Clinical
Studies

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

 
Female doctor talking to male patient

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

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 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).

Therapeutic Focus

Classic CAH in adults

Type

Phase 3

Status

Active; not recruiting

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).

Therapeutic Focus

Classic CAH in children & adolescents

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 schizoprenia.

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

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.

Therapeutic Focus

Schizophrenia

Type

Phase 2

Status

Enrolling

NBI-1070770

A Phase 1 study of investigational NBI-1070770 for the treatment of major depressive disorder.

Therapeutic Focus

MDD

Type

Phase 1

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

  Neurocrine Biosciences has global rights unless otherwise noted.
* Mitsubishi Tanabe Pharma Corporation has commercialization rights in Japan and other select Asian markets.