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).

Therapeutic Focus

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).

Therapeutic Focus

CIAS

Type

Phase 2

Status

Active; not recruiting

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.

Therapeutic Focus

Schizophrenia

Type

Phase 2

Status

Enrolling

NBI-1070770

A Phase 2 study of investigational NBI-1070770 for the treatment of major depressive disorder.

Therapeutic Focus

MDD

Type

Phase 2

Status

Enrolling

NBI-1117570

A Phase 1 study of investigational NBI-1117570 for the treatment of symptoms of psychosis and cognition in neurological and neuropsychiatric conditions.

Therapeutic Focus

Symptoms of psychosis and cognition

Type

Phase 1

Status

Enrolling

NBI-1117569

A Phase 1 study of investigational NBI-1117569 for the potential treatment of certain neurological and neuropsychiatric conditions.

Therapeutic Focus

Neurological and neuropsychiatric conditions

Type

Phase 1

Status

Enrolling

NBI-1065890

A Phase 1 study of investigational NBI-1065890 for the potential treatment of certain neurological and neuropsychiatric conditions.

Therapeutic Focus

Neurological and neuropsychiatric conditions

Type

Phase 1

Status

Enrolling

NBI-1117567

A Phase 1 study of investigational NBI-1117567 for the potential treatment of certain neurological and neuropsychiatric conditions.

Therapeutic Focus

Neurological and neuropsychiatric conditions

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.