Congenital Adrenal Hyperplasia
Neurocrine Biosciences completed a Phase II study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of crinecerfont in adult patients with classic congenital adrenal hyperplasia (CAH). The final results from this open-label, multiple-dose, dose-escalation study were reported in June 2020. Neurocrine Biosciences is now enrolling patients in a single, global registrational study of crinecerfont in adult patients with classic CAH. For more information about this Phase III study of crinecerfont, please visit https://www.cahtalyststudy.com/ or clinicaltrials.gov.
Neurocrine Biosciences is conducting a Phase II, open-label, multiple-dose, dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of crinecerfont in pediatric patients (14 to 17 years of age) with classic 21-hydroxylase deficiency CAH. For more information on this Phase II study of crinecerfont in pediatric patients with CAH, please visit CAHlibratePediatricStudy.com or clinicaltrials.gov.
NBIb-1817 (VY-AADC) is currently being evaluated in the Phase II RESTORE-1 trial in patients who have been diagnosed with Parkinson’s disease for at least four years, are not responding adequately to oral medications, and have at least three hours of OFF time during the day, as measured by a validated self-reported patient diary. For more information about the RESTORE-1 clinical trial, please visit restore1study.com.
NBIb-1817 is being developed by Neurocrine Biosciences and Voyager Therapeutics as part of a strategic collaboration announced in January 2019.
Chorea Associated with Huntington Disease
Neurocrine Biosciences is conducting KINECT-HD, a multi-center randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy, safety and tolerability of valbenazine for the treatment of chorea in patients with Huntington disease (HD). HD is a hereditary progressive neurodegenerative disorder, in which many patients may experience chorea, a troublesome involuntary movement disorder. For more information on this Phase III study of valbenazine for the treatment of chorea associated with HD, please visit huntingtonstudygroup.org or clinicaltrials.gov.
NBI-1065844 (TAK-831) is currently being evaluated in a Phase II INTERACT multi-center, randomized, double-blind, placebo-controlled, parallel study to evaluate efficacy, safety, tolerability, and pharmacokinetics of three dose levels as an adjunctive treatment of adult patients with negative symptoms of schizophrenia. For more information on this Phase II study of NBI-1065844, please visit clinicaltrials.gov.
Policy on expanded access to investigational medicines
Individuals interested in participating in clinical trials for Neurocrine Biosciences’ products may visit the “Pipeline” section of the website for information on ongoing clinical trials. At this time, Neurocrine Biosciences does not have an expanded access program that allows patients to have access to the Company’s investigational products prior to FDA approval. Neurocrine Biosciences will update this page as the Company grows and reassesses the approach to expanded access programs. If you have any questions, please contact email@example.com.