NaBen (sodium benzoate) / SyneuRx - LARVOL DELTA

Study to Evaluate Safety & Efficacy of NaBen® as Add-on Treatment for Schizophrenia in Adults (clinicaltrials.gov) - P2/3 | N=280 | Terminated | Sponsor: SyneuRx International (Taiwan) Corp | Phase classification: P2b/3 ➔ P2/3 | Trial completion date: Dec 2024 ➔ Nov 2023 | Recruiting ➔ Terminated | Trial primary completion date: Sep 2024 ➔ Nov 2023; due to commercial strategy

Phase classification • Trial completion date • Trial primary completion date • Trial termination • CNS Disorders • Psychiatry • Schizophrenia

Adaptive Phase II Study to Evaluate the Safety & Efficacy of NaBen® (clinicaltrials.gov) - P2/3 | N=60 | Terminated | Sponsor: SyneuRx International (Taiwan) Corp | N=126 ➔ 60 | Recruiting ➔ Terminated | Trial primary completion date: Jun 2023 ➔ Oct 2023

Enrollment change • Trial primary completion date • Trial termination • CNS Disorders • Psychiatry • Schizophrenia

A Quest for Treatment Discovery in Children and Adolescents With Schizophrenia: Investigational Drugs in Pipeline (AACAP 2023) - "Among the ongoing active phase 2 and phase 3 clinical trials, a descriptive review of trials on NaBen (n = 1), N-methyl-D-aspartate-receptor encephalitis (NMDAE, n = 1), SEP-363856 (n = 2), ALKS 3831 (n = 1), cannabidiol oral solution (n = 1), intravenous immunoglobulin (n = 1), and sulforaphane (n = 1) will be presented. Conclusions New drug development in schizophrenia is on the horizon. The clinicians are excited and optimistic with the treatment advances, and this presentation will make them familiar with the molecules in development."

Clinical • CNS Disorders • Pediatrics • Psychiatry • Schizophrenia

Clinical Perspectives 51 : Novel Treatments on the Horizon: A Glimpse Into the Newer Pharmacological Treatments Under Investigation for the Treatment of Schizophrenia in Pediatric Patients (AACAP 2023) - "Tapan Parikh, MD, will discuss the ongoing phase 2 and phase 3 investigational trials in adolescents with schizophrenia on NaBen, SEP-363856, ALKS 3831, cannabidiol, sulforaphane, intravenous immunoglobulin, and N-methyl-D-aspartate enhancer. Ritvij Satodiya, MD, will present on phase 2 and phase 3 clinical trials on brexpiprazole, cariprazine, olanzapine/samidorphan, levetiracetam, valbenazine, and clozapine for treatment of schizophrenia in adolescents. Conclusions Current treatment for schizophrenia in adolescents is limited and demands a vital need for newer pharmacological agents. This presentation will review the cutting-edge evidence on novel investigational agents and offer insight into the upcoming psychopharmacological evidence for treatment of schizophrenia in pediatric population."

Clinical • CNS Disorders • Pediatrics • Psychiatry • Schizophrenia

Lithium Benzoate Exerts Neuroprotective Effect by Improving Mitochondrial Function, Attenuating Reactive Oxygen Species, and Protecting Cognition and Memory in an Animal Model of Alzheimer's Disease. (PubMed, J Alzheimers Dis Rep) - "Furthermore, chronic administration of LiBen showed protection for cognition as well as spatial memory and reduced the senile plaque deposition in brains of AD animal models. LiBen stands as a promising therapeutic agent for improving cognition and delaying the progression of AD."

Journal • Preclinical • Alzheimer's Disease • CNS Disorders • Dementia • Immunology • Inflammation • Metabolic Disorders

Pharmacokinetics and Safety of Sodium Benzoate, a d-Amino Acid Oxidase (DAAO) Inhibitor, in Healthy Subjects: A Phase I, Open-Label Study. (PubMed, Clin Ther) - "The nonlinear pharmacokinetic response was observed within the dose range up to 2000 mg. Sodium benzoate treatment exhibited a favorable safety profile and was well tolerated at all dose levels. The study results serve as a foundation that should be useful for investigating efficacy and safety in the drug's subsequent clinical development."

Journal • PK/PD data • Alzheimer's Disease • CNS Disorders • Dementia • Psychiatry • Schizophrenia

Sodium Benzoate and/or N-Acetylcysteine Added to TAU in Patients With Early Schizophrenia Spectrum Disorder. (clinicaltrials.gov) - P2 | N=64 | Completed | Sponsor: Pakistan Institute of Living and Learning | Not yet recruiting ➔ Completed

Trial completion • CNS Disorders • Psychiatry • Schizophrenia • Schizophreniform Disorder

Study to Evaluate Safety & Efficacy of NaBen® as Add-on Treatment for Schizophrenia in Adults (clinicaltrials.gov) - P2b/3; N=348; Recruiting; Sponsor: SyneuRx International (Taiwan) Corp; Trial completion date: Dec 2021 ➔ Dec 2024; Trial primary completion date: Jun 2021 ➔ Sep 2024

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

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

Adaptive Phase II Study to Evaluate the Safety & Efficacy of NaBen® (clinicaltrials.gov) - P2/3; N=126; Recruiting; Sponsor: SyneuRx International (Taiwan) Corp; Trial completion date: Dec 2021 ➔ Dec 2023; Trial primary completion date: Jun 2021 ➔ Jun 2023

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

Study to Evaluate Safety & Efficacy of NaBen® as Add-on Treatment for Schizophrenia in Adults (clinicaltrials.gov) - P2b/3; N=348; Recruiting; Sponsor: SyneuRx International (Taiwan) Corp; Trial completion date: Jun 2019 ➔ Dec 2021; Trial primary completion date: Dec 2018 ➔ Jun 2021

Trial completion date • Trial primary completion date

Adaptive Phase II Study to Evaluate the Safety & Efficacy of NaBen® (clinicaltrials.gov) - P2/3; N=126; Recruiting; Sponsor: SyneuRx International (Taiwan) Corp; Trial completion date: Jun 2019 ➔ Dec 2021; Trial primary completion date: Dec 2018 ➔ Jun 2021

Trial completion date • Trial primary completion date

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 2019 ➔ Dec 2021; Trial primary completion date: Jun 2019 ➔ Jun 2021

Trial completion date • Trial primary completion date

Two-part Clinical Study to Evaluate the Safety and Benefits of NaBen® in Adolescents with Schizophrenia Dwuczęściowe badanie kliniczne oceniające bezpieczeństwo i skuteczność preparatu NaBen® w leczeniu schizofrenii u młodzieży. (clinicaltrialsregister.eu) - P2/3; N=126; Sponsor: SyneuRx International (Taiwan) Corp

Clinical • New P2/3 trial