Galectin Therapeutics, Inc. announced that it submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) on January 30, 2013. The IND application supports a proposed indication of GR-MD-02 for treatment of non-alcoholic steatohepatitis (NASH) with advanced fibrosis, or fatty liver disease. The IND application includes twenty seven (27) individual studies that characterize the pharmacology, pharmacokinetics, and toxicology of GR-MD-02 in a number of animal species, including the effects in various animal models of disease.

Additionally, the application describes the manufacture of the drug substance and drug product to be used in human clinical trials.