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SVT-4A1011 is an investigational live biotherapeutic product (LBP) developed by Servatus Biopharmaceuticals for the treatment of insomnia and sleep disorders. It is composed of a consortium of specific live microbial strains that function as a microbiome modulator and bacteria replacement therapy. Unlike traditional sedative-hypnotics that target central nervous system receptors like GABA or orexin, SVT-4A1011 is designed to improve sleep outcomes by influencing the gut-brain axis. The product is administered orally and has been evaluated in a Phase I/II randomized, double-blind, placebo-controlled clinical trial to assess its safety, tolerability, and efficacy in adults with clinically diagnosed insomnia.
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