NEUROCRINE BIOSCIENCES INC (NBIX)
Neurocrine Biosciences, Inc. is a pharmaceutical firm dedicated to the creation, advancement, and commercialization of medicines addressing a spectrum of neurological, endocrine, and psychiatric conditions. Its current therapeutic pipeline and marketed products target disorders such as tardive dyskinesia, Parkinson's disease, endometriosis, and uterine fibroids, alongside numerous experimental compounds in various clinical stages. The company's primary commercial asset is INGREZZA, a VMAT2 inhibitor indicated for the management of tardive dyskinesia. Other available treatments include ONGENTYS, which serves as an auxiliary therapy for individuals with Parkinson's disease who are also receiving levodopa/DOPA decarboxylase inhibitors; ORILISSA, prescribed for the alleviation of moderate to severe pain linked with endometriosis in women; and ORIAHNN, an oral, non-surgical option for pre-menopausal women experiencing significant menstrual bleeding associated with uterine fibroids. Furthermore, Neurocrine is actively progressing a number of drug candidates through clinical development. These include NBI-921352 for treating pediatric patients and adult focal epilepsy; NBI-827104, designed to address rare pediatric epilepsy and essential tremor; NBI-1065845 for major depressive disorder; NBI-1065846 specifically for anhedonia within major depressive disorder; and NBI-118568 for the treatment of schizophrenia. The company also maintains strategic licensing and collaborative ventures with partners such as Heptares Therapeutics Limited, Takeda Pharmaceutical Company Limited, Idorsia Pharmaceuticals Ltd, Xenon Pharmaceuticals Inc., Voyager Therapeutics, Inc., BIAL Portela & Ca, S.A., Mitsubishi Tanabe Pharma Corporation, and AbbVie Inc. Neurocrine Biosciences, Inc. was founded in 1992 and operates from its headquarters in San Diego, California.
Sector: Biological Products, (No Diagnostic Substances)
Industry: Biotechnology
Neurocrine Biosciences, Inc.
Trials need funding. See this company's dilution risk and cash position.
- Phase 4Completed
The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine
Valbenazine, Placebo oral capsule
Tardive Dyskinesia (TD)
NCT03698331Enrollment89StartSep 2018Primary CompletionApr 2019CompletionApr 2019 - Phase 4Completed
Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia
Valbenazine, Placebo oral capsule
Tardive Dyskinesia (TD)
NCT03891862Enrollment135StartMar 2019Primary CompletionDec 2019CompletionJan 2020 - Phase 4Completed
Study of the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Participants With Tardive Dyskinesia
Valbenazine
Schizophrenia, Schizoaffective Disorder +3
NCT05859698Enrollment59StartMay 2023Primary CompletionDec 2024CompletionDec 2024 - Phase 4Recruiting
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
Valbenazine
Schizophrenia, Schizoaffective Disorder +3
NCT07105111Enrollment100StartAug 2025Primary CompletionJun 2028est.CompletionJun 2028est. - Phase 3Terminated
Study Of Indiplon/Placebo With Sertraline In Insomnia Co-Existing With Depression
Indiplon, Sertraline
Insomnia, Depression
NCT00232167Enrollment380StartNov 2005Primary Completion-CompletionApr 2006 - Phase 3Withdrawn
An Exploratory Study of NBI-34060 Capsules and Next Day Functioning
NBI-34060
Insomnia
NCT00525941Enrollment0StartSep 2007Primary CompletionJan 2008CompletionJan 2008 - Phase 3Completed
A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia
NBI-98854, Placebo
Tardive Dyskinesia
NCT02274558Enrollment234StartOct 2014Primary CompletionSep 2015CompletionJul 2016 - Phase 3Completed
Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia
NBI-98854
Tardive Dyskinesia
NCT02405091Enrollment167StartMar 2015Primary CompletionMar 2017CompletionMar 2017 - Phase 3Completed
Comparison of Chronocort® With Standard Glucocorticoid Therapy in Patients With Congenital Adrenal Hyperplasia
Chronocort®, standard glucocorticoid therapy
Congenital Adrenal Hyperplasia
NCT02716818Enrollment122StartFeb 2016Primary CompletionJul 2018CompletionJul 2018 - Phase 3Completed
Treatment of Adrenal Insufficiency in Children
Infacort®
Adrenal Insufficiency
NCT02720952Enrollment24StartMar 2015Primary CompletionJul 2016CompletionJul 2016 - Phase 3Completed
Extension Study for Patients Entered Into Study Infacort 003
Infacort®
Adrenal Insufficiency
NCT02733367Enrollment18StartMar 2016Primary CompletionAug 2018CompletionAug 2018 - Phase 3Completed
Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia
Valbenazine
Tardive Dyskinesia
NCT02736955Enrollment161StartJun 2016Primary CompletionJun 2017CompletionJun 2017 - Phase 3Completed
A Study of the Efficacy, Safety and Tolerability of Chronocort in Treating CAH
Hydrocortisone
Congenital Adrenal Hyperplasia
NCT03062280Enrollment91StartAug 2016Primary CompletionJul 2022CompletionJul 2022 - Phase 3Withdrawn
Open-label Comparison of Chronocort® Versus Standard Glucocorticoid Replacement Therapy
Chronocort®, Standard Care
Congenital Adrenal Hyperplasia
NCT03532022Enrollment0StartOct 2018Primary CompletionOct 2018CompletionJul 2021 - Phase 3Completed
Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease
Valbenazine, Placebo
Chorea, Huntington
NCT04102579Enrollment128StartNov 2019Primary CompletionOct 2021CompletionOct 2021 - Phase 3Completed
Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington Disease
Valbenazine
Chorea, Huntington
NCT04400331Enrollment154StartSep 2020Primary CompletionNov 2025CompletionNov 2025 - Phase 3Active, not recruiting
Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia
Crinecerfont, Placebo
Congenital Adrenal Hyperplasia
NCT04490915Enrollment182StartDec 2020Primary CompletionJul 2023CompletionAug 2027est. - Phase 3Active, not recruiting
Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)
Crinecerfont, Placebo
Congenital Adrenal Hyperplasia
NCT04806451Enrollment103StartJun 2021Primary CompletionMar 2023CompletionAug 2027est. - Phase 3Completed
Comparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia
Chronocort, Cortef
Congenital Adrenal Hyperplasia
NCT05063994Enrollment55StartMay 2022Primary CompletionFeb 2024CompletionFeb 2024 - Phase 3Completed
Journey Study: Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment for Schizophrenia
Placebo, Valbenazine
Schizophrenia
NCT05110157Enrollment442StartNov 2021Primary CompletionFeb 2025CompletionFeb 2025 - Phase 3Completed
Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy
Placebo, Valbenazine
Dyskinesia, Cerebral Palsy
NCT05206513Enrollment86StartApr 2022Primary CompletionOct 2025CompletionMar 2026 - Phase 3Terminated
Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for Schizophrenia
Valbenazine, Placebo
Schizophrenia
NCT05654870Enrollment8StartJan 2023Primary CompletionNov 2023CompletionNov 2023 - Phase 3Enrolling by invitation
Long-term Study to Evaluate Safety and Tolerability of Valbenazine in Participants With Chorea Associated With Huntington Disease in Canada
Valbenazine
Chorea, Huntington
NCT06312189Enrollment7StartApr 2024Primary CompletionApr 2028est.CompletionApr 2028est. - Phase 3Recruiting
Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
NBI-1065845, Placebo
Major Depressive Disorder
NCT06786624Enrollment200StartJan 2025Primary CompletionJul 2027est.CompletionJul 2027est. - Phase 3Recruiting
NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
NBI-1065845, Placebo
Major Depressive Disorder
NCT06911112Enrollment200StartMar 2025Primary CompletionJul 2027est.CompletionJul 2027est.
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 4 | Completed | Valbenazine, Placebo oral capsule | NCT03698331 |
| Phase 4 | Completed | Valbenazine, Placebo oral capsule | NCT03891862 |
| Phase 4 | Completed | Valbenazine | NCT05859698 |
| Phase 4 | Recruiting | Valbenazine | NCT07105111 |
| Phase 3 | Terminated | Indiplon, Sertraline | NCT00232167 |
| Phase 3 | Withdrawn | NBI-34060 | NCT00525941 |
| Phase 3 | Completed | NBI-98854, Placebo | NCT02274558 |
| Phase 3 | Completed | NBI-98854 | NCT02405091 |
| Phase 3 | Completed | Chronocort®, standard glucocorticoid therapy | NCT02716818 |
| Phase 3 | Completed | Infacort® | NCT02720952 |
| Phase 3 | Completed | Infacort® | NCT02733367 |
| Phase 3 | Completed | Valbenazine | NCT02736955 |
| Phase 3 | Completed | Hydrocortisone | NCT03062280 |
| Phase 3 | Withdrawn | Chronocort®, Standard Care | NCT03532022 |
| Phase 3 | Completed | Valbenazine, Placebo | NCT04102579 |
| Phase 3 | Completed | Valbenazine | NCT04400331 |
| Phase 3 | Active, not recruiting | Crinecerfont, Placebo | NCT04490915 |
| Phase 3 | Active, not recruiting | Crinecerfont, Placebo | NCT04806451 |
| Phase 3 | Completed | Chronocort, Cortef | NCT05063994 |
| Phase 3 | Completed | Placebo, Valbenazine | NCT05110157 |
| Phase 3 | Completed | Placebo, Valbenazine | NCT05206513 |
| Phase 3 | Terminated | Valbenazine, Placebo | NCT05654870 |
| Phase 3 | Enrolling by invitation | Valbenazine | NCT06312189 |
| Phase 3 | Recruiting | NBI-1065845, Placebo | NCT06786624 |
| Phase 3 | Recruiting | NBI-1065845, Placebo | NCT06911112 |
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