Clinical Studies

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.

Neurology

Program	Therapeutic focus	Type	Status	See details
KINECT^®-HD2	Chorea in HD	Phase 3; Open-Label	Active; not recruiting	ClinicalTrials.gov Study Website
A Phase 3, open-label study of valbenazine^* is ongoing to evaluate its long-term safety and tolerability, as well as the maintenance of effects in patients with chorea associated with Huntington's disease.
NBI-98854-DCP3018	DCP	Phase 3	Enrolling	ClinicalTrials.gov Study Website
Valbenazine^* is an investigational, selective vesicular monoamine transporter 2 (VMAT2) inhibitor which is in development for the potential treatment of dyskinetic cerebral palsy (DCP), a form of CP where patients experience involuntary and hard to control movements. A Phase 3, randomized, double-blind, placebo-controlled study is ongoing to assess the efficacy, safety, and tolerability of valbenazine in patients with DCP.
NBI-1076986	Movement Disorders	Phase 1	Enrolling
A Phase 1 study is underway of NBI-1076986, an investigational, oral, muscarinic M4-selective acetylcholine antagonist, for the potential treatment of certain movement disorders.
NBI-921355	Epilepsy	Phase 1	Enrolling
A Phase 1 study is underway of NBI-921355, an investigational, selective inhibitor of voltage-gated sodium channels Na_v1.2 and Na_v1.6 in development for the potential treatment of certain types of epilepsy.

Neurology

Program
KINECT^®-HD2
Therapeutic focus	Chorea in HD
Type	Phase 3; Open-Label
Status	Active; not recruiting

A Phase 3, open-label study of valbenazine^* is ongoing to evaluate its long-term safety and tolerability, as well as the maintenance of effects in patients with chorea associated with Huntington's disease.

ClinicalTrials.gov Study Website

Program
NBI-98854-DCP3018
Therapeutic focus	DCP
Type	Phase 3
Status	Enrolling

Valbenazine^* is an investigational, selective vesicular monoamine transporter 2 (VMAT2) inhibitor which is in development for the potential treatment of dyskinetic cerebral palsy (DCP), a form of CP where patients experience involuntary and hard to control movements. A Phase 3, randomized, double-blind, placebo-controlled study is ongoing to assess the efficacy, safety, and tolerability of valbenazine in patients with DCP.

ClinicalTrials.gov Study Website

Program
NBI-1076986
Therapeutic focus	Movement Disorders
Type	Phase 1
Status	Enrolling

A Phase 1 study is underway of NBI-1076986, an investigational, oral, muscarinic M4-selective acetylcholine antagonist, for the potential treatment of certain movement disorders.

Program
NBI-921355
Therapeutic focus	Epilepsy
Type	Phase 1
Status	Enrolling

A Phase 1 study is underway of NBI-921355, an investigational, selective inhibitor of voltage-gated sodium channels Na_v1.2 and Na_v1.6 in development for the potential treatment of certain types of epilepsy.

Neuroendocrinology

Program	Therapeutic focus	Type	Status	See details
CAHtalyst^™  Pediatric Study	CAH in children & adolescents	Phase 3; Open-Label	Active; not recruiting	ClinicalTrials.gov
A global, Phase 3 open-label study is ongoing to evaluate the long-term safety and tolerability of crinecerfont in children and adolescents (2 to 17 years old) with CAH due to 21-OHD.
CAHtalyst^™Adult Study	CAH in adults	Phase 3; Open-Label	Active; not recruiting	ClinicalTrials.gov
A global, Phase 3 open-label study is ongoing to evaluate the long-term safety and tolerability of crinecerfont in adults (18 years and older) with CAH due to 21-OHD.

Neuroendocrinology

Program
CAHtalyst^™  Pediatric Study
Therapeutic focus	CAH in children & adolescents
Type	Phase 3; Open-Label
Status	Active; not recruiting

A global, Phase 3 open-label study is ongoing to evaluate the long-term safety and tolerability of crinecerfont in children and adolescents (2 to 17 years old) with CAH due to 21-OHD.

ClinicalTrials.gov

Program
CAHtalyst^™Adult Study
Therapeutic focus	CAH in adults
Type	Phase 3; Open-Label
Status	Active; not recruiting

A global, Phase 3 open-label study is ongoing to evaluate the long-term safety and tolerability of crinecerfont in adults (18 years and older) with CAH due to 21-OHD.

ClinicalTrials.gov

Neuropsychiatry

Program	Therapeutic focus	Type	Status	See details
Journey^™ Study	Schizophrenia	Phase 3	Enrolling	ClinicalTrials.gov
A Phase 3 randomized, double-blind, placebo-controlled study is underway of valbenazine, an investigative selective vesicular monoamine transporter 2 (VMAT2) inhibitor, to evaluate its efficacy, safety, and tolerability as an add-on treatment for schizophrenia.
Phase 3 Registrational Study	MDD	Phase 3	Initiating	ClinicalTrials.gov
Osavampator/NBI-‘845 is a potential first-in-class, investigational alpha-amino-3-hydroxy-5-menthyl-4-isoxazole propionic acid (AMPA) potentiator studied in patients with inadequate response to treatment in major depressive disorder (MDD). Positive results of a Phase 2 dose-finding clinical study were announced in April 2024.
Phase 3 Registrational Study	Schizophrenia	Phase 3	Initiating
NBI-1117568 is an investigational, oral, muscarinic M4-selective agonist that employs a novel mechanism for the potential treatment of schizophrenia. Positive results of a Phase 2 dose-finding clinical study were announced in August 2024.
NBI-1070770	MDD	Phase 2	Enrolling
NBI-1070770, is an investigational, oral, negative allosteric modulator (NAM) of the NR2B subunit-containing N-methyl-D-aspartate receptor (NR2B-NMDAR). A Phase 2 study is underway of NBI-1070770 for the potential treatment of major depressive disorder (MDD).
NBI-1117570	Symptoms of psychosis and cognition	Phase 1	Enrolling
A Phase 1 study of NBI-1117570, an investigational, oral, muscarinic M1/M4 agonist, is underway for the potential treatment of symptoms of psychosis and cognition in neurological and neuropsychiatric conditions.
NBI-1117569	Neurological and neuropsychiatric conditions	Phase 1	Enrolling
A Phase 1 study of NBI-1117569, an investigational, oral, muscarinic M1/M4 (M4 preferring) acetylcholine agonist, is underway for the potential treatment of certain neurological and neuropsychiatric conditions.
NBI-1065890	Neurological and neuropsychiatric conditions	Phase 1	Enrolling
A Phase 1 study of NBI-1065890, an investigational, oral, selective inhibitor of vesicular monoamine transporter-2 (VMAT2), is underway for the potential treatment of certain neurological and neuropsychiatric conditions.
NBI-1117567	Neurological and neuropsychiatric conditions	Phase 1	Enrolling
A Phase 1 study of NBI-1117567, an investigational, oral, muscarinic M1/M4 (M1 preferring) acetylcholine agonist, is underway for the potential treatment of certain neurological and neuropsychiatric conditions.
NBI-1140675	Neurological and neuropsychiatric conditions	Phase 1	Enrolling
A Phase 1 study of NBI-1140675, an investigational, oral, selective second-generation inhibitor of the vesicular monoamine transporter-2 (VMAT2) in development for the potential treatment of certain neurological and neuropsychiatric conditions.

Neuropsychiatry

Program
Journey^™ Study
Therapeutic focus	Schizophrenia
Type	Phase 3
Status	Enrolling

A Phase 3 randomized, double-blind, placebo-controlled study is underway of valbenazine, an investigative selective vesicular monoamine transporter 2 (VMAT2) inhibitor, to evaluate its efficacy, safety, and tolerability as an add-on treatment for schizophrenia.

ClinicalTrials.gov

Program
Phase 3 Registrational Study
Therapeutic focus	MDD
Type	Phase 3
Status	Initiating

Osavampator/NBI-‘845 is a potential first-in-class, investigational alpha-amino-3-hydroxy-5-menthyl-4-isoxazole propionic acid (AMPA) potentiator studied in patients with inadequate response to treatment in major depressive disorder (MDD). Positive results of a Phase 2 dose-finding clinical study were announced in April 2024.

ClinicalTrials.gov

Program
Phase 3 Registrational Study
Therapeutic focus	Schizophrenia
Type	Phase 3
Status	Initiating

NBI-1117568 is an investigational, oral, muscarinic M4-selective agonist that employs a novel mechanism for the potential treatment of schizophrenia. Positive results of a Phase 2 dose-finding clinical study were announced in August 2024.

Program
NBI-1070770
Therapeutic focus	MDD
Type	Phase 2
Status	Enrolling

NBI-1070770, is an investigational, oral, negative allosteric modulator (NAM) of the NR2B subunit-containing N-methyl-D-aspartate receptor (NR2B-NMDAR). A Phase 2 study is underway of NBI-1070770 for the potential treatment of major depressive disorder (MDD).

Program
NBI-1117570
Therapeutic focus	Symptoms of psychosis and cognition
Type	Phase 1
Status	Enrolling

A Phase 1 study of NBI-1117570, an investigational, oral, muscarinic M1/M4 agonist, is underway for the potential treatment of symptoms of psychosis and cognition in neurological and neuropsychiatric conditions.

Program
NBI-1117569
Therapeutic focus	Neurological and neuropsychiatric conditions
Type	Phase 1
Status	Enrolling

A Phase 1 study of NBI-1117569, an investigational, oral, muscarinic M1/M4 (M4 preferring) acetylcholine agonist, is underway for the potential treatment of certain neurological and neuropsychiatric conditions.

Program
NBI-1065890
Therapeutic focus	Neurological and neuropsychiatric conditions
Type	Phase 1
Status	Enrolling

A Phase 1 study of NBI-1065890, an investigational, oral, selective inhibitor of vesicular monoamine transporter-2 (VMAT2), is underway for the potential treatment of certain neurological and neuropsychiatric conditions.

Program
NBI-1117567
Therapeutic focus	Neurological and neuropsychiatric conditions
Type	Phase 1
Status	Enrolling

A Phase 1 study of NBI-1117567, an investigational, oral, muscarinic M1/M4 (M1 preferring) acetylcholine agonist, is underway for the potential treatment of certain neurological and neuropsychiatric conditions.

Program
NBI-1140675
Therapeutic focus	Neurological and neuropsychiatric conditions
Type	Phase 1
Status	Enrolling

A Phase 1 study of NBI-1140675, an investigational, oral, selective second-generation inhibitor of the vesicular monoamine transporter-2 (VMAT2) in development for the potential treatment of certain neurological and neuropsychiatric conditions.

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

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