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Neurocrine (NBIX) Drug Pipeline

Drug pipeline
Drug NameConditionStageStatusStudy NameTrial Start DateArticle
Nbi-1065890Tardive DyskinesiaPhase IIRecruitingEfficacy, Safety, and Tolerability of NBI-1065890 Versus Placebo in Adults With Tardive DyskinesiaJan 22, 2026―
Nbi-1117570SchizophreniaPhase IINot Yet RecruitingEvaluation of NBI-1117570 in Inpatient Adults With SchizophreniaDec 15, 2025
Nbi-1117568Bipolar I Disorder, ManiaPhase IINot Yet RecruitingAn Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current ManiaDec 15, 2025
Nbi-1117568SchizophreniaPhase IIIRecruitingEfficacy of NBI-1117568 in Preventing Relapse in Adults With SchizophreniaNov 11, 2025
Nbi-1065845Major Depressive DisorderPhase IIIRecruitingA Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)Sep 19, 2025
CrinecerfontCongenital Adrenal HyperplasiaPhase IIRecruitingPharmacokinetics, Safety and Tolerability of Crinecerfont in Participants With Congenital Adrenal Hyperplasia Who Are Less Than 2 Years OldSep 18, 2025
Nbi-1117568SchizophreniaPhase IIIRecruitingNBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With SchizophreniaJul 29, 2025―
ValbenazineMajor Depressive Disorder, Schizophrenia, Bipolar Disorder, Tardive Dyskinesia, Schizoaffective DisorderPhase IVRecruitingA 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) InhibitorJul 29, 2025―
Nbi-1117568SchizophreniaPhase IIIRecruitingNBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With SchizophreniaJul 29, 2025―
Nbi-1065845Major Depressive DisorderPhase IIIRecruitingNBI-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―

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
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 Biosciences (NBIX) have in its pipeline
Neurocrine NBIX is currently developing the following drugs: Nbi-1065890, Nbi-1117570, Nbi-1117568, Nbi-1065845, Crinecerfont, Valbenazine, Nbi-1070770, Nbi-921352, Nbi-827104, Luvadaxistat, Nbi-1065846, Tak-831 Oral Tablet, [14C]Tak-831 Iv Infusion, [14C]Tak-831 Oral Suspension, Tak-653, Ketamine, Nbi-98854, Tak-831 T2, Tak-831 T3. These drug candidates are in various stages of clinical development as the company works toward FDA approval.