NBI-1070770 / Neurocrine Biosciences, Takeda - LARVOL DELTA

Next-Generation Pharmacotherapies for Unipolar Mood Disorders: A Leading Article on Phase II/III Drug Development Across Diverse Mechanisms. (PubMed, CNS Drugs) - "Following the US Food and Drug Administration (FDA) approval of esketamine and brexanolone in 2019, industry investment in therapeutics with novel mechanisms for mood and anxiety disorders has expanded, catalyzing a new wave of innovative interventions...The drug names discussed are ALTO-100, ALTO-203, ALTO-207, ALTO-300, BHV-7000, BI-1569912, BPL-003, COMP360, DT120, ELE-101, GATE-251, GH001, GM-1020, GM-2505, HLP003, MK-1942, NBI-1065845, NBI-1070770, NV-5138, PIPE-307, SEP-363856, SPT-300, VLS-01, and XEN1101. The US Clinical Trials registry (clinicaltrials.gov), MEDLINE, conference proceedings, and company communications such as press releases were consulted to obtain up-to-date trial information and reported outcomes. Overall, the therapeutic landscape shows an expanding range of clinical compounds under active development; nonetheless, persistent challenges remain, including approaches to therapeutics where functional unblinding may occur, the ways in which to..."

Journal • P2/3 data • Review • CNS Disorders • Mood Disorders • Psychiatry

Neurocrine Biosciences Provides Update on Phase 2 Study of NBI-1070770 in Adults with Major Depressive Disorder (PRNewswire) - "Neurocrine Biosciences... announced that its Phase 2 study evaluating the efficacy, safety and tolerability of investigational compound NBI-1070770 in adults with major depressive disorder did not meet the primary endpoint compared to placebo. NBI-1070770 was generally well tolerated. This Phase 2 signal-seeking study enrolled 73 adult patients with a diagnosis of major depressive disorder with inadequate response to at least one antidepressant in their current episode of treatment."

P2 data • Major Depressive Disorder

A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder (clinicaltrials.gov) - P2 | N=73 | Completed | Sponsor: Neurocrine Biosciences | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder (clinicaltrials.gov) - P2 | N=73 | Active, not recruiting | Sponsor: Neurocrine Biosciences | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Neurocrine Biosciences Announces First-Patient Dosed in Phase 2 Clinical Study Evaluating NBI-1070770 in Adults with Major Depressive Disorder (PRNewswire) - "Neurocrine Biosciences...announced that the first patient has been randomized for its Phase 2 clinical study to evaluate the efficacy, safety, and tolerability of investigational compound NBI-1070770 in adults with major depressive disorder....The NBI-1070770 Phase 2 multi-center, randomized, double-blind, placebo-controlled study will enroll approximately 72 adults and is being conducted at centers throughout the United States. The study will evaluate the safety and efficacy of NBI-1070770 in subjects with major depressive disorder compared to placebo on improving symptoms of depression as measured by the Montgomery-Åsberg Depression Rating Scale."

Trial status • Major Depressive Disorder

A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder (clinicaltrials.gov) - P2 | N=72 | Recruiting | Sponsor: Neurocrine Biosciences | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder (clinicaltrials.gov) - P2 | N=72 | Not yet recruiting | Sponsor: Neurocrine Biosciences

New P2 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry