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Neurocrine (NBIX)
NASDAQ:NBIX
Nbi-1065845
Major Depressive Disorder
Phase III
Recruiting
A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Sep 19, 2025
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Crinecerfont
Congenital Adrenal Hyperplasia
Phase II
Not Yet Recruiting
Pharmacokinetics, Safety and Tolerability of Crinecerfont in Participants With Congenital Adrenal Hyperplasia Who Are Less Than 2 Years Old
Sep 18, 2025
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Nbi-1117568
Schizophrenia
Phase III
Recruiting
NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia
Jul 29, 2025
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Valbenazine
Major Depressive Disorder, Schizophrenia, Bipolar Disorder, Tardive Dyskinesia, Schizoaffective Disorder
Phase IV
Recruiting
A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
Jul 29, 2025
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Nbi-1117568
Schizophrenia
Phase III
Recruiting
NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With Schizophrenia
Jul 29, 2025
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Nbi-1065845
Major Depressive Disorder
Phase III
Recruiting
NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Apr 30, 2025
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Nbi-1065845
Major Depressive Disorder
Phase III
Recruiting
Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Apr 30, 2025
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Nbi-1117568
Schizophrenia
Phase III
Recruiting
NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia
Apr 30, 2025
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Nbi-1065845
Major Depressive Disorder
Phase III
Recruiting
NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Mar 28, 2025
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Nbi-1065845
Major Depressive Disorder
Phase III
Recruiting
Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Jan 15, 2025
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Neurocrine (NBIX) have in its pipeline
NBIX is currently developing the following drugs: Nbi-1065845, Crinecerfont, Nbi-1117568. These drug candidates are in various stages of clinical development as the company works toward FDA approval.