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Neurocrine Biosciences Provides Update on Phase 2 Study of NBI-1070770 in Adults with Major Depressive Disorder
Prnewswire· 2025-11-10 21:05
Core Insights - Neurocrine Biosciences announced that its Phase 2 study of NBI-1070770 for major depressive disorder did not meet the primary endpoint compared to placebo, although the compound was generally well tolerated [1][3]. Study Details - The Phase 2 study enrolled 73 adult patients diagnosed with major depressive disorder who had inadequate response to at least one antidepressant [2]. - The study was designed as a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of three dosage strengths of NBI-1070770 over a four-week period [5]. - The primary objective was to assess the change in depression severity from baseline to Day 5 using the Montgomery-Åsberg Depression Rating Scale (MADRS) [5]. Company Background - Neurocrine Biosciences focuses on developing treatments for neurological, neuroendocrine, and neuropsychiatric disorders, with a diverse portfolio that includes FDA-approved treatments and a robust pipeline of compounds in clinical development [7]. - The company acquired the rights to develop NBI-1070770 from Takeda Pharmaceutical Company [4]. Context of Major Depressive Disorder - Major depressive disorder is a leading cause of disability, affecting over 21 million people in the U.S., with about half of patients not achieving sufficient relief from their first antidepressant [6].