ClozaBen (clozapine/sodium benzoate) / SyneuRx - LARVOL DELTA

An Adaptive Phase II/III, Two-Part, Double-Blind, Randomized, Placebo-controlled, Dose-Finding, Multi-center Study of the Safety and Efficacy of NaBen®, as an Add-on Therapy With Clozapine, for Residual Symptoms of Refractory Schizophrenia in Adults (clinicaltrials.gov) - P2/3; N=287; Recruiting; Sponsor: SyneuRx International (Taiwan) Corp; Trial completion date: Dec 2021 ➔ Dec 2026; Trial primary completion date: Jun 2021 ➔ Sep 2026

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Psychiatry • Schizophrenia

Xinyue Biomedicine’s two new schizophrenia drugs are approved by TFDA for Phase II/III clinical trials [Google translation] (udn.com) - "Xinyue (6575) announced today (10) that two new drugs under development-ClozaBen® (SND12), a new drug for treatment of refractory schizophrenia, and NaBen® (SND13), a new drug for adult schizophrenia, have been approved by Taiwan The Food and Drug Administration (T FDA ) of the Ministry of Health and Welfare approved the implementation of Phase 2(b)/Phase 3 human clinical trials....Xinyue predicts that the second interim analysis of SND13 can be conducted this year. If the results of the interim analysis do not require an increase in the number of cases, the clinical trials can be completed and blindedness can be resolved in 2022; SND12 is also expected to conduct an interim analysis in 2022."

Clinical data • New P2/3 trial • Trial completion date • CNS Disorders • Schizophrenia