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
NBI-1076986	Movement Disorders	Phase 1
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
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.
NBI-1117567	Alzheimer's Cognition	Phase 1
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 psychiatric conditions.

Neurology Expand Collapse

Endocrinology

Program	Therapeutic focus	Type	See details
CAHtalyst™ Pediatric Study	CAH in children & adolescents	Phase 3; Open-Label	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	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.
NBI-74788-CAH2032	CAH	Phase 2; Open-Label	ClinicalTrials.gov
A Phase 2 open-label study is ongoing to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of crinecerfont in pediatric patients (3 months to less than 4 years of age) with congenital adrenal hyperplasia.
NBI-74788-CAH2011	CAH	Phase 2	ClinicalTrials.gov
A global, Phase 2 open-label study is ongoing to evaluate the pharmacokinetics, safety, and tolerability of crinecerfont in pediatric patients (0 to less than 2 years of age) with congenital adrenal hyperplasia.
NBIP-01435	CAH	Phase 1
A Phase 1 study is underway of NBIP-01435, an investigational long-acting corticotropin-releasing factor type 1 receptor antagonist in development for the potential treatment of CAH.
NBIP-02118	Obesity	Phase 1
A Phase 1 study of NBIP-02118, an investigational corticotropin-releasing factor type 2 receptor agonist in development for the potential treatment of obesity.
NBIP-01968	Obesity	Phase 1
A Phase 1 study of NBIP-01968, an investigational GLP-1/GIP/glucagon receptor triple agonist being developed as a therapy for obesity. NBIP-01968 is intended primarily for use in fixed-dose combination with NBIP-02118, the company’s investigational corticotropin-releasing factor type 2 receptor agonist.

Endocrinology Expand Collapse

Program

CAHtalyst™ Pediatric Study

Therapeutic focus

CAH in children & adolescents

Type

Phase 3; Open-Label

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

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

Program

NBI-74788-CAH2032

Therapeutic focus

CAH

Type

Phase 2; Open-Label

A Phase 2 open-label study is ongoing to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of crinecerfont in pediatric patients (3 months to less than 4 years of age) with congenital adrenal hyperplasia.

ClinicalTrials.gov

Program

NBI-74788-CAH2011

Therapeutic focus

CAH

Type

Phase 2

A global, Phase 2 open-label study is ongoing to evaluate the pharmacokinetics, safety, and tolerability of crinecerfont in pediatric patients (0 to less than 2 years of age) with congenital adrenal hyperplasia.

ClinicalTrials.gov

Program

NBIP-01435

Therapeutic focus

CAH

Type

Phase 1

A Phase 1 study is underway of NBIP-01435, an investigational long-acting corticotropin-releasing factor type 1 receptor antagonist in development for the potential treatment of CAH.

Program

NBIP-02118

Therapeutic focus

Obesity

Type

Phase 1

A Phase 1 study of NBIP-02118, an investigational corticotropin-releasing factor type 2 receptor agonist in development for the potential treatment of obesity.

Program

NBIP-01968

Therapeutic focus

Obesity

Type

Phase 1

A Phase 1 study of NBIP-01968, an investigational GLP-1/GIP/glucagon receptor triple agonist being developed as a therapy for obesity. NBIP-01968 is intended primarily for use in fixed-dose combination with NBIP-02118, the company’s investigational corticotropin-releasing factor type 2 receptor agonist.

Psychiatry

Program	Therapeutic focus	Type	See details
Phase 3 Registrational Study	MDD	Phase 3	ClinicalTrials.gov
Osavampator/NBI-'845 is a potential first-in-class, investigational alpha-amino-3-hydroxy-5-methyl-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	ClinicalTrials.gov
Direclidine/NBI-'568 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-1117570	Symptoms of psychosis and cognition	Phase 2	ClinicalTrials.gov
A Phase 2 study of NBI-1117570, an investigational, oral, muscarinic M1/M4 agonist, is underway for the potential treatment of schizophrenia.
NBI-1065890	Neurological and neuropsychiatric conditions	Phase 2	ClinicalTrials.gov
A Phase 2 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 psychiatric conditions.
NBI-1117568	Bipolar Mania	Phase 2	ClinicalTrials.gov
A Phase 2 study of NBI-1117568, an investigational, oral, muscarinic M4 selective agonist, is in development for the potential treatment of adults with bipolar disorder with current mania.
NBI-1140675	Neurological and neuropsychiatric conditions	Phase 1
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 psychiatric conditions.
NBI-1117569	Alzheimer's Psychosis	Phase 1
A Phase 1 study of NBI-1117569 is an investigational, oral, M1/M4 agonist, is underway for the potential treatment of Alzheimer's disease psychosis.

Psychiatry Expand Collapse

Program

Phase 3 Registrational Study

Therapeutic focus

MDD

Type

Phase 3

Osavampator/NBI-'845 is a potential first-in-class, investigational alpha-amino-3-hydroxy-5-methyl-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

Direclidine/NBI-'568 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.

ClinicalTrials.gov

Program

NBI-1117570

Therapeutic focus

Symptoms of psychosis and cognition

Type

Phase 2

A Phase 2 study of NBI-1117570, an investigational, oral, muscarinic M1/M4 agonist, is underway for the potential treatment of schizophrenia.

ClinicalTrials.gov

Program

NBI-1065890

Therapeutic focus

Neurological and neuropsychiatric conditions

Type

Phase 2

A Phase 2 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 psychiatric conditions.

ClinicalTrials.gov

Program

NBI-1117568

Therapeutic focus

Bipolar Mania

Type

Phase 2

A Phase 2 study of NBI-1117568, an investigational, oral, muscarinic M4 selective agonist, is in development for the potential treatment of adults with bipolar disorder with current mania.

ClinicalTrials.gov

Program

NBI-1140675

Therapeutic focus

Neurological and neuropsychiatric conditions

Type

Phase 1

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 psychiatric conditions.

Program

NBI-1117569

Therapeutic focus

Alzheimer's Psychosis

Type

Phase 1

A Phase 1 study of NBI-1117569 is an investigational, oral, M1/M4 agonist, is underway for the potential treatment of Alzheimer's disease psychosis.

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