NBI-1117570 / Nxera Pharma, Neurocrine Biosciences - LARVOL DELTA

Evaluation of NBI-1117570 in Inpatient Adults With Schizophrenia (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Neurocrine Biosciences | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Psychiatry • Schizophrenia

Nxera Pharma…announces that its partner Neurocrine Biosciences Inc. ('Neurocrine') has initiated and dosed the first patient(s) in a Phase 2 clinical study of NBI-1117570 ('NBI-’570') in adults with schizophrenia (GlobeNewswire) - "As a result, Nxera will receive milestone payments of US$22.5 million from Neurocrine pursuant to the agreement. The milestone payments will be recognised as revenue in Q1 FY2026....The Phase 2 study (NCT07288333) is a double-blind, placebo-controlled trial designed to evaluate the efficacy, safety and tolerability of NBI-‘570 in adult patients with schizophrenia requiring in-patient treatment. The study is expected to enroll approximately 120 patients."

Financing • Trial status • CNS Disorders • Schizophrenia

Nxera Pharma Operational Highlights and Consolidated Results for the First Quarter 2025 (GlobeNewswire) - "Neurocrine Biosciences, Inc. outlined clinical development plans for the partnered muscarinic agonist portfolio in 2025, including Initiation of Phase 3 registrational studies with NBI-1117568 (an oral, muscarinic M4-selective agonist) in schizophrenia in 1H 2025; Initiation of a Phase 2 study with NBI-1117568 in bipolar mania in 2H 2025; Initiation of a Phase 2 study with NBI-1117570 (a dual M1 / M4 agonist) in schizophrenia in 2H 2025; Data readouts for NBI-1117570, NBI-1117567 (M1-preferring), and NBI-1117569 (M4-preferring) expected in 2025, all of which are being advanced in Phase 1 trials targeting neurological and neuropsychiatric conditions."

Clinical data • New P2 trial • New P3 trial • CNS Disorders • Schizophrenia

Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating Effects of NBI-1117570 in Healthy Adults (PRNewswire) - "Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today announced the initiation of its Phase 1 first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound NBI-1117570 in healthy adult participants....'The selectivity profile of NBI-1117570 in targeting M1 and M4 receptors may provide an opportunity to treat symptoms of both psychosis and cognition across a broad range of neurological and neuropsychiatric conditions.'"

New P1 trial • CNS Disorders • Schizophrenia